LeukoStrat CDx FLT3 Mutation Assay
FDA premarket approval P160040/S004 · decided 2018-12-21
Approval details
- PMA number
- P160040
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LeukoStrat CDx FLT3 Mutation Assay
- Generic name
- Somatic gene mutation detection system
- Applicant
- Invivoscribe Technologies, Inc.
- Date received
- 2018-11-06
- Decision date
- 2018-12-21
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- San Diego, CA
- 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
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