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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTHERASCREEN KRAS RGQ PCR KIT
Generic NameSomatic gene mutation detection system
ApplicantQIAGEN GmbH
QIAGEN Strasse 1
Hilden 40724
PMA NumberP110027
Date Received07/25/2011
Decision Date05/23/2014
Product Code OWD 
Docket Number 14M-0726
Notice Date 06/10/2014
Advisory Committee Pathology
Clinical TrialsNCT00339183
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE THERASCREEN KRAS RGQ PCR KIT, WHICH IS TO BE USED AS A COMPANION DIAGNOSTIC FOR THE DRUG VECTIBIX (PANITUMUMAB). THIS DEVICE IS INDICATED FOR:THE THERASCREEN KRAS RGQ PCR KIT IS A REAL-TIME QUALITATIVE PCR ASSAY USED ON THE ROTOR-GENE 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) AND VECTIBIX (PANITUMUMAB) BASED ON A KRAS NO MUTATION DETECTED TEST RESULT.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 
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