BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P990056 · Supplement: S003 · Decision Aug 10, 2006
    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
    ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET
    PMA Number
    P990056
    Supplement Number
    S003
    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
    August 10, 2006
    Date Received
    February 13, 2006
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR FORMULATION CHANGE TO THE HAMA INTERFERENCE REDUCTION PROTEINS TO IMPROVE ASSAY ROBUSTNESS WITH REGARD TO POTENTIAL HAMA INTERFERENCE FOR THE ELECSYS TOTAL PSA IMMUNOASSAY AND CHANGES IN MATRIX, ANTIGEN AND CALIBRATOR 1 TARGET VALUE FOR THE ELECSYS TOTAL PSA CALSET. THE ELECSYS TOTAL PSA CALSET, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME, ELECSYS TOTAL PSA CALSET II.

    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