BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P050051 · Decision Jun 1, 2006
    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
    ABBOTT ARCHITECT AUSAB
    PMA Number
    P050051
    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
    June 1, 2006
    Date Received
    December 9, 2005
    Expedited Review
    N
    Docket Number
    06M-0321

    Advisory Committee Statement

    APPROVAL FOR THE ARCHITECT AUSAB REAGENT KIT, WHICH IS INDICATED FOR: ARCHITECT AUSAB REAGENT KIT: THE ARCHITECT AUSAB ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (DIPOTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN) AND NEONATAL SERUM. IT IS INTENDED FOR QUANTITATIVE MEASUREMENT OF ANTIBODY RESPONSE FOLLOWING HEPATITIS B VIRUS (HBV) VACCINATION, DETERMINATION OF HBV IMMUNE STATUS, AND FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION WHEN USED IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION. ARCHITECT AUSAB CALIBRATORS: THE ARCHITECT AUSAB CALIBRATORS ARE USED TO CALIBRATE THE ARCHITECT I SYSTEM WHEN THE SYSTEM IS USED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) USING THE ARCHITECT AUSAB REAGENT KIT. THE PERFORMANCE OF THE ARCHITECT AUSAB CALIBRATORS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAYS. ARCHITECT AUSAB CONTROLS: THE ARCHITECT AUSAB CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THE ARCHITECT I SYSTEM WHEN USED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) USING THE ARCHITECT AUSAB REAGENT KIT. THE PERFORMANCE OF THE ARCHITECT AUSAB CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAYS.

    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)