|
Device | cobas EGFR Mutation Test v2 |
Generic Name | somatic gene mutation detection system |
Applicant |
ROCHE |
4300 hacienda drive |
po box 9002 |
pleasanton, CA 94588 |
|
PMA Number | P120019 |
Supplement Number | S031 |
Date Received | 04/30/2020 |
Decision Date | 10/27/2020 |
Product Code |
OWD
|
Advisory Committee |
Pathology |
Supplement Type | normal 180 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
Approval for cobas® EGFR Mutation Test v2 label expansion to obtain companion diagnostic group labeling claim for EGFR Tyrosine Kinase Inhibitors (TKI) for specific EGFR mutations detected by the test. |