BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P990012 · Supplement: S001 · Decision Mar 13, 2007
    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
    ROCHE ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFORMATORY TEST AND PRECICONTROL HBSAG
    PMA Number
    P990012
    Supplement Number
    S001
    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
    March 13, 2007
    Date Received
    September 29, 2004
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A NEW INSTRUMENT PLATFORM. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY TEST AND ELECSYS PRECICONTROL HBSAG AND IS INDICATED: ELECSYS HBSAG IMMUNOASSAY - FOR THE IN VITRO QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (SODIUM HEPARIN, K3-EDTA, SODIUM CITRATE). ASSAY RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THE LABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B. IN ADDITION, THIS ASSAY MAY BE USED TO SCREEN FOR HEPATITIS B INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES AT HIGH RISK OF ACQUIRING HBV DURING THE PERINATAL PERIOD. THE ELECTROCHEMILUMI-NESCENCE IMMUNOASSAY ?ECLIA? IS INTENDED FOR USE ON THE ROCHE ELECSYS 2010 AND MODULAR ANALYTICS E170 (ELECSYS MODULE) IMMUNOASSAY ANALYZERS. THE ELECSYS HBSAG CONFIRMATORY TEST - FOR THE IN VITRO QUALITATIVE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN IN HUMAN SERUM AND PLASMA (SODIUM HEPARIN, EDTA-K3, SODIUM CITRATE) SAMPLES REPEATEDLY REACTIVE WHEN TESTED WITH THE ELECSYS HBSAG IMMUNOASSAY. THE ELECSYS HBSAG CONFIRMATORY IMMUNOASSAY IS INTENDED FOR USE ON THE ROCHE ELECSYS 2010 AND MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZERS. ELECSYS PRECICONTROL HBSAG - FOR QUALITY CONTROL OF THE ELECSYS HBSAG IMMUNOASSAY ON THE ELECSYS 2010 AND MODULAR ANALYTICS E170 ANALYZERS WHEN TESTING HUMAN SERUM. THE PERFORMANCE OF THE PRECICONTROL HBSAG HAS NOT BEEN ESTABLISHED WITH ANY OTHER HBSAG 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)