BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

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

    PMA: P000021 · Decision Jul 5, 2001
    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
    DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE
    PMA Number
    P000021
    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
    July 5, 2001
    Date Received
    June 5, 2000
    Expedited Review
    N
    Docket Number
    01M-0310

    Advisory Committee Statement

    APPROVAL FOR THE DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE. THE DEVICE IS INDICATED FOR THE FOLLOWING: THE PSA METHOD FOR THE DIMENSION(R) CLINICAL CHEMISTRY SYSTEM WITH THE HETEROGENEOUS IMMUNOASSAY MODULE IS AN IN VITRO DIAGNOSTIC TEST INTENDED TO QUANTITATIVELY MEASURE PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM: 1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN AGED 50 YEARS OR OLDER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF CANCER. 2) AS AN AID IN THE MANAGEMENT (MONITORING) 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