cobas® EGFR Mutation Test, v2.0
FDA premarket approval P120019/S042 · decided 2025-12-31
Approval details
- PMA number
- P120019
- Supplement
- S042
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- cobas® EGFR Mutation Test, v2.0
- Generic name
- Somatic gene mutation detection system
- Applicant
- Roche
- Date received
- 2025-12-02
- Decision date
- 2025-12-31
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Peasanton, CA
- Statement
- changes to QC testing of filters used in reagent manufacturing
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HOMOCYSTEINE TEST (K113793) | Roche | 2012-06-05 |
| TQ HBA1C GEN3 (K102914) | Roche | 2011-01-20 |