BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    PMA: P850048 · Supplement: S024 · Decision Feb 7, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
    Trade Name
    ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
    PMA Number
    P850048
    Supplement Number
    S024
    Device Class
    FDA Class 3
    Product Code
    MTF
    Generic Name
    Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 7, 2011
    Date Received
    January 10, 2011
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ADD THE FOLLOWING NEW WARNING LABEL TO ALL ACCESS DXI SYSTEMS. ¿WARNING¿ ERRONEOUS RESULTS CAN OCCUR IF REAGENT PACKS ARE NOT LOADED PROPERLY. 1) NEVER TRANSFER A PARTIAL REAGENT PACK THAT WAS USED ON A DIFFERENT SYSTEM. 2) ALWAYS LOAD A REAGENT PACK BEFORE SCANNING THE BAR CODE (ACCESS/ACCESS 2 ONLY). FOR SPECIFIC INSTRUCTIONS, CONSULT THE SYSTEM DOCUMENTATION.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer