BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

    PMA: P110012 · Supplement: S022 · Decision Aug 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
    Trade Name
    Vysis ALK Break Apart FISH Probe Kit
    PMA Number
    P110012
    Supplement Number
    S022
    Device Class
    FDA Class 3
    Product Code
    OWE
    Generic Name
    Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 5, 2025
    Date Received
    February 5, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the expansion of the Indications for Use for the Vysis ALK Break Apart FISH Probe Kit to include an indication for ENSACOVE® (ensartinib). The device, as modified, will be marketed under the trade name Vysis ALK Break Apart FISH Probe Kit and is indicated for:INTENDED USE The Vysis ALK Break Apart FISH Probe Kit is a qualitative test to detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) tissue specimens from non-small cell lung cancer (NSCLC) patients.INDICATION FOR USE The Vysis ALK Break Apart FISH Probe Kit is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib), ALUNBRIG® (brigatinib), and ENSACOVE® (ensartinib) in accordance with the approved therapeutic product labeling.

    Classifications

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

    Product Code Device Name
    OWE Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement