- Device
- LeukoStrat CDx FLT3 Mutation Assay
- Applicant
- Invivoscribe Technologies, Inc.
- PMA number
- P160040
- Supplement
- S006
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2020-05-14
- Decision code
- APPR
- Date received
- 2019-10-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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.