The Uric Acid assay is used for the quantitation of uric acid in serum, plasma, or urine on the ALCYON 300/300i Analyzer. Measurements of uric acid are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

Device Description

Uric Acid is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma, or urine. The Uric Acid assay is a clinical chemistry assay in which uric acid is oxidized to allantoin by uricase with the production of hydrogen peroxide. The peroxide reacts with 4-aminoantipyrine and TBHB in the presence of peroxidase to yield a quinoneimine dye. The resulting change in absorbance at 550 nm is proportional to the uric acid concentration in the sample.

AI/ML Overview

The Abbott Laboratories Uric Acid assay is an in vitro diagnostic device for the quantitative determination of uric acid in human serum, plasma, or urine. The study presented demonstrates its substantial equivalence to predicate devices, namely the Roche Cobas Mira Plus Automated Chemistry Uric Acid assay (for serum) and the Boehringer Mannheim Uric Acid assay on the Hitachi 717 Analyzer (for urine).

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Predicate Device)	Reported Device Performance (Abbott Uric Acid Assay)	Target Material/Application
Correlation Coefficient	"similar clinical results" (to Roche)	0.9918	Serum
	"similar clinical results" (to B-M)	0.9854	Urine
Slope	Not explicitly stated, but implied as close to 1	0.981	Serum
		0.951	Urine
Y-intercept	Not explicitly stated, but implied as close to 0	0.599 mg/dL	Serum
		0.435 mg/dL	Urine
Total %CV (Precision)	Not explicitly stated, but implied as acceptable for diagnostic assays	Level 1: 2.8%Level 2: 2.3%	Serum
		Level 1: 4.4%Level 2: 3.2%	Urine
Linearity	Not explicitly stated, but implied as relevant range	Up to 26 mg/dL	Not specified
Limit of Quantitation (Sensitivity)	Not explicitly stated, but implied as clinically relevant	0.3 mg/dL	Not specified

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

The document does not explicitly state the exact sample sizes used for the method comparison studies. It mentions "Comparative performance studies were conducted" and "Precision studies were conducted using two levels of control material."

Test Set Sample Size: Not explicitly stated for either method comparison or precision studies.
Data Provenance: Not specified (e.g., country of origin). The studies appear to be retrospective in the sense that they are comparing the performance of the new device against existing, established predicate devices using collected samples. No information suggests it was a prospective trial with patient enrollment.

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

This information is not applicable as the study design focuses on a method comparison against predicate devices, not on a human-read diagnostic interpretation. The "ground truth" for the test set is established by the measurements obtained from the predicate devices.

4. Adjudication Method for the Test Set:

This information is not applicable as the study design is a method comparison, not an expert-based adjudication of diagnostic findings. The results from the predicate devices serve as the reference.

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:

This information is not applicable. The device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

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

Yes, this study essentially represents a standalone performance evaluation of the Uric Acid assay on the ALCYON 300/300i Analyzer. The "algorithm" here refers to the chemical assay method implemented on the analyzer. Its performance is evaluated independently against predicate methods, without human interpretation in the diagnostic process beyond setting up the samples and reviewing the quantitative results.

7. The Type of Ground Truth Used:

The ground truth for the method comparison studies was established by the measurements provided by the predicate devices:

Roche Cobas Mira Plus Automated Chemistry Uric Acid assay for serum samples.
Boehringer Mannheim Uric Acid assay on the Hitachi 717 Analyzer for urine samples.

For precision studies, the ground truth would be inferred from the known values of the control materials used.

8. The Sample Size for the Training Set:

This information is not applicable. This is an in vitro diagnostic assay based on established chemical reactions, not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" for such a device involves optimizing the biochemical reaction parameters and instrument settings during development.

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

This information is not applicable for the reasons stated in point 8. The development of such assays relies on biochemical principles rather than "ground truth" established from labeled data like in machine learning.

Summary

{0}------------------------------------------------

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 31, 1998
Device Trade or Proprietary Name:	Uric Acid
Device Common/Usual Name or Classification Name:	Uric Acid
Classification Number/Class:	75CDO/Class I

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:

Uric Acid 510(k) April 29, 1998 Uric AcidE2. Iwp

Section II Page I

{1}------------------------------------------------

Substantial Equivalence:

The Uric Acid assay is substantially equivalent to the following devices:

Roche® Cobas Mira® Plus Automated Chemistry Uric Acid assay (K922762) for . the serum application
Boehringer Mannheim® Uric Acid assay (K873363) on the Hitachi® 717 Analyzer . 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 uric acid. .
. Both assays vield similar clinical results.

Differences to Roche:

There is a minor difference between the assay ranges. .
Similarities to Boehringer Mannheim:
Both assays are in vitro clinical chemistry methods. .
. Both assays can be used for the quantitative determination of uric acid.
. Both assays yield similar clinical results.

Differences to Boehringer Mannheim:

. There is a minor difference between the assay ranges.

Intended Use:

The Uric Acid assay is used for the quantitation of uric acid in human serum, plasma, or urine on the ALCYON 300/300i Analyzer.

Performance Characteristics:

Comparative performance studies were conducted using the ALCYON™ Analyzer. The Uric Acid assay method comparison yielded acceptable correlation with the Roche

Uric Acid 510(k) April 29, 1998 Uric AcidE2.1wp

Section II Page 2

{2}------------------------------------------------

Cobas Mira Plus Automated Chemistry System Uric Acid assay for the serum application and the Boehringer Mannheim Uric Acid assay on the Hitachi 717 Analyzer for the urine application. For the serum application, the correlation coefficient = 0.9918, slope = 0.981 and the Y-intercept = 0.599 mg/dL. For the urine application, the correlation coefficient = 0.9854, slope = 0.951 and the Y-intercept = 0.435 mg/dL. Precision studies were conducted using the Uric Acid 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 2.8% and Level 2/Panel 112 is 2.3%. For the urine application, the total %CV for Level 1/Panel 131 is 4.4% and Level 2/Panel 132 is 3.2%. The Uric Acid assay is linear up to 26 mg/dL. The limit of quantitation (sensitivity) of the Uric Acid assay is 0.3 mg/dL. These data demonstrate that the performance of the Uric Acid assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Uric Acid assay for the serum application and the Boehringer Mannheim Uric Acid assay on the Hitachi 717 Analyzer for the urine application.

Conclusion:

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

Uric Acid 510(k) April 29, 1998 Uric AcidE2. Iwp

Section II Page 3

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle image.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

7 1998 MAY

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

K981189 Re : Uric Acid Requlatory Class: I Product Code: CDO March 31, 1998 Dated: Received: April 2, 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, 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. ਜੋ 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.

{4}------------------------------------------------

Page 2

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 Gutman

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

{5}------------------------------------------------

510(k) Number (if known):

Device Name:

Indications For Use:

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number k 981189

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

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

(Optional Format 1-2-96)

Uric Acid 510(k) April 29, 1998 Uric AcidE2.lvp

Regulation Number and Section

§ 862.1775 Uric acid test system.

(a)
Identification. A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.(b)
Classification. Class I (general controls). The device, when it is solely intended for use as an acid reduction of ferric ion test, a phosphotungstate reduction test, a gasometric uricase test, an ultraviolet uricase test, or an oxygen rate uricase test, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.