LeukoStrat CDx FLT3 Mutation Assay
FDA premarket approval P160040/S006 · decided 2020-05-14
Approval details
- PMA number
- P160040
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- 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
- 2019-10-17
- Decision date
- 2020-05-14
- Days to decision
- 210 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- San Diego, CA
- 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 fro
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.