BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

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

    PMA: P990012 · Decision Jun 1, 2001
    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
    ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG
    PMA Number
    P990012
    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    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    June 1, 2001
    Date Received
    March 4, 1999
    Expedited Review
    N
    Docket Number
    01M-0507

    Advisory Committee Statement

    APPROVAL FOR THE ELECSYS. HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG. THE DEVICES ARE INDICATED FOR: ELECSYS HBSAG IMMUNOASSAY IS AN IMMUNOASSAY FOR THE IN VITRO QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA-K3, 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 WHO ARE AT HIGH RISK OF ACQUIRING HBV DURING THE PERINATAL PERIOD. THE ELECTROCHEMILUMINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ROCHE ELECSYS 2010 IMMUNOASSAY SYSTEM. ELECSYS HBSAG CONFIRMATORY IS AN IMMUNOASSAY FOR THE IN VITRO QUALITATIVE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA-K3, SODIUM CITRATE) SAMPLES REPEATEDLY REACTIVE WHEN TESTED WITH ELECSYS 2010 HBSAG IMMUNOASSAY. PRECICONTROL HBSAG IS USED FOR QUALITY CONTROL OF THE ELECSYS HBSAG IMMUNOASSAY ON THE ELECSYS 2010 IMMUNOASSAY SYSTEM 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)