THxID BRAF assay kit

Somatic Gene Mutation Detection System

FDA Premarket Approval P120014 S008

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

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 binimetinib [mektovi], the braf v600e mutation for treatment with dabrafenib [tafinlar®], the braf v600e or v600k mutation for treatment with trametinib [mekinist®].

• Device: THxID BRAF assay kit
• Classification Name: Somatic Gene Mutation Detection System
• Generic Name: Somatic Gene Mutation Detection System
• Applicant: BioMerieux, Inc.
• Date Received: 2017-07-03
• Decision Date: 2018-06-27
• PMA: P120014
• Supplement: S008
• Product Code: OWD
• Docket Number: Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia
• Advisory Committee: Pathology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: bioMerieux, Inc. 595 Anglum Rd. hazelwood, MO 63042

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

Device ID	PMA	Supp
03573026354909	P120014	000