BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P030040 · Decision Aug 6, 2004
    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, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS
    PMA Number
    P030040
    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
    August 6, 2004
    Date Received
    September 11, 2003
    Expedited Review
    N
    Docket Number
    05M-0158

    Advisory Committee Statement

    APPROVAL FOR THE ADVIA CENTAUR HBC IGM. HBC IGM READY PACK REAGENTS: THIS DEVICE IS INDICATED FOR USE FOR THE ADVIA CENTAUR HBC IGM ASSAY AND IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETERMINATION IF IGM RESPONSE TO HEPATITIS B VIRUS CORE ANTIGEN IN HUMAN SERUM AND PLASMA (EDTA OR LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM. THE ASSAY USES RECOMBINANT HBC ANTIGEN. THIS ASSAY MAY BE USED IN COMBINATION WITH OTHER HEPATITIS B VIRUS (HBV) MARKET ASSAYS TO DEFINE THE CLINICAL STATUS OF KNOWN HBV INFECTED PATIENTS OR CAN BE COMBINED WITH OTHER HBV, HAV (HEPATITIS A VIRUS), 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 OR IMMUNOSUPPRESSED 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. HBC IGM QUALITY CONTROL MATERIALS: THE CONTROLS ARE INDICATED FOR IN VITRO DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE HBC IGM ASSAY ON THE ADVIUA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HBC IGM QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBC IGM 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)