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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 EGFR MUTATION TEST
Generic NameSomatic gene mutation detection system
ApplicantROCHE
4300 HACIENDA DRIVE
PO BOX 9002
PLEASANTON, CA 94588
PMA NumberP120019
Date Received11/08/2012
Decision Date05/14/2013
Product Code OWD 
Docket Number 13M-0594
Notice Date 05/17/2013
Advisory Committee Pathology
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE COBAS® EGFR MUTATION TEST. THE COBAS® EGFR MUTATION TEST IS A REAL-TIME PCR TEST FOR THE QUALITATIVE DETECTION OF EXON 19 DELETIONS AND EXON 21 (L858R) SUBSTITUTION MUTATIONS OFTHE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED (FFPET) HUMAN NON-SMALL CELL LUNG CANCER (NSCLC) TUMOR TISSUE. THE TEST IS INTENDED TO BE USED AS AN AID IN SELECTING PATIENTS WITH METASTATIC NSCLC FOR WHOM TARCEVA® (ERLOTINIB), AN EGFR TYROSINE KINASE INHIBITOR (TK1), IS INDICATED. 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S028 S029 S030 S031 S032 S033 S034 S035 S036 
S037 S038 
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