BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

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

    PMA: P910065 · Supplement: S001 · Decision Sep 10, 1999
    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
    ST AIA-PACK PA
    PMA Number
    P910065
    Supplement Number
    S001
    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
    September 10, 1999
    Date Received
    March 25, 1999
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    00M-1523

    Advisory Committee Statement

    Approval for the AIA-PACK PA. The device is designed for in vitro diagnostic use only for the quantitative measurement of Prostate Specific Antigen (PSA) in human serum on TOSOH AIA System analyzers. This device is indicated for the measurement of serum PSA in conjunction with Digital Rectal Examination (DRE) as an aid in the detection of prostate cancer (CaP) in men fifty years of age and older. Prostate biopsy is required for the diagnosis of cancer. The device is further indicated for the serial measurement of PSA in human serum to be used as an aid in the management of patients with prostatic cancer.

    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