BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    PMA: P000021 · Supplement: S013 · Decision May 19, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
    Trade Name
    DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE
    PMA Number
    P000021
    Supplement Number
    S013
    Device Class
    FDA Class 3
    Product Code
    MTF
    Generic Name
    Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 19, 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 CHEMILUMINESENCE2) APPROPRIATE REAGENT PROCESS CHANGES TO ACCOMMODATE CHEMILUMINESENCE DETECTION3) USAGE ON THE DIMENSION VISTA 1500 SYSTEM4) USAGE ON THE DIMENSION VISTA 3000T SYSTEM WHICH CONSISTS OF TWO DIMENSION VISTA1500 SYSTEMS CONNECTED BY A SAMPLE TRACK TRANSPORT MECHANISM5) USAGE ON THE DIMENSION VISTA 1500 SYSTEM CONNECTED TO THE STREAMLAB ANALYTICALWORKCELL LABORATORY AUTOMATION SYSTEM6) THE NEW DIMENSION VISTA PSA CALIBRATOR FOR USE WITH THE DIMENSION VISTA TPSA AND FPSA METHODS.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIMENSION VISTA TPSA FLEXREAGENT CARTRIDGE AND IS INDICATED FOR THE FOLLOWING USES:THE TPSA METHOD IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUANTITATIVE MEASUREMENT OF TOTAL PROSTATESPECIFIC ANTIGEN (PSA) IN HUMAN SERUM AND PLASMA ON THE DIMENSION VISTA SYSTEM: 1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN 50 YEARS OR OLDER. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER. 2) AS AN AID IN THEMANAGEMENT (MONITORING) OF PROSTATE CANCER PATIENTS.THE DIMENSION VISTA PSA CALIBRATOR WILL BE MARKETED SEPARATELY FOR USE WITH THE DIMENSIONVISTA TPSA FLEX REAGENT AND IS INDICATED FOR THE CALIBRATION OF TOTAL (TPSA) AND FREE (FPSA) PROSTATE SPECIFIC ANTIGEN METHODS ON THE DIMENSION VISTA SYSTEMS.

    Classifications

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

    Product Code Device Name
    MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer