Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-133: CLSI C30-A2, Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities. (InVitro Diagnostics)
Date of Standard: 2002. |
| Address of Standards Organization: |
| Clinical Laboratory Standards Institute (CLSI) |
| 950 West Valley Road |
| Suite 2500 |
| Wayne, PA 19087 |
| |
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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: |
| All Ancillary (Bedside) Blood Glucose Testing Devices |
|
| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE |
|
| Type of Standard: |
| National, Vertical |
| 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 |
| |
|
| Relevant Guidance: |
Assessing the Safety/Effectiveness of Home-Use In Vitro Diagnostic Devices (IVDs): Draft Points to Consider Regarding Labeling and Premarket
Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems
Points to Consider for Collection of Data in Support of In Vitro Device Submissions for 510(k) Clearance |
|
| 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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