BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

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

    PMA: P170037 · Decision Jan 30, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
    Trade Name
    Sangia Total PSA Test
    PMA Number
    P170037
    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    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    January 30, 2019
    Date Received
    November 7, 2017
    Expedited Review
    N
    Docket Number
    19M-0505

    Advisory Committee Statement

    Approval for the Sangia Total PSA Test. The Sangia Total PSA Test is an immunoassay indicated to quantitatively measure total PSA in capillary whole blood from a fingerstick collected by a healthcare professional and is used in conjunction with a digital rectal exam (DRE) as an aid in the detection of prostate cancer in men aged 50 years and older. The Sangia Total PSA Test is performed using the Claros 1 Analyzer in point-of-care settings. 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