Cobas 4800 Braf V600 Mutation Test
FDA premarket approval P110020 · Somatic gene mutation detection system
PMA numberP110020
Approval
- Applicant
- Roche Molecular Systems, Inc.
- Received
- April 25, 2011
- Decision date
- August 17, 2011 (APPR)
- Supplements
- 44, latest March 17, 2026
- Product code
- OWD – Somatic Gene Mutation Detection System
Approval order 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 FOR TREATMENT WITH VEMURAFENIB.