Identity
- Trade Name
- COBAS KRAS MUTATION TEST FDA PMA
- Generic Name
- Somatic gene mutation detection system FDA PMA
Identifiers
- PMA Number
- P140023 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 KRAS Mutation Test is a real-time PCR-based somatic gene mutation detection system. It identifies seven somatic mutations in codons 12 and 13 of the KRAS gene in DNA extracted from formalin-fixed paraffin-embedded human colorectal cancer tumor tissue. This test aids in determining whether patients may be candidates for treatment with cetuximab or panitumumab based on a no-mutation-detected result.
The test is designed for use with the Cobas 4800 System, requiring sample preparation via the Cobas DNA Sample Preparation Kit and automated amplification/detection on the Cobas Z 480 Analyzer. It is supplied as a single-use diagnostic device and is approved for clinical use in the United States under an FDA PMA (P140023). Specimens must be processed in accordance with manufacturer instructions to ensure accurate mutation detection.
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 | P140023 | Class III | Active |
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Manufacturer
- Manufacturer
- Roche Molecular Systems, Inc.
Sources (1)
- FDA PMA P140023 24 fields · synced Sep 18, 2026