BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

    PMA: P190022 · Decision Dec 7, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
    Trade Name
    4Kscore Test
    PMA Number
    P190022
    Device Class
    FDA Class 3
    Product Code
    QRF
    Generic Name
    Multi-analyte test system with algorithmic analysis for detection of prostate cancer
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 7, 2021
    Date Received
    September 6, 2019
    Expedited Review
    N
    Docket Number
    21M-1271

    Advisory Committee Statement

    Approval for the 4Kscore Test.The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following information: a patient’s age, previous biopsy, and digital rectal exam (DRE). The 4Kscore Test is indicated for use with other patient information as an aid in the decision for prostate biopsy in men 45 years of age and older who have an abnormal age-specific total PSA and/or abnormal DRE. The 4Kscore Test is intended to aid in detection of aggressive prostate cancer (Gleason score >= 7/Gleason Grade Group >= 2) for whom a biopsy would be recommended by a urologist, based on current standards of care before consideration of the 4Kscore Test.A 4Kscore < 5.0 is associated with decreased likelihood of a Gleason score >= 7 on biopsy. Prostate biopsy is required for the diagnosis of cancer. The test is not recommended more than once every 6 months.The test is intended for professional use only, and is performed at a single-site BioReference Laboratories, Inc.

    Classifications

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

    Product Code Device Name
    QRF Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer