BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P100039 · Decision Jan 20, 2012
    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 ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL
    PMA Number
    P100039
    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
    January 20, 2012
    Date Received
    August 17, 2010
    Expedited Review
    N
    Docket Number
    12M-0075

    Advisory Committee Statement

    APPROVAL FOR ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND ADVIA CENTAUR ANTI-HBS2 (AHBS2) QUALITY CONTROL MATERIAL FOR USE ON THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THIS DEVICE IS INDICATED FOR: ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY, THE ADVIA CENTAUR ANTI-HB2 ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE AND QUANTITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMAN ADULT, ADOLESCENT, AND PEDIATRIC SERUM OF PLASMA (EDTA, LITHIUM-HEPARINIZED, OR SODIUM-HEPARINIZED) AND NEONATAL SAMPLES USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. 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 SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.THIS ASSAY HAS NOT BEEN FDA-CLEARED OR APPROVED FOR THE SCREENING OF BLOOD OR PLASMA DONORS. ADVIA CENTAUR ANTI-HBS2 (AHBS2) QUALITY CONTROL MATERIAL, FOR IN VITRO DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE ANTI-HBS2 ASSAY ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE ANTI-HBS2 QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS 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)