BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P970038 · Decision Mar 10, 1998
    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
    TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY
    PMA Number
    P970038
    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
    March 10, 1998
    Date Received
    August 29, 1997
    Expedited Review
    N
    Docket Number
    98M-0201

    Advisory Committee Statement

    Approval for the Tandem(R)-R free PSA assay and Tandem(R)-MP free PSA assay. The Tandem(R)-R free PSA Immunoradiometric Assay is an In Vitro device for the quantitative measurement of free prostate specific antigen (free PSA) in human serum. The Tandem(R)-MP free PSA Immunoenzymetric Assay is an In Vitro device for the quantitative measurement of free prostate specific antigen (free PSA) in human serum. Hybritech's Tandem free PSA assays are intened to beused with Tandem (total) PSa to calculate the ration of fee PSA to total PSA expressed as a percentage (percent free PSA). Percent free PSA as measured by Hybritech's Tandem assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic condtions, when used in conjuction with Tandem (total) PSA for prostate cancer detection in men aged 50 years and older with total PSA between 4 and 10 ng/ml and digital rectal examination finding 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