BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P100032 · Supplement: S007 · Decision Dec 19, 2013
    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 ANTI-HBC TEST SYSTEM
    PMA Number
    P100032
    Supplement Number
    S007
    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
    December 19, 2013
    Date Received
    September 4, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MIGRATION OF CLAIMS FROM THE FDA APPROVED ELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC ON THE ELECSYS 2010 ANALYZER TO THE COBAS E 411 IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC AND IS INDICATED FOR:ELECSYS ANTI-HBC IMMUNOASSAYTHE ELECSYS ANTI-HBC IMMUNOASSAY IS INTENDED FOR THE IN VITRO QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC) IN HUMAN SERUM AND PLASMA (LITHIUM HEPARIN, SODIUM CITRATE, K2-EDTA) IN ADULT PATIENTS WITH THE SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B (HBV) INFECTION. THE DETECTION OF TOTAL ANTI-HBC IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR HBV INFECTION. FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE. THE ELECSYS ANTI-HBC IMMUNOASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY. THE ELECTROCHEMILUMINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ELECSYS 2010 AND THE COBAS E 411 IMMUNOASSAY ANALYZERS.ELECSYS PRECICONTROL ANTI-HBC ELECSYS PRECICONTRO1 ANTI-HBC IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI-HBC IMMUNOASSAY ON THE ELECSYS 2010 AND THE COBAS E411 IMMUNOASSAY ANALYZERS.

    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)