BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Antigen(Complexed),Prostate Specific,(Cpsa)

    PMA: P990055 · Supplement: S001 · Decision Dec 7, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Antigen(Complexed),Prostate Specific,(Cpsa)
    Trade Name
    BAYER ACS:180 OR ADVIA CENTAUR COMPLEX PSA ASSAYS
    PMA Number
    P990055
    Supplement Number
    S001
    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
    December 7, 2001
    Date Received
    March 27, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF THE ASSAY TO THE BAYER ACS:180 AND ADVIA CENTAUR ANALYZERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES BAYER ACS:180 OR ADVIA CENTAUR COMPLEXED PSA ASSAY AND ARE INDICATED AS FOLLOWS: THIS IN VITRO DEVICE IS INTENDED TO QUANTITATIVELY MEASURE COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) IN HUMAN SERUM USING THE BAYER DIAGNOSTICS IMMUNO 1, THE ACS:180 SYSTEM, OR THE ADVIA CENTAUR 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.

    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)