BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    PMA: P990056 · Decision Nov 22, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
    Trade Name
    ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET
    PMA Number
    P990056
    Device Class
    FDA Class 3
    Product Code
    MTF
    Generic Name
    Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 22, 2000
    Date Received
    October 4, 1999
    Expedited Review
    N
    Docket Number
    00M-1660

    Advisory Committee Statement

    APPROVAL FOR THE ELECSYS(R) TOTAL PSA IMMUNOASSAY AND ELECSYS(R) TOTAL PSA CALSET. THE DEVICE, A QUANTITATIVE IN VITRO DIAGNOSTIC TEST FOR TOTAL PROSTATE-SPECIFIC ANTIGEN (TPSA) IN HUMAN SERUM AND PLASMA IS INDICATED FOR THE MEASUREMENT OF TOTAL PSA IN CONJUNCTION WITH DOGOTA; RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS OR OLDER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THE TEST ID FURTHER INDICATED FOR SERIAL MEASUREMENT OF TPSA TO AID IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS. THE ELECTOCHEMILUMINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ROCHE ELECSYS(R) 1010 AND 2010 IMMUNOASSAY ANALYZERS.

    Classifications

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

    Product Code Device Name
    MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer