BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    PMA: P020027 · Decision Jan 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
    Trade Name
    DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS
    PMA Number
    P020027
    Device Class
    FDA Class 3
    Product Code
    MTG
    Generic Name
    Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 24, 2003
    Date Received
    July 5, 2002
    Expedited Review
    N
    Docket Number
    03M-0046

    Advisory Committee Statement

    APPROVAL FOR THE DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS. THE DIMENSION FPSA FLEX REAGENT CARTRIDGE IS INDICATED FOR: THE FPSA METHOD FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM WITH THE HETEROGENOUS IMMUNOASSAY MODULE IS AN IN VITRO DIAGNOSTIC TEST INTENDED TO QUANTITATIVELY MEASURE FREE PROSTATE SPECIFIC ANTIGEN (FPSA) IN HUMAN SERUM. MEASUREMENT OF FPSA ARE USED IN CONJUNCTION WITH TOTAL PSA (TPSA) METHOD ON DIMENSION SYSTEM TO CALCULATE FPSA TO TPSA RATIO EXPRESSED AS A PERCENT FPSA. THE PERCENT FPSA IS USED AS AN AID IN DISTINGUISHING PROSTATE CANCER FROM BENIGN PROSTATE CONDITIONS IN MEN 50 YEARS OR OLDER WITH TPSA OF 4.0 TO 10.0 NG/ML [UG/L] AND DIGITAL RECTAL EXAMINATION (DRE) FINDINGS NOT SUSPICIOUS FOR CANCER. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER. THE DIMENSION T/F PSA CALIBRATOR IS INDICATED FOR: THE T/F PSA CALIBRATOR IS AN IN VITRO DIAGNOSTIC PRODUCT INTENDED TO BE USED TO CALIBRATE THE TOTAL (TPSA) AND FREE (FPSA) PROSTATE SPECIFIC ANTIGEN METHODS FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM WITH THE HETEROGENEOUS IMMUNOASSAY MODULE. THIS PRODUCT WAS DESIGNED TO MEET THE NEEDS OF USERS TO ASSURE ACCURATE RESULTS OVER THE ASSAY RANGE OF THESE METHODS.

    Classifications

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

    Product Code Device Name
    MTG Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions