BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    PMA: P240021 · Decision Dec 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
    Trade Name
    Atellica IM Total PSA II (tPSAII)
    PMA Number
    P240021
    Device Class
    FDA Class 3
    Product Code
    MTF
    Generic Name
    Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 3, 2025
    Date Received
    June 20, 2024
    Expedited Review
    N
    Docket Number
    FDA-7025

    Advisory Committee Statement

    Approval for the Atellica IM total PSA II (tPSAII):The Atellica IM total PSA II (tPSAII) assay is for in vitro diagnostic use in the quantitative measurement of total prostate-specific antigen (PSA) in human serum and plasma (EDTA and lithium-heparin) using the Atellica IM Analyzer. This assay is indicated as an aid in the detection of prostate cancer in conjunction with a digital rectal exam (DRE) in men aged 50 years and older. A prostate biopsy is required for the diagnosis of prostate cancer.

    Classifications

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

    Product Code Device Name
    MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer