Identity
- Trade Name
- Praxis Extended RAS Panel FDA PMA
- Generic Name
- Next generation sequencing oncology panel, somatic or germline variant detection system FDA PMA
Identifiers
- PMA Number
- P160038 FDA PMA
- FDA Product Code
- PQP FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APWD FDA PMA
The Praxis Extended RAS Panel is a qualitative in vitro diagnostic test classified as a next-generation sequencing oncology panel for somatic or germline variant detection. It employs targeted high-throughput parallel sequencing to identify 56 specific mutations in RAS genes—KRAS (exons 2, 3, and 4) and NRAS (exons 2, 3, and 4)—within DNA extracted from formalin-fixed, paraffin-embedded (FFPE) colorectal cancer tissue samples.
This test is designed for use on the Illumina MiSeqDx instrument and is intended to aid in determining patient eligibility for treatment with Vectibix (panitumumab) based on a no-mutation-detected result. Supplied as a single-use diagnostic reagent, the device requires processing in a clinical laboratory setting and is subject to FDA Premarket Approval (PMA P160038). Sterility and regulatory compliance are ensured through the manufacturer’s validated protocols.
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 | P160038 | Class III | Active |
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Manufacturer
- Manufacturer
- Illumina, Inc.
Sources (1)
- FDA PMA P160038 24 fields · synced Sep 18, 2026