LeukoStrat CDx FLT3 Mutation Assay
FDA premarket approval P160040 · decided 2017-04-28
Approval details
- PMA number
- P160040
- Trade name
- LeukoStrat CDx FLT3 Mutation Assay
- Generic name
- Somatic gene mutation detection system
- Applicant
- Invivoscribe Technologies, Inc.
- Date received
- 2016-09-02
- Decision date
- 2017-04-28
- Days to decision
- 238 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- Yes
- Location
- San Diego, CA
- Statement
- Approval for the LeukoStrat® CDx FLT3 Mutation Assay is a PCR-based, in vitro diagnostic test designed to detect internal tandem duplication (ITD) mutations and the tyrosine kinase domain 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 R
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