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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: 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.
 
DeviceTHxID BRAF assay kit
Generic Namesomatic gene mutation detection system
ApplicantbioMerieux, Inc.
595 anglum rd.
hazelwood, MO 63042
PMA NumberP120014
Supplement NumberS008
Date Received07/03/2017
Decision Date06/27/2018
Product Code OWD 
Advisory Committee Pathology
Clinical TrialsNCT01909453
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order 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 binimetinib [Mektovi], the BRAF V600E mutation for treatment with dabrafenib [Tafinlar®], the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist®].
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