← Product Code [CDQ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ) · K962418

# UREA NITROGEN (BUN) LIQUI-UV (K962418)

_Stanbio Laboratory · CDQ · Dec 26, 1996 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K962418

## Device Facts

- **Applicant:** Stanbio Laboratory
- **Product Code:** [CDQ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ.md)
- **Decision Date:** Dec 26, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1770
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

The device is used for the kinetic quantitative determination of Urea Nitrogen (BUN) in serum.

## Device Story

In vitro diagnostic test kit; measures Urea Nitrogen (BUN) in serum. Principle: kinetic measurement of NADH to NAD conversion via urease and glutamic dehydrogenase (GLDH) enzymes; decrease in absorbance monitored. Components: two reagents (BUN Buffer R1, BUN Enzyme R2) and 30mg/dL standard. Used in clinical laboratory settings by technicians/pathologists. Output: quantitative BUN concentration. Clinical utility: assessment of renal function and nitrogen balance.

## Clinical Evidence

Bench testing only. Method comparison against predicate device yielded correlation coefficient of 0.999 and regression equation y = 1.012x - 0.47. Additional validation included precision, linearity, sensitivity, stability, and interference studies; all results acceptable.

## Technological Characteristics

In vitro diagnostic reagent kit. Enzymatic kinetic assay (Urease/GLDH). Measures absorbance decrease at 340nm. Components: Buffer (R1), Enzyme (R2), Standard. Manual or automated analyzer application.

## Regulatory Identification

A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

## Predicate Devices

- BUN, UV Urease/GLDH (Kinetic) (Boehringer Mannheim)

## Submission Summary (Full Text)

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{0}

DEC 26 1996
K9C2418

# 510(k) SUMMARY

## Submitter's Name

Kirk Johnson
Tel. (210) 222-2108
Stanbio Laboratory, Inc.
Fax (210) 227-6367
2930 East Houston Street
San Antonio, TX 78202

Prepared By Kirk Johnson
June 18, 1996

## Product Name

Trade name-Urea Nitrogen (BUN) Liqui-UV®
Common name-Urea Nitrogen (BUN)
Classification name-Urease and Glutamic Dehydrogenase, Urea Nitrogen
Class II, 75CDQ

## Substantial Equivalence of Device

This test is substantially equivalent to:
Product Name: BUN, UV Urease/GLDH (Kinetic)
Manufacturer: Boehringer Mannheim

## Description of Device

The device test kit is comprised of two reagents, BUN Buffer (R1) and BUN Enzyme (R2), and a standard, 30mg/dL. A working reagent is prepared by combining five parts BUN Buffer (R1) to one part BUN Enzyme (R2).

## Intended Use of Device

The device is used for the kinetic quantitative determination of Urea Nitrogen (BUN) in serum.

## Comparison of Devices

Both Urea Nitrogen (BUN) methods measure kinetically the decrease in absorbance due to consumption and conversion of NADH to NAD.

## Performance Data

Substantial equivalency was demonstrated by method comparison. Correlation was performed between the two test kits with a correlation coefficient of 0.999 and a regression equation of $y = 1.012x - 0.47$.

In addition, precision, linearity, sensitivity, stability and interference studies were performed on Stanbio Laboratory, Inc., version of Urea Nitrogen (BUN) Liqui-UV®, Catalog # 2020. Results of these tests were found to be acceptable.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K962418](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K962418)

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