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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 Dr.
P.O. Box 9002
Peasanton, CA 94588
PMA NumberP120019
Supplement NumberS027
Date Received03/01/2019
Decision Date01/27/2025
Product Code OWD 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for cobas' EGFR Mutation Test v2 label to include Roche Cell-free DNA Collection Tube as an alternative blood collection tube.
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