BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    PMA: P000027 · Supplement: S002 · Decision Feb 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37

    Basic Information

    Device Name
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
    Trade Name
    ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHEK
    PMA Number
    P000027
    Supplement Number
    S002
    Device Class
    FDA Class 2
    Product Code
    LTJ
    Generic Name
    PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 24, 2003
    Date Received
    October 11, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR DESIGN CHANGES TO MODIFY THE COMPOSITION AND VOLUMES OF THE REAGENTS, AND LABELING CHANGES TO ADD CLAIMS FOR THE USE OF LITHIUM AND NH4-HEPARIN PLASMA SAMPLES, TO ELIMINATE THE RECOMMENDATION FOR NA CITRATE PLASMA, AND TO OMIT THE SAMPLE DILUTION CLAIM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS FREE PSA IMMUNOASSAY AND IS INDICATED FOR THE IN VITRO QUANTITATIVE DETERMINATION OF FREE PROSTATE-SPECIFIC ANTIGEN IN HUMAN SERUM AND PLASMA. THE ELECSYS FREE PSA IMMUNOASSAY IS INDICATED FOR MEASUREMENT OF FPSA IN CONJUNCTION WITH THE ELECSYS TOTAL PSA ASSAY TO DEVELOP A RATIO (%FPSA) OF FPSA TO TPSA. THIS RATIO IS USEFUL WHEN USED IN CONJUNCTION WITH THE ELECSYS TOTAL PSA TEST AS AN AID IN DISTINGUISHING PROSTATE CANCER FROM BENIGN PROSTATIC CONDITIONS IN MEN AGE 50 YEARS OR OLDER WHO HAVE A DIGITAL RECTAL EXAMINATION (DRE) THAT IS NOT SUSPICIOUS FOR PROSTATE CANCER AND AN ELECSYS TOTAL PSA VALUE IN THE RANGE 4 NG/ML TO 10 NG/ML. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THE ELECTROCHEMILUMI-NISCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ROCHE DIAGNOSTICS ELECSYS 1010 AND 2010, AND THE MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZERS.

    Classifications

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

    Product Code Device Name
    LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers