BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P030029 · Supplement: S003 · Decision Jul 31, 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 AHBS
    PMA Number
    P030029
    Supplement Number
    S003
    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
    July 31, 2009
    Date Received
    August 11, 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 ANTI-HBS ASSAY TO A NEW PLATFORM IN THE CENTAUR FAMILY OF INSTRUMENTS, THE CENTAUR CP.ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS ON THE CENTAUR CP ANALYZERTHE ADVIA CENTAUR ANTI-HBS ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMANSERUM OR PLASMA (EDTA OR HEPARINIZED) USING THE ADVIA CENTAUR CP SYSTEM. THE ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS(HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICALMARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. AREACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS ANDSYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.ADVIA CENTAUR ANTI-HBS QUALITY CONTROLS ON THE CENTAUR CP ANALYZERTHE ADVIA CENTAUR ANTI-HBS QUALITY CONTROLS ARE INTENDED FOR IN VITRO DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE ANTI-HBS ASSAY ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE ADVIA CENTAUR ANTI-HBS QUALITY CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAY.

    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)