Urea Nitrogen Test (K903334)

No FDA recalls on record, checked 22 Oct 2026.

Full name

Urea Nitrogen Test

510(k) Number

K903334 ↗

FDA Product Code

CDQ

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 Em Diagnostic Systems, Inc. →

• What types of samples can the Urea Nitrogen Test measure, and why is this important for clinical use?

  The Urea Nitrogen Test is designed to measure urea nitrogen levels in whole blood, serum, plasma, and urine. This versatility is important because urea nitrogen is a key metabolic byproduct that helps assess renal function and metabolic disorders. Measuring it across multiple sample types allows clinicians to evaluate kidney health, dehydration, liver function, and other systemic conditions without needing separate tests for each sample type.

• Is this test system intended for single-use, and if so, why does that matter for laboratory workflows?

  Yes, the Urea Nitrogen Test is intended for single-use only, meaning each test kit is designed for one use and cannot be reused or sterilized. This matters for laboratory workflows because it ensures accuracy by preventing contamination or degradation of reagents over multiple uses. Single-use also reduces the risk of cross-contamination between samples, which is critical for reliable diagnostic results in clinical chemistry.

• How is the Urea Nitrogen Test chemically analyzed, and what does this mean for its diagnostic reliability?

  The test employs urease and glutamic dehydrogenase chemistry to quantify urea nitrogen. This biochemical method breaks down urea into ammonia and other compounds, which are then measured to determine nitrogen levels. The use of these specific enzymes ensures high specificity and sensitivity, which is essential for accurate diagnosis and monitoring of renal and metabolic disorders. The chemistry is standardized to meet clinical chemistry regulations (e.g., FDA 862.1770), reinforcing its reliability.

• What regulatory pathway was followed for this device, and what does that indicate about its compliance standards?

  The Urea Nitrogen Test was cleared through the FDA 510(k) pathway (K903334), specifically under special controls for Class II devices in the Clinical Chemistry category. This indicates the device underwent rigorous review by the FDA’s Clinical Chemistry (CH) advisory committee to ensure it meets performance standards for diagnostic accuracy. The clearance date (1990) and compliance with regulation 862.1770 further confirm it adheres to established clinical chemistry guidelines for in vitro diagnostics.

• Are there multiple models or sizes available for this test system, and if not, how is it supplied for laboratory use?

  The provided data does not specify multiple models or sizes for the Urea Nitrogen Test, implying it is likely supplied as a standardized test system for laboratory use. Since it is classified under FDA product code CDQ and intended for single-use, it is probably packaged as individual kits or reagent strips designed for consistent, reproducible testing across different samples. Laboratories would receive pre-configured components to perform the test without additional customization.