BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P190022 · Supplement: S003 · Decision Jul 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
    Trade Name
    4Kscore Test
    PMA Number
    P190022
    Supplement Number
    S003
    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
    July 25, 2025
    Date Received
    January 28, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of the DRE Unavailable variant as part of the 4KScore Test system

    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