BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P190034 · Decision Feb 23, 2021
    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 II, PreciControl Anti-HBs, Anti-HBs CalCheck
    PMA Number
    P190034
    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 23, 2021
    Date Received
    December 30, 2019
    Expedited Review
    N
    Docket Number
    21M-0228

    Advisory Committee Statement

    Approval for the Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck.Elecsys Anti-HBs II Immunoassay for the in vitro quantitative determination of total antibodies to the hepatitis B surface antigen (HBsAg) in human adult, pregnant women, and pediatric (ages 2 to 21 years) serum and plasma (K2-EDTA and K3-EDTA). Assay results may be used as an aid in the determination of susceptibilty 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 symptons 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 or from vaccination.The electrochemiluminescence immunoassay ECLIA is intended for use on the cobas e 601 immunoassay analyzer.PreciControl Anti-HBsPreciControl Anti-HBs is used for quality control of the Elecsys Anti-HBs immunoassay on the Elecsys and cobas e immunoassay analyzers and of the Elecsys Anti-HBs II immunoassay on the cobas e 601 immunoassay analyzer. The performance of PreciControl Anti-HBs has not been established with any other anti-HBs assay.Anti-HBs CalCheckAnti-HBs CalCheck is an assayed control material for use in the verification of the calibration established by the Elecsys Anti-HBs immunoassay on the cobas e immunoassay analyzers and by the Elecsys Anti-HBs II immunoassay on the cobas e 601 immunoassay 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)