BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P040004 · Supplement: S002 · Decision Oct 20, 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 TOTAL READYPACK REAGENTS AND ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS
    PMA Number
    P040004
    Supplement Number
    S002
    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
    October 20, 2009
    Date Received
    August 26, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE TRANSITION OF THE ADVIA CENTAUR HBC TOTAL ASSAY TO A NEW PLATFORM IN THE CENTAUR FAMILY OF INSTRUMENTS, THE CENTAUR CP. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR HBC TOTAL ASSAY AND IS INDICATED FOR:ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS ON THE CENTAUR CP ANALYZER:THE ADVIA CENTAUR HBC TOTAL ASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVEDETERMINATION 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 CP SYSTEM. THIS ASSAY CAN BE USED AS AN AID IN THE DIAGNOSIS OFINDIVIDUALS 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 ININDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN. ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS ON THE CENTAUR CP ANALYZER:FOR MONITORING THE PERFORMANCE OF THE HBC TOTAL ASSAY ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HBC TOTAL QUALITY CONTROL MATERIAL HAS NOT BEENESTABLISHED 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)