Identity
- Trade Name
- cobas EGFR MUTATION TEST v2 FDA PMA
- Generic Name
- Somatic gene mutation detection system FDA PMA
Identifiers
- PMA Number
- P150044 FDA PMA
- FDA Product Code
- OWD FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APCB FDA PMA
The Cobas EGFR Mutation Test v2 is a real-time PCR test designed for the qualitative detection of defined epidermal growth factor receptor gene mutations. It is indicated as a companion diagnostic to assist in selecting non-small cell lung cancer patients for targeted therapies, including erlotinib and osimertinib.
This test utilizes DNA isolated from formalin-fixed paraffin-embedded tumor tissue or circulating-free tumor DNA from plasma. Specimens are processed using the Cobas DNA Sample Preparation Kit or the Cobas cfDNA Sample Preparation Kit, with amplification and detection performed on the Cobas z 480 analyzer. The device has received FDA PMA authorization.
Frequently asked questions
What is the primary purpose of the Cobas EGFR Mutation Test v2?
The test is a companion diagnostic used to identify specific EGFR gene mutations in patients with non-small cell lung cancer to help determine eligibility for targeted drug therapies.
What types of specimens can be used with this test?
The test can be performed using DNA isolated from formalin-fixed paraffin-embedded tumor tissue or circulating-free tumor DNA derived from plasma collected in EDTA anti-coagulated peripheral whole blood.
What equipment is required to run this test?
The system requires the Cobas DNA Sample Preparation Kit for tissue samples or the Cobas cfDNA Sample Preparation Kit for plasma, and the Cobas z 480 analyzer for automated amplification and 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 | P150044 | Class III | Active |
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Manufacturer
- Manufacturer
- Roche Molecular Systems, Inc.
Sources (1)
- FDA PMA P150044 24 fields · synced Sep 18, 2026