BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P090024 · Supplement: S004 · Decision Jul 12, 2018
    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
    Atellica IM Hepatitis B e Antigen (HBeAg)
    PMA Number
    P090024
    Supplement Number
    S004
    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
    July 12, 2018
    Date Received
    December 22, 2017
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for migration of the ADVIA Centaur Hepatitis B e Antigen and the ADVIA Centaur Hepatitis B e Antigen Quality Control onto the Atellica IM analyzer. The device, as modified, will be marketed under the trade name Atellica IM Hepatitis B e Antigen (HBeAg) and Atellica IM Hepatitis B e Antigen Quality Control (HBeAg QC) and is indicated for: Atellica IM Hepatitis Be Antigen (HBeAg)The Atellica IM Hepatitis Be Antigen (HBeAg) assay is an in vitro diagnostic immunoassay for use in the qualitative determination of the hepatitis B e antigen (HBeAg) in human serum and plasma (potassium EDTA, lithium heparin, and sodium heparin) from individuals who have signs and symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection using the Atellica™ IM Analyzer. This assay, in conjunction with other serological and clinical information, is intended only for the determination of chronic infection with hepatitis B virus. Atellica IM Hepatitis B e Antigen Quality Control (HBeAg QC)The Atellica® IM Hepatitis B e Antigen Quality Control (HBeAg QC) is for use in monitoring theperformance of the Atellica IM HBeAg assay using the Atellica® IM Analyzer.The performance of the Atellica IM HBeAg quality control material has not been establishedwith any other HBeAg 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)