SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT

K982236 · Sigma Diagnostics, Inc. · CDQ · Aug 5, 1998 · Clinical Chemistry

Device Facts

• Record ID: K982236
• Device Name: SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT
• Applicant: Sigma Diagnostics, Inc.
• Product Code: CDQ · Clinical Chemistry
• Decision Date: Aug 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1770
• Device Class: Class 2

Intended 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.

Device Story

In vitro diagnostic reagent for quantitative determination of urea nitrogen in human serum or urine. Utilizes enzymatic reaction: urea hydrolyzed by urease to ammonia and carbon dioxide; ammonia reacts with alpha-ketoglutarate and NADH via glutamate dehydrogenase (GLDH) to produce L-glutamate and NAD. Urea concentration proportional to absorbance change over fixed time interval. Features single-vial format and patented dynamic stabilization process to regenerate NADH, extending shelf life. Used in clinical laboratories on automated or manual systems. Results interpreted by clinicians to assess protein metabolism, kidney function, and diagnose conditions like liver disease, congestive heart failure, or renal impairment.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing and comparison to predicate device.

Technological Characteristics

Enzymatic reagent system (urease/GLDH). Single-vial liquid reagent. Patented dynamic stabilization process for NADH regeneration. Quantitative spectrophotometric measurement based on absorbance change.

Indications for Use

Indicated for the quantitative, diagnostic determination of Urea or Urea Nitrogen in human serum or urine for the diagnosis and treatment of renal and metabolic diseases.

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

• TRACE Scientific BUN Reagent kit (K971477)

Submission Summary (Full Text)

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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 < 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.

The Sigma Diagnostics INFINITY™ BUN Reagent (Procedure No. 63) is substantially equivalent to. and is the same product as the TRACE Scientific BUN Reagent kit cleared by the FDA as K971477.

## References

- 1. Tietz Textbook of Clinical Chemistry, Burtis CA and Ashwood ER (Eds). Second Edition. WB Saunders Company, 1994
- 2. Talke H. Schubert GE. Klin Wochschr 19: 43:174
- Tiffany TO, Jansen JM, Burtis CA, Overton JB, Scott CD. Clin Chem 18:829-40. 1972 3.

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AUG - 5 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

William Gilbert, Ph.D. · Manager, Scientific Affairs Sigma Diagnostics Inc. 545 South Ewinq Avenue St. Louis, , Missouri 63103

Re : K982236 INFINITY™ BUN Reagent Regulatory Class: I Product Code: CDQ Dated: June 23, 1998 Received: June 25, 1998

Dear Dr. Gilbert:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

sincerely yours,
Steven Sitman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _

Device Name: INFINITY™ BUN Reagent

## 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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use__
(Per 21 CFR 801.109)

(Division Sign-Off
Division of Clinical Laboratory Devices
510(k) Number K982236
OR
Over-The-Counter Use__