BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P210003 · Decision Aug 10, 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
    ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit
    PMA Number
    P210003
    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
    August 10, 2022
    Date Received
    February 8, 2021
    Expedited Review
    N
    Docket Number
    22M-1906

    Advisory Committee Statement

    Approval for the ARCHITECT HBsAg NEXT Qualitative Reagent Kit. The HBsAg Next Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of Hepatitis B surface antigen (HBsAg) in human adult and pediatric (2 years to 21 years of age) serum, serum separator tube, and plasma (dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator, sodium heparin) on the ARCHITECT i System.The assay may also be used to screen for hepatitis B virus (HBV) infection in pregnant women to identify neonates who are at risk for acquiring hepatitis B during the perinatal period. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with HBV (state of infection or associated disease not determined) in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis B infection. ARCHITECT HBsAg NEXT Confirmatory Reagent Kit The HBsAg Next Confirmatory assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative confirmation of the presence of hepatitis B surface antigen (HBsAg) in human adult and pediatric (2 years to 21 years of age) serum, serum separator, and plasma (dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator, sodium heparin) by means of specific antibody neutralization on the ARCHITECT i SystemAssay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with the hepatitis B virus (HBV) (state of infection or associated disease not determined) in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis B infection.It is intended to be used for the confirmation of samples found to be repeatedly reactive by HBsAg Next Qualitative.It is intended to be used for the confirmation of samples found to be repeatedly reactive by HBsAg Next Qualitative.ARCHITECT HBsAg NEXT Qualitative CalibratorsThe HBsAg Next Qualitative Calibrators are for the calibration of the ARCHITECT i System when used for qualitative determination and confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma.ARCHITECT HBsAg NEXT Qualitative ControlsThe HBsAg Next Qualitative Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the qualitative detection and for the confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma.ARCHITECT HBsAg NEXT Confirmatory Manual DiluentThe HBsAg Next Confirmatory Manual Diluent is used for manually diluting specimens for testing on the ARCHITECT i System.

    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)