BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

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

    PMA: P000021 · Supplement: S003 · Decision Dec 30, 2003
    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 TPSA FLEX REAGENT CARTRIDGE
    PMA Number
    P000021
    Supplement Number
    S003
    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
    December 30, 2003
    Date Received
    December 17, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF THE DIMENSION TPSA FLEX REAGENT CARTRIDGE ON THE DIMENSION RXL MAX ANALYZER. THE DEVICE WILL BE MARKETED UNDER THE SAME TRADE NAME AND IS INDICATED FOR: THE TPSA METHOD FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM WITH THE HETEROGENEOUS IMMUNOASSAY MODULE IS AN IN VITRO DIAGNOSTIC TEST INTENDED TO QUANTITATIVELY MEASURE TOTAL PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM AND PLASMA: 1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN 50 YEARS OR OLDER. PROSTATE BIOPSY IS REQUIRED FOR 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