Instrument, Glucose, Noninvasive Technology
Basic Information
- Device Name
- Instrument, Glucose, Noninvasive Technology
- Trade Name
- GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
- PMA Number
- P990026
- Device Class
- FDA Class 3
- Product Code
- NCT
- Generic Name
- INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- March 22, 2001
- Date Received
- June 1, 1999
- Expedited Review
- Y
- Docket Number
- 01M-0371
Advisory Committee Statement
APPROVAL FOR THE GLUCOWATCH(R) AUTOMATIC GLUCOSE BIOGRAPHER. THE DEVICE IS INDICATED FOR: THE GLUCOWATCH(R) AUTOMATIC GLUCOSE BIOGRAPHER IS A GLUCOSE MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN GLUCOSE LEVELS IN ADULTS (AGE 18 AND OLDER) WITH DIABETES. THE DEVICE IS INTENDED FOR USE BY PATIENTS AT HOME AND IN HEALTH CARE FACILITIES. THE GLUCOWATCH BIOGRAPHER IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO SUPPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE 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 WHOULD 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 |
|---|---|---|---|
| NCT | Instrument, Glucose, Noninvasive Technology | FDA class 3 | Unknown |