BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    PMA: P950021 · Supplement: S029 · Decision Sep 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
    Trade Name
    Atellica IM Prostate-Specific Antigen (PSA)
    PMA Number
    P950021
    Supplement Number
    S029
    Device Class
    FDA Class 3
    Product Code
    MTG
    Generic Name
    Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 23, 2024
    Date Received
    June 25, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    placement of Atellica IM assay onto the Atellica CI Analyzer with Atellica Sample Handler configuration.

    Classifications

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

    Product Code Device Name
    MTG Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions