BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P020027 · Supplement: S009 · Decision May 17, 2010
    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
    FPSA FLEX REAGENT CARTRIDGE
    PMA Number
    P020027
    Supplement Number
    S009
    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
    May 17, 2010
    Date Received
    December 2, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES:1) DETECTION TECHNOLOGY FROM SPECTROPHOTOMETRY TO CHEMILUMINESENCE;2) APPROPRIATE REAGENT PROCESS CHANGES TO ACCOMMODATE CHEMILUMINESENCE DETECTION;3) USAGE ON THE DIMENSION VISTA 1500 SYSTEM;4) USAGE ON THE DIMENSION VISTA 3000T SYSTEM WHICH CONSISTS OF TWO DIMENSION VISTA1500 SYSTEMS CONNECTED BY A SAMPLE TRACK TRANSPORT MECHANISM; AND5) USAGE ON THE DIMENSION VISTA 1500 SYSTEM CONNECTED TO THE STREAMLAB ANALYTICALWORKCELL LABORATORY AUTOMATION SYSTEM.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIMENSION VISTA FPSA FLEXREAGENT CARTRIDGE AND IS INDICATED FOR:THE FPSA METHOD FOR THE DIMENSION VISTA SYSTEM IS AN IN VITRO DIAGNOSTIC TEST INTENDED TO QUANTITATIVELY MEASURE FREE PROSTATESPECIFIC ANTIGEN (FPSA) IN HUMAN SERUM AND PLASMA. MEASUREMENTS OF FPSA ARE USED IN CONJUNCTION WITH TOTAL PSA (TPSA) METHOD ON DIMENSION VISTA SYSTEN 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 1.0 NG/ML AND DRE FINDINGS NOT SUSPICIOUS FOR CANCER. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER.

    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