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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
Classification Namesomatic gene mutation detection system
Generic Namesomatic gene mutation detection system
Applicant
QIAGEN MANCHESTER LTD
skelton house
lloyd street north
manchester M15 6
PMA NumberP110027
Date Received07/25/2011
Decision Date05/23/2014
Product Code
OWD[ Registered Establishments with OWD ]
Docket Number 14M-0726
Notice Date 06/10/2014
Advisory Committee Pathology
Clinical Trials NCT00339183
NCT00364013
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S002 S003 S004 S005 S006 S007 S008 S009 S010 
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