BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    PMA: P230043 · Supplement: S007 · Decision Jun 2, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
    Trade Name
    Cologuard Plus™
    PMA Number
    P230043
    Supplement Number
    S007
    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
    June 2, 2026
    Date Received
    March 6, 2026
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to use a new Class I instrument, referred to as the Capture Aspiration Module (CAM), in the laboratory workflow of the Cologuard Plus test.

    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