BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

    PMA: P230001 · Decision May 3, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
    Trade Name
    ColoSense®
    PMA Number
    P230001
    Device Class
    FDA Class 3
    Product Code
    SBB
    Generic Name
    System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 3, 2024
    Date Received
    January 20, 2023
    Expedited Review
    N

    Advisory Committee Statement

    ColoSense is a qualitative in vitro diagnostic test intended for the detection of colorectal neoplasia associated RNA markers and for the presence of occult hemoglobin in human stool. A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA) or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at average-risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

    Classifications

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

    Product Code Device Name
    SBB System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection