BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    PMA: P060003 · Decision Aug 7, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
    Trade Name
    AXSYM, AUSAB
    PMA Number
    P060003
    Device Class
    FDA Class 3
    Product Code
    LOM
    Generic Name
    Test, hepatitis b (b core, be antigen, be antibody, b core igm)
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    August 7, 2006
    Date Received
    February 10, 2006
    Expedited Review
    N
    Docket Number
    07M-0161

    Advisory Committee Statement

    APPROVAL FOR THE AXSYM AUSAB ASSAY. THE DEVICE IS INDICATED FOR: AXSYM AUSAB REAGENT PACK IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) INTENDED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN ADULT AND PEDIATRIC SERUM (INCLUDING SERUM COLLECTED IN SERUM SEPARATOR TUBES) OR PLASMA (COLLECTED IN SODIUM HEPARIN). THE ASSAY IS USED FOR THE QUANTITATIVE MEASUREMENT OF ANTIBODY RESPONSE TO HEPATITIS B VIRUS (HBV) VACCINATION FOR THE DETERMINATION OF HBV IMMUNE STATUS, AND FOR THE DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION WHEN USED IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION. THE AXSYM AUSAB STANDARD CALIBRATORS ARE USED FOR THE CALIBRATION OF THE AXSYM SYSTEM WHEN THE SYSTEM IS USED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) USING THE AXSYM AUSAB REAGENT PACK. THE PERFORMANCE OF THE AXSYM AUSAB STANDARD CALIBRATORS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAYS. THE AXSYM AUSAB CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THE AXSYM SYSTEM (REAGENT, CALIBRATORS, AND INSTRUMENT) WHEN USED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) WHEN USING THE AXSYM AUSAB REAGENT PACK. THE PERFORMANCE OF THE AXSYM AUSAB CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAYS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LOM Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)