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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Namesomatic gene mutation detection system
Generic Namesomatic gene mutation detection system
skeleton house, lloyd street north
PMA NumberP110030
Date Received07/28/2011
Decision Date07/06/2012
Withdrawal Date 11/07/2014
Product Code
OWD[ Registered Establishments with OWD ]
Docket Number 12M-0735
Notice Date 07/16/2012
Advisory Committee Pathology
Clinical Trials NCT00079066
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the therascreen kras rgq pcr kit. This device is indicated for: the therascreen kras rgq pcr kit is a real-time qualitative pcr assay used on the rotorgene q mdx instrument for the detection of seven somatic mutations in the human kras oncogene, using dna extracted from formalin fixed paraffin-embedded (ffpe), colorectal cancer (crc) tissue. The therascreen kras rgq pcr kit is intended to aid in the identification of crc patients for treatment with erbitux (cetuximab) based on a kras no mutation detected test result.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling