BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P030040 · Supplement: S004 · Decision Apr 9, 2009
    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
    ADVIA CENTAUR HBC IGM READYPACK REAGENTS/QUALITY CONTROL MATERIALS
    PMA Number
    P030040
    Supplement Number
    S004
    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
    Decision Code
    APPR
    Decision Date
    April 9, 2009
    Date Received
    March 9, 2009
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDING ADVIA CENTAUR XP INSTRUMENT TO THE INTENDED USE OF THE APPROVED DEVICE ADVIA CENTAUR HBC IGM ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETEDUNDER THE TRADE NAME ADVIA CENTAUR HBC IGM ASSAY AND IS INDICATED FOR:THE ADVIA CENTAUR HBC IGM ASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVEDETERMINATION OF IGM RESPONSE TO HEPATITIS B VIRUS CORE ANTIGEN IN HUMAN SERUM ANDPLASMA (EDTA OR LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR AND ADVIACENTAUR XP SYSTEMS. THE ASSAY USES RECOMBINANT HBC ANTIGEN. THIS ASSAY MAY BE USED IN COMBINATION WITH OTHER HEPATITIS B VIRUS (HBV) MARKER ASSAYS TO DEFINE THE CLINICAL STATUS OF KNOWN HBV INFECTED PATIENTS OR CAN BE COMBINED WITH OTHER HBV. HAV (HEPATITIS AVIRUS), AND HCV (HEPATITIS C VIRUS) ASSAYS FOR THE DIAGNOSIS OF PATIENTS PRESENTING SYMPTOMS OF ACUTE VIRAL HEPATITIS.ASSAY PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED FOR IMMUNOCOMPRO-MISED ORIMMUNOSUPPRESSED PATIENTS, CORD BLOOD, NEONATAL SPECIMENS, INFANTS, OR CHILDREN.ASSAY PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED WHEN THE ADVIA CENTAUR HBC IGM ASSAY IS USED IN CONJUNCTION WITH OTHER MANUFACTURERS' ASSAYS FOR SPECIFIC HBV SEROLOGICAL MARKERS.

    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)