Recognition List Number: 010 Publication Date: 06/01/2004
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-100: ISO 15197 First edition 2003-05-01, In Vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. (InVitro Diagnostics)
Date of Standard: 2003. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) | | DIVISION OF CHEMISTRY AND TOXICOLOGY DEVICES (DCTD) |
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| Devices Affected: |
| IN VITRO DIAGNOSTIC DEVICES FOR THE MEASUREMENT OF GLUCOSE |
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| Processes Affected: |
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| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §862.1345 |
Glucose Dehydrogenase, Glucose |
Class 2 |
LFR |
| §862.1345 |
Glucose Oxidase, Glucose |
Class 2 |
CGA |
| §862.1345 |
Hexokinase, Glucose |
Class 2 |
CFR |
| §862.1345 |
System, Test, Blood Glucose, Over The Counter |
Class 2 |
NBW |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Patricia Bernhardt |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room 5654 |
| Silver Spring MD 20993 |
| 301/796-6136 |
| Email: patricia.bernhardt@fda.hhs.gov |
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