Tài liệu mô tả tóm tắt kỹ thuật trang thiết bị y tế

Tài liệu mô tả tóm tắt kỹ thuật trang thiết bị y tế

1253/20/RV Trang 1

Công ty TNHH Roche Việt Nam Tầng 27, Pearl Plaza, 561A Điện Biên Phủ, Quận Bình Thạnh, Thành Phố Hồ Chí Minh Ngày 06 tháng 10 năm 2020

TÀI LIỆU MÔ TẢ TÓM TẮT KỸ THUẬT TRANG THIẾT BỊ Y TẾ

Chủng loại sản phẩm: SI2 (05172179190)

STT Đề mục Nội dung mô tả tóm tắt

1 Mô tả sản phẩm trang thiết bị y tế

1.1 Mô tả trang thiết bị y tế

Tóm tắt

Các xét nghiệm y khoa có thể bị ảnh hưởng bởi các thành phần nội sinh và ngoại sinh có trong mẫu. Một số yếu tố có tiềm năng gây nhiễu này có thể nhận biết được trong giai đoạn tiền phân tích bởi sự hiện màu của mẫu, trong khi đó các yếu tố khác chỉ được phát hiện khi nhận được thông tin bổ sung và/hoặc các phương pháp phân tích trực tiếp. Sự nhiễu gây ra bởi lipid huyết (độ đục), tán huyết và vàng da (bilirubin) thường khó dự đoán vì chúng phụ thuộc rõ rệt vào phương pháp. Các giới hạn tại đó việc phân tích có thể thực hiện được mô tả trong mỗi phương pháp chịu sự nhiễu đó. Chỉ thị của châu Âu về chẩn đoán in vitro (IVDD) khẳng định nhà cung cấp thuốc thử phải định nghĩa các giới hạn thích hợp. Mỗi báo cáo trên kết quả thu được ở phòng thí nghiệm phải có một chú thích mô tả “cảm quan” của mẫu. Nếu phát hiện lipid huyết hoặc một màu sắc có liên quan, loại hình của kết quả được mô tả trong mỗi trường hợp, ví dụ “có lipid”, “tán huyết” hay “vàng da”. Có thể định lượng các yếu tố ảnh hưởng này với ứng dụng Serum Index Gen.2 (SI2) trên tất cả các hệ thống cobas c. Tất cả các máy phân tích có thể bán định lượng và báo cáo kết quả chỉ số lipid huyết (L), chỉ số tán huyết (H) và chỉ số vàng da (I).

Kết quả chỉ số huyết thanh rất hữu ích trong kiểm soát mức độ nhiễu tiềm tàng do lipid huyết (độ đục), tán huyết và vàng da (bilirubin).

Lipid huyết

Lipid huyết được định nghĩa là độ đục trong mẫu huyết thanh và huyết tương có thể thấy được bằng mắt thường. Nguyên nhân thường xuyên nhất của lipid huyết là sự tăng nồng độ triglyceride trong huyết tương và huyết thanh. Điều này có thể do chế độ ăn, rối loạn chuyển hóa lipoprotein hoặc tiêm tuyền lipid.

Tán huyết


1253/20/RV Trang 2


Tán huyết được định nghĩa là sự phóng thích của các thành phần nội bào của hồng cầu và các tế bào máu khác vào không gian ngoại bào của máu. Chúng có thể xuất hiện trong cơ thể (ví dụ do phản ứng truyền máu hoặc nhiễm ký sinh trùng sốt rét) cũng như xảy ra ngoài cơ thể trong tất cả các khâu của giai đoạn tiền phân tích (lấy mẫu, vận chuyển mẫu và bảo quản). Sau khi tách tế bào máu, có thể phát hiện tán huyết trong huyết thanh và huyết tương bởi màu đỏ do hemoglobin.

Vàng da

Vàng da được định nghĩa là sự tăng nồng độ các loại bilirubin khác nhau (liên hợp và không liên hợp) trong huyết tương và huyết thanh. Nồng độ bilirubin tăng có thể do các bệnh hoặc các điều kiện, như trong quá trình ly huyết, làm phóng thích bilirubin nhanh hơn tốc độ gan có thể chuyển hóa. Tương tự trong trường hợp gan chưa trưởng thành và một số bệnh khác mà cơ chế liên hợp bilirubin suy giảm cũng sẽ gây tăng bilirubin không liên hợp trong máu. Tắc nghẽn ống mật hay tổn thương cấu trúc tế bào gan làm tăng cả nồng độ bilirubin liên hợp (trực tiếp) và không liên hợp (gián tiếp) trong hệ tuần hoàn.

Nguyên lý xét nghiệm

Xét nghiệm Serum Index Gen.2 dựa trên tính toán độ hấp thu của mẫu pha loãng ở cặp bước sóng nhị sắc khác nhau để biểu thị bán định lượng mức lipid huyết, tán huyết và vàng da trong mẫu huyết thanh và huyết tương.

Máy phân tích lấy một phần mẫu bệnh phẩm và pha loãng với dung dịch muối (natri chloride 0.9 %) để đo độ hấp thu cho lipid huyết ở 660 nm (bước sóng sơ cấp) và 700 nm (bước sóng thứ cấp), cho tán huyết ở 570 nm (bước sóng sơ cấp) và 600 nm (bước sóng thứ cấp), và cho vàng da ở 480 nm (bước sóng sơ cấp) và 505 nm (bước sóng thứ cấp). Từ các giá trị độ hấp thu này máy phân tích tính toán chỉ số huyết thanh sử dụng các yếu tố sau:

A = 25 (đơn vị quy ước) hay 40 (đơn vị quốc tế)

B = 122000 (đơn vị quy ước hay đơn vị quốc tế)

C = 10 (đơn vị quy ước hay đơn vị quốc tế)

D = 1600 (đơn vị quy ước) hay 94 (đơn vị quốc tế)

E = 19000 (đơn vị quy ước hay đơn vị quốc tế)

F = 180000 (đơn vị quy ước hay đơn vị quốc tế)

C, A, và D là các yếu tố tỷ lệ xích phụ thuộc sự pha loãng mẫu và phụ thuộc đơn vị quy định mức độ gây nhiễu bán định lượng. B, E và F là yếu tố hiệu chỉnh dùng để điều chỉnh quang phổ nhiễu do giao thoa. Chúng không phụ thuộc vào sự pha loãng mẫu vì dựa vào tỷ lệ của các độ hấp thu. Chỉ số huyết thanh có thể được lập trình theo đơn vị quy ước hoặc đơn vị quốc tế. Phải đảm bảo rằng các yếu tố tỷ lệ xích được cài đặt phù hợp với đơn vị đã lựa chọn. Tham khảo tài liệu dành cho người sử dụng tương ứng của từng máy phân tích.


1253/20/RV Trang 3


Thuốc thử dung dịch tham gia xét nghiệm

R1 Natri chloride 9 %

1.2 Danh mục linh kiện và phụ kiện

Không áp dụng

1.3 Mục đích/Chỉ định sử dụng

Xét nghiệm in vitro dùng để bán định lượng chỉ số lipid huyết, chỉ số tán huyết và chỉ số vàng da trong huyết thanh và huyết tương người trên các hệ thống cobas c.

1.4 Hướng dẫn sử dụng

Lấy và chuẩn bị mẫu

Để lấy và chuẩn bị mẫu, chỉ sử dụng ống hoặc dụng cụ lấy mẫu thích hợp.

Chỉ những mẫu được liệt kê dưới đây đã được thử nghiệm và được chấp nhận.

Huyết thanh

Huyết tương: Huyết tương chống đông bằng Li‑heparin, K2‑EDTA, K3‑EDTA, citrate, huyết tương chống đông bằng NaF/Na‑heparin và NaF/K‑oxalate

Các loại mẫu phẩm được liệt kê đã được thử nghiệm cùng với bộ các ống nghiệm lấy mẫu chọn lọc, có bán trên thị trường vào thời điểm xét nghiệm, nghĩa là không phải tất cả các ống lấy mẫu của các nhà sản xuất đều được thử nghiệm. Các bộ ống chứa mẫu của các nhà sản xuất khác nhau có thể làm từ những vật liệu khác nhau có khả năng ảnh hưởng đến kết quả xét nghiệm trong một số trường hợp. Khi xử lý mẫu trong các ống chính (ống chứa mẫu), phải tuân theo hướng dẫn của nhà sản xuất ống.

Ly tâm các mẫu có kết tủa trước khi thực hiện xét nghiệm.

Lưu ý: Đo Sample Index Gen.2 song song với các thông số tương ứng.

Sử dụng thuốc thử

Sẵn sàng để sử dụng

Xét nghiệm

Để tối ưu hiệu năng xét nghiệm, nên tuân theo hướng dẫn trong tài liệu này cho các máy tương ứng. Tham khảo hướng dẫn vận hành cho từng xét nghiệm đặc hiệu tương ứng.

Hiệu năng của ứng dụng không được thẩm định bởi Roche không được đảm bảo và phải được xác định bởi người sử dụng.

Chuẩn

Mẫu chuẩn H2O

Kiểu chuẩn định Tuyến tính

Tần suất chuẩn định Chuẩn mẫu trắng

- sau khi thay đổi lô thuốc thử

Tính toán


1253/20/RV Trang 4


Hệ thống cobas c tự động tính toán nồng độ chất phân tích trong mỗi mẫu đo.

Giá trị chỉ số huyết thanh hiển thị và được in ra không có đơn vị.

Khi sử dụng yếu tố tỷ lệ xích ở đơn vị quy ước, giá trị hiển thị và in ra cho H và I tương ứng với nồng độ gần đúng của hemoglobin và bilirubin theo mg/dL.

Có sự tương quan yếu giữa chỉ số L (tương ứng với độ đục) và nồng độ triglyceride.

Khi sử dụng yếu tố tỷ lệ xích ở đơn vị quốc tế, giá trị hiển thị và in ra cho H và I tương ứng với nồng độ gần đúng của hemoglobin và bilirubin theo µmol/L.

1.5 Chống chỉ định Không áp dụng cho sản phẩm IVD

1.6 Cảnh báo và thận trọng

Dùng trong chẩn đoán in vitro.

Áp dụng các cảnh báo thông thường cần thiết cho việc xử lý các loại thuốc thử phòng thí nghiệm.

Loại bỏ các chất thải tuân theo hướng dẫn của địa phương.

Bảng dữ liệu an toàn hóa chất có sẵn để cung cấp cho chuyên viên sử dụng khi có yêu cầu.

1.7 Tác dụng bất lợi có thể xảy ra

Không có

2 Thông tin sản phẩm đã lưu hành tại các nước (nếu có)

Nước tham chiếu Tình trạng sản phẩm đã được lưu hành Ngày cấp

EU Đã cấp phép lưu hành 21/03/2019

Xem tài liệu Thông tin lưu hành sản phẩm đính kèm.

3 Chỉ định đã đăng ký ở các nước khác:


4 Thông tin về tính an toàn/ vận hành đáng lưu ý của sản phẩm trang thiết bị y tế

Xem tài liệu Thông tin về tính an toàn đính kèm.

Tôi xin bảo đảm những nội dung trên là đúng sự thật và xin chịu trách nhiệm trước pháp luật về các thông tin đã kê khai nêu trên. Công ty TNHH Roche Việt Nam (Đã ký)


DANH SÁCH TÀI LIỆU ĐÍNH KÈM

STT Nội dung

1. Thông tin về tính an toàn

2. Thông tin lưu hành sản phẩm


1. Thông tin về tính an toàn

ll

1 5000pcs16

001 set (24 ) 717-0475

1298500316 solution Sys Clean Solution I1216 Reference Electrolyte 300ML Reference Electrolyte

1252122 A e A

1488457122 EHBAIC1555421216 Solution for HIT 917 / Acid Wash1555430216 -D / Basic Wash oD I Basic Wash1555448216 for HIT 917 12x59ML

6 for HIT 917132001 32 4-0750

1662970122 e

1662988122 Elecsys,cobas 9.1706799001 Y TIP ELECSYS'ZOIO/cobas 84111706802001 CUP 10/cobas e411

732277122 Diluent 2x16ml e Universal11776576322 ' Vials e Vials

7 1 liner 2010/cobas e411 line:11 1 18-set (cuvettes) *HP Cell

1761001 1000ul VS lb0x=l 1000 V5 250/ VS II

1930346122 Wash e Wash12020688001 set ‘ Cell/ 767-8525

12029774001 win tubes 1 box = 6x300 TubesCleanerCheck Cassette

Integra Check Sample SolutionDEPROTEINIZER (6x21ML) Deprotelnizer

Cleaner 150Tests1 hncrocuvetten COBAS

1044869001 Cup with hole blueM e M

Wash M Wash M150001 ASTE—LINER M asteliner M

122 Diluent Elecsys.cobas e .42949122 Vials e Vials

03149501001 CE ELECTRODE ElectrodeDiluent 2x36ml Universal

9004357108001 Cnvette Segment ‘ Cuvette04489225190 cobas c

190 cobas 604489357190 9% Di], cobas c CL

190 C1 9% SI Gen.2, cobas c,04490398001 c 111 for cobas c 11

' 190 Diluent Gen.2, cobas c, Hitachi Gen.21 Cell Set, C311 Cell

04593138190 pack, cobas c, 20/ TI90 11

190 Cleaner 1, cobas c Cleaner 1

40955001 False Bottom Tube (2000 pcs) False Bottom Tube45876001 6000 e-Line . 6000 e-connection

190 7 ‘ Cobas C1114230190 9% cobas c 111 _ Diluent 9%4248190 cobas cl 11

l 4000 c311 :alone ‘ V H c 311

65.001 cobas c 111 1 , .Etcher

Cat No Description DMS Name10394246001 Cobas sample cup 5000pcs Sample Cup11223879216 Hitergent Hitergent11229621001 Cuvelte set (24 pos) 717-0475 ReactionCell11298500316 ISE cleaning solution Sys Clean ISE CleaningSo1uLion I Elecsys SysClean11360981216 ISE Reference Electrolyte 300ML ISEReference Electrolyte113612S2122 Diluent Hepatitis A Elecsys,cobas e Diluent Hepatitis A11485457122 Haemolyse Reageht EHBAIC Hemulyzing Reagent11555421216 SMS Solution for HIT 917 SMS I Acid Wash11555430216 NaOH D I Basic Wash NAOH D I Basic Wash11555-148216 Hitergent fur I-HT 917 12x59ML Hitergent11557335216 NaCl Solution for HIT 917 large SALINE11563132001 React,cell(32 pcsfset)714-0750 Reaction Cell11662970122 CleanCell Elecsys,cobas e CleanCel111662988122 ProCeed Elecsymcobas e ProCe1l11706799001 ASSAY TIP ELECSYS'2010.*'cubas E411 AssayTip11706802001 ASSAY CUP ELECSYS2010/cobas e411 AssayCupl1?322i77122 Universal Diluent 21(16ml Ell2cslrs,cobas e Diluent Universal11776576322 Ca1Set Vials Elecsys,cobas e Calumet Vials11800507001 Clean liner Elecsys 9010/cobas e411 Clean~Linerl1B09407001 Cell 18-set (cuvettes) *IIP Reaction Cell11901761001 Tips 100010 VS lbox-10x960tips Tips 1000 al VS 250/ VS II11930346122 Sys WashElecsys,cobas e SysWash12020688001 Cell set Reaction Cells' '767-852512029774001 Twin tubes 1 box - c 6x300 pos *LM Twin Tubes 20754765322 cobs Integra Cleaner Cleaner 20757136322 cobs Integra Check Cassette CHECK 20757144322 cobs Integra Check Sample Check Solution Sample 20?63071122 ISE DEPROTEINIZER cobs Integra (6x21ML) ISE Deproteinizer 20764337322 cobs Integra Cleaner 150Tests CLEAN 21043862001 Integra Mlcmcuvetten Curette COBAS INTEGRA 21044869001 c o b s Integra Cup with hole Cobas Cup blue 03004899190 PreClean M Elecsys,cobas B PreCIean M 03005712190 Probe Wash M Elecsys,cobas e PmbeWash M 03023150001 WASTE-LINER M Wasteliner M 03028542122 EslrJProg. Diluent File»:sys,c:ubas e Diluent Progesterone/Estradiol

