THxID BRAF assay kit
FDA premarket approval P120014/S008 · decided 2018-06-27
Approval details
- PMA number
- P120014
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THxID BRAF assay kit
- Generic name
- Somatic gene mutation detection system
- Applicant
- bioMerieux, Inc.
- Date received
- 2017-07-03
- Decision date
- 2018-06-27
- Days to decision
- 359 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Hazelwood, MO
- Statement
- Approval for the THxID®-BRAF kit. It 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 paraffin-embedded (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 or V600K mutation for treatment with encorafenib [Braftovi] in combination with bi
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