BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Panther Fusion GI Bacterial Assay

    K Number: K251868 · Decision Sep 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    37
    Applicant Total
    2
    Review Days
    99

    Basic Information

    Device Name
    Panther Fusion GI Bacterial Assay
    K Number
    K251868
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3990
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hologic
    Date Received
    June 18, 2025
    Decision Date
    September 25, 2025
    Product Code
    PCH
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PCH), ordered by most recent decision date.

    LIAISON PLEX Gastrointestinal Flex Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Xpert GI Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Panther Fusion GI Expanded Bacterial Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    QIAstat-Dx GI Panel 2 Mini B

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Hologic

    K Number Device Name
    K161575 Affirm Lateral Arm Upright Biopsy Accessory