BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P080008 · Supplement: S002 · Decision Jan 18, 2013
    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
    VIDAS FREE PSA RT
    PMA Number
    P080008
    Supplement Number
    S002
    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 18, 2013
    Date Received
    October 11, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR UPDATING THE PACKAGING INSERT BY DEFINING THE PHRASE"INSTRUMENT OF THE VIDAS FAMILY" AS "INSTRUMENT OF THE VIDAS FAMILY: VIDAS OR MINIVIDAS"AND REPLACING "INSTRUMENTS OF THE VIDAS FAMILY" WITH "VIDAS INSTRUMENTS" IN THEINTENDED USE. THE DEVICE, VIDAS® TOTAL PSA, IS INTENDED FOR USE WITH THE VIDAS INSTRUMENTS(VITEK® IMMUNODIAGNOSTIC ASSAY SYSTEM) AS AN AUTOMATED ENZYME-LINKED FLUORESCENTIMMUNOASSAY (ELFA) FOR THE QUANTITATIVE MEASUREMENT OFTOTAL PROSTATE SPECIFIC ANTIGEN IN HUMAN SERUM. THE VIDAS TPSA ASSAY IS INDICATED AS AN AID IN THE MANAGEMENT OF PATIENTS WITH PROSTATE CANCER AND AS AN AID IN THE DETECTION OF PROSTATE CANCER IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (ORE) IN MEN AGE 50 YEARS OR OLDER. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF PROSTATE CANCER. THE DEVICE, VIDAS® FREE PSA RT, IS AN AUTOMATED QUANTITATIVE TEST FOR USE ON THE VIDAS INSTRUMENTS, FOR THE QUANTITATIVE MEASUREMENT OF THE FREE FRACTION OF PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM USING THE ELF A TECHNIQUE (ENZYME LINKED FLUORESCENT ASSAY). THE VIDAS FREE PSA RT IS INTENDED TO BE USED IN CONJUNCTION WITH THE VIDAS TPSA ASSAY IN MEN AGE 50 YEARS OR OLDER WHO HAVE DIGITAL RECTAL EXAMINATION (ORE) THAT IS NOT SUSPICIOUS FOR PROSTATE CANCER AND VIDAS TPSA VALUES BETWEEN 4 AND 10 NG/ML TO DETERMINE THE % FREE PSA VALUE. THE VIDAS % FREE PSA VALUE CAN BE USED AS AN AID IN DISCRIMINATING BETWEEN PROSTATE CANCER AND BENIGN DISEASE. 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