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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLeukoStrat CDx FLT3 Mutation Assay
Generic NameSomatic gene mutation detection system
ApplicantINVIVOSCRIBE TECHNOLOGIES, INC
10222 Barnes Canyon Road, Building 1
San Diego, CA 92121
PMA NumberP160040
Supplement NumberS006
Date Received10/17/2019
Decision Date05/14/2020
Product Code OWD 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for distribution of the Leukostrat® CDx FLT3 Mutation Assay on the 3500xL Dx Genetic Analyzer Instrument. The device, as modified, will be marketed under the trade name LeukoStrat CDx FLT3 Mutation Assay and is indicated for:The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) 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 assessment of patients with AML for whom RYDAPT® (midostaurin) treatment is being considered.The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom XOSPATA® (gilteritinib) treatment is being considered.The test is for use on the 3500xL Dx Genetic Analyzer.
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