Approval for the thxid braf kit for use on the abi 7500 fast dx real-time pcr instrument. This device is indicated for: the thxid braf kit is an in vitro diagnostic device intended for the qualitative detection of the braf v600e and v600k mutations in dna samples extracted from formalin-fixed paraffinembedded (ffpe) human melanoma tissue. The thxid braf kit is a real-time pcr test on the abi 7500 fast dx system and is intended to be used as an aid in selecting melanoma patients whose tumors carry the braf v600e mutation for treatment with dabrafenib [tafinlar®] and as an aid in selecting melanoma patients whose tumors carry the braf v600e or v600k mutation for treatment with trametinib [mekinist].
| Device | BIOMERIEUX THXID BRAF ASSAY KIT |
| Classification Name | Somatic Gene Mutation Detection System |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | BioMerieux, Inc. |
| Date Received | 2012-07-31 |
| Decision Date | 2013-05-29 |
| Notice Date | 2013-06-14 |
| PMA | P120014 |
| Supplement | S |
| Product Code | OWD |
| Docket Number | 13M-0709 |
| Advisory Committee | Pathology |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | bioMerieux, Inc. 595 Anglum Rd. hazelwood, MO 63042 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P120014 | | Original Filing |
| S012 |
2021-11-23 |
30-day Notice |
| S011 |
2021-02-12 |
30-day Notice |
| S010 |
2020-01-31 |
30-day Notice |
| S009 |
2019-08-07 |
30-day Notice |
| S008 |
2017-07-03 |
Normal 180 Day Track |
| S007 |
2016-10-27 |
30-day Notice |
| S006 |
2016-01-11 |
Normal 180 Day Track |
| S005 |
2015-05-08 |
30-day Notice |
| S004 |
2015-03-03 |
Special (immediate Track) |
| S003 |
2015-02-24 |
Normal 180 Day Track |
| S002 |
2014-10-15 |
135 Review Track For 30-day Notice |
| S001 |
2014-10-10 |
135 Review Track For 30-day Notice |
NIH GUDID Devices