BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Antigen(Complexed),Prostate Specific,(Cpsa)

    PMA: P990055 · Supplement: S012 · Decision Jun 10, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Antigen(Complexed),Prostate Specific,(Cpsa)
    Trade Name
    ADVIA CENTAUR XP CPSA ASSAY ON THE ADVIA CENTAUR XP (WITH VERSION 5.0 SOFTWARE)
    PMA Number
    P990055
    Supplement Number
    S012
    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
    June 10, 2009
    Date Received
    April 10, 2009
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF THE ADVIA CENTAUR XP INSTRUMENT (WITH VERSION 5.0SOFTWARE) TO THE INSTRUMENT(S) USING THE ADVIA CENTAUR CPSA ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR AND ADVIA CENTAUR XP CPSA ASSAY AND ISINDICATED 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 AND OLDER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THIS ASSAY IS FURTHER INDICATED AS AN AID IN THE MANAGEMENT (MONITORING) OF PATIENTS WITH PROSTATE CANCER.

    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)