Urea/BUN, Scal, Nortrol, Abtrol
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K073295 FDA 510(k)
- FDA Product Code
- CDQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1770 FDA 510(k)
- Regulation Number
- 862.1770 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is an in vitro diagnostic reagent for the quantitative determination of urea and blood urea nitrogen (BUN) in serum or plasma, utilizing enzymatic methods with urease and glutamic dehydrogenase. It is classified under the Urease and Glutamic Dehydrogenase, Urea Nitrogen category and is designed for clinical chemistry applications, enabling accurate biochemical analysis in laboratory settings.
The Urea/BUN, Scal, Nortrol, Abtrol reagents are supplied as dry, ready-to-use powder or liquid formulations for manual or automated laboratory testing systems. They are intended for single-use only and require reconstitution or dilution prior to use, adhering to In Vitro Diagnostic Device (IVD) regulations under EU IVDR and FDA 510(k) clearance (K073295). Compliance with EU Directive 98/79/EC (IVDD) is also noted, with no MRI safety considerations. Storage conditions and shelf life are specified in the accompanying instructions for use.
Frequently asked questions
What clinical chemistry applications does this device support, and how does it measure urea and BUN levels?
This device supports quantitative biochemical analysis in clinical chemistry laboratories by measuring urea and blood urea nitrogen (BUN) levels using enzymatic methods. It employs urease and glutamic dehydrogenase to break down urea, enabling precise detection in serum or plasma samples. The reagents are designed for use in both manual and automated testing systems, ensuring compatibility with standard laboratory workflows.
Are the Urea/BUN reagents single-use only, and what preparation is required before use?
Yes, these reagents are intended for single-use only. Prior to use, they must be reconstituted or diluted according to the instructions for use, as they are supplied as dry powder or liquid formulations. This preparation step ensures accurate and reliable test results.
What storage conditions should be followed for these reagents, and how long can they be stored?
The storage conditions and shelf life are detailed in the accompanying instructions for use, which must be followed strictly. While the exact details are not provided here, adherence to these guidelines is critical to maintaining reagent efficacy and ensuring valid test results.
What regulatory pathways have been followed for this device, and which standards apply?
This device has undergone FDA 510(k) clearance (K073295) and complies with EU In Vitro Diagnostic Device Regulations (IVDR) and the former EU Directive 98/79/EC (IVDD). It is classified under the Urease and Glutamic Dehydrogenase, Urea Nitrogen category and is intended for clinical chemistry applications, adhering to relevant regulatory standards for in vitro diagnostics.
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
IVDD
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K073295 | Class II | Active |
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Manufacturer
- Manufacturer
- Thermofisher Scientific OY
Sources (2)
- FDA 510(k) K073295 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026