BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P060005 · Decision May 11, 2007
    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
    IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS
    PMA Number
    P060005
    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
    May 11, 2007
    Date Received
    February 14, 2006
    Expedited Review
    N
    Docket Number
    07M-0409

    Advisory Committee Statement

    APPROVAL FOR THE IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAY. THESE DEVICES ARE INDICATED FOR: THE IMMULITE / IMMULITE 1000 FREE PSA ASSAY IS INDICATED FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE / IMMULITE 1000 ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF FREE PROSTATE-SPECIFIC ANTIGEN (PSA) NOT BOUND TO ALPHA 1-ANTICHYMOTRYPSIN OR OTHER BINDING PROTEINS (UNCOMPLEXED) IN HUMAN SERUM (INCLUDING SERUM COLLECTED IN SERUM GLASS, SERUM PLASTIC AN SERUM GEL SEPARATOR TUBES). MEASUREMENT OF FREE PSA IS USED IN CONJUNCTION WITH IMMULITE / IMMULITE 1000 TOTAL PSA TO DETERMINE A RATIO OF FREE PSA TO TOTAL PSA (PERCENT FREE PSA). THE PERCENT FREE PSA IS USED AS AN AID IN DISCRIMINATING PROSTATE CANCER FROM BENIGN DISEASE IN MEN 50 YEARS OR OLDER WITH IMMULITE / IMMULITE 1000 TOTAL PSA VALUES BETWEEN 4 AND 10 NG/ML AND DIGITAL RECTAL EXAM (DRE) FINDINGS NOT SUSPICIOUS OF CANCER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THE IMMULITE 2000 FREE PSA ASSAY IS INDICATED FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE 2000 ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF FREE PROSTATE-SPECIFIC ANTIGEN (PSA) NOT BOUND TO ALPHA 1-ANTICHYMOTRYPSIN OR OTHER BINDING PROTEINS (UNCOMPLEXED) IN HUMAN SERUM (INCLUDING SERUM COLLECTED IN SERUM GLASS, SERUM PLASTIC AN SERUM GEL SEPARATOR TUBES). MEASUREMENT OF FREE PSA IS USED IN CONJUNCTION WITH IMMULITE 2000 TOTAL PSA TO DETERMINE A RATIO OF FREE PSA TO TOTAL PSA (PERCENT FREE PSA). THE PERCENT FREE PSA IS USED AS AN AID IN DISCRIMINATING PROSTATE CANCER FROM BENIGN DISEASE IN MEN 50 YEARS OR OLDER WITH IMMULITE 2000 TOTAL PSA VALUES BETWEEN 4 AND 10 NG/ML AND DIGITAL RECTAL EXAM (DRE) FINDINGS NOT SUSPICIOUS OF CANCER. PROSTATE BIOPSY IS REQUIRED FOR THE 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