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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    PMA: P080008 · Decision Oct 8, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
    Trade Name
    VIDAS FREE PSA RT ASSAY
    PMA Number
    P080008
    Device Class
    FDA Class 3
    Product Code
    MTG
    Generic Name
    Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    October 8, 2009
    Date Received
    March 21, 2008
    Expedited Review
    N
    Docket Number
    09M-0536

    Advisory Committee Statement

    APPROVAL FOR THE VIDASFREE PSA RT ASSAY. THE VIDAS FPSA RT IS AN AUTOMATED QUANTITATIVETEST FOR USE ON THE VIDAS INSTRUMENTS, FOR THE QUANTITATIVE MEASUREMENT OF THE FREE FRACTION OFPROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM USING THE ELFA TECHNIQUE (ENZYME LINKEDFLUORESCENT ASSAY). THE VIDAS FPSA RT IS INTENDED TO BE USED IN CONJUNCTION WITH THE VIDASTPSA ASSAY IN MEN AGE 50 YEARS OR OLDER WHO HAVE DIGITAL RECTAL EXAMINATION (DRE) THAT IS NOTSUSPICIOUS FOR PROSTATE CANCER AND VIDAS TPSA VALUES BETWEEN 4 AND 10 NG/ML TO DETERMINE THE %FREE PSA VALUE. THE VIDAS %FPSA VALUE CAN BE USED AS AN AID IN DISCRIMINATING BETWEEN PROSTATE CANCER AND BENIGN DISEASE. 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
    MTG Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions