The Urea Nitrogen assay is used for the quantitation of urea nitrogen in human serum, plasma, or urine. Measurements obtained by this device are used in diagnosis and treatment of certain renal and metabolic diseases.

Device Description

Urea Nitrogen is an in vitro diagnostic assay for the quantitative determination of urea nitrogen in human serum, plasma, or urine. The Urea Nitrogen assay is a clinical chemistry assay in which the the urea in the sample is hydrolyzed by urease to ammonia (NH3) and carbon dioxide (CO2). A second reaction, catalyzed by glutamate dehydrogenase (GLD), converts ammonia and a-ketoglutarate to glutamate and water with the concurrent oxidation of reduced nicotinamide adenine dinucleotide (NADH) to nicotinamide adenine dinucleotide (NAD). Two moles of NADH are oxidized for each mole of urea present. The initial rate of decrease in absorbance at 340 nm is proportional to the urea concentration in the sample.

AI/ML Overview

The Abbott Laboratories Urea Nitrogen assay is an in vitro diagnostic device for the quantitative determination of urea nitrogen in human serum, plasma, or urine, used in the diagnosis and treatment of renal and metabolic diseases. It underwent a 510(k) submission to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly defined by demonstrating "acceptable correlation" in comparative performance studies and acceptable precision. The reported performance is as follows:

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (Serum Application)	Reported Device Performance (Urine Application)
Correlation Coefficient (vs Predicate)	Acceptable correlation	0.9897 (vs Roche Cobas Mira Plus)	0.9995 (vs Boehringer Mannheim)
Slope (vs Predicate)	Acceptable correlation	0.963 (vs Roche Cobas Mira Plus)	1.046 (vs Boehringer Mannheim)
Y-intercept (vs Predicate)	Acceptable correlation	1.206 mg/dL (vs Roche Cobas Mira Plus)	-1.208 mg/dL (vs Boehringer Mannheim)
Total %CV (Level 1)	Acceptable precision	4.9%	3.0%
Total %CV (Level 2)	Acceptable precision	3.9%	3.3%
Linearity		Up to 120 mg/dL	Not specified for urine independently
Limit of Quantitation (Sensitivity)		1.8 mg/dL	Not specified for urine independently

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size for the test set used in the comparative performance studies. It only states that "Comparative performance studies were conducted" and presents summary statistics (correlation coefficient, slope, Y-intercept).

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given it's a 510(k) submission for a clinical chemistry assay, the data would typically be derived from laboratory tests, and the intent is for prospective clinical use.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is an in vitro diagnostic assay where the "ground truth" is established by the comparative performance against legally marketed predicate devices using objective measurements, not by expert interpretation of images or other subjective assessments.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessment to resolve discrepancies in expert opinions. This device's performance is assessed through quantitative comparisons with predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a standalone in vitro diagnostic assay, not an AI-assisted diagnostic tool designed to aid human readers. Therefore, an MRMC study and
the concept of human reader improvement with AI assistance do not apply.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The entire submission describes the performance of the Abbott Urea Nitrogen assay itself (the "algorithm only" in the context of an IVD) without human-in-the-loop performance modifications or assistance. Its performance characteristics (correlation, precision, linearity, sensitivity) were measured intrinsically and compared to predicate devices.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the comparative performance studies, the "ground truth" was established by the results obtained from the legally marketed predicate devices:

Roche Cobas Mira Plus Automated Chemistry System Urea Nitrogen assay (K954000) for the serum application.
Boehringer Mannheim Urea Nitrogen assay on the Hitachi 717 Analyzer (K771923) for the urine application.

These predicate devices are assumed to provide accurate measurements of urea nitrogen, serving as the reference for determining the substantial equivalence of the new device.

