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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.
 
DeviceCOBAS KRAS MUTATION TEST
Generic Namesomatic gene mutation detection system
Applicant
Roche Molecular Systems, Inc.
4300 hacienda drive
pleasanton, CA 94588-2722
PMA NumberP140023
Date Received10/23/2014
Decision Date05/07/2015
Product Code OWD 
Docket Number 15M-1708
Notice Date 05/18/2015
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE COBAS KRAS MUTATION TEST. THIS DEVICE IS INDICATED FOR THE FOLLOWING:THE COBAS KRAS MUTATION TEST, FOR USE WITH THE COBAS 4800 SYSTEM, IS A REAL-TIME PCR TEST FOR THE DETECTION OF SEVEN SOMATIC MUTATIONS IN CODONS 12 AND 13 OF THE KRAS GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED HUMAN COLORECTAL CANCER (CRC) TUMOR TISSUE. THE TEST IS INTENDED TO BE USED AS AN AID IN THE IDENTIFICATION OF CRC PATIENTS FOR WHOM TREATMENT WITH ERBITUX (CETUXIMAB) OR WITH VECTIBIX (PANITUMUMAB) MAY BE INDICATED BASED ON A NO MUTATION DETECTED RESULT.SPECIMENS ARE PROCESSED USING THE COBAS DNA SAMPLE PREPARATION KIT FOR MANUAL SAMPLE PREPARATION AND THE COBAS Z 480 ANALYZER FOR AUTOMATED AMPLIFICATION AND DETECTION.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements:  S006 S007 S008 S005 S002 S001 S004 S003 
S019 S023 S018 S021 S020 S017 S015 S016 S010 
S011 S009 S013 S012 S014 S022 
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