Sensor, Glucose, Invasive
Basic Information
- Device Name
- Sensor, Glucose, Invasive
- Trade Name
- GUARDIAN RT CONTINUOUS GLUCOSE MONITORING SYSTEM
- PMA Number
- P980022
- Supplement Number
- S011
- Device Class
- FDA Class 3
- Product Code
- MDS
- Generic Name
- Sensor, glucose, invasive
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 18, 2005
- Date Received
- August 20, 2004
- Supplement Type
- Panel Track
- Expedited Review
- Y
- Docket Number
- 05M-0454
Advisory Committee Statement
APPROVAL FOR THE GUARDIAN RT. THE DEVICE IS INDICATED FOR CONTINUOUS OR PERIODIC MONITORING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN IN ADULTS (AGES 18 AND OLDER) WITH DIABETES MELLITUS FOR THE PURPOSE OF IMPROVING DIABETES MANAGEMENT. IT ALERTS IF A GLUCOSE LEVEL FALLS BELOW OR RISES ABOVE PRESET VALUES. VALUES ARE NOT INTENDED TO BE USED DIRECTLY FOR MAKING THERAPY ADJUSTMENTS, BUT RATHER TO PROVIDE AN INDICATION OF WHEN A FINGER STICK MAY BE REQUIRED. ALL THERAPY ADJUSTMENTS WOULD BE BASED ON MEASUREMENTS OBTAINED USING A HOME GLUCOSE MONITOR AND NOT ON GUARDIAN VALUES. GUARDIAN RT PROVIDES REAL-TIME GLUCOSE VALUES THAT ALLOW USERS TO TRACK PATTERNS IN GLUCOSE CONCENTRATIONS AND TO POSSIBLY IDENTIFY EPISODES OF LOW AND HIGH BLOOD GLUCOSE EPISODES. IT ALSO STORES THE DATA SO THAT IT CAN BE ANALYZED TO TRACK PATTERNS. GLUCOSE DATA CAN BE FURTHER DOWNLOADED TO PC SOFTWARE FOR ANALYSIS OF HISTORICAL GLUCOSE VALUES.
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 |
|---|---|---|---|
| MDS | Sensor, Glucose, Invasive | FDA class 3 | Unknown |