Blood Urea Nitrogen (BUN) Procedure
by Data Medical Associates, Inc. 510(k)
Active
510(k) K863260
Overview
The Blood Urea Nitrogen (BUN) Procedure is a diagnostic device classified as a Urease and Glutamic Dehydrogenase Urea Nitrogen Test System. It measures urea nitrogen levels in whole blood, serum, plasma, and urine to aid in the diagnosis and monitoring of renal and metabolic disorders. Urea nitrogen is a byproduct of protein metabolism, and its concentration provides critical clinical insights into kidney function and overall metabolic health.
This procedure is intended for use in clinical chemistry laboratories and is supplied as a reagent-based test system. It is regulated under FDA 510(k) clearance (K863260) under the classification CDQ and falls under Regulation 862.1770. The device is designed for single-use per test kit, with no indication of sterility or MRI safety requirements. Storage and handling follow standard laboratory protocols for reagent-based diagnostic tests, and its regulatory status is confirmed as FDA 510(k) clearance.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK863260 | Date9 Sep 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CDQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1770
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Data Medical Associates, Inc.
Questions
What clinical conditions does this Blood Urea Nitrogen (BUN) test help diagnose?
This BUN test system measures urea nitrogen levels in whole blood, serum, plasma, and urine to provide critical insights into kidney function and metabolic health. Elevated urea nitrogen levels can indicate impaired renal function, dehydration, or metabolic disorders, while lower levels may suggest liver dysfunction or malnutrition. Clinicians use these results to diagnose and monitor conditions like chronic kidney disease, acute renal failure, and metabolic imbalances.
How is the BUN test system supplied, and what type of use is intended?
The BUN test system is supplied as a reagent-based test kit designed for single-use per test. Each kit contains the necessary reagents to perform one BUN measurement. It is intended exclusively for use in clinical chemistry laboratories, where trained personnel can conduct the test under controlled conditions. The system is not intended for home use or point-of-care testing outside of a laboratory setting.
Is sterility or MRI safety a consideration for this device?
The BUN test system does not have any specified sterility requirements, as it is a reagent-based diagnostic test intended for in vitro use in a laboratory environment. Additionally, there are no MRI safety considerations for this device, as it is not designed for use in or around MRI equipment. Standard laboratory protocols for reagent-based tests apply to storage and handling.
What regulatory approval does this BUN test system hold?
This BUN test system holds FDA 510(k) clearance under the classification CDQ and falls under Regulation 862.1770. The clearance number is K863260, and it was determined to be substantially equivalent to a predicate device by the FDA. The device is classified under the Clinical Chemistry advisory committee and is intended for use in clinical laboratories to measure urea nitrogen levels.
Are there different models or sizes available for this BUN test system?
The provided data does not specify multiple models or sizes for this BUN test system. It is described as a single reagent-based test kit designed for measuring urea nitrogen levels in various sample types. If additional variations exist, they would likely be referenced in the product documentation or additional regulatory filings not included in this dataset.