Raichem BUN Rate Reagent (Liquid)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K041051 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)
The Raichem BUN Rate Reagent (Liquid) is a liquid reagent designed for use in quantitative enzymatic assays to measure urea nitrogen levels in blood samples. Classified under the nomenclature ‘Urease and Glutamic Dehydrogenase, Urea Nitrogen,’ this device employs enzymatic methods to determine blood urea nitrogen (BUN) rates, aiding in the assessment of renal function and metabolic health.
Supplied as a liquid reagent, the Raichem BUN Rate Reagent (Liquid) is intended for in vitro diagnostic use in clinical chemistry laboratories. It is regulated under 21 CFR §862.1770 and holds an FDA 510(k) clearance (K041051) with a classification as a Class II device. The product is not specified as single-use or reusable, nor is its sterility or MRI safety status detailed in the available data.
Frequently asked questions
What is the primary clinical use of the Raichem BUN Rate Reagent (Liquid) in a laboratory setting?
The Raichem BUN Rate Reagent (Liquid) is designed for quantitative enzymatic assays to measure blood urea nitrogen (BUN) rates in clinical chemistry laboratories. By employing urease and glutamic dehydrogenase, it helps assess renal function and metabolic health, making it useful for evaluating kidney performance and overall patient health.
How is the Raichem BUN Rate Reagent (Liquid) supplied, and what form does it take?
The reagent is supplied exclusively as a liquid formulation, intended for in vitro diagnostic use. It is not specified whether it is single-use or reusable, nor is its sterility status detailed in the available data, so handling and usage should follow manufacturer guidelines for liquid reagents in clinical chemistry.
What regulatory pathway was followed for FDA clearance of this reagent, and what classification does it hold?
The Raichem BUN Rate Reagent (Liquid) received FDA clearance through a Traditional 510(k) pathway (K041051) and is classified as a Class II device under 21 CFR §862.1770. The clearance was determined to be *substantially equivalent* to a predicate device, and it was reviewed by the Clinical Chemistry (CH) Advisory Committee.
Are there any specific storage or handling instructions mentioned for this reagent?
The provided data does not explicitly detail storage conditions or handling instructions for the Raichem BUN Rate Reagent (Liquid). However, as a liquid reagent for in vitro diagnostic use, it should generally be stored according to standard laboratory protocols for enzymatic reagents—typically at refrigerated temperatures (2–8°C) and protected from light until use. Always refer to the manufacturer’s labeling for precise guidance.
What types of laboratories or settings would benefit most from using this reagent?
This reagent is intended for clinical chemistry laboratories that perform quantitative enzymatic assays for blood urea nitrogen (BUN) measurements. It is particularly useful in settings where renal function assessment is critical, such as hospitals, reference laboratories, or specialized diagnostic centers that rely on enzymatic methods for metabolic and kidney health evaluations.
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: RAICHEM BUN RATE REAGENT (LIQUID) (K041051) — FDA 510(k) | Innolitics, RAICHEM BUN RATE REAGENT (LIQUID) 510(k) K041051 - FDA.report, PDF K041051 - Raichem Bun Rate Reagent (Liquid)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K041051 | Class II | Active |
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Manufacturer
- Manufacturer
- Hemagen Diagnostics, Inc.
Sources (1)
- FDA 510(k) K041051 24 fields · synced Sep 20, 2026