Who is the manufacturer of UREA NITROGEN (BUN) LIQUI-UV?

Stanbio Laboratory filed the 510(k) submission for UREA NITROGEN (BUN) LIQUI-UV (K962418).

What is the FDA product code for UREA NITROGEN (BUN) LIQUI-UV?

CDQ. It is classified under 21 CFR 862.1770 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for UREA NITROGEN (BUN) LIQUI-UV?

510(k) clearance (submission type: Traditional).

What are the predicate devices for UREA NITROGEN (BUN) LIQUI-UV?

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

Who can help prepare an FDA 510(k) submission like UREA NITROGEN (BUN) LIQUI-UV?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

UREA NITROGEN (BUN) LIQUI-UV

K962418 · Stanbio Laboratory · CDQ · Dec 26, 1996 · Clinical Chemistry

Device Facts

Record ID	K962418
Device Name	UREA NITROGEN (BUN) LIQUI-UV
Applicant	Stanbio Laboratory
Product Code	CDQ · Clinical Chemistry
Decision Date	Dec 26, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1770
Device Class	Class 2

Intended 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.

Indications for Use

Indicated for the kinetic quantitative determination of Urea Nitrogen (BUN) in serum for clinical diagnostic purposes.

Regulatory Classification

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)

Related Devices

K981918 — UREA · Abbott Laboratories · Jul 28, 1998
K981123 — UREA · Trace Scientific , Ltd. · Apr 24, 1998
K960115 — HICHEM BUN/UREA REAGENT KIT · Elan Pharma, Inc. · Mar 29, 1996
K041051 — RAICHEM BUN RATE REAGENT (LIQUID) · Hemagen Diagnostics, Inc. · Jun 30, 2004
K021385 — ATAC PAK BUN REAGENT · Elan Diagnostics · Jul 12, 2002

Submission Summary (Full Text)

{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.