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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DeviceLeukoStrat CDx FLT3 Mutation Assay
Generic NameSomatic gene mutation detection system
10222 Barnes Canyon Road, Building 1
San Diego, CA 92121
PMA NumberP160040
Date Received09/02/2016
Decision Date04/28/2017
Product Code OWD 
Docket Number 17M-2766
Notice Date 05/18/2017
Advisory Committee Pathology
Clinical TrialsNCT00651261
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
Approval for the LeukoStrat® CDx FLT3 Mutation Assay is a PCR-based, in vitro diagnostic test designed to detect internal tandem duplication (ITD) mutations and the tyrosine kinase domain mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML). The LeukoStrat® CDx FLT3 Mutation Assay is used as an aid in the selection of patients with AML for whom RYDAPT (midostaurin) treatment is being considered. The Leukostrat® CDx FLT3 Mutation Assay is to be performed only at Laboratory for Personalized Molecular Medicine (LabPMM) LLC, a single site laboratory located at 6330 Nancy Ridge Dr., San Diego, CA 92121.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S001 S002 S003 S004 S006 S007 S008 S009 S010 S011 S012