03142949122 ContrulSet Vials EIecsys,cobas e ConLrolSet Vials 03149501001 REFERENCE ELECTRODE REF Electrode 03183971122 Universal Diluent 2x36m1 Elecsys,cobas e Diluent Universal 03609987190 Diluent MultiAssay Elecsys,coba.s e Diluent MultiAssa§r 04357108001 Micro Cuvette Segment Micro Curette Segment 04489225190 SMS, cubes c SMS 04489241190 NaOH D, cobas c NaOHD 04489357190 NACI 9% Dil, cobas c NACL 04489365190 NAC! 9% SI Gen.2, cobas c, Integra sly

04490398001 cobs c 111 ISE-Option ISE for cobs c 111 analyzer 04522630190 ISE Diluent Gen.2, cob's c, Hitachi ISE Diluent Gen.2 04555040001 Cell Set cubes C311 Reaction Cell 04593138190 Multi pack, cobs c, Integra 2Df'401'20 MULTI 04663632190 Activator for cobs c,Integra,c111 Activator 04703725190 Sample Cleaner 1, cobs c Sample Cleaner 1 04740955001 RD Standard False Bottom Tube (2000 pos) RD Standard False Bottom Tube 04745876001 cobs 6000 e~Li.ne cobas 6000 e-connection 04774221190 Pwidoxalphosphat Cobas C111 PYP 04774230190 NaCL 9% cobas c 111 NaCl Diluent 9% 04774248190 Cleaner Basisch cobas cl11 CLEAN 04826876001 Cobas 4000 c311 stand alone system cobas c 311 04838165001 ISE ETCIIIER cobs c I l l system ISE Etcher

04838181001 ISE DEPROTEINIZER cobas C 111 system ISE Deproteinizer 04851013190 INSTC, 65 Tests, cobas C INSTC 04854241001 Reaction cell sets for cobas c 501 Reaction Cell 04880277190 Multiclean 2x2 L Mudticlean 04880285190 Cell Wash Solution I/NaOH-D 2x1,8 L Cell Wash Solution I / NAOII-D 04880293190 CleanCell M 2x2 L Elecsys,cobas e Cleanflell M 04880307190 Acid wash Solution 2xl,8 L Cell Wash Solution II / Acid Wash 04880340190 ProCel1 M 2x2 L Elecsys,cobas e ProCel1 M 04880480190 ISE Diluent Gen.2, 2x2 Liter ISE Diluent Gen.2 04880994190 cobas C SPECIAL CELL CLEANING SOLUTION SCCS 04885775001 cobas 6000 C-line cobas 6000 e-extension 01885783001 cobas 6000 E2-line cobas 6000 e~e>L1ension 04939719001 Reaction Cell Set for cobas c701/711 Reaction Cell 04952324001 Cohos 6000 "2nd Rack rotor" cobas 6000 2nd rotor 05007232190 Haemolyse reagent 800T cobas C 111 A113132

I

05085713001 Sample Cup Micro 13/16 Sample Cup Micro 13/16 05168376190 Antigen Excess Reagent, c701 START 05172071190 INSTC, l30Tests, cobas c701 LNSTC 05172128190 NaOH-D, cobas c 701 NAOHD 05172136190 SMS, cobas c 70 l SMS 05172152190 NAC! 9% Dil, c o b s C 701 NACL 05172179190 NACI 9% SI Gen.2, 3000Tests cobas c701 $12

05192943190 Diluent Universal 2 2x36rnl Elecsys Diluent Universal 2 05352991190 Sample Cleaner 1, cobs 8000 Sample Cleaner 1 05422485190 EcoTergent, c o b s c311 ECO-D 05641497001 cobas 8000 cobas ISE module ISE 900 module 05641519001 cobs 8000 cobs Transport Line Transport Line 05642060001 cobs 8000 cobs Transport Belt 1 Transport Belt 1 05642086001 cobs 8000 c o b s Transport Belt 2 Transport Belt 2 05642094001 cobs 8000 cobs Transport Belt 3 Transport Belt 3 05642116001 cobs 8000 cobs Transport Belt 4 Transport Belt 4 05694302001 AssayTip/AssayCup tray AssayTip/AssayCup tray

05867266001 RESTOP CAPS BLUE 13MM (5000pcs) Restop Caps blue 13mm 05873720001 Std. cobs p 612, QSI w/0 recap cobs p 612 05893003001 std. c o b s p471 centrifuge unit c o b s p 471 05907543190 EcoTergent, cobas c 701 ECO-D 05944317190 Folate RBC Ilemolyzing Elecsys,cobas e Folate RBC Hemolyzing Reagent 05958024190 Sample Cleaner 2, cobs 6000 Sample Cleaner 2 05968828190 Sample Cleaner 2, cobs 8000 Sample Cleaner 2 05979854190 Internal Standard Insert, ISE Internal Standard Insert - ISE 05989990001 cobs 8000 Transport Belt 1 (w/o ISE) BELT G 05990009001 cobs 8000 Transport Belt 2 (w/0 ISE) BELT H 05990017001 cobas 8000 Transport Belt 3 (wlo ISE) cobs' 8000 modular analyzer series

05990025001 cobas 8000 Transport Belt 4 (w/0 ISE) Transport Belt 4 (w/o ISE) 06372546001 cobas 8000 B-Gate KIT 06473253001 cobas 8000 additional ISE kit cobas 8000 Additional ISE KIT 06483810190 CDC1, Closed Development Channel CDC01-CDC10, Closed Development Channels 01-10

06483836190 CDC2, Closed Development Channel CDC01-CDCIO, Closed Development Channels 01-10 06483844190 CDC3, Closed Development Channel CDC01-CDC10, Closed Development Channels 01 10 06483879190 CDC4, Closed Development Channel CDC01-CDC10, Closed Development Channels 01-10

06483887190 CDC5, Closed Development Channel CDC01-CDC10, Closed Development Channels 01 10 06483895190 CDC6, Closed Development Channel CDC01 CDC10, Closed Development Channels 01-10 06483909190 CDC7, Closed Development Channel CDC01-CDC10, Closed Development Channels 01-10

06483925190 CDC8, Closed Development Channel CDC01-CDCIO, Closed Development Channels 01-10

06483933190 CDC9, Closed Development Channel CDC01~CDC10, Closed Development Channels 01-10

06483941190 CDC10, Closed Development Channel CDCOl-CDC10, Closed Development Channels 01-10

06544410190 EcoTergent, cobs c501/502, l2X59 ml Eco-D 06766323001 Conveyor Connection Module (2x Hitachi) CCM Zfach Hitachi (Conveyor Connection Module)

dot3

Highlight

06770517001 Cobas6000 Connection Unit COBAS 6000 CONNECTION UNIT 06770550001 Modular Connection Unit MODULAR CONNECTION UNIT 06770568001 CONVEYOR 1 Unit (0,5m) CONVEYOR 1 UNIT (0.5m) 06770576001 CONVEYOR 2 Unit (lm) CONVEYOR 2 UNIT (lm) 06770584001 Power Supply Unit POWER SUPPLY UNIT 06770592001 TURN UNIT TURN UNIT 06884750001 B-Gate Interface B-Gate Interface 06908799190 ProCell M G2 2x2L Elecsys E2G ProCell II M 06908853190 PreClear\ M G2 2x2L Elecsys EZG PreClean II M 06919979001 Conveyor Connection Module (3x Hitachi) CCM 3 fach Hitachi (Conveyor Connection Module) 06924484001 cobas 8000 connection Unit COBAS 8000 CONNECTION UNIT 06924514001 HST Connection Unit HST connection unit 06981810001 cobs p512/612 con. kit cobs color cobas p512/p612 connection kit 07050763001 Automated Tip Loader (ATL) Automated Tip Loader (ATL) 07084307001 Aliquot Tips 2000 Aliquot Tips 2000 07092571190 Chagas PC Elecsys PreciControl Chagall 07123841001 cobas 8100 Model Alpha (IPB, DSF, OBS) cobs 8100 Model Alpha 07123850001 ¢8100 Model Beta (IPB,DSP,OPB,BCL,AQM) cobas 8100 Model Beta 07123868001 cobas 8100 ACU ACU for cobas 8100 07123876001 c o b s 8100 RSF (Restopper Flex-caps) RSF for cobas 8100 07123892001 cobs 8100 OBS (Output Buffer/Sorter) OBS for cobas 8100 07123914001 cobas 8100 AOB AOB for cobas 8100 07123922001 c 8100 BCL (Barcode Labeler/Tube Feeder) BCL for cobas 8100 07123957001 cobas 8100 BCL - FBT Modification let FBT mod. Kit for BCL 07123990001 cobas 8100 2nd BCL Modification Kit 2nd BCL mod. Kit for BCL and AQM 07124015001 cobas 8100 RPM (Reformatter Version 1) RPM for cobas 8100 07224656190 Special Cell Cleaning Solution, c513 SCCS 07276001001 CCM Bidirectional Interface CCM bidirectional unit 07299001190 Diluent Universal EZG Diluent Universal 07299010190 Diluent MultiAssay E2G Diluent MultiAssay 07399774001 13mm sample disk tube adapter (sdta} 13 mm sample disk tube adapter 07439822001 c8100 v2 Type Alpha (IPB,DSP,OBS,CRW,CU) cobs 8100 Model Alpha with CRW 07439920001 c8100v2 Beta(IPB,DSP,BCL,AQM,OBS,CRW,CU) cobas 8100 Model Beta with CRW 07439997001 c8100 v2 CLO CLO for cobas 8100 07440006001 c8100 v2 CLW CLW for cobas 8100 07440022001 c8100 v2 CRO CRO for cobas 8100 07440049001 c8100 v2 CRW CRW for cobas 8100 07440057001 c8100 v2 PXT PXT for cobas 8100 07440065001 c8100 v2 RFX incl. Conn. RFX for cobas 8100 07440073001 c8100 v2 SCM SCM for cobas 8100 07440081001 c8100 v2 SLL SLL for cobas 8100 07440090001 c8100 v2 SLR SLR for cobas 8100 07440103001 £8100 v2 TL] 300 TLI300 for cobas 8100 07440111001 c8100 v2 TL] 600 TLI600 for cobas 8100 07440120001 c8100 v2 TL] 900 TLI)00 for cobas 8100 07440138001 c8100 v2 TL] 1200 TLI1200 for cobas 8100 07440146001 c8100 v2 TL] 1500 TL1500 for cobas 8100 07441541001 c8100 v2 TL] 1800 TLI800 for cobas 8100 07441592001 c8100 v2 TL]2100 TLI2100 for cobas 8100 07441606001 c8100 v2 TL]2400 TL12400 for cobas 8100 07441614001 c8100 v2 TL] 2700 TLI2700 for cobas 8100 07441622001 c8100 v2 TL] 3000 TLI3000 for cobas 8100 07474652001 cobs 8100 Signal Tower Signal Tower 07474687001 cobas 8100° Connection let STA-R Connection kit STA-R 07476124001 Universal Connection Unit (UCU) UCE for cobas 8100 07563116001 COBAS P 612 PRE-ANALYTICAL SYSTEM cobs p612 07563124001 COBAS P 512 PRE-ANALYTICAL SYSTEM cobs p 512 07563787001 COBAS P 471 CENTRIFUGE UNIT cobas p 471

\ C

C I

07667574001 OUTPUT UNIT Output unit 07667680001 Add-On Buffer Unit Type-2 Add-On Buffer Unit 07700814001 Reaction Cell c 513 Reaction Cell for cobas c $13 07787120001 IPB for cobas 8100 07787138001 AQM for c o b s 8100 07787146001 DSP for cobas 8100 07802536001 SW DM C8000 v1.05.01 cobs 8000* Data Manager 07902697001 Liaison XL Connection Module 08010595001 2nd BCI, for cobas 8100 08015589001 RSS for cobas 8100 08015597001 2nd IPB for cobas 8100 08126232001 Self-Contained ISE Support Box cobs 8000 ISE Support Box 08137200001 100 pos tray IPB/OBS mod let 08137218001 H] IT/Sysmex Tray Lane Arm cover 08137536001 HH'l` l tray IPB/OBS mod kit

l

08137579001 HHT 2 tray IPB/OBS mod kit 08137595001 HHT + 1 tray IPB/OBS mod kit 08137633001 Sysmex Tray OBS mod kit

J


2. Thông tin lưu hành sản phẩm

Tháng 6, 2019 1/ 7

Mẫu số 02

TÀI LIỆU KỸ THUẬT ĐỐI VỚI THUỐC THỬ, CHẤT HIỆU CHUẨN, VẬT LIỆU KIỂM SOÁT IN VITRO

_________

Công ty TNHH Roche Việt Nam Tầng 27, tòa nhà Pearl Plaza, 561A Điện Biên Phủ, Phường 25, quận Bình Thạnh, thành phố Hồ Chí Minh. Ngày 06 tháng 10 năm 2020

SI2 (05172179190)

STT Đề mục Nội dung

I Tóm tắt chung về trang thiết bị y tế

1.1 Mô tả tổng quan

Các xét nghiệm y khoa có thể bị ảnh hưởng bởi các thành phần nội sinh và ngoại sinh có trong mẫu. Một số yếu tố có tiềm năng gây nhiễu này có thể nhận biết được trong giai đoạn tiền phân tích bởi sự hiện màu của mẫu, trong khi đó các yếu tố khác chỉ được phát hiện khi nhận được thông tin bổ sung và/hoặc các phương pháp phân tích trực tiếp. Sự nhiễu gây ra bởi lipid huyết (độ đục), tán huyết và vàng da (bilirubin) thường khó dự đoán vì chúng phụ thuộc rõ rệt vào phương pháp. Các giới hạn tại đó việc phân tích có thể thực hiện được mô tả trong mỗi phương pháp chịu sự nhiễu đó. Chỉ thị của châu Âu về chẩn đoán in vitro (IVDD) khẳng định nhà cung cấp thuốc thử phải định nghĩa các giới hạn thích hợp. Mỗi báo cáo trên kết quả thu được ở phòng thí nghiệm phải có một chú thích mô tả “cảm quan” của mẫu. Nếu phát hiện lipid huyết hoặc một màu sắc có liên quan, loại hình của kết quả được mô tả trong mỗi trường hợp, ví dụ “có lipid”, “tán huyết” hay “vàng da”. Có thể định lượng các yếu tố ảnh hưởng này với ứng dụng Serum Index Gen.2 (SI2) trên tất cả các hệ thống cobas c. Tất cả các máy phân tích có thể bán định lượng và báo cáo kết quả chỉ số lipid huyết (L), chỉ số tán huyết (H) và chỉ số vàng da (I).

Kết quả chỉ số huyết thanh rất hữu ích trong kiểm soát mức độ nhiễu tiềm tàng do lipid huyết (độ đục), tán huyết và vàng da (bilirubin).

Lipid huyết

Lipid huyết được định nghĩa là độ đục trong mẫu huyết thanh và huyết tương có thể thấy được bằng mắt thường. Nguyên nhân thường xuyên nhất của lipid huyết là sự tăng nồng độ triglyceride trong huyết tương và huyết thanh. Điều này có thể do chế độ ăn, rối loạn chuyển hóa lipoprotein hoặc tiêm tuyền lipid.

Tán huyết

Tháng 6, 2019 2/ 7

Tán huyết được định nghĩa là sự phóng thích của các thành phần nội bào của hồng cầu và các tế bào máu khác vào không gian ngoại bào của máu. Chúng có thể xuất hiện trong cơ thể (ví dụ do phản ứng truyền máu hoặc nhiễm ký sinh trùng sốt rét) cũng như xảy ra ngoài cơ thể trong tất cả các khâu của giai đoạn tiền phân tích (lấy mẫu, vận chuyển mẫu và bảo quản). Sau khi tách tế bào máu, có thể phát hiện tán huyết trong huyết thanh và huyết tương bởi màu đỏ do hemoglobin.

Vàng da

Vàng da được định nghĩa là sự tăng nồng độ các loại bilirubin khác nhau (liên hợp và không liên hợp) trong huyết tương và huyết thanh. Nồng độ bilirubin tăng có thể do các bệnh hoặc các điều kiện, như trong quá trình ly huyết, làm phóng thích bilirubin nhanh hơn tốc độ gan có thể chuyển hóa. Tương tự trong trường hợp gan chưa trưởng thành và một số bệnh khác mà cơ chế liên hợp bilirubin suy giảm cũng sẽ gây tăng bilirubin không liên hợp trong máu. Tắc nghẽn ống mật hay tổn thương cấu trúc tế bào gan làm tăng cả nồng độ bilirubin liên hợp (trực tiếp) và không liên hợp (gián tiếp) trong hệ tuần hoàn.

1.2 Lịch sử đưa sản phẩm ra thị trường

Vui lòng xem Phụ lục 1.2_1.4_Registration Status

Nước tham chiếu

Tình trạng sản phẩm đã được lưu hành

Ngày cấp


1.3 Mục đích sử dụng


1.4 Danh mục các nước đã được cấp

Vui lòng xem Phụ lục 1.2_1.4_Registration Status

Nước tham chiếu

Tình trạng sản phẩm đã được lưu hành

Ngày cấp


1.5

Tình trạng các hồ sơ xin cấp phép đã nộp nhưng chưa đượ cấp phép tại các nước

Không có thông tin cụ thể

1.6

Các thông tin quan trọng liên quan đến sự an toàn/hiệu quả của sản phẩm

Không có.

Vui lòng xem Phụ lục 1.6_FSCA

II Mô tả trang thiết bị y tế

2.1 Mô tả trang thiết bị y tế

Nguyên lý xét nghiệm

Xét nghiệm Serum Index Gen.2 dựa trên tính toán độ hấp thu của mẫu

Tháng 6, 2019 3/ 7

pha loãng ở cặp bước sóng nhị sắc khác nhau để biểu thị bán định

lượng mức lipid huyết, tán huyết và vàng da trong mẫu huyết thanh và

huyết tương.

Máy phân tích lấy một phần mẫu bệnh phẩm và pha loãng với dung

dịch muối (natri chloride 0.9 %) để đo độ hấp thu cho lipid huyết ở

660 nm (bước sóng sơ cấp) và 700 nm (bước sóng thứ cấp), cho tán

huyết ở 570 nm (bước sóng sơ cấp) và 600 nm (bước sóng thứ cấp), và

cho vàng da ở 480 nm (bước sóng sơ cấp) và 505 nm (bước sóng thứ

cấp). Từ các giá trị độ hấp thu này máy phân tích tính toán chỉ số huyết

thanh sử dụng các yếu tố sau: A = 25 (đơn vị quy ước) hay 40 (đơn vị quốc tế)

B = 122000 (đơn vị quy ước hay đơn vị quốc tế)

C = 10 (đơn vị quy ước hay đơn vị quốc tế)

D = 1600 (đơn vị quy ước) hay 94 (đơn vị quốc tế)

E = 19000 (đơn vị quy ước hay đơn vị quốc tế)

F = 180000 (đơn vị quy ước hay đơn vị quốc tế)

C, A, và D là các yếu tố tỷ lệ xích phụ thuộc sự pha loãng mẫu và phụ

thuộc đơn vị quy định mức độ gây nhiễu bán định lượng. B, E và F là

yếu tố hiệu chỉnh dùng để điều chỉnh quang phổ nhiễu do giao thoa.

Chúng không phụ thuộc vào sự pha loãng mẫu vì dựa vào tỷ lệ của các

độ hấp thu. Chỉ số huyết thanh có thể được lập trình theo đơn vị quy

ước hoặc đơn vị quốc tế. Phải đảm bảo rằng các yếu tố tỷ lệ xích được

cài đặt phù hợp với đơn vị đã lựa chọn. Tham khảo tài liệu dành cho

người sử dụng tương ứng của từng máy phân tích.

Thuốc thử dung dịch tham gia xét nghiệm

R1 Natri chloride 9 %

Vật liệu cần thiết (không cung cấp sẵn)

Trang thiết bị thông thường của phòng thí nghiệm.

Vui lòng xem Phụ lục 2.1_EP

2.2 Hướng dẫn sử dụng

Lấy và chuẩn bị mẫu

Để lấy và chuẩn bị mẫu, chỉ sử dụng ống hoặc dụng cụ lấy mẫu thích hợp.

Chỉ những mẫu được liệt kê dưới đây đã được thử nghiệm và được chấp nhận.

Huyết thanh

Huyết tương: Huyết tương chống đông bằng Li‑heparin, K2‑EDTA, K3‑EDTA, citrate, huyết tương chống đông bằng NaF/Na‑heparin và

Tháng 6, 2019 4/ 7

NaF/K‑oxalate

Các loại mẫu phẩm được liệt kê đã được thử nghiệm cùng với bộ các ống nghiệm lấy mẫu chọn lọc, có bán trên thị trường vào thời điểm xét nghiệm, nghĩa là không phải tất cả các ống lấy mẫu của các nhà sản xuất đều được thử nghiệm. Các bộ ống chứa mẫu của các nhà sản xuất khác nhau có thể làm từ những vật liệu khác nhau có khả năng ảnh hưởng đến kết quả xét nghiệm trong một số trường hợp. Khi xử lý mẫu trong các ống chính (ống chứa mẫu), phải tuân theo hướng dẫn của nhà sản xuất ống.

Ly tâm các mẫu có kết tủa trước khi thực hiện xét nghiệm.

Lưu ý: Đo Sample Index Gen.2 song song với các thông số tương ứng.

Sử dụng thuốc thử

Sẵn sàng để sử dụng

Xét nghiệm

Để tối ưu hiệu năng xét nghiệm, nên tuân theo hướng dẫn trong tài liệu này cho các máy tương ứng. Tham khảo hướng dẫn vận hành cho từng xét nghiệm đặc hiệu tương ứng.

Hiệu năng của ứng dụng không được thẩm định bởi Roche không được đảm bảo và phải được xác định bởi người sử dụng.

Chuẩn

Mẫu chuẩn H2O

Kiểu chuẩn định Tuyến tính

Tần suất chuẩn định Chuẩn mẫu trắng

- sau khi thay đổi lô thuốc thử

Tính toán

Hệ thống cobas c tự động tính toán nồng độ chất phân tích trong mỗi mẫu đo.

Giá trị chỉ số huyết thanh hiển thị và được in ra không có đơn vị.

Khi sử dụng yếu tố tỷ lệ xích ở đơn vị quy ước, giá trị hiển thị và in ra cho H và I tương ứng với nồng độ gần đúng của hemoglobin và bilirubin theo mg/dL.

Có sự tương quan yếu giữa chỉ số L (tương ứng với độ đục) và nồng độ triglyceride.

Khi sử dụng yếu tố tỷ lệ xích ở đơn vị quốc tế, giá trị hiển thị và in ra cho H và I tương ứng với nồng độ gần đúng của hemoglobin và bilirubin theo µmol/L.

2.3 Chống chỉ định Không áp dụng cho IVD

2.4 Cảnh báo và thận trọng

Dùng trong chẩn đoán in vitro.

Áp dụng các cảnh báo thông thường cần thiết cho việc xử lý các loại thuốc thử phòng thí nghiệm.

Loại bỏ các chất thải tuân theo hướng dẫn của địa phương.

Bảng dữ liệu an toàn hóa chất có sẵn để cung cấp cho chuyên viên sử dụng khi có yêu cầu.

Tháng 6, 2019 5/ 7

2.5 Tác dụng bất lợi có thể xảy ra

Không có

2.6 Phương pháp thay thế (nếu có)

Không có

2.7 Các thông số kỹ thuật

Loại mẫu

Huyết thanh và huyết tương người

Bảo quản và độ ổn định:

Hạn dùng ở 2‑8 °C: Xem ngày hết hạn trên nhãn cobas c pack.

Đang sử dụng và để lạnh trên máy phân tích: 4 tuần

Đặt ở bộ nạp/xuất hộp thuốc thử: 24 giờ

Khoảng đo

Huyết thanh/huyết tương

Chỉ số L 10‑2000

Chỉ số H 5‑1200

Chỉ số I 0.5‑60

Giới hạn phát hiện dưới

Chỉ số L 10

Chỉ số H 5

Chỉ số I 0.5

Giới hạn phát hiện dưới tương ứng với nồng độ chất phân tích thấp nhất mà máy có thể đo được và phân biệt được với giá trị không. Giá trị này được tính toán bằng nồng độ chuẩn thấp nhất cộng với 3 lần độ lệch chuẩn (chuẩn 1 + 3 SD, độ lặp lại, n = 21).

Độ chính xác

Độ chính xác được xác định với việc sử dụng mẫu từ người và mẫu chứng theo đề cương nội bộ với độ lặp lại (n = 21). Kết quả thu được trình bày dưới đây:

Tháng 6, 2019 6/ 7

So sánh phương pháp

Các giá trị chỉ số huyết thanh của các mẫu huyết thanh/huyết tương người thu được trên máy cobas c 701 (y) được so sánh với các giá trị thu được sử dụng chỉ số huyết thanh trên máy cobas c 501 (x).

III Sản xuất trang thiết bị y tế

3.1 Nhà sản xuất

Tên và địa chỉ nhà sản xuất:

Roche Diagnostics GmbH

Sandhofer Strasse 116, 68305 Mannheim, Đức

Tháng 6, 2019 7/ 7

Hệ thống quản lý chất lượng áp dụng:

ISO 13485:2016

Vui lòng xem Phụ lục 3.1_ISO

3.2 Độ ổn định

Bảo quản và độ ổn định:

Hạn dùng ở 2‑8 °C: Xem ngày hết hạn trên nhãn cobas c pack.

Đang sử dụng và để lạnh trên máy phân tích: 4 tuần

Đặt ở bộ nạp/xuất hộp thuốc thử: 24 giờ

Vui lòng xem Phụ lục 3.2_Stability Report

IV Báo cáo nghiên cứu

4.1 Nghiên cứu tiền lâm sàng và lâm sàng

Vui lòng xem Phụ lục 4.1_Performance Report

4.2

Tài liệu tham khảo của nghiên cứu tiền lâm sàng và lâm sàng

Cơ sở đăng ký lưu hành cảm kết những nội dung trên là đứng sự thật và chịu trách nhiệm trước pháp luật về các thông tin đã kê khai nêu trên.

Người đại diện hợp pháp của cơ sở

(Đã ký)

DANH SÁCH PHỤ LỤC

Phụ lục Nội dung

01 1.2_1.4_Registration Status

02 1.6_FSCA

03 2.1_EP

04 3.1_ISO

05 3.2_Stability Report

06 4.1_Performance Report

07 4.1 Risk Management Report

08 Composition

09 Manufacturing

10 Specification and CoA

11 SDS

1.2_1.4_Registration Status

1.6_FSCA

ll

1 5000pcs16

001 set (24 ) 717-0475

1298500316 solution Sys Clean Solution I1216 Reference Electrolyte 300ML Reference Electrolyte

1252122 A e A

1488457122 EHBAIC1555421216 Solution for HIT 917 / Acid Wash1555430216 -D / Basic Wash oD I Basic Wash1555448216 for HIT 917 12x59ML

6 for HIT 917132001 32 4-0750

1662970122 e

1662988122 Elecsys,cobas 9.1706799001 Y TIP ELECSYS'ZOIO/cobas 84111706802001 CUP 10/cobas e411

732277122 Diluent 2x16ml e Universal11776576322 ' Vials e Vials

7 1 liner 2010/cobas e411 line:11 1 18-set (cuvettes) *HP Cell

1761001 1000ul VS lb0x=l 1000 V5 250/ VS II

1930346122 Wash e Wash12020688001 set ‘ Cell/ 767-8525

12029774001 win tubes 1 box = 6x300 TubesCleanerCheck Cassette

Integra Check Sample SolutionDEPROTEINIZER (6x21ML) Deprotelnizer

Cleaner 150Tests1 hncrocuvetten COBAS

1044869001 Cup with hole blueM e M

Wash M Wash M150001 ASTE—LINER M asteliner M

122 Diluent Elecsys.cobas e .42949122 Vials e Vials

03149501001 CE ELECTRODE ElectrodeDiluent 2x36ml Universal

9004357108001 Cnvette Segment ‘ Cuvette04489225190 cobas c

190 cobas 604489357190 9% Di], cobas c CL

190 C1 9% SI Gen.2, cobas c,04490398001 c 111 for cobas c 11

' 190 Diluent Gen.2, cobas c, Hitachi Gen.21 Cell Set, C311 Cell

04593138190 pack, cobas c, 20/ TI90 11

190 Cleaner 1, cobas c Cleaner 1

40955001 False Bottom Tube (2000 pcs) False Bottom Tube45876001 6000 e-Line . 6000 e-connection

190 7 ‘ Cobas C1114230190 9% cobas c 111 _ Diluent 9%4248190 cobas cl 11

l 4000 c311 :alone ‘ V H c 311

65.001 cobas c 111 1 , .Etcher

Cat No Description DMS Name10394246001 Cobas sample cup 5000pcs Sample Cup11223879216 Hitergent Hitergent11229621001 Cuvelte set (24 pos) 717-0475 ReactionCell11298500316 ISE cleaning solution Sys Clean ISE CleaningSo1uLion I Elecsys SysClean11360981216 ISE Reference Electrolyte 300ML ISEReference Electrolyte113612S2122 Diluent Hepatitis A Elecsys,cobas e Diluent Hepatitis A11485457122 Haemolyse Reageht EHBAIC Hemulyzing Reagent11555421216 SMS Solution for HIT 917 SMS I Acid Wash11555430216 NaOH D I Basic Wash NAOH D I Basic Wash11555-148216 Hitergent fur I-HT 917 12x59ML Hitergent11557335216 NaCl Solution for HIT 917 large SALINE11563132001 React,cell(32 pcsfset)714-0750 Reaction Cell11662970122 CleanCell Elecsys,cobas e CleanCel111662988122 ProCeed Elecsymcobas e ProCe1l11706799001 ASSAY TIP ELECSYS'2010.*'cubas E411 AssayTip11706802001 ASSAY CUP ELECSYS2010/cobas e411 AssayCupl1?322i77122 Universal Diluent 21(16ml Ell2cslrs,cobas e Diluent Universal11776576322 Ca1Set Vials Elecsys,cobas e Calumet Vials11800507001 Clean liner Elecsys 9010/cobas e411 Clean~Linerl1B09407001 Cell 18-set (cuvettes) *IIP Reaction Cell11901761001 Tips 100010 VS lbox-10x960tips Tips 1000 al VS 250/ VS II11930346122 Sys WashElecsys,cobas e SysWash12020688001 Cell set Reaction Cells' '767-852512029774001 Twin tubes 1 box - c 6x300 pos *LM Twin Tubes 20754765322 cobs Integra Cleaner Cleaner 20757136322 cobs Integra Check Cassette CHECK 20757144322 cobs Integra Check Sample Check Solution Sample 20?63071122 ISE DEPROTEINIZER cobs Integra (6x21ML) ISE Deproteinizer 20764337322 cobs Integra Cleaner 150Tests CLEAN 21043862001 Integra Mlcmcuvetten Curette COBAS INTEGRA 21044869001 c o b s Integra Cup with hole Cobas Cup blue 03004899190 PreClean M Elecsys,cobas B PreCIean M 03005712190 Probe Wash M Elecsys,cobas e PmbeWash M 03023150001 WASTE-LINER M Wasteliner M 03028542122 EslrJProg. Diluent File»:sys,c:ubas e Diluent Progesterone/Estradiol

