BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Glucose Oxidase, Glucose

    PMA: P990026 · Supplement: S008 · Decision Aug 26, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    145
    Registration Numbers
    145

    Basic Information

    Device Name
    Glucose Oxidase, Glucose
    Trade Name
    GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER
    PMA Number
    P990026
    Supplement Number
    S008
    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
    August 26, 2002
    Date Received
    September 19, 2001
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    Y
    Docket Number
    02M-0412

    Advisory Committee Statement

    APPROVAL FOR THE GLUCOWATCH G2 BIOGRAPHER, WHICH EXPANDS THE INDICATIONS FOR USE TO INCLUDE CHILDREN/ADOLESCENTS (AGE 7 TO 17) TO THE CURRENTLY APPROVED INDICATIONS FOR USE. THIS DEVICE IS NOW INDICATED FOR THE FOLLOWING: 1) THE GLUCO WATCH G2 BIOGRAPHER IS A GLUCOSE MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN GLUCOSE LEVELS IN ADULTS (AGE 18 AND OLDER) AND CHILDREN/ADOLESCENTS (AGE 7 TO 17) WITH DIABETES. THIS DEVICE IS INTENDED FOR USE BY PATIENTS AT HOME AND IN HEALTH CARE FACILITIES. THE DEVICE IS FOR PRESCRIPTION USE ONLY. 2) THE GLUCOWATCH G2 BIOGRAPHER IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO SUPPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. 3) 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 MINIMIZED 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
    CGA Glucose Oxidase, Glucose