SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT

• K Number: K982236
• Device Name: SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT
• Manufacturer: SIGMA DIAGNOSTICS, INC.
• Date Cleared: 1998-08-05 ( 41 days)
• Product Code: CDQ
• Regulation Number: 862.1770

Intended Use

The Sigma Diagnostics INFINITY™ BUN Reagent is intended for the in vitro quantitative, diagnostic determination of Urea (or Urea Nitrogen) in human serum or urine on both automated and manual svstems. The Sigma Diagnostics INFINITY™ BUN Reagent is a device intended to measure urea nitrogen (an end product of nitrogen metabolism) in serum. Measurements obtained by the device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Device Description

The enzyme methodology employed in this reagent is based on the reaction first described by Talke and Schubert. To shorten and simplify the assay, the calculations are based on the discovery of Tiffany, et al.3 that urea concentration is proportional to absorbance change over a fixed time interval. The series of reactions involved in the assay system is as follows: 1. Urea is hydrolyzed in the presence of water and urease to produce ammonia and carbon dioxide. Urea + H2O Urease < 2NH3 + CO2 2. In the presence of glutamate dehydrogenase (GLDH) and reduced nicotinamide adenine dinucleotide (NADH), the ammonia combines with a-ketoglutarate (α-ΚG) to produce L-glutamate. NH3 + α-KG + NADH ___ GLDH_____ GLDH____ L-Glutamate + NAD INFINITY BUN reagent has the convenience of being a single vial reagent and also incorporates a patented dynamic stabilization process which regenerates NADH from NAD (oxidized NADH), thereby increasing the shelf life of the reagent.

Predicate Devices

K971477

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a chemical reagent and enzymatic reactions for measuring urea nitrogen, with no mention of AI or ML technologies.

Therapeutic

No

The device is an in vitro diagnostic reagent used to measure urea nitrogen for diagnostic purposes, not to treat a condition or disease.

Diagnostic

Yes

The Intended Use / Indications for Use section explicitly states that the reagent is "intended for the in vitro quantitative, diagnostic determination of Urea (or Urea Nitrogen)" and that "Measurements obtained by the device are used in the diagnosis and treatment of certain renal and metabolic diseases."

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a chemical reagent kit used for in vitro diagnostic testing, not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use/Indications for Use: The document explicitly states the reagent is "intended for the in vitro quantitative, diagnostic determination of Urea (or Urea Nitrogen) in human serum or urine". It also mentions that the measurements are "used in the diagnosis and treatment of certain renal and metabolic diseases." This clearly indicates the device is used outside of the body (in vitro) for diagnostic purposes.
• Device Description: The description details a chemical reaction used to measure a substance (urea nitrogen) in a biological sample (serum or urine). This is characteristic of an in vitro diagnostic test.
• Predicate Device: The mention of a predicate device (K971477; TRACE Scientific BUN Reagent kit) which is also a BUN reagent kit, further supports its classification as an IVD. Predicate devices are typically other legally marketed devices of the same type and intended use.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Sigma Diagnostics INFINITY™ BUN Reagent is a device intended to measure urea nitrogen (an end product of nitrogen metabolism) in serum. Measurements obtained by the device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Product codes

CDQ

Device Description

Sigma Diagnostics INFINITY™ BUN Reagent is intended for the in vitro quantitative, diagnostic determination of Urea (or Urea Nitrogen) in human serum or urine on both automated and manual svstems.

Urea is the major end product of protein nitrogen metabolism in humans. It constitutes the largest fraction of the non-protein nitrogen component of the blood. Urea is produced in the liver and excreted through the kidneys in the urine. Consequently, the circulating levels of urea depend upon protein intake, protein catabolism and kidney function. Elevated urea levels can occur with dietary changes, diseases which impair kidney function, liver diseases, congestive heart failure, diabetes, and infections.

The enzyme methodology employed in this reagent is based on the reaction first described by Talke and Schubert. To shorten and simplify the assay, the calculations are based on the discovery of Tiffany, et al.3 that urea concentration is proportional to absorbance change over a fixed time interval.

The series of reactions involved in the assay system is as follows:

• 1. Urea is hydrolyzed in the presence of water and urease to produce ammonia and carbon dioxide.
     Urea + H2O Urease

Regulation Number and Section

§ 862.1770 Urea nitrogen test system.

(a)
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.(b)
Classification. Class II.

Summary

0

K982236

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

INFINITY™ BUN Reagent, Procedure 63

Sigma Diagnostics INFINITY™ BUN Reagent is intended for the in vitro quantitative, diagnostic determination of Urea (or Urea Nitrogen) in human serum or urine on both automated and manual svstems.

Urea is the major end product of protein nitrogen metabolism in humans. It constitutes the largest fraction of the non-protein nitrogen component of the blood. Urea is produced in the liver and excreted through the kidneys in the urine. Consequently, the circulating levels of urea depend upon protein intake, protein catabolism and kidney function. Elevated urea levels can occur with dietary changes, diseases which impair kidney function, liver diseases, congestive heart failure, diabetes, and infections.

The enzyme methodology employed in this reagent is based on the reaction first described by Talke and Schubert. To shorten and simplify the assay, the calculations are based on the discovery of Tiffany, et al.3 that urea concentration is proportional to absorbance change over a fixed time interval.

The series of reactions involved in the assay system is as follows:

• 1. Urea is hydrolyzed in the presence of water and urease to produce ammonia and carbon dioxide.
     Urea + H2O Urease