Blood-Urea-Nitrogen (BUN) Analyzer 2

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K761061 ↗

FDA Product Code

CDS

Device Class

Class II

Regulation

21 CFR Part 862.1770

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• Immage Immunochemistry System Haptoglobin (Hpt) Reagent

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See all devices from Beckman Instruments, Inc. →

• What clinical setting is the BUN Analyzer 2 designed for, and how does that affect its use?

  The BUN Analyzer 2 is specifically intended for use in clinical laboratory settings, where precise measurements of urea nitrogen in blood are required. This designates it as a point-of-care or laboratory instrument rather than a portable or bedside device, ensuring controlled conditions for accurate ion-specific electrode readings. Laboratories benefit from its classification under Clinical Chemistry, which aligns with standardized workflows for blood chemistry analysis.

• How is the BUN Analyzer 2 supplied, and does it require any special handling before use?

  The device is supplied as a Class 2 medical device by Beckman Instruments, Inc., but the data does not specify whether it is single-use or reusable. However, as an electrode-based ion-specific analyzer, it is likely designed for multi-use with proper maintenance (e.g., electrode calibration, cleaning, and storage per manufacturer guidelines). Clinicians should consult the included instructions for cleaning protocols and storage conditions to ensure accuracy and longevity of the device.

• Are there multiple models or sizes of the BUN Analyzer 2, and how would I identify the correct one for my lab?

  The data lists multiple registration numbers (e.g., 3003030793, 3005643513), which may correspond to different model variants or configurations of the BUN Analyzer 2. These identifiers are used for regulatory tracking rather than clinical differentiation, so the exact specifications (e.g., bench-top vs. modular, sample volume capacity) would require reviewing the manufacturer’s documentation or contacting Beckman Instruments. Always verify compatibility with your lab’s workflow before purchase.

• What should I know about the device’s regulatory pathway and compliance before purchasing?

  The BUN Analyzer 2 received FDA 510(k) clearance (K761061) through the Traditional pathway, meaning it was deemed substantially equivalent to a predicate device already on the market. This clearance confirms its compliance with U.S. FDA standards for Class 2 devices under product code CDS (Clinical Diagnostic Substances). For international use, additional regulatory pathways (e.g., CE marking for Europe) may apply, so check with Beckman Instruments or local health authorities to ensure full compliance with your region’s requirements.