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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceBIOMERIEUX THXID BRAF ASSAY KIT
Generic NameSomatic gene mutation detection system
ApplicantbioMerieux, Inc.
595 Anglum Rd.
Hazelwood, MO 63042
PMA NumberP120014
Date Received07/31/2012
Decision Date05/29/2013
Product Code OWD 
Docket Number 13M-0709
Notice Date 06/14/2013
Advisory Committee Pathology
Clinical TrialsNCT01153763
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE THXID BRAF KIT FOR USE ON THE ABI 7500 FAST DX REAL-TIME PCR INSTRUMENT. THIS DEVICE IS INDICATED FOR: THE THXID BRAF KIT 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 PARAFFINEMBEDDED (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 MUTATION FOR TREATMENT WITH DABRAFENIB [TAFINLAR®] AND AS AN AID IN SELECTING MELANOMA PATIENTS WHOSE TUMORS CARRY THE BRAF V600E OR V600K MUTATION FOR TREATMENT WITH TRAMETINIB [MEKINIST].
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 
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