BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P130015 · Decision Mar 14, 2014
    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® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG
    PMA Number
    P130015
    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 14, 2014
    Date Received
    May 30, 2013
    Expedited Review
    N
    Docket Number
    14M-0326

    Advisory Committee Statement

    APPROVAL FOR THE ELECSYS HBEAG IMMUNOASSAY AND ELECSYS PRECICONTROL HBEAG. THIS DEVICE IS INDICATED FOR:ELECSYS HBEAG IMMUNOASSAYTHE ELECSYS HBEAG IMMUNOASSAY IS INTENDED FOR THE IN VITRO QUALITATIVE DETERMINATION OF HEPATITIS B E ANTIGEN (HBEAG) IN HUMAN SERUM OR PLASMA (K2-EDTA, LITHIUM OR SODIUM HEPARIN, AND SODIUM CITRATE) IN ADULT PATIENTS WITH SYMPTOMS OF HEPATITIS OR AT RISK FOR HEPATITIS B VIRUS (HBV) INFECTION. THE 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 OR RECOVERY FROM HEPATITIS B INFECTION. THE ELECTROCHEMILUMIN-ESCENCE IMMUNOASSAY ECLIA IS INTENDED FOR USE ON THE MODULAR ANALYTICS E170 ANALYZER.ELECSYS PRECICONTROL HBEAG ELECSYS PRECICONTROL HBEAG IS USED FOR QUALITY CONTROL OF THE ELECSYS HBEAG IMMUNOASSAY ON THE MODULAR ANALYTICS E170 ANALYZER.

    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)