Identifiers
- 510(k) Number
- K212745 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 ORAcollect Dx is a saliva specimen collection device designed for the collection of DNA samples. Classified as a DNA Specimen Collection Device under the FDA’s nomenclature, it is intended for use in clinical chemistry applications, facilitating the non-invasive retrieval of saliva for genetic or molecular testing.
Supplied as a single-use device, ORAcollect Dx is intended for sterile collection procedures in clinical or research settings. It is regulated under FDA 510(k) clearance (K212745) and the EU Medical Device Regulation (MDR), with a product code of OYJ. The device requires proper storage as per manufacturer guidelines to maintain integrity prior to use.
Frequently asked questions
What types of testing can the ORAcollect® Dx device be used for, and why is it considered non-invasive?
The ORAcollect® Dx is designed for genetic or molecular testing in clinical chemistry applications, as it collects saliva-based DNA samples. It is considered non-invasive because it eliminates the need for blood draws or painful tissue sampling, instead relying on a simple saliva collection process that patients can perform comfortably.
Is the ORAcollect® Dx intended for single-use only, and if so, why is this important?
Yes, the ORAcollect® Dx is supplied as a single-use device, meaning each unit is meant for one collection procedure only. This design ensures sterility and contamination prevention, which is critical for accurate DNA analysis in clinical or research settings where sample integrity must be maintained.
How should the ORAcollect® Dx be stored before use, and why does proper storage matter?
The ORAcollect® Dx requires proper storage as per manufacturer guidelines to preserve its integrity before use. Improper storage—such as exposure to extreme temperatures or moisture—could compromise the device’s sterility or functionality, potentially affecting the quality of the collected DNA sample for downstream testing.
What regulatory pathways does the ORAcollect® Dx follow, and how does this impact its use?
The ORAcollect® Dx is cleared under FDA 510(k) (K212745) and complies with the EU Medical Device Regulation (MDR). This means it has undergone regulatory review to ensure safety and performance for clinical chemistry applications, including DNA specimen collection, and can be legally used in both U.S. and EU markets for authorized purposes.
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K212745 | Class II | Active |
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Manufacturer
- Manufacturer
- DNA Genotek Inc
- FDA Applicant
- DNA Genotek, Inc.
Sources (2)
- FDA 510(k) K212745 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026