Seralyzer Blood Urea Nitrogen (BUN)

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K801269 ↗

FDA Product Code

JGZ

Device Class

Class II

Regulation

21 CFR Part 862.1770

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Miles Laboratories, Inc. →

• What is the Seralyzer BUN analyzer used for?

  The Seralyzer Blood Urea Nitrogen (BUN) analyzer is designed for clinical chemistry applications to measure urea nitrogen levels in whole blood, serum, plasma, and urine. These measurements help diagnose and monitor renal (kidney) and metabolic disorders by quantifying urea concentration, which reflects kidney function and metabolic health.

• How is the Seralyzer BUN analyzer supplied and what are its key components?

  The Seralyzer BUN analyzer is supplied as a reusable instrument, meaning the core device itself is intended for repeated use in controlled laboratory settings. It operates using disposable reagents, which manage sterility and simplify maintenance. The system relies on o-phthalaldehyde chemistry to detect urea via fluorescence, requiring proper calibration and adherence to manufacturer guidelines for accurate results.

• Is the Seralyzer BUN analyzer single-use or reusable?

  The instrument itself is reusable, designed for long-term use in clinical laboratories under proper maintenance protocols. However, the reagents used in the analyzer are single-use, ensuring sterility and consistency in measurements. This setup reduces contamination risks while allowing the analyzer hardware to remain functional for extended periods.

• What storage conditions should be followed for the Seralyzer BUN analyzer?

  The reusable instrument should be stored in a clean, dry environment protected from dust, moisture, and extreme temperatures to maintain its functionality. Single-use reagents must be stored according to the manufacturer’s instructions, typically in a cool, dry place away from direct sunlight until use. Proper storage ensures reagent stability and instrument reliability for accurate BUN measurements.

• What regulatory pathway was followed for the FDA clearance of this device?

  The Seralyzer BUN analyzer received FDA 510(k) clearance under the Traditional review pathway, classified as a Class II device (Regulation Number 862.1770). This classification indicates it poses moderate risk and requires specific controls to ensure safety and effectiveness in clinical settings. The clearance was granted based on substantial equivalence to a predicate device, as determined by the FDA.