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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceTHERASCREEN KRAS RGQ PCR KIT
Generic NameSomatic gene mutation detection system
ApplicantQIAGEN 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 
Docket Number 12M-0735
Notice Date 07/16/2012
Advisory Committee Pathology
Clinical TrialsNCT00079066
Expedited Review Granted? No
Combination ProductYes
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  
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