BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

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

    PMA: P040008 · Decision Jul 8, 2004
    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
    VIDAS TPSA ASSAY
    PMA Number
    P040008
    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    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    July 8, 2004
    Date Received
    February 17, 2004
    Expedited Review
    N
    Docket Number
    04M-0342

    Advisory Committee Statement

    APPROVAL FOR THE VIDAS TPSA ASSAY INDICATED AS FOLLOWS: VIDAS TPSA IS INTENDED FOR USE WITH A VIDAS (VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM) INSTRUMENT AS AN AUTOMATED ENZYME-LINKED FLUORESCENT IMMUNOASSAY (ELFA) FOR THE QUANTITATIVE MEASUREMENT OF TOTAL PROSTATE SPECIFIC ANTIGEN IN HUMAN SERUM. THE VIDAS TPSA ASSAY IS INDICATED AS AN AID IN THE MANAGEMENT OF PATIENTS WITH PROSTATE CANCER AND AS AN AID IN THE DETECTION OF PROSTATE CANCER IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) IN MEN AGE 50 YEARS OR OLDER. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF PROSTATE CANCER.

    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