BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    PMA: P950021 · Supplement: S004 · Decision Mar 19, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37

    Basic Information

    Device Name
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
    Trade Name
    TOTAL PSA MICROTITER ELISA
    PMA Number
    P950021
    Supplement Number
    S004
    Device Class
    FDA Class 2
    Product Code
    LTJ
    Generic Name
    PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 19, 2002
    Date Received
    September 20, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ADD A MICROTITER PLATE CAPTURE SYSTEM TO THE CURRENT DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ONCOGENE SCIENCE TOTAL PSA MICROTITER ELISA AND IS INDICATED FOR THE FOLLOWING: THE ONCOGENE SCIENCE TOTAL PSA MICROTITER ELISA IS AN IN VITRO DIAGNOSTIC ASSAY INTENDED TO QUANTITATIVELY MEASURE TOTAL PSA IN HUMAN SERUM. THE ASSAY DETECTS PSA BOTH AS A FREE MOLECULE, AND WHEN COMPLEXED BY OTHER MOLECULES, PRINCIPALLY ALPHA-1-ANTICHYMOTRYPSIN (ACT). THIS DEVICE IS INDICATED FOR THE MEASUREMENT OF SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS AND OLDER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THE ONCOGENE SCIENCE TOTAL PSA MICROTITER ELISA IS FURTHER INDICATED FOR FOLLOW-UP AND MONITORING OF PATIENTS WITH PROSTATE CANCER. PSA LEVELS MEASURED BY THIS DEVICE SHOULD BE USED IN CONJUNCTION WITH INFORMATION AVAILABLE FROM CLINICAL AND OTHER DIAGNOSTIC PROCEDURES IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers