BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    PMA: P230043 · Decision Oct 3, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
    Trade Name
    Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus™
    PMA Number
    P230043
    Device Class
    FDA Class 3
    Product Code
    PHP
    Generic Name
    System, colorectal neoplasia, DNA methylation and hemoglobin detection
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 3, 2024
    Date Received
    December 22, 2023
    Expedited Review
    N
    Docket Number
    24M-4797

    Advisory Committee Statement

    A qualitative in vitro diagnostic test intended for the detection of colorectal neoplasia-associated DNA markers and for the presence of occult hemoglobin in human stool. The Cologuard Plus test is performed on samples collected using the Cologuard Plus Collection Kit. A positive result may indicate the presence of colorectal cancer (CRC) or advance precancerous lesions (APL) and should be followed by a colonoscopy. The Cologuard Plus test is indicated to screen adults 45 years or older who are at average risk for CRC. The Cologuard Plus test is not a replacement for diagnostic colonoscopy in high-risk individuals. The Cologuard Plus test is performed at Exact Sciences, Madison, WI.

    Classifications

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

    Product Code Device Name
    PHP System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection