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®].

DeviceTHxID BRAF assay kit
Classification NameSomatic Gene Mutation Detection System
Generic NameSomatic Gene Mutation Detection System
ApplicantBioMerieux, Inc.
Date Received2017-07-03
Decision Date2018-06-27
PMAP120014
SupplementS008
Product CodeOWD
Docket NumberPremarket 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 CommitteePathology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address bioMerieux, Inc. 595 Anglum Rd. hazelwood, MO 63042

Supplemental Filings

Supplement NumberDateSupplement Type
P120014Original 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 IDPMASupp
03573026354909 P120014 000

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