BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P050051 · Supplement: S004 · Decision Jul 23, 2009
    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
    ARCHITECT AUSAB, ARCHITECT I1000 SYSTEM
    PMA Number
    P050051
    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 23, 2009
    Date Received
    February 12, 2009
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO EXTEND THE APPLICATION OF THE ARCHITECT AUSAB ASSAY, CURRENTLY APPROVED FOR USE ON THE ABBOTT ARCHITECT I2000/ I 2000SR, ONTO A NEW ARCHITECT I SYSTEM FAMILY MEMBER, THE ARCHITECT I 1000SR.ARCHITECT AUSAB REAGENT KIT ON ARCHITECT I 1000SR: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, LITHIUMHEPARIN, AND SODIUM HEPARIN) AND NEONATAL SERUM. IT IS INTENDED FOR QUANTITATIVEMEASUREMENT OF ANTIBODY RESPONSE FOLLOWING HEPATITIS B VIRUS (HBV) VACCINATION,DETERMINATION OF HBV IMMUNE STATUS, AND FOR THE LABORATORY DIAGNOSIS OF HBV DISEASEASSOCIATED WITH HBV INFECTION WHEN USED IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION.ARCHITECT AUSAB CALIBRATORS ON ARCHITECT I 1000SR: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 ANYOTHER ANTI-HBS ASSAY.ARCHITECT AUSAB CONTROLS ON ARCHITECT I 1000SR:THE ARCHITECT AUSAB CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THEARCHITECT I SYSTEM WHEN USED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) USING THE ARCHITECT AUSAB REAGENT KIT. THEPERFORMANCE OF THE ARCHITECT AUSAB CONTROLS HAS NOT BEEN ESTABLISHED WITH ANYOTHER ANTI-HBS 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)