cobas EGFR Mutation Test v2
FDA premarket approval P120019/S016 · decided 2018-04-18
Approval details
- PMA number
- P120019
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- cobas EGFR Mutation Test v2
- Generic name
- Somatic gene mutation detection system
- Applicant
- Roche
- Date received
- 2017-10-27
- Decision date
- 2018-04-18
- Days to decision
- 173 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Peasanton, CA
- Statement
- Approval of the cobas® EGFR Mutation Test v2. The device is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood. The test is indicated as a companion diagnosti
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HOMOCYSTEINE TEST (K113793) | Roche | 2012-06-05 |
| TQ HBA1C GEN3 (K102914) | Roche | 2011-01-20 |