Glucose Oxidase, Glucose
Basic Information
- Device Name
- Glucose Oxidase, Glucose
- Trade Name
- GLUCOWATCH 2 BIOGRAPHER
- PMA Number
- P990026
- Supplement Number
- S011
- Device Class
- FDA Class 2
- Product Code
- CGA
- Generic Name
- GLUCOSE OXIDASE, GLUCOSE
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Advisory Committee
- Clinical Chemistry
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 21, 2002
- Date Received
- December 11, 2001
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR MODIFICATIONS TO THE ELECTRICAL HARDWARE AND SOFTWARE OF THE ORIGINAL GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GLUCOWATCH2 BIOGRAPHER AND IS INDICATED FOR: THE GLUCOWATCH2 BIOGRAPHER IS A GLUCOSE MONITORING DEVICE INTENDED FOR DETECTING TRENDS AND TRACKING PATTERNS IN GLUCOSE LEVELS IN ADULTS (AGE 18 AND OLDER) WITH DIABETES. THIS DEVICE IS INTENDED FOR USE BY PATIENTS AT HOME AND IN HEALTHCARE FACILITIES. THE DEVICE IS FOR PRESCRIPTION USE ONLY. THE GLUCOWATCH 2 BIOGRAPHER IS INTENDED FOR USE AS AN ADJUNCTIVE DEVICE TO SUPPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE GLUCOWATCH2 BIOGRAPHER IS INDICATED FOR USE IN THE DETECTION AND ASSESSMENT OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS. INTERPRETATION OF BIOGRAPHER RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | Clinical Chemistry |