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: S001 · Decision Oct 10, 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
    PMA Number
    P020027
    Supplement Number
    S001
    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
    October 10, 2003
    Date Received
    September 29, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF THE FOLLOWING MODIFICATIONS TO THE DIMENSION FPSA FLEX REAGENT CARTRIDGE: 1) ADDITION OF LITHIUM HEPARIN PLASMA AS A SAMPLE TYPE IN THE INTENDED USE AND THE PACKAGE LABELING. 2) ADDITION OF THE DISCLAIMER "RESULTS OF THIS TEST SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS" TO THE RESULTS SECTION OF THE PACKAGE LABELING. 3) CORRECTION OF THE UNITS FOR IGG IN THE PACKAGE LABELING FROM 6 G/ML TO 6 G/DL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME, DIMENSION FPSA FLEX REAGENT CARTRIDGE AND IS INDICATED AS FOLLOWS: 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 AND PLASMA. MEASUREMENTS OF FPSA ARE USED IN CONJUNCTION WITH TOTAL PSA (TPSA) ON THE DIMENSION SYSTEM TO CALCULATE FPSA TO TPSA RATIO EXPRESSED AS 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 PROSTATE 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