03142949122 ContrulSet Vials EIecsys,cobas e ConLrolSet Vials 03149501001 REFERENCE ELECTRODE REF Electrode 03183971122 Universal Diluent 2x36m1 Elecsys,cobas e Diluent Universal 03609987190 Diluent MultiAssay Elecsys,coba.s e Diluent MultiAssa§r 04357108001 Micro Cuvette Segment Micro Curette Segment 04489225190 SMS, cubes c SMS 04489241190 NaOH D, cobas c NaOHD 04489357190 NACI 9% Dil, cobas c NACL 04489365190 NAC! 9% SI Gen.2, cobas c, Integra sly

04490398001 cobs c 111 ISE-Option ISE for cobs c 111 analyzer 04522630190 ISE Diluent Gen.2, cob's c, Hitachi ISE Diluent Gen.2 04555040001 Cell Set cubes C311 Reaction Cell 04593138190 Multi pack, cobs c, Integra 2Df'401'20 MULTI 04663632190 Activator for cobs c,Integra,c111 Activator 04703725190 Sample Cleaner 1, cobs c Sample Cleaner 1 04740955001 RD Standard False Bottom Tube (2000 pos) RD Standard False Bottom Tube 04745876001 cobs 6000 e~Li.ne cobas 6000 e-connection 04774221190 Pwidoxalphosphat Cobas C111 PYP 04774230190 NaCL 9% cobas c 111 NaCl Diluent 9% 04774248190 Cleaner Basisch cobas cl11 CLEAN 04826876001 Cobas 4000 c311 stand alone system cobas c 311 04838165001 ISE ETCIIIER cobs c I l l system ISE Etcher

04838181001 ISE DEPROTEINIZER cobas C 111 system ISE Deproteinizer 04851013190 INSTC, 65 Tests, cobas C INSTC 04854241001 Reaction cell sets for cobas c 501 Reaction Cell 04880277190 Multiclean 2x2 L Mudticlean 04880285190 Cell Wash Solution I/NaOH-D 2x1,8 L Cell Wash Solution I / NAOII-D 04880293190 CleanCell M 2x2 L Elecsys,cobas e Cleanflell M 04880307190 Acid wash Solution 2xl,8 L Cell Wash Solution II / Acid Wash 04880340190 ProCel1 M 2x2 L Elecsys,cobas e ProCel1 M 04880480190 ISE Diluent Gen.2, 2x2 Liter ISE Diluent Gen.2 04880994190 cobas C SPECIAL CELL CLEANING SOLUTION SCCS 04885775001 cobas 6000 C-line cobas 6000 e-extension 01885783001 cobas 6000 E2-line cobas 6000 e~e>L1ension 04939719001 Reaction Cell Set for cobas c701/711 Reaction Cell 04952324001 Cohos 6000 "2nd Rack rotor" cobas 6000 2nd rotor 05007232190 Haemolyse reagent 800T cobas C 111 A113132

I

05085713001 Sample Cup Micro 13/16 Sample Cup Micro 13/16 05168376190 Antigen Excess Reagent, c701 START 05172071190 INSTC, l30Tests, cobas c701 LNSTC 05172128190 NaOH-D, cobas c 701 NAOHD 05172136190 SMS, cobas c 70 l SMS 05172152190 NAC! 9% Dil, c o b s C 701 NACL 05172179190 NACI 9% SI Gen.2, 3000Tests cobas c701 $12

05192943190 Diluent Universal 2 2x36rnl Elecsys Diluent Universal 2 05352991190 Sample Cleaner 1, cobs 8000 Sample Cleaner 1 05422485190 EcoTergent, c o b s c311 ECO-D 05641497001 cobas 8000 cobas ISE module ISE 900 module 05641519001 cobs 8000 cobs Transport Line Transport Line 05642060001 cobs 8000 cobs Transport Belt 1 Transport Belt 1 05642086001 cobs 8000 c o b s Transport Belt 2 Transport Belt 2 05642094001 cobs 8000 cobs Transport Belt 3 Transport Belt 3 05642116001 cobs 8000 cobs Transport Belt 4 Transport Belt 4 05694302001 AssayTip/AssayCup tray AssayTip/AssayCup tray

05867266001 RESTOP CAPS BLUE 13MM (5000pcs) Restop Caps blue 13mm 05873720001 Std. cobs p 612, QSI w/0 recap cobs p 612 05893003001 std. c o b s p471 centrifuge unit c o b s p 471 05907543190 EcoTergent, cobas c 701 ECO-D 05944317190 Folate RBC Ilemolyzing Elecsys,cobas e Folate RBC Hemolyzing Reagent 05958024190 Sample Cleaner 2, cobs 6000 Sample Cleaner 2 05968828190 Sample Cleaner 2, cobs 8000 Sample Cleaner 2 05979854190 Internal Standard Insert, ISE Internal Standard Insert - ISE 05989990001 cobs 8000 Transport Belt 1 (w/o ISE) BELT G 05990009001 cobs 8000 Transport Belt 2 (w/0 ISE) BELT H 05990017001 cobas 8000 Transport Belt 3 (wlo ISE) cobs' 8000 modular analyzer series

05990025001 cobas 8000 Transport Belt 4 (w/0 ISE) Transport Belt 4 (w/o ISE) 06372546001 cobas 8000 B-Gate KIT 06473253001 cobas 8000 additional ISE kit cobas 8000 Additional ISE KIT 06483810190 CDC1, Closed Development Channel CDC01-CDC10, Closed Development Channels 01-10

06483836190 CDC2, Closed Development Channel CDC01-CDCIO, Closed Development Channels 01-10 06483844190 CDC3, Closed Development Channel CDC01-CDC10, Closed Development Channels 01 10 06483879190 CDC4, Closed Development Channel CDC01-CDC10, Closed Development Channels 01-10

06483887190 CDC5, Closed Development Channel CDC01-CDC10, Closed Development Channels 01 10 06483895190 CDC6, Closed Development Channel CDC01 CDC10, Closed Development Channels 01-10 06483909190 CDC7, Closed Development Channel CDC01-CDC10, Closed Development Channels 01-10

06483925190 CDC8, Closed Development Channel CDC01-CDCIO, Closed Development Channels 01-10

06483933190 CDC9, Closed Development Channel CDC01~CDC10, Closed Development Channels 01-10

06483941190 CDC10, Closed Development Channel CDCOl-CDC10, Closed Development Channels 01-10

06544410190 EcoTergent, cobs c501/502, l2X59 ml Eco-D 06766323001 Conveyor Connection Module (2x Hitachi) CCM Zfach Hitachi (Conveyor Connection Module)

dot3

Highlight

06770517001 Cobas6000 Connection Unit COBAS 6000 CONNECTION UNIT 06770550001 Modular Connection Unit MODULAR CONNECTION UNIT 06770568001 CONVEYOR 1 Unit (0,5m) CONVEYOR 1 UNIT (0.5m) 06770576001 CONVEYOR 2 Unit (lm) CONVEYOR 2 UNIT (lm) 06770584001 Power Supply Unit POWER SUPPLY UNIT 06770592001 TURN UNIT TURN UNIT 06884750001 B-Gate Interface B-Gate Interface 06908799190 ProCell M G2 2x2L Elecsys E2G ProCell II M 06908853190 PreClear\ M G2 2x2L Elecsys EZG PreClean II M 06919979001 Conveyor Connection Module (3x Hitachi) CCM 3 fach Hitachi (Conveyor Connection Module) 06924484001 cobas 8000 connection Unit COBAS 8000 CONNECTION UNIT 06924514001 HST Connection Unit HST connection unit 06981810001 cobs p512/612 con. kit cobs color cobas p512/p612 connection kit 07050763001 Automated Tip Loader (ATL) Automated Tip Loader (ATL) 07084307001 Aliquot Tips 2000 Aliquot Tips 2000 07092571190 Chagas PC Elecsys PreciControl Chagall 07123841001 cobas 8100 Model Alpha (IPB, DSF, OBS) cobs 8100 Model Alpha 07123850001 ¢8100 Model Beta (IPB,DSP,OPB,BCL,AQM) cobas 8100 Model Beta 07123868001 cobas 8100 ACU ACU for cobas 8100 07123876001 c o b s 8100 RSF (Restopper Flex-caps) RSF for cobas 8100 07123892001 cobs 8100 OBS (Output Buffer/Sorter) OBS for cobas 8100 07123914001 cobas 8100 AOB AOB for cobas 8100 07123922001 c 8100 BCL (Barcode Labeler/Tube Feeder) BCL for cobas 8100 07123957001 cobas 8100 BCL - FBT Modification let FBT mod. Kit for BCL 07123990001 cobas 8100 2nd BCL Modification Kit 2nd BCL mod. Kit for BCL and AQM 07124015001 cobas 8100 RPM (Reformatter Version 1) RPM for cobas 8100 07224656190 Special Cell Cleaning Solution, c513 SCCS 07276001001 CCM Bidirectional Interface CCM bidirectional unit 07299001190 Diluent Universal EZG Diluent Universal 07299010190 Diluent MultiAssay E2G Diluent MultiAssay 07399774001 13mm sample disk tube adapter (sdta} 13 mm sample disk tube adapter 07439822001 c8100 v2 Type Alpha (IPB,DSP,OBS,CRW,CU) cobs 8100 Model Alpha with CRW 07439920001 c8100v2 Beta(IPB,DSP,BCL,AQM,OBS,CRW,CU) cobas 8100 Model Beta with CRW 07439997001 c8100 v2 CLO CLO for cobas 8100 07440006001 c8100 v2 CLW CLW for cobas 8100 07440022001 c8100 v2 CRO CRO for cobas 8100 07440049001 c8100 v2 CRW CRW for cobas 8100 07440057001 c8100 v2 PXT PXT for cobas 8100 07440065001 c8100 v2 RFX incl. Conn. RFX for cobas 8100 07440073001 c8100 v2 SCM SCM for cobas 8100 07440081001 c8100 v2 SLL SLL for cobas 8100 07440090001 c8100 v2 SLR SLR for cobas 8100 07440103001 £8100 v2 TL] 300 TLI300 for cobas 8100 07440111001 c8100 v2 TL] 600 TLI600 for cobas 8100 07440120001 c8100 v2 TL] 900 TLI)00 for cobas 8100 07440138001 c8100 v2 TL] 1200 TLI1200 for cobas 8100 07440146001 c8100 v2 TL] 1500 TL1500 for cobas 8100 07441541001 c8100 v2 TL] 1800 TLI800 for cobas 8100 07441592001 c8100 v2 TL]2100 TLI2100 for cobas 8100 07441606001 c8100 v2 TL]2400 TL12400 for cobas 8100 07441614001 c8100 v2 TL] 2700 TLI2700 for cobas 8100 07441622001 c8100 v2 TL] 3000 TLI3000 for cobas 8100 07474652001 cobs 8100 Signal Tower Signal Tower 07474687001 cobas 8100° Connection let STA-R Connection kit STA-R 07476124001 Universal Connection Unit (UCU) UCE for cobas 8100 07563116001 COBAS P 612 PRE-ANALYTICAL SYSTEM cobs p612 07563124001 COBAS P 512 PRE-ANALYTICAL SYSTEM cobs p 512 07563787001 COBAS P 471 CENTRIFUGE UNIT cobas p 471

\ C

C I

07667574001 OUTPUT UNIT Output unit 07667680001 Add-On Buffer Unit Type-2 Add-On Buffer Unit 07700814001 Reaction Cell c 513 Reaction Cell for cobas c $13 07787120001 IPB for cobas 8100 07787138001 AQM for c o b s 8100 07787146001 DSP for cobas 8100 07802536001 SW DM C8000 v1.05.01 cobs 8000* Data Manager 07902697001 Liaison XL Connection Module 08010595001 2nd BCI, for cobas 8100 08015589001 RSS for cobas 8100 08015597001 2nd IPB for cobas 8100 08126232001 Self-Contained ISE Support Box cobs 8000 ISE Support Box 08137200001 100 pos tray IPB/OBS mod let 08137218001 H] IT/Sysmex Tray Lane Arm cover 08137536001 HH'l` l tray IPB/OBS mod kit

l

08137579001 HHT 2 tray IPB/OBS mod kit 08137595001 HHT + 1 tray IPB/OBS mod kit 08137633001 Sysmex Tray OBS mod kit

J

2.1_EP

Essential Principle A / NA

Method of Conformity Identity of Specific Document

CONFIDENTIAL AND PROPRIETARY

DiaDoc-ID Template: 0000000000001200000150941|000|01|007 2/13

6 Essential Principles A1 Medical devices should be designed and manufactured in such a way that, when used under the conditions and for the purposes intended and, where applicable, by virtue of the technical knowledge, experience, education or training, and the medical and physical conditions of intended users, they will perform as intended by the manufacturer and not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.

A ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes

ISO 13485 Certificate, CE Declaration of Conformity

ISO 14971 Medical devices – Application of risk management to medical devices

Risk Management Summary

IEC 62366 Medical devices, Application of usability engineering to medical devices.

Warnings (Labelling), Risk Management Summary

A2 The solutions adopted by the manufacturer for the design and manufacture of the devices should conform to safety principles, taking account of the generally acknowledged state of the art. When risk reduction is required, the manufacturer should control the risks so that the residual risk associated with each hazard is judged acceptable. The manufacturer should apply the following principles in the priority order listed: - identify known or foreseeable hazards and estimate the associated risks arising from the intended use and foreseeable misuse; - eliminate risks as far as reasonably practicable through inherently safe design and manufacture; - reduce as far as reasonably practicable the remaining risks by taking adequate protection measures, including alarms; and - inform users of any residual risks.

A ISO 14971 Medical devices – Application of risk management to medical devices

Risk Management Summary, Instructions for use

EN 62366 Medical devices, Application of usability engineering to medical devices.

Warnings (Labelling), Risk Management Summary

ISO 18113-1 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements

Labelling

ISO 18113-2 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use

Labelling

A3 Medical devices should achieve the performance intended by the manufacturer and be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose.







EN 13612 Performance evaluation of in vitro diagnostic medical devices

Application Report, Labelling

EN 13975 Sampling procedures used for acceptance testing of in-vitro diagnostic medical devices –Statistical aspects

Quality Control Specification Certificate of Analyses

A4 The characteristics and performances referred to in Clauses A1, A2 and A3 should not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer’s instructions.


Risk Management Summary, Labelling


Application Report

EN 23640 Evaluation of stability of in vitro diagnostic reagents

Stability Certificate

A5 Medical devices should be designed, manufactured and packaged in such a way that their characteristics and performances during their intended use will not be adversely affected by transport and storage conditions (for example, fluctuations of temperature and humidity) taking account of the instructions and information provided by the manufacturer.



A6 All known and foreseeable risks, and any undesirable effects, should be minimised and be acceptable when weighed against the benefits of the intended performance of medical devices during normal conditions of use.



8 Design and Manufacturing Requirements C1 Chemical, physical and biological properties





C1.1 The IVD medical devices should be designed and manufactured in such a way as to ensure the characteristics and performance referred to in Section 6. Particular attention should be paid to the possibility of impairment of analytical performance due to incompatibility between the materials used and the specimens and/or analyte (measurand) to be detected (such as biological tissues, cells, body fluids and microorganisms), taking account of its intended purpose.


Risk Management Summary, Instructions for use, Safety Data Sheet


Application Report

C1.2 The IVD medical devices should be designed, manufactured and packaged in such a way as to minimize the risk posed by contaminants and residues to the persons involved in the transport, storage and use of the devices and to patients, taking account of the intended purpose of the device.



C1.3 The IVD medical devices should be designed and manufactured in such a way as to reduce as far as reasonably practicable and appropriate the risks posed by substances that may leach or leak from the IVD medical device. Special attention should be given to substances which are carcinogenic, mutagenic or toxic to reproduction.



C1.4 IVD medical devices should be designed and manufactured in such a way as to reduce as far as reasonably practicable and appropriate risks posed by the unintentional ingress or egress of substances into or from the IVD medical device taking into account the device and the nature of the environment in which it is intended to be used.



C2 Infection and microbial contamination C3 IVD medical devices incorporating materials of biological origin

C2.1 The IVD medical devices and manufacturing processes should be designed in such a way as to eliminate or to reduce as far as reasonably practicable and appropriate the risk of infection to user, professional or lay, or, where applicable, other person . The design should: • allow easy and safe handling; and, where necessary: • reduce as far as reasonably practicable and appropriate any microbial leakage from the IVD medical device and/or microbial exposure during use; and • prevent microbial contamination of the IVD medical device or specimen where applicable, by the user, professional or lay, or other person.



IEC 62366 Medical devices, Application of usability engineering to medical devices.



Application Report





C3.1 Where IVD medical devices include tissues, cells and substances originating from animals, the processing, preservation, testing and handling of tissues, cells and substances of animal origin should be carried out so as to provide optimal safety for user, professional or lay, or other person. In particular, safety with regard to viruses and other transmissible agents should be addressed by implementation of validated methods of elimination or inactivation in the course of the manufacturing process. This may not apply to certain IVD medical devices if the activity of the virus and other transmissible agent are integral to the intended purpose of the IVD medical device or when such elimination or inactivation process would compromise the performance of the IVD medical device. National regulations may require that the manufacturer and/or the Regulatory Authority retain information on the geographical origin of the animals.

NA EN 13641 No tissues, cells and substances originating from animals included.

Material Safety Data Sheet

C3.2 Where IVD medical devices include human tissues, cells and substances, the selection of sources, donors and/or substances of human origin, the processing, preservation, testing and handling of tissues, cells and substances of such origin should be carried out so as to provide optimal safety for user, professional or lay, or other person. In particular, safety with regard to viruses and other transmissible agents should be addressed by implementation of validated methods of elimination or inactivation in the course of the manufacturing process. This may not apply to certain IVD medical devices if the activity of the virus and other transmissible agent are integral to the intended purpose of the IVD medical device or when such elimination or inactivation process would compromise the performance of the IVD medical device

NA EN 13641 No human tissues, cells and substances are included.


C3.3 Where IVD medical devices include cells and substances of microbial origin, the processing, preservation, testing and handling of cells and substances should be carried out so as to provide optimal safety for user, professional or lay, or other person. In particular, safety with regard to viruses and other transmissible agents should be addressed by implementation of validated methods of elimination or inactivation in the course of the manufacturing process. This may not apply to certain IVD medical devices if the activity of the virus and other transmissible agent are integral to the intended purpose of the IVD medical device or when such elimination or inactivation process would compromise the performance of the IVD medical device.

NA EN 13641 No cells and substances of microbial origin are included.


C2.2 IVD medical devices labelled either as sterile or as having a special microbiological state should be designed, manufactured and packaged to ensure they remain so when placed on the market and remain so under the transport and storage conditions specified by the manufacturer, until the protective packaging is damaged or opened.

NA Not labelled either as sterile or as having a special microbiological state.

C2.3 IVD medical devices labelled either as sterile or as having a special microbiological state should have been processed, manufactured and, if applicable, sterilized by appropriate, validated methods.

NA Not labelled either as sterile or as having a special microbiological state.

C2.4 IVD medical devices intended to be sterilized should be manufactured in appropriately controlled (e.g. environmental) conditions.

NA Not intended to be sterilized





C2.5 Packaging systems for non-sterile IVD medical devices should maintain the integrity and cleanliness of the device.


Risk Management Summary, Labelling

NA Devices are not to be sterilized prior to use

C4 Environmental properties

C4.1 If the IVD medical device is intended for use in combination with other devices or equipment, the whole combination, including the connection system should not impair the specified performance of the devices. Any restrictions on use applying to such combinations should be indicated on the label and/or in the instructions for use.



EN 980 Symbols for use in the labelling of medical devices

Labelling


Labelling

C4.2 IVD medical devices should be designed and manufactured in such a way as to remove or reduce as far as reasonably practicable and appropriate: C4.2.1 the risk of injury to user, professional or lay, or other person in connection with their physical and ergonomic features; C4.2.2 the risk of use error due to the ergonomic features, human factors and the environment in which the IVD medical device is intended to be used; C4.2.3 risks connected with reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, pressure, humidity, temperature or variations thereof; C4.2.4 the risks associated with the use of the IVD medical device when it comes into contact with materials, liquids, and gases to which it is exposed during normal conditions of use; C4.2.5 the risk associated with the possible negative interaction between software and the environment within which it operates and interacts; C4.2.6 the risks of accidental penetration of substances into the IVD medical device; C4.2.7 the risk of incorrect identification of specimens/samples; C4.2.8 the risks of reasonably foreseeable interference with other devices such as carry over between IVD medical devices.



IN GENERELL CE Declaration of Conformity

C4.3 IVD medical devices should be designed and manufactured in such a way as to minimize the risks of fire or explosion during normal use and in single fault condition. Particular attention should be paid to IVD medical devices whose intended use includes exposure to or use in association with flammable substances or substances which could cause combustion.


Risk Management Summary, Material Safety Data Sheet





C4.4 IVD medical devices should be designed and manufactured in such a way that adjustment, calibration, and maintenance, where such is necessary to achieve the performances intended, can be done safely.



C4.5 IVD medical devices should be designed and manufactured in such a way as to facilitate the safe disposal of any waste substances.



C5 Performance characteristics

C5.1 IVD medical devices should be designed and manufactured in such a way that the performance characteristics support the intended use, based on appropriate scientific and technical methods. In particular, where appropriate, the design should address sensitivity, specificity, accuracy which is trueness and precision (repeatability and reproducibility), control of known relevant interference and limits of detection. These performance characteristics need to be maintained during the lifetime of the IVD medical device as indicated by the manufacturer.

A EN 13612 Performance evaluation of in vitro diagnostic medical devices

Application Report

C5.2 Where the performance of devices depends on the use of calibrators and/or control materials, the traceability of values assigned to such calibrators and/or control materials should be assured through available reference measurement procedures and/or available reference materials of a higher order.

A


Application Report

ISO 17511 In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values assigned to calibrators and control materials

Labeling (Traceability Section Instruction for use)

ISO 18153 In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials

Labeling (Traceability Section Instruction for use)





C5.3 Wherever possible values expressed numerically should be in commonly accepted, standardized units, and understood by the users of the device. Note: While SG1 generally supports convergence on the global use of internationally standardized measurement units, considerations of safety, user familiarity, and established clinical practice may justify the use of other recognized measurement units.

A ISO 18113-1 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements

Labelling


Labelling

C6 Protection against radiation No radiation

C6.1 IVD medical devices should be designed, manufactured and packaged in such a way that exposure of user, professional or lay, or other person to the emitted radiation (intended, unintended, stray or scattered) is reduced as far as reasonably practicable and appropriate.

NA

C6.2 When IVD medical devices are intended to emit potentially hazardous, visible and/or invisible radiation, they should as far as reasonably practicable and appropriate be: - designed and manufactured in such a way as to ensure that the characteristics and the quantity of radiation emitted can be controlled and/or adjusted; and - fitted with visual displays and/or audible warnings of such emissions.

NA

C7 IVD medical devices that incorporate software and standalone IVD medical device software

No Software

C7.1 For IVD medical devices which incorporate software or for standalone software that are IVD medical devices in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, verification and validation.

NA

C8 IVD medical devices connected to, or equipped with, an energy source No energy source





C8.1 IVD medical devices where the safety of the patient depends on an internal power supply in the IVD medical device should be equipped with a means of determining the state of the power supply.

NA

C8.2 IVD medical devices should be designed and manufactured in such a way as to reduce as far as reasonably practicable and appropriate the risks of creating electromagnetic interference which could impair the operation of this or other devices or equipment in the usual environment.

NA

C8.3 IVD medical devices should be designed and manufactured in such a way as to provide an adequate level of intrinsic immunity to electromagnetic disturbance to enable them to operate as intended.

NA

C8.4 IVD medical devices should be designed and manufactured in such a way as to avoid,as far as reasonably practicable, the risk of accidental electric shocks to the user, professional or lay, or other person both during normal use of the device and in the event of a single fault condition in the device, provided the IVD medical device is installed and maintained as indicated by the manufacturer.

NA

C9 Protection against mechanical and thermal risks No IVD Medical Device Instrument

C9.1 IVD medical devices should be designed and manufactured in such a way as to protect the user, professional or lay, or other person against mechanical risks connected with, for example, resistance to movement, instability and moving parts.

NA

C9.2 Where there are risks due to the presence of moving parts, risks due to break-up or detachment, or leakage of substances, then appropriate protection means must be incorporated.

NA

C9.3 IVD medical devices should be designed and manufactured in such a way as to reduce to the lowest practicable level the risks arising from vibration generated by the devices, taking account of technical progress and of the means available for limiting vibrations, particularly at source, unless the vibrations are part of the specified performance.

NA

C9.4 IVD medical devices should be designed and manufactured in such a way as to reduce to the lowest practicable level the risks arising from the noise emitted, taking account of technical progress and of the means available to reduce noise, particularly at source.

NA





C9.5 Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy supplies which the user, professional or lay, or other person has to handle should be designed and constructed in such a way as to minimize all possible risks.

NA

C9.6 IVD medical devices should be designed and manufactured in such a way as to reduce to the lowest practicable level, the risk of error when certain parts within the device are intended to be connected or reconnected before or during use.

NA

C9.7 Accessible parts of the IVD medical devices (excluding the parts or areas intended to supply heat or reach given temperatures) and their surroundings should not attain potentially dangerous temperatures under normal use.

NA

5.14 Protection against the risks posed to the patient by supplied energy or substances No medical electrical equipment

5.14.1 Devices for supplying the patient with energy or substances should be designed and constructed in such a way that the delivered amount can be set and maintained accurately enough to guarantee the safety of the patient and of the user.

NA

5.14.2 Devices should be fitted with the means of preventing and/or indicating any inadequacies in the delivered amount which could pose a danger. Devices should incorporate suitable means to prevent, as far as possible, the accidental release of dangerous levels of energy from an energy and/or substance source.

NA

5.14.3 The function of the controls and indicators should be clearly specified on the devices. Where a device bears instructions required for its operation or indicates operating or adjustment parameters by means of a visual system, such information should be understandable to the user and, as appropriate, the patient.

NA

C10 Protection against the risks posed by IVD medical devices for self-testing No self-testing IVD Medical Device

C10.1 IVD medical devices for self-testing should be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to lay persons and the influence resulting from variation that can reasonably be anticipated in the lay person’s technique and environment. The information and instructions provided by the manufacturer should be easy for the lay person to understand and apply.

NA

C10.2 IVD medical devices for self-testing should be designed and manufactured in such a way as to reduce as far as reasonably practicable the risk of error by the lay person in the handling of the device and, if applicable, the specimen, and also in the interpretation of results.

NA

C10.3 IVD medical devices for self-testing should, where reasonably possible, include a procedure by which the lay person can verify that, at the time of use, the product will perform as intended by the manufacturer.

NA





C11 Label and Instructions for Use

C11.1 Users should be provided with the information needed to identify the manufacturer, to use the device safely and to ensure the intended performance, taking account of their training and knowledge. This information should be easily understood Further information is provided in GHTF/SG1/N70:2011 Label and Instructions for Use for Medical Devices.

A ISO 18113-1 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements

Labelling


Labelling

EN 980 Symbols for use in the labelling of medical devices

Labelling


Application Report





C12 Performance evaluation including analytical performance and, where appropriate, clinical performance

C12.1 For an IVD medical device a performance evaluation should be conducted in accordance with GHTF guidance. The performance evaluation should review analytical performance data and, where appropriate, clinical performance data in the form of any: • literature; • performance study reports; and • experience gained by routine diagnostic testing. to establish that the IVD medical device achieves its intended performance during normal conditions of use and that the known, and foreseeable risks, and any undesirable effects, are minimised and acceptable when weighed against the benefits of the intended performance.

A EN 13612 Performance evaluation of in vitro diagnostic medical devices

Application Report, Labeling, Performance Evaluation Report

C12.2 Clinical performance studies using specimens from human subjects should be carried out in accordance with the spirit of the Declaration of Helsinki. This includes every step in the clinical performance study from first consideration of the need and justification of the study to publication of the results. In addition, some countries may have specific regulatory requirements for informed consent.

NA EN 13612 In general not applicable because use of left over samples is exempted.

CE Declaration of Conformity



List of applicable standards:

EN Standards:

EN 980 Symbols for use in the labelling of medical devices EN 13612 Performance evaluation of in vitro diagnostic medical devices EN 23640 Evaluation of stability of in vitro diagnostic reagents EN 13641 Elimination or reduction of risk of infection related to in vitro diagnostic reagents EN 13975 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

ISO Standards:

ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes ISO 14971 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) ISO 17511 In vitro diagnostic medical devices - Measurement of quantities in biological samples -- Metrological traceability of values assigned to

calibrators and control materials ISO 18113-1 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements ISO 18113-2 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for

professional use ISO 18153 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic

concentration of enzymes assigned calibrators and control materials

3.1_ISO

3.2_Stability Report


Doc.No. 04489365190_05172179190_PV StabiReal_OBS_Transport_11-Apr-2017

Page 2 of 3

Table of content

1. REAGENT REAL TIME STABILITY .............................................................................................................................. 3

1.1. Purpose .............................................................................................................................................................. 3

1.2. Testing Procedure/ Acceptance Criteria ............................................................................................................ 3

1.3. Results ............................................................................................................................................................... 3

1.4. Conclusion ......................................................................................................................................................... 3


Doc.No. 04489365190_05172179190_PV StabiReal_OBS_Transport_11-Apr-2017

Page 3 of 3

1. Reagent Real Time Stability

1.1. Purpose The purpose of the real time stability study is to examine the possibility of long-term storage at 2 to 8°C.

1.2. Testing Procedure/ Acceptance Criteria The testing of the real-time stability (storage at 2 to 8°C) is done according to current standard operating procedures. The function of 3 lots is tested at least after production, in the middle of the shelf life and after expiry. Acceptance criteria for stability study:

Sample Specification Sodium Chloride 87.3 – 92.7 mg/mL

1.3. Results Refer to Certificate of Stability

1.4. Conclusion The results of this real time stability program show the stability of SI2 under the tested conditions. The claimed shelf life is stated on the Stability Certificate.

Document Information:

Document Author: Jaeschke, Irmgard {DOMC~Mannheim}Business Area / Unit: Roche Professional DiagnosticsConfidentiality: ConfidentialDocument Class: Device History RecordDocument Type: Device History RecordDocument Creator: Jaeschke, Irmgard {DOMC~Mannheim}Document Lifecycle Status: SignedValid From: 18-Feb-2019 15:07:27 (UTC)Valid To: Document Title: C_0201_RSZ_20756350000Document Number: 0000000000001008019000279Document Version: 11Template: No

Global Group: Regulatory AffairsGlobal SubGroup: Certificate of Stability(Reg.)Local Group: Reg. Stab. CertificatesLanguage: EnglishSite: RDG GermanyDepartment: C_DOMCCDocument Applies To: C_QC Centralized AssaysDocument Description: Diluent NaCl 9 % / Serum Index Gen.2 (SI2)and Sample Index

Gen.2 (SI2) - "Only for use in Regulatory Affairs"

Electronic Signatures: Signed By: schenkw1 (Walter Schenk {DOMCC})Role: ReviewerSignature Differentiation: Quality ControlSigned Date: 18-Feb-2019 10:54:06 (UTC)

Signed By: loewh (Heiner Loew {DOMC})Role: ApproverSignature Differentiation: Quality ControlSigned Date: 18-Feb-2019 14:55:56 (UTC)

This copy will not be updated. Verify the status of this version in DiaDoc or contact your ROCHE representative prior to use.Diese Kopie wird nicht aktualisiert. Überprüfen Sie vor Gebrauch den Status dieser Version im DiaDoc oder kontaktieren Sie Ihren ROCHE

Ansprechpartner.Esta copia no va a ser actualizada. Verifique el “status” de esta versión en DiaDoc o contacte a su representante de ROCHE antes de

utilizarla.

Confidentiality: Confidential

Title: C_0201_RSZ_20756350000 Document Number: 0000000000001008019000279

Print Comment:Print Date:

Version: 11 Status: Signed Valid from: 18-Feb-2019 15:07:27 (UTC)

Cover Page 1 (1)

Certificate of Stability

Product: Diluent NaCl 9 % Catalog No. 207563503220448935719004774230190051721521900517215221408063494190

Serum Index Gen.2 (SI2) Catalog No. 04489365190NaCl 9 % 05172179190

05172179214

Sample Index Gen.2 (SI2) Catalog No. 08063516190NaCl 9 %

Based onAssay of Sodium chloride

Procedure: In accordance with the Testing procedure.

Stability test report lot-no.: 60026901See enclosure.



Stable at least 21 months, stored at +2 to +8 °C.

Roche Diagnostics GmbHRoche Diagnostics Global OperationsQuality Control Mannheim

D-68305 MannheimPhone: +49-621-759-0Fax: +49-621-759-2890


Title: C_0201_RSZ_20756350000 Document Number: 0000000000001008019000279Print Comment:Print Date:

Version: 11 Status: Signed Valid from: 18-Feb-2019 15:07:27 (UTC)Content Page 1 (3)

Material/Catalog No.:05172179190

Stability test report lot-no: 60026901

Parameter Results

At the timeof release-

testing(start 0)

after 7 months

after 15 months

after 23 months

Sodium chloride(87.3 - 92.7 mg/mL) 90.1 mg/mL 88.0 mg/mL 89.8 mg/mL 92.0 mg/mL



Parameter Results


testing(start 0)

after 7 months

after 14 months

after 22 months




Parameter Results


testing(start 0)

after 8 months

after 14 months

after 22 months





Multi-purpose reagent (R1), Sodium chloride solution Mat. No. 12108216001is used for:

Diluent NaCl 9 % Cat. No. 20756350322(COBAS INTEGRA)

Diluent NaCl 9 % Cat. No. 04489357190(Roche/Hitachi cobas c)

Diluent NaCl 9 % Cat. No. 04774230190(cobas c 111)

Diluent NaCl 9 % Cat. No. 05172152190(Roche/Hitachi cobas c 701/702)

Diluent NaCl 9 % Cat. No. 08063494190(Roche/Hitachi cobas c 503)

Serum Index Gen.2 (NaCl 9 %) Cat. No. 04489365190(cobas c/COBAS INTEGRA)

Serum Index Gen.2 (NaCl 9 %) Cat. No. 05172179190(Roche/Hitachi cobas c 701/702)

Sample Index Gen.2 (NaCl 9 %) Cat. No. 08063516190(Roche/Hitachi cobas c 503)

HIL Test Cat. No. 07470045190(cobas t 511/711)

And

Multi-purpose reagent (R1), Sodium chloride solution Mat. No. 12108216118is used for:

Diluent NaCl 9 % Cat. No. 05172152214(Roche/Hitachi cobas c 701/702)

Serum Index Gen.2 (NaCl 9 %) Cat. No. 05172179214(Roche/Hitachi cobas c 701/702)

The composition from reagent Sodium chloride solution Mat. No. 12108216001 and Mat. No. 12108216118 are identical, therefore the measured results are transferable.





PV Stability

Page 2 of 5

Table of content

1. REAGENT REAL TIME STABILITY ................................................................................................................................ 3

1.1. Purpose .............................................................................................................................................................. 3 1.2. Testing Procedure/ Acceptance Criteria ............................................................................................................ 3 1.3. Results ............................................................................................................................................................... 3 1.4. Conclusion ......................................................................................................................................................... 3

2. REAGENT IN-USE STABILITY ...................................................................................................................................... 4 2.1. Purpose .............................................................................................................................................................. 4 2.2. Definition ........................................................................................................................................................... 4 2.3. Methods/Testing Procedure .............................................................................................................................. 4 2.4. Acceptance Criteria ........................................................................................................................................... 5 2.5. Conclusion ......................................................................................................................................................... 5


PV Stability

Page 3 of 5

1. Reagent Real Time Stability

1.1. Purpose The purpose of the real time stability study is to examine the possibility of long-term storage at 2 to 8°C.

1.2. Testing Procedure/ Acceptance Criteria The testing of the real-time stability (storage at 2 to 8°C) is done according to current standard operating procedures. The function of 3 lots is tested at least after production, in the middle of the shelf life and after expiry. Acceptance criteria for stability study:

Sample Specification Sodium Chloride 87.3 – 92.7 mg/mL

1.3. Results Refer to Certificate of Stability

1.4. Conclusion The results of this real time stability program show the stability of SI2 under the tested conditions. The claimed shelf life is stated on the Stability Certificate.


PV Stability

Page 4 of 5

2. Reagent in-use stability

2.1. Purpose Transport and on-board stabilities, as described in the respective package inserts of SI2 are determined by testing one reagent lot.

2.2. Definition Reagent in-use stability shows product stability within specified limits after opening and putting into use.

2.3. Methods/Testing Procedure On-board stability, Transport stability and Reagent Manager Autoloader On board Stability (ALOBS), c701/702 only. Stabilities are measured in a combined study. On-board reagent stability: Integra, c501: The reagent is stored on-board the analyzer for 12 weeks. The first testing point was unstressed reagent, the second testing point was after on-board time and the third testing point was ≥10% after on-board time. At these testing points the samples were tested with n=21 and the within-run precision was calculated. In addition, the linearity was measured with 11 levels in triplicate determinations and method comparison of stressed vs. fresh reagent was performed. c701: The reagent is stored on-board the analyzer for 4 weeks and ALOBS for 24 hours. The first testing point was unstressed reagent, the second testing point was after on-board time and the third testing point was ≥10% after on-board time. At these 3 testing points the samples were tested with n=21 and the within-run precision was determined. The sample recovery at these testing points was calculated. In addition, the linearity was measured with 12 levels in triplicate determinations and method comparison of stressed vs. fresh reagent was performed. c503: The reagent is stored on-board the analyzer for 26 weeks. The first testing point was unstressed reagent, other testing points were after transport stress for 5 days at 35°C (initial onboard time point), after on-board time and ≥10% after on-board time. At these testing points the samples were tested with n=21 and the within-run precision was determined. The sample recovery at these testing points was calculated. In addition the linearity was measured with 16 levels and triplicate determinations.


PV Stability

Page 5 of 5

Transport stability: The confirmation occurs at the end of the real-time stressing using the first lot of the real-time test (combination of real-time stability). Recovery was measured. Refer to Certificate of Stability.

2.4. Acceptance Criteria See Master and A-Level Application reports

2.5. Conclusion The presented data are all within the specified acceptance criteria.

4.1_Performance Report


PV Perf

Page 2 of 8

Table of content 1. SPECIFICATIONS ................................................................................................................................................... 3

2. MATERIALS AND METHODS .................................................................................................................................. 3

3. SUMMARY / CONCLUSION .................................................................................................................................... 3

4. RESULTS APPLICATION REPORT SI2 ....................................................................................................................... 4

4.1. PRECISION ................................................................................................................................................................. 4 Purpose ............................................................................................................................................................................ 4 Definition ......................................................................................................................................................................... 4 Methods / Testing Procedure .......................................................................................................................................... 4 Results ............................................................................................................................................................................. 4 References ....................................................................................................................................................................... 4

4.2. ANALYTICAL SENSITIVITY ............................................................................................................................................... 5 Purpose ............................................................................................................................................................................ 5 Definition ......................................................................................................................................................................... 5 Methods / Testing Procedure .......................................................................................................................................... 5 Results ............................................................................................................................................................................. 5 References ....................................................................................................................................................................... 5

4.3. ANTICOAGULANTS / GEL SEPARATION TUBES .................................................................................................................... 6 Purpose ............................................................................................................................................................................ 6 Definition ......................................................................................................................................................................... 6 Methods/Testing Procedure ............................................................................................................................................ 6 Results ............................................................................................................................................................................. 6 References ....................................................................................................................................................................... 6

4.4. LINEARITY .................................................................................................................................................................. 7 Purpose ............................................................................................................................................................................ 7 Definition ......................................................................................................................................................................... 7 Methods/Testing Procedure ............................................................................................................................................ 7 Results ............................................................................................................................................................................. 7 References ....................................................................................................................................................................... 7

4.5. METHOD COMPARISON ................................................................................................................................................ 8 Purpose ............................................................................................................................................................................ 8 Definition ......................................................................................................................................................................... 8 Methods/Testing Procedure ............................................................................................................................................ 8 Results ............................................................................................................................................................................. 8 References ....................................................................................................................................................................... 8


PV Perf

Page 3 of 8

1. Specifications For SI2 please see the following application reports Master Application report for: - c501 - I400 - c503 A-level Application report for: - c311 - c701

2. Materials and Methods See Application reports for SI2 as above.

3. Summary / Conclusion See Application reports for SI2 as above.


PV Perf

Page 4 of 8

4. Results Application report SI2 4.1. Precision

Purpose The purpose of this study is to evaluate the precision of the assay.

Definition Precision is the performance characteristic representing the random error in a series of measurements from a homogeneous sample. Precision was determined according to an internal protocol.

Methods / Testing Procedure Precision measurements were conducted to evaluate repeatability (within-run precision). Precision was determined as follows: ≥ 3 samples are measured with 21-fold determination.

Results See Master and A-level Application reports

References N/A


PV Perf

Page 5 of 8

4.2. Analytical sensitivity

Purpose This report describes the analytical sensitivity of the assay.

Definition Lower Detection Limit (LDL): Lowest amount of analyte in a sample that can be detected with (stated) probability.

Methods / Testing Procedure LDL 21 determinations of an analyte-free sample were obtained in a single run on one instrument. Mean and SD were calculated and LDL determined.

Results See Master and A-level Application reports

References N/A


PV Perf

Page 6 of 8

4.3. Anticoagulants / Gel separation tubes

Purpose The purpose of this study is the assessment of the usability of various plasma types and primary tubes compared to serum or to a dedicated plasma type.

Definition This method describes the specimen comparison between serum and plasma samples.

Methods/Testing Procedure Integra, c501: The effect on quantitation of analyte in the presence of anticoagulants was determined by comparing values obtained from native samples with samples spiked with analyte drawn into Serum, Li-Heparin- and K2-EDTA-Plasma and Serum tubes with separation gel. The data for K2-EDTA- and Li-Heparin-Plasma demonstrate that there is no significant difference in absorbance for serum and plasma. Therefore, other plasma types (K3-EDTA-, Citrate-, NaF/Na-heparin- and NaF/K-oxalate-Plasma) are claimed in addition. The samples of each plasma type were measured together with the serum sample of the same donor in single replicates. c503: The effect on quantitation of analyte in the presence of anticoagulants was determined by comparing values obtained from native samples with samples spiked with analyte drawn into Serum, Li-Heparin-, K2-EDTA-, K3-EDTA-, Citrate-, NaF/Na-Heparin- and NaF/K-Oxalate-Plasma and Serum tubes with separation gel. The samples of each plasma type were measured together with the serum sample of the same donor in single replicates.

Results See Master Application reports

References N/A


PV Perf

Page 7 of 8

4.4. Linearity

Purpose The purpose of this study was to give evidence that the assay is linear over the entire specified measuring range (lower and upper limit of the measuring range).

Definition Linearity is the ability of a test to provide results that are directly proportional to the concentration of the analyte in the test sample. The linearity is tested by plotting known levels of an analyte against the measured values.

Methods/Testing Procedure Integra, c501: Dilution series were prepared using human serum pools with concentrations above the upper end of the measuring range. Dilutions were made using serum. The dilution series contain at least 9 concentrations. Samples were assayed in 3-fold determination within a single run. The linearity data were analyzed with regards to linear, quadratic and cubic polynomials according to CLSI EP06. In the first step, a linearity check was performed with a first order (linear) regression and then with higher order models (quadratic and cubic). c503: Dilution series were prepared using human sample pools (serum, plasma, urine or CSF) with concentrations above the upper end of the measuring range. Dilutions were made using 0.9% NaCl. The dilution series contains at least 9 concentrations. Samples were assayed in 4-fold determination within a single run. The linearity data were analyzed with regards to linear, quadratic and cubic polynomials according to CLSI EP06. In the first step, a linearity check was performed with a first order (linear) regression and then with higher order models (quadratic and cubic).

Results See Master application reports

References CLSI EP6: Evaluation of the Linearity of Quantitative Measurement Procedures


PV Perf

Page 8 of 8

4.5. Method Comparison

Purpose c501: This report describes the method comparison of the SI2 assay on a cobas c501 analyzer vs. the Roche/Hitachi 917 analyzer. c701: This report describes the method comparison of the SI2 assay on a cobas c701 analyzer vs. the cobas c501 analyzer. Integra: This report describes the method comparison of the SI2 assay on a COBAS INTEGRA analyzer vs. the Roche/Hitachi 917 analyzer. c503: Sample index values for human serum and plasma samples obtained on a cobas c 503 analyzer were compared with those determined using the corresponding reagent on a cobas c 501 analyzer.

Definition This method comparison shows the extent of relationship between two methods (e.g. intercept, slope, correlation) according to CLSI EP09.

Methods/Testing Procedure The study was performed on analyzers (see purpose above) using the SI2 assay and the reference assay. Samples were measured in single determinations. Potential effects were assessed by Passing/Bablok and Linear regression analysis according to CLSI EP09.

Results See Master and A-Level Application reports

References CLSI EP09: Measurement Procedure Comparison and Bias Estimation Using Patient Samples

4.1 Risk Management Report

Document ID: 0000000000001200000060357 000 03 007

Title: Y_04.16_Att01_ATTM_EN

Document Valid From / Version: 01-Jan-2014 00:11:09 (UTC) / 03r

Cover SheetVersion HistoryVersion 1: New, according to Div. Standard DS42

Version 2: editorial changes

Version 3: Editorial changes and bugfixes. Changed severity rating according to new DS42-02

Product:

History:

Version Date Changes Author

4,00 see DIAdoc Transfer to new template. Addition of cobas c 503 Franka Wieder

5,00 see DIAdoc Addition of references and not used risks from the generic analysis Franka Wieder

6,00 see DIAdoc

Addition of SPV to material numbers.

Addition of material number for c701 produced in AMS. Sandra Applis

7,00 see DIAdoc Update of product table and used references and comments. Sandra Applis

8,00 see DIAdoc

Evaluation of impact of risk control measures on existing risks added.

Overall risk, state-of-the art, products assessed updated acc. to new

version of RP0001. Update of references used. Patricia Weber

Participants of the risk analysis:Name Organization Responsibility Date, Signature

see DIADoc see DIADoc see DIADoc see DIADoc

Comments:> Author and Moderator may be identical

> If the template is processed in a Document Management System (DMS), signatures on this page may be replaced by signatures during the

workflow in the DMS:

Risk Management Report (Customized Route)

URCIII: 08063516190

URCI: 04489365190; URCII: 05172179190, 05172179214;

KTemplate - Copying permitted / Kopieren erlaubt Page 1 (7)

Document ID: 0000000000001200000060357 000 03 007


Document Valid From / Version: 01-Jan-2014 00:11:09 (UTC) / 03 r

Using this MS-Excel Tool

Shifting / inserting /deleting rows:

a) Shifting

b) Delete/Insert

c) Define printing area

d) Print out the whole document with an on-going page number

e) Only Print the rows filled in "Analysis"

Use this tool in consideration of the Divisional Standard DS 42. Information of relevance to this analysis but not fitting into this format shall be

documented separately and referenced.

Definition of printing area does not work with this Add - In. For defining the printing

area use the standard MS-Excel functionality "View/Ansicht" and select "Page brake

preview/Umbruchsvorschau". You will recognize a blue surrounding which displays

the boarders for the print out. You can now drag the boarder to fit your needs.

To perform one of these operations go to the MS-Excel Add - In "Adapt Rows, set print area".

