BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P190022 · Supplement: S002 · Decision Jan 30, 2024
    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
    The 4Kscore Test
    PMA Number
    P190022
    Supplement Number
    S002
    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
    January 30, 2024
    Date Received
    November 1, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for software changes made to the B2 Laboratory Information System (LIS) and Specimen Processing Module (SPM) of the 4Kscore Test.

    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