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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCOBAS EGFR MUTATION TEST V2
Generic NameSomatic gene mutation detection system
ApplicantROCHE
4300 HACIENDA DRIVE
PO BOX 9002
PLEASANTON, CA 94588
PMA NumberP120019
Supplement NumberS007
Date Received05/28/2015
Decision Date11/13/2015
Product Code OWD 
Docket Number 15M-4344
Notice Date 11/30/2015
Advisory Committee Pathology
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE COBAS® EGFR MUTATION TEST V2. THIS DEVICE IS INDICATED FOR:THE COBAS® EGFR MUTATION TEST V2 IS A REAL-TIME PCR TEST FOR THE QUALITATIVE DETECTION OF DEFINED MUTATIONS OF THE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED TUMOR TISSUE (FFPET) FROM NON-SMALL CELL LUNG CANCER (NSCLC) PATIENTS. THE TEST IS INTENDED TO AID IN IDENTIFYING PATIENTS WITH NSCLC WHOSE TUMORS HAVE DEFINED EGFR MUTATIONS AND FOR WHOM SAFETY AND EFFICACY OF A DRUG HAVE BEEN ESTABLISHED AS FOLLOWS: TARCEVA® (ERLOTINIB)/EXON 19 DELETIONS AND L858R AND TAGRISSO® (OSIMERTINIB) T790M. DRUG SAFETY AND EFFICACY HAVE NOT BEEN ESTABLISHED FOR THE FOLLOWING EGFR MUTATIONS ALSO DETECTED BY THE COBAS® EGFR MUTATION TEST V2: TARCEVA® (ERLOTINIB)/G719X, EXON 20 INSERTIONS, T790M, S768I AND L861Q/TAGRISSO® (OSIMERTINIB)/G719X, EXON 19 DELETIONS, L858R, EXON 20 INSERTIONS, S768I, AND L861Q. FOR MANUAL SAMPLE PREPARATION, FFPET SPECIMENS ARE PROCESSED USING THE COBAS® DNA SAMPLE PREPARATION KIT AND THE COBAS Z 480 ANALYZER IS USED FOR AUTOMATED AMPLIFICATION AND DETECTION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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