BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

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

    PMA: P950021 · Supplement: S002 · Decision Dec 22, 2000
    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
    ACS:180(TM)/ADVIA CENTAUR(TM) PSA ASSAY
    PMA Number
    P950021
    Supplement Number
    S002
    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 22, 2000
    Date Received
    July 31, 2000
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    01M-0038

    Advisory Committee Statement

    APPROVAL FOR THE ACS:180 AND ADVIA CENTAUR IMMUNOASSAY ANALYZERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ACS:180 PSA IMMUNOASSAY AND ADVIA CENTAUR PSA IMMUNOASSAY AND IS INDICATED FOR THE FOLLOWING: THE BAYER ACS:180(TM) AND ADVIA CENTAUR(TM) PSA ASSAYS ARE IN VITRO DEVICES INTENDED FORO THE QUANTITATIVE MEASUREMENT OF PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM. THESE DEVICES ARE INDICATED FOR THE MEASUREMENT OF SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION PROSTATE CANCER IN MEN AGED 50 YEARS AND OLDER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THESE DEVICES ARE FURTHER INDICATED 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