Identity
- Trade Name
- COBAS 4800 BRAF V600 MUTATION TEST FDA PMA
- Generic Name
- Somatic gene mutation detection system FDA PMA
Identifiers
- PMA Number
- P110020 FDA PMA
- FDA Product Code
- OWD FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
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. It is a real-time PCR test performed on the COBAS 4800 system and is intended to aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with vemurafenib.
The test is supplied as a kit for use with the COBAS 4800 system and is regulated under FDA PMA (P110020). It is intended for use in clinical laboratory settings by trained professionals. The device is not sterile, not single-use, and has no stated MRI safety restrictions; storage and handling should follow manufacturer guidelines for reagents and controls.
Frequently asked questions
What type of specimen is required for the COBAS 4800 BRAF V600 Mutation Test?
The test requires DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue, as specified in the device's intended use statement.
Is the COBAS 4800 BRAF V600 Mutation Test a standalone device or does it require additional equipment?
The test is a real-time PCR assay designed to be used exclusively on the COBAS 4800 system, meaning it requires the COBAS 4800 instrument for execution and cannot be performed as a standalone test.
What is the clinical purpose of the COBAS 4800 BRAF V600 Mutation Test according to its authorization?
The test is intended to aid in selecting melanoma patients whose tumors harbor the BRAF V600E mutation for treatment with vemurafenib, serving as a companion diagnostic to guide therapy selection.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P110020 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Molecular Systems, Inc.
Sources (1)
- FDA PMA P110020 24 fields · synced Sep 18, 2026