1. Select the "Move" Tab

2. Enter a row number in the "Row to be moved" field (format Row:Column (A8 or

A9)) or mark the row with a left click after selecting the "Row to be moved" field with

you cursor. You can choose any column number in a row, only the row is important

for the functionality.

3. Enter a row number in the "Insert before Row:" indicating the location in which you

want to insert the row (Format Row:Column (B12)) or mark it with a left click after

selecting the "Insert before Row:" field with you cursor.

4. Confirm your entry with "OK" or cancel it with "Abort".

1. Select the "Delete/Insert" tab

2. Enter a row number in the "Select a Row" field (format Row:Column) or select a

row with left click after selecting the "Row to be moved" field with you cursor. Select

one of the actions.

3. Choose the intended action or abort.

Insert (new Row): a new row is inserted in the location that was entered in "Select a

Row".

Insert (Multiple rows): multiple new rows are inserted in the location that was entered

in "Select a Row". After pushing the "Insert (Multiple rows)" button you will be asked

how many rows you would like to add in a separate window (Nr. 4 screenshot).

Choose a value between 1 and 200.

Insert (Header): a new header row is inserted (shaded grey). The text will not

interfere with the graph calculation.

Delete Row: the row specified in "Select a Row" will be deleted.

Select the sheets "Cover sheet", "Data-Entry", "Graph" and "General" by constantly

pressing the STRG-Key and left click on the sheets. Then go to the printing dialogue

and select "Print". You should get all pages needed with an on-going page number

If you create a printout of the report but you don´t want to print the empty rows, you

have to do this by filtering. Click on the little arrow pointing downwards (shown by the

red arrow) and deselect "(Blank/Leere)". All rows without any input will be hidden for

the printout. If you want to show them again, do this by selecting "(Blank/Leere)"

again

1

2

3

4


Document ID: 0000000000001200000060357 000 03 007



8,00 Author:

Nr. Functionu

sab

ilit

y r

ela

ted

(x)

Hazard

Hazardous

situation

(cause of harm)

Established controls Harm

Pro

bab

ilit

y o

f

Occu

ren

ce

Severi

ty

Ris

k (

Co

lou

r)

Po

sit

ion

in

gra

ph

Additional measures for

reducing risks (or

rationale, if a yellow risk

cannot be further

reduced)

Responsible

reference

documentati

on

Pro

bab

ilit

y o

f

Occu

ren

ce

Severi

ty

Ris

k (

Co

lou

r)

Po

sit

ion

in

gra

ph

1 Use of the concept

individual incorrect results

of any assay due to endo-

geneous interference in

urine and CSF

no automatic detectability

of hemolysis in urine and

CSF and of icterus in

CSF by the analyzer

Monitoring of patient results

over time. Measurement of

quality control material.

indirect harm to patients

due to incorrect assay

results

8 6 06 08description and warning in

instructions for use in the section

"Limitations".

R&D and labelinginstructions for

use3 6 06 03

1 Use of the concept

individual incorrect results

of any assay due to endo-

geneous interference in

urine and CSF

no automatic detectability

of hemolysis in urine and

CSF and of icterus in

CSF by the analyzer

Monitoring of patient results

over time. Measurement of

quality control material.

indirect harm to patients

due to incorrect assay

results

8 6 06 08extension of use of sample index

also in urine and CSF on newer

systems (starting with cobas pro)

project team

cobas pro

instrument

specifications

cobas pro

3 6 06 03

Product:

Risk Analysis

URCI: 04489365190; URCII: 05172179190, 05172179214;

URCIII: 08063516190

Risk Reduction

Patricia Weber


Document ID: 0000000000001200000060357 000 03 007



8,00

10 High 0 0 0 0 0 10 High 0 0 0 0 0

8 Moderate 0 0 2 0 0 8 Moderate 0 0 0 0 0

6 Low 0 0 0 0 0 6 Low 0 0 0 0 0

3 Remote 0 0 0 0 0 3 Remote 0 0 2 0 0

1 Theoretical 0 0 0 0 0 1 Theoretical 0 0 0 0 0

Negligible Moderate High Critical Catastrophic Negligible Moderate High Critical Catastrophic

1 3 6 8 10 1 3 6 8 10

from Graph

from

Analysis from Graph

from

Analysis

red area: 0 0 red area: 0 0

yellow area: 2 2 yellow area: 0 0

green area: 0 0 green area: 2 2

Overall: 2 2 Overall: 2 2

Sum of equally coloured fields: Sum of equally coloured fields:

Status before Risk Reduction Status after Risk Reduction

Pro

ba

bil

ity

of

Oc

cu

rre

nc

e o

f H

arm

(P

)

Severity of harm (S) Severity of harm (S)

Pro

ba

bil

ity

of

Oc

cu

rre

nc

e o

f H

arm

(P

)

Representation of Risks for Health, Environment or Property before and after Risk Reduction

Product: URCI: 04489365190; URCII: 05172179190, 05172179214; Version:

URCIII: 08063516190

Patricia Weber


Document ID: 0000000000001200000060357 000 03 007



8,00 Author:

References used:

State of the art:

Overall risk / benefit :

use - IFU) according the established DCC process and QAP's.

hazardous situations are not negatively affected by the introduction of the risk control measures.

The implementation of the risk control measures did not introduce new hazards or hazardous situations. The estimated risks for previously identified

Homogeneous assay, run as automated assay on clinical chemistry analysers (professional use). Probability of occurrence P considered

application reports and design validation) are documented and made available to the customer in the package inserts/ method sheets (instruction for

Expected assay performance (data from application reports and design validation), acceptable residual risks and limitations of the device (data from

The overall residual risk is acceptable (all residual risks "green").

1.2.9-13 These performance data are not provided for a diluent

1.2.2-3 and 5-6 Diluent, no calibrator and controls are involved

1.1.2 Diluent, no calibrator and controls are involved

P1 (device deficiency to hazard) and P2 (hazard to harm). The following risks from the System Group Risk Analysis do not apply:

Clinical risk: see below **

1.6 Diluent, no dependency from sample material

1.4 Diluent, no calibrator are involved - 1.5 Diluent, no controls are involved

1.3.3.4 Diluent, no dependency from sample material - 1.3.3.5 Ready to use, no preparation necessary

IFU SI2 cobas Integra 400 plus/800, Version 02 (without USA), Version 03 (USA only)

IFU SI2 cobas c 503, Version 01

IFU SI2 cobas c 701/702, Version 06 (without USA), Version 06 (USA only)

IFU SI2 cobas c 311/501/502, Version 06, Version 08 (USA only);

Product Specification Document SerumIndex-Hit, Version 08, SampleIndex-Hit, Version 01 (Hitachi); SerumIndex-Int, Version 01 (Integra)

Analyzers, V3, 01-Apr-2018 (Diadoc No. 1200000285330).

Generic Usability Engineering (UEF) for Reagents and Reagent Carriers Clinical Chemistry/Homogenous ImmunoAssays on Roche/Hitachi ClinChem

System Group Risk Analysis ClinChem/HIA for Roche Hitachi/cobas c and cobas Integra Systems, V7, 01-Apr-2017 (DIAdoc No. 1008005000322)

Product: Patricia WeberURCI: 04489365190; URCII: 05172179190, 05172179214;

URCIII: 08063516190


Document ID: 0000000000001200000060357 000 03 007



8,00 Author

** State of the art (continuous): Clinical Risk with Severity of harm statement

Product: URCI: 04489365190; URCII: 05172179190, 05172179214; Patricia Weber

URCIII: 08063516190

Severity Risk Classification of SI2: 6

From QAP 04.16, risk severity 6 (high): harm to the user, patient, environment or property without permanent damage.

Rationale: Erroneous results might lead to inappropriate assessment of interferents in the sample, which might result in repeat testing or additional diagnostic tests, leading to additional blood draws, causing harm to the patient.

(Severity of harm of incorrect assay results themselves, is addressed in the generic risk assessment and the individual risk assessments of the assays).


Document ID: 0000000000001200000060357 000 03 007



Classification

Occurrence of Hazardous Situation (O)

Index Effect

1 Very unlikely

3 Exceptional

6 Rare

8 Occasional

10 (Regular)/Frequent

Detectability of Hazardous Situation (D)

Index Effect

1 Certain

3 Probable

6 Unreliable

8 Difficult

10 Undetectable

Severity of harm (S)

Index Effect

1 Negligible

3 Moderate

6 High

8 Critical

10 Catastrophic(*3)

Probability of Occurrence of Harm (P)

Index Effect Criteria (*) quantitative

corresp.

1 Theoretical In theory possible, in practice virtually impossible; in years of experience with similar products

in comparable use, this harm was never actually observed.≤ 10-7

3 Remote On the basis of experience with similar products in comparable use, harm could occur but

remain the exception to the rule.10-7 – 10-6

6 Low Harm has been rarely observed and may occur sporadically but not systematically.10-6 – 10-5

8 Moderate Harm will occasionally occur.10-5 – 10-4

10 High Almost inevitable that a harm will occur or must be expected regularly.≥ 10-4

Means of detection are available and suitable but rely on operation as intended, documented and trained.

Immediate detection of the hazardous situation is not certain and needs special awareness.

No or small impairment of product performance, with no perceptible direct or indirect harm to the user/patient

Life-threatening(*1)

or serious harm to the user, patient, environment or property with permanent damage.

Hazardous situation is difficult to detect and will become evident only indirectly and with delay.

Hazardous situation or relevant characteristics cannot be detected. Hidden failure function.

Criteria

Harm to the user, patient, environment or property without permanent damage.

Loss of product function perceptible to the user, patient, environment or property but with no direct or indirect

physical harm.

Note (*1) Life-threatening:

Life-threatening is to be used for all situations where the malfunctioning IVD caused direct or indirect harm which leads or may lead to a situation endangering life.

A situation which is endangering life due to direct or indirect harm may be caused by malfunctioning IVDs that are leading to a medical decision, action taken or not taken on the specific

affected result provided by the IVD, but mostly likely not being the unique basis for the decision/action.

Note (*2) Death:

Situations where death will occur due to direct or indirect harm may be caused by malfunctioning IVDs that are immediately leading to a medical decision, action taken or not taken on the

results provided by the IVD as most likely being the unique basis for the decision/action.

Note (*3):

These proposed criteria can be adapted for products used in support of diabetes monitoring and disease management to better describe the possible harm to the user. For these systems the

“vegetative state to user” is also evaluated as “catastrophic”.

Criteria

In theory possible, in practice virtually impossible; in years of experience with similar products in comparable

use, this hazardous situation was never actually observed.

On the basis of experience with similar products in comparable use, the hazardous situation could occur but

remain the exception to the rule.

The hazardous situation has been rarely observed and may occur sporadically but not systematically.

The hazardous situation will occasionally occur.

Almost inevitable that the hazardous situation will occur or must be expected regularly.

Death(*2)

to user or patient due to product performance failures or errors.

Criteria

Immediate detection of the hazardous situation is certain, a failure is obvious (e.g. stoppage or alarm).


Composition


Document Author: Hieb, Maria {DQRS~Penzberg}Business Area / Unit: Roche Professional DiagnosticsConfidentiality: ConfidentialDocument Class: Quality System RecordDocument Type: Quality System RecordDocument Creator: Hieb, Maria {DQRS~Penzberg}Document Lifecycle Status: EffectiveValid From: 30-Sep-2020 11:20:23 (UTC)Valid To: Document Title: R_RA_Comp_SI2Document Number: 0000000000001200000231934Document Version: 03Template: No

Global Group: Regulatory AffairsLanguage: EnglishSite: RDG GermanyDocument Description: Composition for SI2

Electronic Signatures: Signed By: spensbes (Stefanie Spensberger {DQRSPC7C6164})Role: ReviewerSignature Differentiation: Regulatory AffairsSigned Date: 30-Sep-2020 10:16:54 (UTC)

Signed By: stratilr (Rebecca Stratil {DQRSPC7C})Role: ApproverSignature Differentiation: Regulatory AffairsSigned Date: 30-Sep-2020 11:11:40 (UTC)



utilizarla.


Title: R_RA_Comp_SI2 Document Number: 0000000000001200000231934


Version: 03 Status: Effective Valid from: 30-Sep-2020 11:20:23 (UTC)

Cover Page 1 (1)

Roche Diagnostics GmbH

Composition

SI2

Serum index Gen.2

Cat. No. 04489365 190, 05172179 190, 05172179 214

Sample Index Gen.2

Cat. No. 08063516 190

R1 aqueous matrix

Component Concentration

Reactive components --- ---

Buffer Sodium chloride 9 %

Preservatives --- ---

Stabilizers --- ---

Ingredients of biological

origin (+ indication of

source)

--- ---


Title: R_RA_Comp_SI2 Document Number: 0000000000001200000231934Print Comment:Print Date:

Version: 03 Status: Effective Valid from: 30-Sep-2020 11:20:23 (UTC)Content Page 1 (1)

Manufacturing


DM-Manuf

Page 2 of 4

1. Manufacturer Information Legal Manufacturer: The SI2 assays are manufactured by Roche Diagnostics GmbH (RDG). The address is as follows:

Roche Diagnostics GmbH Sandhofer Strasse 116 D-68305 Mannheim Germany

Physical Manufacturer: Following SI2 assays are manufactured by Roche Diagnostics GmbH (RDG): SI2 (REF 04489365190) SI2 (REF 05172179190) SI2 (REF 08063516190) The address is as follows:

Roche Diagnostics GmbH Sandhofer Strasse 116 D-68305 Mannheim Germany

Following SI2 assay is manufactured by Roche Diagnostics Suzhou Ltd.: SI2 (REF 05172179214) The address is as follows:

Roche Diagnostics (Suzhou) Ltd. No. 259 Zhongyuan Road 215028 Suzhou, Jiangsu PEOPLE’S REPUBLIC OF CHINA

Final QC Release The final QC release is done according to release testing and specifications defined by the legal manufacturer Roche Diagnostics GmbH (RDG).


DM-Manuf

Page 3 of 4

2. Quality Management System

The above mentioned Roche manufacturing facilities is certified under a Quality Management System according to ISO 13485. 3. Manufacturing A general overview of the manufacturing process is provided in the attached manufacturing flowchart.


DM-Manuf

Page 4 of 4

Specification and CoA


Document Author: Maschat, Cordula {DOMC~Mannheim}Business Area / Unit: Roche Professional DiagnosticsConfidentiality: ConfidentialDocument Class: Device Master RecordDocument Type: Device Master RecordDocument Creator: Maschat, Cordula {DOMC~Mannheim}Document Lifecycle Status: SignedValid From: 03-Jul-2019 12:42:37 (UTC)Valid To: Document Title: C_0201_RSP_05172179000Document Number: 0000000000001008018000977Document Version: 04Template: No

Global Group: Regulatory AffairsGlobal SubGroup: Specification Prod. (Registr.)Local Group: Reg. SpecificationSite: RDG GermanyDepartment: C_DOMCCDocument Description: Serum Index Gen.2 (SI2) - "Only for use in Regulatory Affairs"Change Request eCCP PLM: 400096525

Electronic Signatures: Signed By: maschac1 (Cordula Maschat {DOMCSD})Role: ReviewerSignature Differentiation: Quality ControlSigned Date: 03-Jul-2019 06:50:16 (UTC)

Signed By: kneisses (Sandra Kneissel {DOMC})Role: ApproverSignature Differentiation: Quality ControlSigned Date: 03-Jul-2019 12:36:01 (UTC)



utilizarla.


Title: C_0201_RSP_05172179000 Document Number: 0000000000001008018000977


Version: 04 Status: Signed Valid from: 03-Jul-2019 12:42:37 (UTC)

Cover Page 1 (1)

Specification

Product: Serum Index Gen.2 Catalog No. 05172179190(SI2) 05172179214

Intended use:In vitro test for the semi-quantitative determination of the lipemia index, hemolysis index andicterus index in human serum and plasma on cobas c systems.

