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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
Classification Namesomatic gene mutation detection system
Generic Namesomatic gene mutation detection system
Applicant
INVIVOSCRIBE TECHNOLOGIES, INC
6330 nancy ridge drive
suite 106
san diego, CA 92121
PMA NumberP160040
Supplement NumberS002
Date Received03/30/2018
Decision Date11/28/2018
Product Code
OWD[ Registered Establishments with OWD ]
Advisory Committee Pathology
Clinical Trials NCT02421939
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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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