BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

    PMA: P150041 · Decision Apr 11, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)
    Trade Name
    VYSIS CLL FISH PROBE KIT
    PMA Number
    P150041
    Device Class
    FDA Class 3
    Product Code
    PNK
    Generic Name
    Fluorescence in situ hybridization, chromosome 17p deletion (TP53)
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 11, 2016
    Date Received
    October 30, 2015
    Expedited Review
    N
    Docket Number
    16M-1167

    Advisory Committee Statement

    The Vysis CLL FISH Probe Kit is a test to detect deletion of the LSI TP53 probe target via fluorescence in situ hybridization (FISH) in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL).The test is indicated for detecting deletion of the LSI TP53 probe target (17p-) as an aid in identifying those patients with CLL for whom treatment with VENCLEXTA® (venetoclax) is indicated. Vysis CLL FISH Probe Kit is not intended for monitoring of residual disease.

    Classifications

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

    Product Code Device Name
    PNK Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)