BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Antigen(Complexed),Prostate Specific,(Cpsa)

    PMA: P990055 · Decision Sep 8, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Antigen(Complexed),Prostate Specific,(Cpsa)
    Trade Name
    BAYER IMMUNO 1 COMPLEXED PSA ASSAY
    PMA Number
    P990055
    Device Class
    FDA Class 3
    Product Code
    NAF
    Generic Name
    ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 8, 2000
    Date Received
    October 1, 1999
    Expedited Review
    N
    Docket Number
    00M-1524

    Advisory Committee Statement

    APPROVAL FOR THE BAYER IMMUNO 1(TM) COMPLEXED PSA ASSAY. THE IN VITRO DEVICE IS INTENDED TO QUANTITATIVELY MEASURE COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) IN HUMAN SERUM ON THE BAYER IMMUNO 1(TM) SYSTEM. THIS DEVICE IS INDICATED FOR THE MEASUREMENT OF SERUM COMPLEXED PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS OR OLDER. BIOPSY OF THE PROSTATE IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THIS DEVICE IS FURTHER INDICATED AS AN AID IN THE MANAGEMENT (MONITORING) OF PROSTATE CANCER PATIENTS. THIS DIAGNOSTIC METHOD IS NOT INTENDED FOR USE ON ANY OTHER SYSTEM.

    Classifications

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

    Product Code Device Name
    NAF Antigen(Complexed),Prostate Specific,(Cpsa)