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 rydapt (midostaurin) 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 site laboratory located at 6330 nancy ridge dr. , san diego, ca 92121.
| Device | LeukoStrat CDx FLT3 Mutation Assay |
| Classification Name | Somatic Gene Mutation Detection System |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | INVIVOSCRIBE TECHNOLOGIES, INC |
| Date Received | 2016-09-02 |
| Decision Date | 2017-04-28 |
| Notice Date | 2017-05-18 |
| PMA | P160040 |
| Supplement | S |
| Product Code | OWD |
| Docket Number | 17M-2766 |
| Advisory Committee | Pathology |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | INVIVOSCRIBE TECHNOLOGIES, INC 6330 Nancy Ridge Drive suite 106 san Diego, CA 92121 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160040 | | Original Filing |
| S010 |
2022-03-15 |
30-day Notice |
| S009 |
2021-07-12 |
30-day Notice |
| S008 |
2021-07-09 |
Special (immediate Track) |
| S007 | | |
| S006 |
2019-10-17 |
Normal 180 Day Track |
| S005 | | |
| S004 |
2018-11-06 |
Real-time Process |
| S003 |
2018-04-12 |
Normal 180 Day Track No User Fee |
| S002 |
2018-03-30 |
Normal 180 Day Track |
| S001 |
2017-12-22 |
30-day Notice |
NIH GUDID Devices