Urea Nitrogen(Bun)

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

510(k) Number

K863925 ↗

FDA Product Code

CDQ

Device Class

Class II

Regulation

21 CFR Part 862.1770

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Creatinine

  Class II

  FDA 510(k) K880629 Active Cleared 23 Mar 1988

• Uric Acid

  Class I

  FDA 510(k) K863924 Active Cleared 24 Nov 1986

• Cholesterol

  Class I

  FDA 510(k) K863927 Active Cleared 24 Nov 1986

• Hemoglobin

  Class II

  FDA 510(k) K883683 Active Cleared 6 Oct 1988

• Triglycerides

  Class I

  FDA 510(k) K863923 Active Cleared 24 Nov 1986

• Bilirubin (Direct)

  Class II

  FDA 510(k) K881172 Active Cleared 7 Jun 1988

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• What types of samples can this analyzer measure blood urea nitrogen (BUN) levels in, and how does it determine the results?

  This analyzer is designed to measure BUN levels in serum or plasma samples. It uses enzymatic methods, specifically urease and glutamic dehydrogenase reactions, to quantify urea nitrogen concentrations. These reactions chemically break down urea to detect and calculate its presence, providing accurate renal function and hydration status assessments.

• Is this device intended for single-use, or can it be reused in a clinical setting?

  The device is not labeled as single-use or sterile, meaning it is intended for reusable use in clinical laboratories and medical settings. Proper maintenance, calibration, and cleaning per manufacturer guidelines are required to ensure accurate and safe operation over repeated use.

• What regulatory pathway was followed for this device’s approval, and what class does it fall under?

  This analyzer was cleared through the FDA 510(k) pathway under the classification K863925, with a Traditional 510(k) review. It is classified as a Class II device under FDA regulation 862.1770, indicating it poses moderate risk and requires specific controls to ensure safety and effectiveness.

• Are there any size or compatibility restrictions for using this analyzer in a lab environment?

  The device is not labeled for MRI compatibility, nor are there specific size constraints mentioned. Its operational parameters align with standard laboratory instrumentation, meaning it should fit typical clinical chemistry lab setups without size-related limitations.