COBAS EGFR MUTATION TEST V2
FDA premarket approval P120019/S007 · decided 2015-11-13
Approval details
- PMA number
- P120019
- Supplement
- S007
- Supplement type
- Panel 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
- 2015-05-28
- Decision date
- 2015-11-13
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- Yes
- Location
- Peasanton, CA
- Statement
- APPROVAL FOR THE COBAS® EGFR MUTATION TEST V2. THIS DEVICE IS INDICATED FOR:THE COBAS® EGFR MUTATION TEST V2 IS A REAL-TIME PCR TEST FOR THE QUALITATIVE DETECTION OF DEFINED MUTATIONS OF THE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED TUMOR TISSUE (FFPET) FROM NON-SMALL CELL LUNG CANCER (NSCLC) PATIENTS. THE TEST IS INTENDED TO AID IN IDENTIFYING PATIENTS WITH NSCLC WHOSE TUMORS HAVE DEFINED EGFR MUTATIONS AND FOR WHOM SAFETY AND EFFICACY OF
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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 |