Somatic Gene Mutation Detection System
Basic Information
- Device Name
- Somatic Gene Mutation Detection System
- Trade Name
- Roche cobas DNA Sample Preparation Kit, COBAS 4800 BRAF V600 MUTATION TEST
- PMA Number
- P110020
- Supplement Number
- S016
- Device Class
- FDA Class 3
- Product Code
- OWD
- Generic Name
- Somatic gene mutation detection system
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 7, 2016
- Date Received
- June 30, 2016
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for the cobas® 4800 BRAF V600 Mutation Test. The cobas® 4800 BRAF V600 Mutation Test is an in vitro diagnostic device intended for the qualitative detection of 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 for treatment with the targeted therapies listed in the table below, in accordance with the approved therapeutic product labeling: Therapeutic Therapeutic Indication Test ResultZELBORAF® (vemurafenib) BRAF V600E Mutation DetectedCOTELLIC® (cobimetinib), in combination with ZELBORAF® (vemurafenib) BRAF V600E or V600K* Mutation Detected* *Due to cross-reactivity by the cobas® 4800 BRAF V600 Mutation Test, the clinical trial for cobimetinib, in combination with vemurafenib, included some patients whose tumor carried the BRAF V600K mutation.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OWD | Somatic Gene Mutation Detection System | FDA class 3 | Unknown |