Genomadix Cube CYP2C19 System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220026 FDA 510(k)
- FDA Product Code
- NTI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3360 FDA 510(k)
- Regulation Number
- 862.3360 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Genomadix Cube CYP2C19 System is a Drug Metabolizing Enzyme Genotyping System designed for molecular genotyping of the CYP2C19 gene. It automates DNA extraction from buccal samples, PCR amplification, and fluorescence-based detection of CYP2C19 alleles to assess genetic variations linked to drug metabolism.
This system is a portable, sample-to-result thermal cycling instrument intended for use in clinical toxicology settings. Supplied as a single-use or reusable component system (depending on module configuration), it generates results in approximately one hour. The device is FDA 510(k)-cleared under classification II (NTI product code) and operates without MRI restrictions. Storage and handling follow standard molecular diagnostic 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. Sources consulted: CYP2C19 Genotyping - Genomadix, Home - Genomadix, Genomadix Cube CYP2C19 System High | Buy Online | Genomadix™ | Fisher ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220026 | Class II | Active |
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Manufacturer
- Manufacturer
- Genomadix, Inc.
Sources (1)
- FDA 510(k) K220026 24 fields · synced Sep 18, 2026