Somatic Gene Mutation Detection System
Basic Information
- Device Name
- Somatic Gene Mutation Detection System
- Trade Name
- LeukoStrat CDx FLT3 Mutation Assay
- PMA Number
- P160040
- Supplement Number
- S004
- Device Class
- FDA Class 3
- Product Code
- OWD
- Generic Name
- Somatic gene mutation detection system
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 21, 2018
- Date Received
- November 6, 2018
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OWD | Somatic Gene Mutation Detection System | FDA class 3 | Unknown |