The center for devices and radiological health (cdrh) of the food and drug administration (fda) has completed its review of your premarket approval application (pma) supplement, which requested approval of changes made to the instructions for use of the leukostrat cdx flt3 mutation assay. Your submission meets the criteria in 21 cfr 814. 39(d)(2) for a "special pma supplement - changes being effected". Based upon the information submitted, the pma supplement is approved.
| Device | LeukoStrat CDx FLT3 Mutation Assay |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | INVIVOSCRIBE TECHNOLOGIES, INC |
| Date Received | 2021-07-09 |
| Decision Date | 2021-08-05 |
| PMA | P160040 |
| Supplement | S008 |
| Product Code | OWD |
| Advisory Committee | Pathology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | INVIVOSCRIBE TECHNOLOGIES, INC 10222 Barnes Canyon Road, Building 1 san Diego, CA 92121 |
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