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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Generic Namefluorescence in situ hybridization, platelet-derived growth factor receptor, beta polypeptide (pdgfrb), rearrangement
500 chipeta way
salt lake city, UT 84108
HDE NumberH140005
Date Received11/26/2014
Decision Date12/18/2015
Product Code
PMI[ Registered Establishments with PMI ]
Docket Number 15M-4948
Notice Date 01/14/2016
Advisory Committee Pathology
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval for the pdgfrb fish for gleevec eligibility in myelodysplastic syndrome/myeloproliferative disease (mds/mpd). This device is indicated for the qualitative detection of pdgfrb gene rearrangement from fresh bone marrow samples of patients with mds/mpd with a high index of suspicion based on karyotyping showing a 5q31~33 anomaly. The pdgfrb fish assay is indicated as an aid in the selection of mds/mpd patients for whom gleevec (imatinib mesylate) treatment is being considered. This assay is for professional use only and is to be performed at a single laboratory site.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling