BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P010054 · Decision Feb 28, 2002
    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-HBS
    PMA Number
    P010054
    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
    February 28, 2002
    Date Received
    September 10, 2001
    Expedited Review
    N
    Docket Number
    02M-0179

    Advisory Committee Statement

    APPROVAL FOR THE ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS. THE ELECSYS ANTI-HBS IMMUNOASSAY IS INDICATED FOR: THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO THE HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (EDTA). THE ELECTROCHEMILUMIN-ESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ROCHE ELECSYS 2010 IMMUNOASSAY ANALYZER. ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR 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. THE DETECTION OF ANTI-HBS IS INDICATIVE OF LABORATORY DIAGNOSIS OF SEROCONVERSION FROM HEPATITIS B VIRUS (HBV) INFECTION. THE ELECSYS PRECICONTROL ANTI-HBS IS INDICATED FOR: THE PRECICONTROL ANTI-HBS IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI-HBS IMMUNOASSAY ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER. THE PERFORMANCE OF THE PRECICONTROL ANTI-HBS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS 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)