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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceTHERASCREEN KRAS RGQ PCR KIT
Classification Namesomatic gene mutation detection system
Generic Namesomatic gene mutation detection system
Applicant
QIAGEN MANCHESTER LTD
skeleton house, lloyd street north
manchester 
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
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