Premarket Approval (PMA)

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.

• Device: Roche cobas EGFR Mutation Test, Roche cobas® DNA Sample Preparation Kit, cobas® EGFR Mutation Test v2, Roche cobas® cfD
• Generic Name: Somatic gene mutation detection system
• Applicant: Roche; 4300 Hacienda Dr.; P.O. Box 9002; Peasanton, CA 94588
• PMA Number: P120019
• Supplement Number: S035
• Date Received: 07/20/2023
• Decision Date: 08/17/2023
• Product Code: OWD
• Advisory Committee: Pathology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Elimination of redundant in-process testing.