BUN (Urease) Reagent
by Coulter Electronics, Inc. 510(k)
Active
510(k) K781253
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781253 | Date21 Aug 1978 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CDN
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1770
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a urease reagent used for photometric measurement of blood urea nitrogen (BUN) levels. It falls under the classification of diagnostic reagents for clinical chemistry, specifically designed to catalyze the hydrolysis of urea into ammonia and carbon dioxide, enabling quantitative analysis of urea nitrogen in serum or plasma samples. The reaction produces measurable colorimetric changes, allowing for accurate determination of BUN concentrations in laboratory settings.
The BUN (Urease) Reagent is supplied as a single-use reagent intended for in vitro diagnostic use in clinical chemistry laboratories. It is classified as a Class II device under FDA regulations (Product Code CDN) and was granted FDA 510(k) clearance (K781253) in 1978. The reagent is not sterile and must be handled in accordance with standard laboratory protocols. Storage conditions and shelf life are not specified in the regulatory data but are typically governed by manufacturer guidelines for reagent stability. No additional regulatory authorisations beyond the 510(k) clearance are mentioned.
Other devices from Coulter Electronics, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the BUN (Urease) Reagent used for?
The BUN (Urease) Reagent is designed for photometric measurement of blood urea nitrogen (BUN) levels in serum or plasma samples. It catalyzes the hydrolysis of urea into ammonia and carbon dioxide, producing measurable colorimetric changes that enable precise quantification of urea nitrogen concentrations in clinical chemistry laboratories.
Is the BUN (Urease) Reagent sterile?
No, the BUN (Urease) Reagent is not sterile. It is supplied as a single-use reagent intended for in vitro diagnostic use, and must be handled according to standard laboratory protocols to ensure accuracy and safety.
How is the BUN (Urease) Reagent supplied?
The reagent is supplied as a single-use item, intended exclusively for in vitro diagnostic applications in clinical chemistry settings. The exact packaging format (e.g., vials, ampoules) is not specified in the regulatory data but would follow typical reagent supply standards for laboratory use.
What regulatory pathway does the BUN (Urease) Reagent follow?
The BUN (Urease) Reagent was granted FDA 510(k) clearance under the Traditional pathway in 1978 (K781253) and is classified as a Class II device under FDA regulations (Product Code CDN). It was reviewed by the Clinical Chemistry (CH) Advisory Committee and is substantially equivalent to a predicate device.
What are the storage and shelf-life considerations for this reagent?
The regulatory data does not specify storage conditions or shelf life for the BUN (Urease) Reagent. However, like most reagents, it should be stored according to manufacturer guidelines to maintain stability and accuracy. Always refer to the product labeling or manufacturer instructions for precise storage requirements.