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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 NumberS004
Date Received11/06/2018
Decision Date12/21/2018
Product Code OWD 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the LeukoStrat CDx FLT3 Mutation Assay. The device is a PCR-based in vitro diagnostic test designed to detect internal tandem duplications (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 selection 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 selection of patients with AML for whom XOSPATA® (gilteritinib) 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 laboratory site, located at 10222 Barnes Canyon Rd., Bldg. 1, San Diego, CA 92121.
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