BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P210019 · Decision Jul 27, 2022
    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
    ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)
    PMA Number
    P210019
    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 27, 2022
    Date Received
    May 11, 2021
    Expedited Review
    N
    Docket Number
    22M-1740

    Advisory Committee Statement

    Approval for the ADVIA Centaur® HBc Total 2 (HBcT2) assay. The ADVIA Centaur HBc Total 2 (HBcT2) assay is an in vitro diagnostic immunoassay for use in the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBV) in human adult serum and plasma (EDTA, lithium heparin, and sodium heparin) using the Approval for the ADVIA Centaur XP and ADVIA Centaur XPT systems.This assay can be used as an aid in the diagnosis of adults with acute or chronic hepatitis B virus (HBV) infection, and in the determination of the clinical status of HBV-infected individuals in conjunction with other HBV serological markers, for the laboratory diagnosis of HBV disease associated with HBV infection. This assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.This assay is not intended for screening donors of blood or blood products or human cells, tissues, and cellular and tissue-based products (HCT/Ps).Approval for the ADVIA Centaur® HBc Total 2 Quality Control (HBcT2 QC).The ADVIA Centaur® HBc Total 2 (HBcT2) Quality Control material is for in vitro diagnostic use for monitoring the performance of the ADVIA Centaur HBc Total 2 (HBcT2) assay using the ADVIA Centaur systems.The performance of the ADVIA Centaur HBcT2 Quality Control material has not been with any other anti-HBc Total assay.Approval for the Atellica IM® HBc Total 2 (HBcT2) assay.The Atellica IM HBc Total 2 (HBcT2) assay is an in vitro diagnostic immunoassay for use in the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBV) in human adult serum and plasma (EDTA, lithium heparin, and sodium heparin) using the Atellica IM Analyzer.This assay can be used as an aid in the diagnosis of adults with acute or chronic hepatitis B virus (HBV) infection and in the determination of the clinical status of HBV-infected individuals in conjunction with other HBV serological markers, for the laboratory diagnosis of HBV disease associated with HBV infection. This assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.This assay is not intended for screening donors of blood or blood products or human cells, tissues, and cellular and tissue-based products (HCT/Ps).Approval for the Atellica IM® HBc Total 2 Quality Control (HBcT2 QC).The Atellica IM HBc Total 2 (HBcT2) Quality Control material is for in vitro diagnostic use for monitoring the performance of the Atellica IM HBc Total 2 (HBcT2) assay using the Atellica IM systems.The performance of the Atellica IM HBcT2 Quality Control material has not been with any other anti-HBc Total 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)