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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

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

    PMA: P050049 · Decision Jun 1, 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 HBSAG, HBSAG CONFIRMATORY, AND AXSYM HBSAG CONTROLS
    PMA Number
    P050049
    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    Approved (Withdrawn)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
    June 1, 2006
    Date Received
    December 6, 2005
    Expedited Review
    N
    Docket Number
    07M-0174

    Advisory Committee Statement

    APPROVAL FOR THE ABBOTT AXSYM HBSAG ASSAY, WHICH IS INDICATED FOR: AXSYM HBSAG: AXSYM HBSAG IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) INTENDED FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN NEONATAL SERUM, AND ADULT AND PEDIATRIC SERUM (INCLUDING SERUM COLLECTED IN SERUM SEPARATOR TUBES) OR PLASMA (COLLECTED IN POTASSIUM EDTA, SODIUM CITRATE, SODIUM HEPARIN, LITHIUM HEPARIN, OR PLASMA SEPARATOR TUBES). THE ASSAY IS USED AS AN AID IN THE DIAGNOSIS OF ACUTE OR CHRONIC HEPATITIS B VIRUS (HBV) INFECTION IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION. THE ASSAY MAY BE USED TO TEST FOR HBV INFECTION IN PREGNANT WOMEN. AXSYM HBSAG CONFIRMATORY: AXSYM HBSAG CONFIRMATORY IN S MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) INTENDED FOR THE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN NEONATAL SERUM, AND ADULT AND PEDIATRIC SERUM (INCLUDING SERUM COLLECTED IN SERUM SEPARATOR TUBES) OR PLASMA (COLLECTED IN POTASSIUM EDTA, SODIUM CITRATE, SODIUM HEPARIN, LITHIUM HEPARIN, OR PLASMA SEPARATOR TUBES). THE ASSAY IS USED FOR CONFIRMATION OF SAMPLES FOUND TO BE REPEATEDLY REACTIVE BY THE AXSYM HBSAG ASSAY. THE ASSAY MAY BE USED TO CONFIRM HEPATITIS B VIRUS (HBV) INFECTION IN PREGNANT WOMAN. AXSYM HBSAG CONTROLS: THE AXSYM HBSAG POSITIVE AND NEGATIVE CONTROLS ARE FOR USE IN MONITORING THE PERFORMANCE OF THE AXSYM HBSAG REAGENT KIT AND THE AXSYM HBSAG CONFIRMATORY KIT. THE PERFORMANCE OF THE AXSYM HBSAG CONTROLS HAVE NOT BEEN ESTABLISHED WITH ANY OTHER HBSAG 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)