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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namesomatic gene mutation detection system
Generic Namesomatic gene mutation detection system
bioMerieux, Inc.
595 anglum rd.
hazelwood, MO 63042
PMA NumberP120014
Date Received07/31/2012
Decision Date05/29/2013
Product Code
OWD[ Registered Establishments with OWD ]
Docket Number 13M-0709
Notice Date 06/14/2013
Advisory Committee Pathology
Clinical Trials NCT01153763
Expedited Review Granted? Yes
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007