BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P040004 · Decision Dec 22, 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 TOTAL READYPACK REAGENTS/ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS
    PMA Number
    P040004
    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
    December 22, 2004
    Date Received
    January 30, 2004
    Expedited Review
    N
    Docket Number
    05M-0109

    Advisory Committee Statement

    APPROVAL FOR THE ADVIA CENTAUR HBC TOTAL. HBC TOTAL READYPACK REAGENTS: THE ADVIA CENTAUR HBC TOTAL ASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO THE CORE ANTIGEN OF THE HEPATITIS B VIRUS (HBC TOTAL) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, OR LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM. THIS ASSAY CAN BE USED AS AN AID IN THE DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B VIRUS (HBV) INFECTION AND IN THE DETERMINATION OF THE CLINICAL STATUS OF HBV-INFECTED INDIVIDUALS IN CONJUNCTION WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. THIS ASSAY CAN ALSO BE USED AS AN AID IN THE DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN. HBC TOTAL QUALITY CONTROL MATERIALS: THE CONTROLS ARE INDICATED FOR IN VITRO DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE HBC TOTAL ASSAY ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HBC TOTAL QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBC TOTAL 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)