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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 St. N.
Manchester 
PMA NumberP110030
Date Received07/28/2011
Decision Date07/06/2012
Withdrawal Date11/07/2014
Product Code OWD 
Docket Number 12M-0735
Notice Date 07/16/2012
Advisory Committee Pathology
Clinical TrialsNCT00079066
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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
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