BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    PMA: P230015 · Decision Oct 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
    Trade Name
    Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC
    PMA Number
    P230015
    Device Class
    FDA Class 2
    Product Code
    LOM
    Generic Name
    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
    Regulation Number
    866.3172
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    October 17, 2025
    Date Received
    April 17, 2023
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QCAccess HBsAg The Access HBsAg assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of hepatitis B surface antigen (HBsAg) in human pediatric (7 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2) EDTA, tripotassium (K3) EDTA, sodium citrate, acid citrate dextrose (ACD), and citrate phosphate dextrose (CPD)] using the DxI 9000 Access Immunoassay Analyzer.The Access HBsAg assay is used for the laboratory diagnosis of acute or chronic hepatitis B virus (HBV) infection in individuals with signs and symptoms of hepatitis or at risk for hepatitis B virus infection, when used in conjunction with other serological and clinical information. The assay may also be used to screen for HBV infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during the perinatal period.The Access HBsAg assay is for use on the DxI 9000 Access Immunoassay Analyzer only.This assay has not been approved for use in the screening of blood, plasma, or tissue donors or cadaveric specimens.ACCESS HBsAg CALIBRATOR The Access HBsAg Calibrator is intended to calibrate the Access HBsAg and Access HBsAg Confirmatory assays for the in vitro qualitative detection and confirmation of hepatitis B surface antigen (HBsAg) in human serum and plasma using the DxI 9000 Access Immunoassay Analyzer.For additional information, refer to the Access HBsAg and Access HBsAg Confirmatory reagent Instructions for Use.ACCESS HBsAg QC The Access HBsAg QC is intended for monitoring system performance of the Access HBsAg and Access HBsAg Confirmatory assays. The Access HBsAg QC is for use on the DxI 9000 Access Immunoassay Analyzer.For additional information, refer to the Access HBsAg and Access HBsAg Confirmatory reagent Instructions for Use.ACCESS HBsAg CONFIRMATORYHepatitis B Virus Surface AntigenThe Access HBsAg Confirmatory assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative confirmation of the presence of hepatitis B surface antigen (HBsAg) in human pediatric (7 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2) EDTA, tripotassium (K3) EDTA, sodium citrate, acid citrate dextrose (ACD), and citrate phosphate dextrose (CPD)] that have been found to be repeatedly reactive in the Access HBsAg assay using the DxI.

    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 Antigen, B Surface Antigen, Be Antigen)