8. The Sample Size for the Training Set

Not applicable. This is a traditional in vitro diagnostic assay, not a machine learning or AI-based device that requires a distinct "training set" in the conventional sense. The development of such an assay involves reagent formulation, instrument calibration, and optimization based on chemical principles and experimental data, rather than training on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no specific "training set" in the context of this traditional IVD development. The "ground truth" in the development of such assays is based on established analytical chemistry principles, reference methods, and quality control materials.

Summary

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K981123

APR 2 4 1998

510(k) Summary

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs (972) 518-7861 Fax (972) 753-3367

Date of Preparation of this Summary:	March 26, 1998
Device Trade or Proprietary Name:	Urea
Device Common/Usual Name or Classification Name:	Urea Nitrogen
Classification Number/Class:	75CDQ/Class II

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K98123 .

Test Description:

Substantial Equivalence:

The Urea Nitrogen assay is substantially equivalent to the following devices:

Urea Nitrogen 510(k) March 26, 1998 BUNKfinal.lwp

Section II Page 1 0000012

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Roche® Cobas Mira® Plus Automated Chemistry System Urea Nitrogen assay • • (K954000) for the serum application
Boehringer Mannheim® Urea Nitrogen assay on the Hitachi® 717 Analyzer . (K771923) for the urine application

These assays yield similar Performance Characteristics.

Similarities to Roche:

Both assays are in vitro clinical chemistry methods. .
Both assays can be used for the quantitative determination of urea nitrogen. .
Both assays yield similar clinical results. .

Differences to Roche:

There is a minor difference between the assay range. .
Similarities to Boehringer Mannheim:
Both assays are in vitro clinical chemistry methods. .
Both assays can be used for the quantitative determination of urea nitrogen. .
. Both assays vield similar clinical results.

Differences to Boehringer Mannheim:

There is a minor difference between the assay range .

Intended Use:

The Urea Nitrogen assay is used for the quantitation of urea nitrogen in human serum, plasma, or urine.

Performance Characteristics:

Comparative performance studies were conducted using the ALCYON™ Analyzer. The Urea Nitrogen assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Urea Nitrogen assay for the serum application and the Boehringer Mannheim Urea Nitrogen assay on the Hitachi 717 Analyzer for the urine application. For the serum application, the correlation

Section II Page 2

0000013

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coefficient = 0.9897, slope = 0.963, and Y-intercept = 1.206 mg/dL. For the urine application, the correlation coefficient = 0.9995, slope = 1.046, and Y-intercept = -1.208 mg/dL. Precision studies were conducted using the Urea Nitrogen assay. Within-run, between-run, and between-day studies were performed using two levels of control material. For the serum application, the total %CV for Level 1/Panel 111 is 4.9% and Level 2/Panel 112 is 3.9%. For the urine application, the total %CV for Level 1/Panel 111 control is 3.0% and Level 2/Panel 112 is 3.3%. The Urea Nitrogen assay is linear up to 120 mg/dL. The limit of quantititation (sensitivity) of the Urea Nitrogen assay is 1.8 mg/dL. These data demonstrate that the performance of the Urea Nitrogen assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Urea Nitrogen assay for the serum application and the Boehringer Mannheim Urea Nitrogen assay on the Hitachi 717 Analyzer for the urine application.

Conclusion:

The Urea Nitrogen assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System Urea Nitrogen assay for the serum application and the Boehringer Mannheim Urea Nitrogen assay on the Hitachi 717 Analyzer for the urine application as demonstrated by results obtained in the studies.

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Section II Page 3 0000014

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 2 4 1998

Mark Littlefield .Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Re: K981123 Urea Nitrogen Requlatory Class: II Product Code: CDQ Dated: March 26, 1998 March 27, 1998 Received:

Dear Mr. Littlefield:

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 requlations affecting your device can be found in the Code of Federal Requlations, 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 requlations.

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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 (770) 488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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): K 981123

Urea Nitrogen Device Name:

Indications For Use:

ﺎﺕ ﺍﻟﻤ (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ... ... . . . . . . . Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Clinical Laboratory Devices. 510(k) Number .

く

00000006

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.