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Oragene DX

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K192920

by DNA Genotek Inc

Identifiers

510(k) Number
K192920 FDA 510(k)
FDA Product Code
OYJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1675 FDA 510(k)
Regulation Number
862.1675 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Oragene DX is a Dna Specimen Collection, Saliva device, designed for the collection, stabilization, and preservation of saliva samples for downstream molecular analysis. It falls under the Clinical Chemistry category and is classified as a Class II medical device under FDA regulations. The device ensures the integrity of genetic material by preventing degradation through proprietary stabilization technology, enabling reliable DNA extraction for research, diagnostics, and forensic applications.

Oragene DX is supplied as a single-use collection kit, comprising a collection tube and a swab or saliva-inducing device, depending on the variant. The device is non-sterile as intended for pre-collection handling, but the collection tube itself contains a stabilizing solution that preserves sample quality for extended periods without refrigeration. It is not MRI-compatible and is available in multiple registration numbers (e.g., 3009746061, 3011057574) corresponding to different product variants. Authorized under FDA 510K and IVDR, it adheres to regulatory standards for specimen collection devices in clinical chemistry workflows.

Frequently asked questions

What types of samples can the Oragene® DX device collect, and how does it ensure sample integrity for molecular analysis?

The Oragene® DX is designed specifically for saliva sample collection, including both passive drool and swab-based methods depending on the variant. Its proprietary stabilization technology prevents DNA degradation, ensuring high-quality genetic material for reliable downstream molecular analysis like research, diagnostics, or forensic testing. The stabilizing solution inside the collection tube preserves sample integrity for extended periods without refrigeration.

Is the Oragene® DX device single-use, and if so, what components make up a typical collection kit?

Yes, the Oragene® DX is a single-use device. Each kit includes a collection tube containing the stabilizing solution and either a swab or a saliva-inducing device, depending on the variant. This design ensures hygiene and prevents cross-contamination between samples.

Does the Oragene® DX require refrigeration for storage, and what are the implications for handling and shipping?

No, the Oragene® DX does not require refrigeration for storage. The stabilizing solution inside the collection tube preserves sample quality for extended periods at room temperature, simplifying handling and shipping logistics. This makes it ideal for field collections, remote testing, or non-laboratory environments.

Are there different models or variants of the Oragene® DX, and how can I identify which one is right for my needs?

Yes, the Oragene® DX comes in multiple variants, each with distinct registration numbers (e.g., 3009746061, 3011057574). These variants may differ in collection method (e.g., swab vs. passive drool) or other technical specifications. The manufacturer’s documentation or support team can help match the right variant to your specific application, such as research, diagnostics, or forensic use.

Is the Oragene® DX collection tube itself sterile, and how should it be handled before use?

The Oragene® DX collection tube itself is not sterile, as it is intended for pre-collection handling. However, the tube contains a stabilizing solution that ensures sample integrity. Proper hygiene practices, such as washing hands or using gloves before handling the tube or swab, are recommended to maintain sample purity before collection.

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 (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
DNA Genotek Inc
FDA Applicant
DNA Genotek, Inc.

Sources (2)

  • FDA 510(k) K192920 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026