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 urea in the sample is hydrolyzed by urease to ammonia (NH3) and carbon dioxide (CO2). A second reaction, catalyzed by glutamate dehydrogenase (GLDH), 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 340/380 nm is proportional to the urea concentration in the sample.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary for the Urea Nitrogen assay:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the Urea Nitrogen assay focuses on demonstrating "substantial equivalence" to a predicate device rather than defining specific, prescriptive acceptance criteria. Substantial equivalence implies that the performance of the new device is comparable to the predicate such that it can be marketed for the same intended use without raising new questions of safety or effectiveness.

Therefore, the "acceptance criteria" are implied by the performance of the predicate device and the new device's ability to demonstrate similar performance characteristics.

Performance Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Urea Nitrogen Assay)
Method Comparison	Acceptable correlation with predicate	Serum: Correlation coefficient = 0.9974, slope = 1.038, Y-intercept = 0.904 mg/dL
		Urine: Correlation coefficient = 0.9919, slope = 0.983, Y-intercept = 9.993 mg/dL
Precision	Acceptable precision (comparable to predicate)	Serum: Total %CV = 1.8% (Level 1), 2.0% (Level 2)
		Urine: Total %CV = 3.8% (Level 1), 3.1% (Level 2)
Linearity/Assay Range	Acceptable linearity (comparable to predicate)	Serum: up to 234.4 mg/dL
		Urine: up to 1,991.1 mg/dL
Limit of Quantitation (Sensitivity)	Acceptable sensitivity (comparable to predicate)	0.9 mg/dL

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

Sample Size: Not explicitly stated in the provided text for the method comparison or precision studies.
Data Provenance: Not specified. It's common for such studies to use human serum, plasma, or urine samples, but the country of origin or whether they were retrospective or prospective is not mentioned.

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

This type of information is generally not applicable to in vitro diagnostic (IVD) assays that measure specific chemical analytes like urea nitrogen. The "ground truth" for these tests isn't established by expert consensus or interpretation of images, but rather by quantitative chemical methods. The comparison is made to a legally marketed predicate device, whose own performance characteristics (including accuracy against reference methods) would have been established previously.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is a quantitative chemical assay, not one that involves human adjudication of diagnostic interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for imaging devices or AI-assisted diagnostic tools where human interpretation is a critical component, and the goal is to evaluate the impact of technology on reader performance. For a quantitative in vitro diagnostic assay, an MRMC study is not appropriate.

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

Yes, the performance characteristics described (method comparison, precision, linearity, sensitivity) are for the "algorithm only" or the device in standalone mode, as it's an automated in vitro diagnostic assay. There is no human-in-the-loop component in the direct measurement process of this device.

7. The Type of Ground Truth Used

The "ground truth" for this comparative study is the results obtained from the legally marketed predicate device, the Boehringer Mannheim® Urea Nitrogen assay on the Hitachi® 717 Analyzer. The new Urea Nitrogen assay's performance is compared directly against the results generated by this established predicate 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 "training set" in the conventional sense. The "training" of the assay refers to its development and optimization by the manufacturer, but not through a data-driven machine learning process.

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

Not applicable, as there is no "training set" in the context of machine learning for this device. The accuracy and performance of the assay would be established internally by the manufacturer during product development using various analytical methods and potentially reference materials, but these are distinct from "ground truth" for a machine learning training set.

Summary

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510(k) Summary

K981918

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

Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs (972) 518-6062 Fax (972) 753-3367

Date of Preparation of this Summary:	May 29, 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: _______________________________________________________________________________________________________________________________________________

Test Description:

Urea Nitrogen 510(k) May 29, 1998 BUN.IWD

Section II Page 1

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Substantial Equivalence:

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

Boehringer Mannheim® Urea Nitrogen assay (K771923) on the Hitachi® 717 . Analyzer.
Both assays yield similar Performance Characteristics.

Similarities:

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:

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 AEROSET™ System. The Urea Nitrogen assay method comparison vielded acceptable correlation with the the Boehringer Mannheim Urea Nitrogen assay on the Hitachi 717 Analyzer for the serum and urine applications. For the serum application, the correlation coefficient = 0.9974, slope = 1.038, and Y-intercept = 0.904 mg/dL. For the urine application, the correlation coefficient = 0.9919, slope = 0.983, and Y-intercept = 9.993 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 101 is 1.8% and Level 2/Panel 102 is 2.0%. For the urine application, the total %CV for Level 1/Panel 201 control is 3.8% and Level 2/Panel 202 is 3.1%. The Urea Nitrogen assay is linear up to 234.4 mg/dL for the serum application, and 1,991.1 mg/dL for the

Section II Page 2

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urine application. The limit of quantititation (sensitivity) of the Urea Nitrogen assay is 0.9 mg/dL. These data demonstrate that the performance of the Urea Nitrogen assay is substantially equivalent to the performance of the Boehringer Mannheim Urea Nitrogen assay on the Hitachi 717 Analyzer.

Conclusion:

The Urea Nitrogen assay is substantially equivalent to the Boehringer Mannheim Urea Nitrogen assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.

Urea Nitrogen 510(k) May 29, 1998 BUN JWD

Section II Page 3

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Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized human figure with three wavy lines extending from its head. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

JUL 28 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K981918 Re : Urea Requlatory Class : II Product Code: CDO Dated: May 29, 1998 Received: June 1, 1998

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, Druq, 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 General regulation (21 CFR Part 820) and that, Devices: 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 (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.qov/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): ____________________________________________________________________________________________________________________________________________________

Device Name: Urea Nitrogen ________________________________________________________________________________________________________________________________________________________________

Indications For Use:

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 4981918

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

Congurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)

(Optional Format 1-2-96)

000000000

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.