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A.1345 Glucose test system

Diabetes

mellitusHypoglycemiaHyperglycemia

Pancreatic islet cell carcinoma

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1.

Precision

ISO 15197

Repeatability

Intermediate precision

ISO 15197 (2003)3

ISO 15197 (2013)4

CLSI EP5-A2 (2004)5

2.

Accuracy (Method

Comparison)

ISO 15197

System accuracy

x

y

x

y

ISO 15197

ISO 15197 (2003)3

ISO 15197 (2013)4

CLSI EP9-A3 (2013)6

3.

Linearity

CLSI EP6-A (2003)7

4.

Interference

EDTA

Heparin)

ISO 15197

Packed cell volume

ISO 15197 (2013)4

CLSI EP7-A2 (2005)8

4

Interference testing

Acetaminophen (paracetamol)

Ascorbic acid Dopamine

Galactose Gentisic acid

GlutathioneIbuprofenIcodextrinL-DOPA

(L-3,4-dihydroxyphenylalanine)

MaltoseMethyl-DOPAPralidoxime

Iodide (PAM) Salicylate

TolbutamideTolazamideXylose

5.

System Traceability

ISO 15197 (2003)3

ISO 15197 (2013)4

ISO 17511 (2003)9

6.

Stability

ISO 23640 (2011)10

CLSI EP25-A (2009)11

7.

Safety and Reliability

Testing

ISO 15197

(1) General

requirements

(2) Protection against

electric shock

(3) Protection

against mechanical hazards

(4) Electromagnetic

compatibility

(5) Resistance to heat

(6) Resistance to

moisture and liquids

(7)

ISO 15197 (2003)3

ISO 15197 (2013)4

IEC 60601-1 (2012)12

IEC 61010-1 (2010)13

IEC 61010-2-101 (2002)14

IEC 60601-1-2 (2014)15

IEC 61326-1 (2012)16

IEC 61326-2-6 (2012)17

IEC 60068-2-64 (2008)18

5

Protection against liberated

gases, explosion and implosion

(8) Meter

components

(9)

Mechanical resistance to

shock, vibration and impact

(10)

Equipment temperature

exposure limits for storage

(11)

Equipment humidity exposure

limits for storage

8.

Software Validation

Level of

Concern

IntegritySafety

US FDA Guidance

(2005)19

IEC 62304 (2006)20

US FDA Guidance

(2013)21

9.

User Performance

Evaluation

ISO 15197

User performance evaluation

ISO 15197

System accuracy

ISO 15197 (2003)3

ISO 15197 (2013)4

6

10.

Cleaning and

Disinfection

HIVC

HCVBHBV

US FDA Guidance

(2007)22

Health Canada Notice

(2014)23

1. (2013)

2. (2010)

3. ISO15197, In vitro diagnostic test systems -- Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus (2003)

4. ISO15197, In vitro diagnostic test systems -- Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus (2013)

5. CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition (2004)

6. CLSI EP9-A3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Third Edition (2013)

7. CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures, A Statistical Approach; Approved Guideline (2003)

8. CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline- Second Edition (2005)

9. ISO17511, In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values assigned to calibrators and

control materials (2003)

10. ISO 23640, In vitro diagnostic medical devices -- Evaluation of stability of in vitro diagnostic reagents (2011)

11. CLSI EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents (2009)

12. IEC 60601-1:2005/Cor 1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Edition 3.1

13. IEC 61010-1:2010 Ed.3 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements

7

14. IEC 61010-2-101:2002 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro

diagnostic (IVD) medical equipment

15. IEC 60601-1-2:2014 Ed.4.0 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard:

Electromagnetic disturbances - Requirements and tests

16. IEC 61326-1:2012 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements- Edition 2.0

17. IEC 61326-2-6:2012 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD)

medical equipment- Edition 2.0

18. IEC 60068-2-64:2008 Ed.2 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance

19. US FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005)

20. IEC 62304, Medical device software - Software life cycle processes (2006)

21. US FDA Guidance: Radio-Frequency Wireless Technology in Medical Devices (2013)

22. US FDA Draft Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (2014)

23. Health Canada Notice: New Requirements for Medical Device Licence Applications

for Lancing Devices and Blood Glucose Monitoring Systems (File Number:

14-111696-560)