- Device
- LeukoStrat CDx FLT3 Mutation Assay
- Applicant
- Invivoscribe Technologies, Inc.
- PMA number
- P160040
- Supplement
- S004
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2018-12-21
- Decision code
- APPR
- Date received
- 2018-11-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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.