COBAS 4800 BRAF V600 MUTATION TEST
FDA premarket approval P110020 · decided 2011-08-17
Approval details
- PMA number
- P110020
- Trade name
- COBAS 4800 BRAF V600 MUTATION TEST
- Generic name
- Somatic gene mutation detection system
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2011-04-25
- Decision date
- 2011-08-17
- Days to decision
- 114 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR THE COBAS 4800 BRAF V600 MUTATION TEST. THIS DEVICE IS INDICATED FOR: THE COBAS 4800 BRAF V600 MUTATION TEST IS AN IN VITRO DIAGNOSTIC DEVICE INTENDED FOR THE QUALITATIVE DETECTION OF THE BRAF V600E MUTATION IN DNA EXTRACTED FROM FORMALIN-FIXED, PARAFFIN-EMBEDDED HUMAN MELANOMA TISSUE. THE COBAS 4800 BRAF V600 MUTATION TEST IS A REAL-TIME PCR TEST ON THE COBAS 4800 SYSTEM, AND IS INTENDED TO BE USED AS AN AID IN SELECTING MELANOMA PATIENTS WHOSE TUMORS CARRY THE BRAF V600E MUTATION
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