CRCDx RAS Mutation Detection Assay Kit
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- CRCDx RAS Mutation Detection Assay Kit FDA PMA
- Generic Name
- Somatic gene mutation detection system FDA PMA
Identifiers
- PMA Number
- P220005 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 CRCDx RAS Mutation Detection Assay Kit is a qualitative real-time PCR in vitro diagnostic test intended for the detection of 35 variants of KRAS and NRAS exon 2, 3, 4 somatic mutations in genomic DNA extracted from formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue samples. It serves as a companion diagnostic to aid in the identification of colorectal cancer (mCRC) patients who may benefit from treatment with Vectibix (panitumumab) based on a no mutation detected test result.
The device is supplied as a kit for laboratory use and is regulated under FDA PMA approval. It is intended for single-use with genomic DNA extracted from FFPE colorectal cancer tissue samples. The test is designed to detect specific somatic mutations and is used in accordance with the approved therapeutic product labeling for Vectibix.
Frequently asked questions
What is the purpose of the CRCDx RAS Mutation Detection Assay Kit?
The CRCDx RAS Mutation Detection Assay Kit is a qualitative real-time PCR in vitro diagnostic test designed to detect 35 variants of KRAS and NRAS exon 2, 3, 4 somatic mutations in genomic DNA extracted from FFPE colorectal cancer tissue samples. It serves as a companion diagnostic to identify mCRC patients who may benefit from treatment with Vectibix based on a no mutation detected result.
How is the CRCDx RAS Mutation Detection Assay Kit supplied?
The device is supplied as a kit for laboratory use. It is intended for single-use with genomic DNA extracted from FFPE colorectal cancer tissue samples. The kit is regulated under FDA PMA approval and should be used in accordance with the approved therapeutic product labeling for Vectibix.
What types of samples can be used with the CRCDx RAS Mutation Detection Assay Kit?
The CRCDx RAS Mutation Detection Assay Kit is specifically designed for use with genomic DNA extracted from formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue samples. It cannot be used with other sample types.
What mutations does the CRCDx RAS Mutation Detection Assay Kit detect?
The assay detects 35 specific variants of KRAS and NRAS exon 2, 3, 4 somatic mutations. It is not designed to detect other types of mutations or genetic variations outside of these specific targets.
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 | P220005 | Class III | Active |
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Manufacturer
- Manufacturer
- EntroGen, Inc.
Sources (1)
- FDA PMA P220005 23 fields · synced Sep 18, 2026