Test principle:The Serum Index Gen.2 assay is based on calculations of absorbance measurements of dilutedsamples at different bichromatic wavelength pairs to provide a semi-quantitative representationof levels of lipemia, hemolysis and icterus present in serum and plasma samples.The analyzers take an aliquot of the patient specimen and dilute it in saline (0.9 % sodium chloride)to measure the absorbances for lipemia at 660 nm (primary wavelength) and 700 nm (secondarywavelength), for hemolysis at 570 nm (primary wavelength) and 600 nm (secondary wavelength),and for icterus at 480 nm (primary wavelength) and 505 nm (secondary wavelength). From theseabsorbance values the instrument calculates serum index values using the following factors:A = 25 (conventional units) or 40 (international units)B = 122000 (conventional or international units)C = 9 (conventional or international units)D = 1400 (conventional units) or 82 (international units)E = 19000 (conventional or international units)F = 180000 (conventional or international units)C, A, and D are sample dilution-dependent and unit-dependent scaling factors to providesemi-quantitative interference levels. B, E and F are correcting factors which correct overlappinginterference spectra. They are independent of sample dilution since they are based on ratios ofabsorbances. Serum indices can be programmed in either conventional or international units.Make sure that the correct scaling factors are set for the units you chose.Refer to the appropriate user documentation of the analyzer concerned.




Title: C_0201_RSP_05172179000 Document Number: 0000000000001008018000977Print Comment:Print Date:

Version: 04 Status: Signed Valid from: 03-Jul-2019 12:42:37 (UTC)Content Page 1 (2)

Reagents-working solutions:

Sodium chloride solution:

Sodium chloride: 87.3 - 92.7 mg/mL


Title: C_0201_RSP_05172179000 Document Number: 0000000000001008018000977Print Comment:Print Date:

Version: 04 Status: Signed Valid from: 03-Jul-2019 12:42:37 (UTC)Content Page 2 (2)


Document Author: Maschat, Cordula {DOMC~Mannheim}Business Area / Unit: Roche Professional DiagnosticsConfidentiality: ConfidentialDocument Class: Device History RecordDocument Type: Device History RecordDocument Creator: Maschat, Cordula {DOMC~Mannheim}Document Lifecycle Status: SignedValid From: 03-Apr-2019 08:19:03 (UTC)Valid To: Document Title: C_0201_RAZ_05172179000_36417701Document Number: 0000000000001200000357534Document Version: 01Template: No

Global Group: Regulatory AffairsGlobal SubGroup: Certificate of Analysis (Reg.)Local Group: Reg. Certificate of analysisLanguage: EnglishSite: RDG GermanyDepartment: C_DOMCCDocument Applies To: C_QC Centralized AssaysDocument Description: Serum Index Gen.2 (SI2) - "Only for use in Regulatory Affairs"

Electronic Signatures: Signed By: maschac1 (Cordula Maschat {DOMCSD})Role: ReviewerSignature Differentiation: Quality ControlSigned Date: 02-Apr-2019 04:29:52 (UTC)

Signed By: loewh (Heiner Loew {DOMC})Role: ApproverSignature Differentiation: Quality ControlSigned Date: 03-Apr-2019 08:00:15 (UTC)



utilizarla.


Title: C_0201_RAZ_05172179000_36417701 Document Number: 0000000000001200000357534


Version: 01 Status: Signed Valid from: 03-Apr-2019 08:19:03 (UTC)

Cover Page 1 (1)

Certificate of Analysis

Catalog. No. 05172179190

Product Serum Index Gen.2 (SI2)

Order No. Example

Lot 36417701

Expiry date 2020-03-31

Parameter Results

Reagents-working solutions

Sodium chloride solution:

Sodium chloride: 90.5 mg/mL

This lot meets our specification.




Title: C_0201_RAZ_05172179000_36417701 Document Number: 0000000000001200000357534Print Comment:Print Date:

Version: 01 Status: Signed Valid from: 03-Apr-2019 08:19:03 (UTC)Content Page 1 (1)

SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006

Sl2

Version 1.14

Revision Date: 21.06.2019

Date of last issue: 31.01.2019 Date of first issue: 09.10.2012

1 / 10

SECTION 1: Identification of the substance/mixture and of the company/undertaking

1.1 Product identifier

Trade name

: Sl2

Product code

: 05172179190

1.2 Relevant identified uses of the substance or mixture and uses advised against

Recommended restrictions on use

: For professional users only.

1.3 Details of the supplier of the safety data sheet

Company : Roche Diagnostics Deutschland GmbH - Sandhoferstrasse 116 68305 Mannheim Deutschland

Telephone : +496217590 Telefax : +496217592890 Responsible Department : +49(0)621-759-2012, +49(0)621-759-4848

+49(0)8856-60-2629 E-mail address : [email protected]

1.4 Emergency telephone number

In case of emergencies: : Central Works Security Roche Diagnostics GmbH

+49(0)621-759-2203

Centre for detoxification: : Mainz Munich

+49(0)6131-19240 +49(0)89-19240

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture

The product is a kit consisting of individual ingredients. The classification of the ingredients can be obtained from section 3. Section Label elements contains the resulting labelling for the kit.

2.2 Label elements

Labelling (REGULATION (EC) No 1272/2008)

Not a hazardous substance or mixture.

2.3 Other hazards

See SECTION 3

SECTION 3: Composition/information on ingredients

INT R1/2 (B,C )


Sl2

Version 1.14



2 / 10

Classification (REGULATION (EC) No 1272/2008)


Components

Remarks : No hazardous ingredients

For explanation of abbreviations see section 16.

SECTION 4: First aid measures

4.1 Description of first aid measures

General advice

: Do not leave the victim unattended.

If inhaled

: Move to fresh air. If unconscious, place in recovery position and seek medical advice. If symptoms persist, call a physician.

In case of skin contact

: If on skin, rinse well with water.

In case of eye contact

: Immediately flush eye(s) with plenty of water. Remove contact lenses. Protect unharmed eye. If eye irritation persists, consult a specialist.

If swallowed

: Keep respiratory tract clear. Do not give milk or alcoholic beverages. Never give anything by mouth to an unconscious person. If symptoms persist, call a physician. Rinse mouth with water.

4.2 Most important symptoms and effects, both acute and delayed

Symptoms : No information available.

4.3 Indication of any immediate medical attention and special treatment needed

Treatment

: The first aid procedure should be established in consultation with the doctor responsible for industrial medicine.

SECTION 5: Firefighting measures

5.1 Extinguishing media

Suitable extinguishing media

: Use extinguishing measures that are appropriate to local cir-cumstances and the surrounding environment.

5.2 Special hazards arising from the substance or mixture

Specific hazards during fire-fighting

: No information available.


Sl2

Version 1.14



3 / 10

5.3 Advice for firefighters

Special protective equipment for firefighters

: Wear self-contained breathing apparatus for firefighting if nec-essary.

Further information

: Standard procedure for chemical fires. Use extinguishing measures that are appropriate to local cir-cumstances and the surrounding environment.

SECTION 6: Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures

Personal precautions

: Refer to protective measures listed in sections 7 and 8.

6.2 Environmental precautions

Environmental precautions

: Local authorities should be advised if significant spillages cannot be contained.

6.3 Methods and material for containment and cleaning up

Methods for cleaning up

: Wipe up with absorbent material (e.g. cloth, fleece). Keep in suitable, closed containers for disposal.

6.4 Reference to other sections

Treat recovered material as described in the section "Disposal considerations".

SECTION 7: Handling and storage

7.1 Precautions for safe handling

Advice on safe handling

: For personal protection see section 8. Smoking, eating and drinking should be prohibited in the ap-plication area.

Advice on protection against fire and explosion

: Normal measures for preventive fire protection.

Hygiene measures

: Handle in accordance with good industrial hygiene and safety practice.

7.2 Conditions for safe storage, including any incompatibilities

Requirements for storage areas and containers

: Electrical installations / working materials must comply with the technological safety standards.

Further information on stor-age conditions

: See label, package insert or internal guidelines

Advice on common storage

: No materials to be especially mentioned.

Storage class (TRGS 510)

: 12, Non Combustible Liquids

Further information on stor-age stability

: No decomposition if stored and applied as directed.


Sl2

Version 1.14



4 / 10

7.3 Specific end use(s)

Specific use(s)

: Laboratory chemicals

SECTION 8: Exposure controls/personal protection

8.1 Control parameters

INT R1/2 (B,C )

Contains no substances with occupational exposure limit values.

8.2 Exposure controls

Engineering measures

No data available

Personal protective equipment

Eye protection : Safety glasses

Hand protectionMaterial : Protective gloves

Remarks

: The selected protective gloves have to satisfy the specifica-tions of Regulation (EU) 2016/425 and the standard EN 374 derived from it. This recommendation is only valid for the product mentioned in the safety data sheet and provided by us and for the application specified by us. Please observe the instructions regarding permeability and breakthrough time which are provided by the supplier of the gloves. Also take into consideration the specific local conditions under which the product is used, such as the danger of cuts, abrasion, and the contact time. The suitability for a specific workplace should be discussed with the producers of the protective gloves.

Skin and body protection : Protective suit

Respiratory protection : No personal respiratory protective equipment normally re-quired.

SECTION 9: Physical and chemical properties

9.1 Information on basic physical and chemical properties

INT R1/2 (B,C )

Appearance

: liquid

Colour

: colourless

Odour

: none


Sl2

Version 1.14



5 / 10

Odour Threshold

: No data available

pH

: No data available

Melting point/range

: No data available

Boiling point/boiling range

: No data available

Flash point

: does not flash

Evaporation rate

: No data available

Flammability (solid, gas)

: The product is not flammable., Does not sustain combustion.

Upper explosion limit / Upper flammability limit

: No data available

Lower explosion limit / Lower flammability limit

: No data available

Vapour pressure

: No data available

Relative vapour density

: No data available

Relative density

: No data available

Density

: No data available

Solubility(ies) Water solubility

: completely miscible

Solubility in other solvents

: No data available

Partition coefficient: n-octanol/water

: No data available

Auto-ignition temperature

: No data available

Decomposition temperature

: No data available

Viscosity Viscosity, dynamic

: No data available

Viscosity, kinematic

: No data available

Oxidizing properties

: The substance or mixture is not classified as oxidizing.

9.2 Other information

INT R1/2 (B,C )

Flammability (liquids) : Does not sustain combustion.

Self-ignition : No data available


Sl2

Version 1.14



6 / 10

SECTION 10: Stability and reactivity

10.1 Reactivity

No dangerous reaction known under conditions of normal use.

10.2 Chemical stability

Stable under normal conditions.

10.3 Possibility of hazardous reactions

Hazardous reactions

: Stable under recommended storage conditions. No hazards to be specially mentioned.

10.4 Conditions to avoid

Conditions to avoid

: No data available

10.5 Incompatible materials

Materials to avoid

: No data available

10.6 Hazardous decomposition products

No data available

SECTION 11: Toxicological information

11.1 Information on toxicological effects

INT R1/2 (B,C )

Acute toxicity

Not classified based on available information.

Skin corrosion/irritation


Serious eye damage/eye irritation


Respiratory or skin sensitisation

Skin sensitisation


Respiratory sensitisation


Germ cell mutagenicity


Carcinogenicity



Sl2

Version 1.14



7 / 10

Reproductive toxicity


STOT - single exposure


STOT - repeated exposure


Aspiration toxicity


SECTION 12: Ecological information

12.1 Toxicity

INT R1/2 (B,C )

No data available

12.2 Persistence and degradability

INT R1/2 (B,C )

No data available

12.3 Bioaccumulative potential

INT R1/2 (B,C )

No data available

12.4 Mobility in soil

INT R1/2 (B,C )

No data available

12.5 Results of PBT and vPvB assessment

INT R1/2 (B,C )

Not relevant

12.6 Other adverse effects

INT R1/2 (B,C )

No data available

SECTION 13: Disposal considerations

13.1 Waste treatment methods

Product : Can be disposed as waste water, when in compliance with local regulations.

Contaminated packaging : Empty containers should be taken to an approved waste han-dling site for recycling or disposal. Do not re-use empty containers.


Sl2

Version 1.14



8 / 10

SECTION 14: Transport information

14.1 UN number

Not regulated as a dangerous good

14.2 UN proper shipping name


14.3 Transport hazard class(es)


14.4 Packing group


14.5 Environmental hazards


14.6 Special precautions for user

Remarks : Not dangerous goods in the meaning of ADR/RID, ADN, IMDG-Code, ICAO/IATA-DGR

14.7 Transport in bulk according to Annex II of Marpol and the IBC Code

Remarks : Not applicable

SECTION 15: Regulatory information

15.1 Safety, health and environmental regulations/legislation specific for the substance or mix-ture

Seveso III: Directive 2012/18/EU of the European Parliament and of the Council on the control of major-accident hazards involving dangerous substances. Not applicable

Water contaminating class (Germany)

: WGK 1 slightly hazardous to water

INT R1/2 (B,C )

REACH - Candidate List of Substances of Very High Concern for Authorisation (Article 59).

: Not applicable

REACH - List of substances subject to authorisation (Annex XIV)

: Not applicable

Regulation (EC) No 1005/2009 on substances that de-plete the ozone layer

: Not applicable

Regulation (EC) No 850/2004 on persistent organic pol-lutants

: Not applicable

Regulation (EC) No 649/2012 of the European Parlia-ment and the Council concerning the export and import of dangerous chemicals

: Not applicable


Sl2

Version 1.14



9 / 10

REACH - Restrictions on the manufacture, placing on the market and use of certain dangerous substances, preparations and articles (Annex XVII)

: Not applicable

The components of this product are reported in the following inventories: DSL

: All components of this product are on the Canadian DSL

AICS

: On the inventory, or in compliance with the inventory

NZIoC


ENCS


ISHL

: Not in compliance with the inventory

KECI


PICCS


IECSC


TCSI


TSCA

: All substances listed as active on the TSCA inventory

Volatile organic compounds : Directive 2010/75/EU of 24 November 2010 on industrial emissions (integrated pollution prevention and control) Remarks: Not applicable

Labelling (REGULATION (EC) No 1272/2008)


15.2 Chemical safety assessment

A Chemical Safety Assessment is not required for this substance when it is used in the specified applications.

SECTION 16: Other information

Full text of other abbreviations

ADN - European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways; ADR - European Agreement concerning the International Carriage of Dangerous Goods by Road; AICS - Australian Inventory of Chemical Substances; ASTM - American Society for the Testing of Materials; bw - Body weight; CLP - Classification Labelling Packaging Regula-tion; Regulation (EC) No 1272/2008; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute for Standardisation; DSL - Domestic Substances List (Cana-da); ECHA - European Chemicals Agency; EC-Number - European Community number; ECx - Concentration associated with x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule; ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with x% growth rate response; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA - In-ternational Air Transport Association; IBC - International Code for the Construction and Equip-


Sl2

Version 1.14



10 / 10

ment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentra-tion; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International Mari-time Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisa-tion for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships; n.o.s. - Not Otherwise Specified; NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable Effect Loading Rate; NZIoC - New Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Develop-ment; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumu-lative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substanc-es; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evalua-tion, Authorisation and Restriction of Chemicals; RID - Regulations concerning the International Carriage of Dangerous Goods by Rail; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; SVHC - Substance of Very High Concern; TCSI - Taiwan Chemical Substance Inventory; TRGS - Technical Rule for Hazardous Substances; TSCA - Toxic Sub-stances Control Act (United States); UN - United Nations; vPvB - Very Persistent and Very Bioac-cumulative

Further information

The information provided in this Safety Data Sheet is correct to the best of our knowledge, infor-mation and belief at the date of its publication. The information given is designed only as a guid-ance for safe handling, use, processing, storage, transportation, disposal and release and is not to be considered a warranty or quality specification. The information relates only to the specific material designated and may not be valid for such material used in combination with any other materials or in any process, unless specified in the text.

DE / EN / 1810

Tài liệu mô tả tóm tắt kỹ thuật trang thiết bị y tế

Documents

Transcript of Tài liệu mô tả tóm tắt kỹ thuật trang thiết bị y tế