BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P030049 · Supplement: S002 · Decision Sep 25, 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 HBSAG & CONFIRMATORY ASSAYS
    PMA Number
    P030049
    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
    September 25, 2009
    Date Received
    July 30, 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 HBSAG ASSAY AND THE ADVIACENTAUR HBSAG CONFIRMATORY ASSAY TO A NEW PLATFORM IN THE CENTAUR FAMILY OF INSTRUMENTS, THECENTAUR CP.ADVIA CENTAUR HBSAG READYPACK REAGENTS ON THE CENTAUR CP ANALYZER:THE ADVIA CENTAUR HBSAG ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR CP SYSTEM.THE ASSAY MAY BE USED IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION TO DIAGNOSE INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B INFECTION. THE ASSAY MAY ALSO BE USED TO SCREEN FOR HEPATITIS B INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT RISK OF ACQUIRING HEPATITIS B DURING THE PERINATAL PERIOD.THE ADVIA CENTAUR HBSAG CONFIRMATORY ASSAY READYPACK ON THE CENTAUR CP ANALYZER:THE ADVIA CENTAUR HBSAG CONFIRMATORY ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARIN) USING THE ADVIA CENTAUR CP SYSTEM. THE ASSAY IS INTENDED TO BE USED TO CONFIRM THE PRESENCE OFHBSAG IN SAMPLES THAT ARE REPEATEDLY REACTIVE USING THE ADVIA CENTAUR HBSAG ASSAY.ADVIA CENTAUR HBSAG QUALITY CONTROLS ON THE CENTAUR CP ANALYZER:FOR MONITORING THE PERFORMANCE OF THE HBSAG AND HBSAG CONFIRMATORY ASSAYS ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HBSAG QUALITY CONTROL MATERIAL HASNOT BEEN ESTABLISHED WITH ANY OTHER HBSAG OR HBSAG CONFIRMATORY 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)