BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P980007 · Supplement: S003 · Decision Feb 5, 2004
    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
    ABBOTT IMX FREE PSA
    PMA Number
    P980007
    Supplement Number
    S003
    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
    Decision Code
    APPR
    Decision Date
    February 5, 2004
    Date Received
    January 31, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATION OF THE ABBOTT ARCHITECT FREE PSA REAGENTS TO BE USED WITH THE IMX FREE PSA AND IS INDICATED FOR: THE IMX FREE PSA ASSAY IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) FOR THE QUANTITATIVE MEASUREMENT OF FREE PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM. THE IMX FREE PSA ASSAY IS INTENDED TO BE USED IN CONJUNCTION WITH THE IMX TOTAL PSA ASSAY IN MEN AGED 50 YEARS OR OLDER WITH TOTAL PSA VALUES BETWEEN 4 AND 10 NG/ML AND NON-SUSPICIOUS DRE TO DETERMINE THE % FREE PSA VALUE. THE IMX % FREE PSA VALUE CAN BE USED AS AN AID IN DISCRIMINATING BETWEEN PROSTATE CANCER AND BENIGN DISEASE.

    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