BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P970038 · Supplement: S005 · Decision Nov 27, 2002
    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
    ACCESS HYBRITECH FREE PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER
    PMA Number
    P970038
    Supplement Number
    S005
    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
    November 27, 2002
    Date Received
    August 19, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ACCESS HYBRITECH FREE PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER. THE DEVICE IS INDICATED FOR: THE ACCESS HYBRITECH FREE PSA ASSAY IS A PARAMAGNETIC PARTICLE, CHEMILUMINESCENT IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF FREE PROSTATE SPECIFIC ANTIGEN (FREE PSA) IN HUMAN SERUM USING THE ACCESS IMMUNOASSAY SYSTEMS. ACCESS HYBRITECH FREE PSA IS INTENDED TO BE USED WITH HYBRITECH (TOTAL) PSA TO CALCULATE THE RATIO OF FREE PSA TO TOTAL PSA EXPRESSED AS A PERCENTAGE (PERCENT FREE PSA). PERCENT FREE PSA AS MEASURED BY THE HYBRITECH ASSAYS IS INDICATED FOR USE AS AN AID IN DISTINGUISHING PROSTATE CANCER FROM BENIGN PROSTATIC CONDITIONS, WHEN USED IN CONJUNCTION WITH HYBRITECH (TOTAL) PSA FOR PROSTATE CANCER DETECTION IN MEN AGED 50 YEARS AND OLDER WITH TOTAL PSA BETWEEN 4 AND 10 NG/ML WITH DIGITAL RECTAL EXAMINATION FINDINGS THAT ARE NOT SUSPICIOUS FOR CANCER. PROSTATIC BIOPSY IS REQUIRED FOR DIAGNOSIS OF 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