BUN-300/BUN-500 Urea Nitrogen Reagent

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K934533 ↗

FDA Product Code

CDQ

Device Class

Class II

Regulation

21 CFR Part 862.1770

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What types of biological samples can the BUN-300/BUN-500 Urea Nitrogen Reagent measure, and how is it used in a clinical setting?

  The BUN-300/BUN-500 Urea Nitrogen Reagent is designed for quantitative measurement of urea nitrogen in human serum, plasma, whole blood, and urine. It operates through biochemical reactions involving urease and glutamic dehydrogenase, making it suitable for clinical chemistry laboratories to assess renal function or metabolic disorders. Since it is supplied as a liquid reagent for single-use, it must be used in accordance with standard laboratory protocols for in vitro diagnostic testing.

• Is the BUN-300/BUN-500 Urea Nitrogen Reagent intended for repeated use, or is it meant to be discarded after one use?

  The BUN-300/BUN-500 Urea Nitrogen Reagent is explicitly labeled for single-use applications in clinical chemistry settings. This designation ensures consistency and reliability in diagnostic testing, as reuse could compromise sterility or reagent integrity. Laboratories should adhere to this guideline to maintain accurate and safe testing results.

• What regulatory pathway was followed for FDA clearance of the BUN-300/BUN-500 Urea Nitrogen Reagent, and what does this mean for its use?

  The BUN-300/BUN-500 Urea Nitrogen Reagent received FDA 510(k) clearance (K934533) under the Traditional 510(k) pathway, with a decision of *Substantially Equivalent* to a predicate device. This means the manufacturer demonstrated that the reagent performs similarly to an already-cleared urea nitrogen test, meeting FDA requirements outlined in 21 CFR 862.1770. Clinicians and labs can rely on this clearance as evidence of regulatory review for its intended use in measuring urea nitrogen levels.

• Are there specific storage instructions provided for the BUN-300/BUN-500 Urea Nitrogen Reagent, or should it be stored under standard laboratory conditions?

  The provided data does not specify storage conditions for the BUN-300/BUN-500 Urea Nitrogen Reagent. As a liquid reagent for clinical chemistry, it should ideally be stored according to standard laboratory practices—typically at room temperature (15–30°C) or refrigerated (2–8°C), protected from light and contamination. Laboratories should verify the manufacturer’s latest instructions or contact Horizon Diagnostics for precise guidance to ensure reagent stability and performance.