THxID BRAF assay kit

Somatic Gene Mutation Detection System

FDA Premarket Approval P120014 S009

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

Manufacturing site change for a raw material (critical component)

• Device: THxID BRAF assay kit
• Classification Name: Somatic Gene Mutation Detection System
• Generic Name: Somatic Gene Mutation Detection System
• Applicant: BioMerieux, Inc.
• Date Received: 2019-08-07
• Decision Date: 2019-08-26
• PMA: P120014
• Supplement: S009
• Product Code: OWD
• Advisory Committee: Pathology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• 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
03573026559823	P120014	001