The Bayer ADVIA IMS Uric Acid (UA) method is an in vitro diagnostic device intended to measure uric acid in human serum, plasma and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation and other wasting conditions and of patients receiving cytotoxic drugs.

Device Description

Not Found

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Bayer ADVIA IMS Uric Acid method, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary directly presents performance data for the ADVIA IMS Uric Acid method and compares it to a predicate device (ADVIA 1650 Uric Acid) and/or a comparison system (CDC Uricase). While explicit "acceptance criteria" are not stated as defined thresholds (e.g., "CV must be less than X%"), the reported performance demonstrates "substantial equivalence" to the predicate, implying that these levels of performance were acceptable for clearance.

Performance Characteristic	Acceptance Criteria (Implied by Predicate/Comparison)	Reported ADVIA IMS Performance
Imprecision (Serum)	Similar or better CV (%) than ADVIA 1650
Level 3.7 mg/dL	ADVIA 1650: 1.9% CV	2.3% CV
Level 7.7 mg/dL	ADVIA 1650: 1.6% CV	1.6% CV
Level 9.9 mg/dL	ADVIA 1650: 2.3% CV	1.1% CV
Imprecision (Urine)	Similar or better CV (%) than ADVIA 1650
Level 20.2 mg/dL	ADVIA 1650: 2.3% CV (for 12.4 mg/dL)	5.2% CV
Level 28.9 mg/dL	ADVIA 1650: 5.2% CV (for 23.9 mg/dL)	3.6% CV
Level 38.4 mg/dL	(N/A - no direct predicate comparison at this level)	2.6% CV
Correlation (Serum, vs. CDC Uricase)	High correlation (R close to 1), Syx low	Y=0.98X+0.11, Syx=0.27, R=0.999
Correlation (Serum, vs. Advia 1650)	High correlation (R close to 1), Syx low	Y=0.96X+0.29, Syx=0.37, R=0.998
Correlation (Plasma vs. Serum, via Advia 1650)	High correlation (R close to 1), Syx low	Y=1.01X-0.05, Syx=0.08, R=0.998
Correlation (Urine, vs. CDC Uricase)	High correlation (R close to 1), Syx low	Y=1.035X-0.37, Syx=1.11, R=0.999
Correlation (Urine, vs. Advia 1650)	High correlation (R close to 1), Syx low	Y=0.96X-1.08, Syx=2.70, R=0.998
Interfering Substances	Minimal clinically significant change (e.g., well within +/-10%)	Most effects within +/-7%
Analytical Range (Serum)	Comparable to predicate for intended use	0-26 mg/dL
Analytical Range (Urine)	Comparable to predicate for intended use	0-230 mg/dL

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

The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.

Imprecision Study (Serum): The "Level (mg/dL)" values suggest multiple measurements were taken at three different concentrations, but the exact number of replicates or individual samples is not provided.
Imprecision Study (Urine): Similar to serum, the exact number of replicates or individual samples is not provided.
Correlation Studies:
- Serum vs. CDC Uricase: N = 117
- Serum vs. Advia 1650: N = 100
- Plasma (Y) vs. Serum (X) with Advia 1650: N = 54
- Urine vs. CDC Uricase: N = 10
- Urine vs. Advia 1650: N = 63
Interfering Substances: The Uric Acid Conc. (mg/dL) values suggest testing at specific concentrations, but the number of samples for each interferent is not provided.

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

This information is not provided in the 510(k) summary. For in vitro diagnostic devices like this, "ground truth" is typically established by reference methods or validated comparative systems (e.g., CDC Uricase), rather than by human expert consensus or pathology review in the same way it would be for an imaging-based AI device.

4. Adjudication Method for the Test Set

This is not applicable for this type of in vitro diagnostic device study. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI devices that assist human diagnosticians (e.g., CAD systems for radiology). The ADVIA IMS Uric Acid method is a standalone laboratory instrument for quantitative measurement, not an AI assisting human readers.

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

Yes, the studies presented are standalone performance studies of the ADVIA IMS Uric Acid method. The device measures uric acid levels automatically; there is no "human-in-the-loop" once the sample is loaded and the test initiated. The performance metrics (imprecision, correlation, interference) directly reflect the algorithm's and instrument's capabilities.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the test set was established using:

Reference Methods: The "CDC Uricase" method is cited as a comparison system for correlation studies in both serum and urine. This is a highly accurate and standardized reference method for uric acid measurement.
Predicate Device/Comparative System: The "Advia 1650" (the predicate device) was used as a comparison system for imprecision, correlation, and for comparing plasma vs. serum. This indicates that the performance of the new device was benchmarked against an already legally marketed and accepted method.

8. The Sample Size for the Training Set

This is not applicable in the context of this device. The ADVIA IMS Uric Acid method is an enzymatic assay based on established biochemical principles, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is characterized through analytical validation studies using patient samples and quality controls, which are the "test sets" described above.

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

As mentioned above, this is not applicable because the device does not employ machine learning or AI that would necessitate a "training set" with ground truth established through, for example, expert annotation. The device's underlying chemistry and optical detection principles are well-understood and do not require iterative training.

Summary

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

MAR 1 8 2003

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Uric Acid Method for ADVIA IMS

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

The assigned 510(k) number is: HOA2096 (leave blank)

1. Intended Use

2. Predicate Device

Product Name	Reagent Part #	Calibrator Part #
ADVIA 1650 Uric Acid	B01-4131-01	T03-1291-62

3. Device / Method

Product Name	Reagent BAN #	Calibrator BAN #
ADVIA IMS Uric Acid	07383256	06798711

A. Imprecision (serum)

ADVIA IMS	Advia 1650
Level(mg/dL)	TotalCV (%)	Level(mg/dL)	TotalCV(%)
3.7	2.3	3.9	1.9
7.7	1.6	8.6	1.6
9.9	1.1	10.0	2.3

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

Imprecision (urine)

ADVIA IMS		Advia 1650
Level (mg/dL)	Total CV (%)	Level (mg/dL)	Total CV (%)
20.2	5.2	12.4	2.3
28.9	3.6	23.9	5.2
38.4	2.6

B. Correlation (Y=ADVIA IMS, X=Comparison system)

Specimen type	Comparison System (X)	N	Regression Equation	Syx (mg/dL)	R	Sample Range (mg/dL)
Serum	CDC Uricase	117	Y=0.98X+0.11	0.27	0.999	1.5-26.2
Serum	Advia 1650	100	Y=0.96X+0.29	0.37	0.998	1.5-23.6
Plasma (y), Serum (x)	Advia 1650	54	Y=1.01X-0.05	0.08	0.998	2.8-7.3
Urine	CDC Uricase	10	Y=1.035X-0.37	1.11	0.999	3.8-182.8
Urine	Advia 1650	63	Y=0.96X-1.08	2.70	0.998	5.7-198.7

C. Interfering Substances

Interfering	Interfering Sub.Conc. (mg/dL)	Uric AcidConc. (mg/dL)	Effect(% change)
Bilirubin(unconjugated)	30	7.6	-5
Bilirubin(conjugated)	30	7.6	-6
Hemoglobin	750	7.5	-7
Lipids (Intralipid)	1000	7.0	-1
Acetaminophen	280 µg/mL	20.9	-5
Ascorbic Acid	200	21.1	-5
Salicylate	500	21.3	-5

Analytical Range (serum): 0-26 mg/dL

Analytical Range (urine): 0-230 mg/dL

Laure S. Adli

Kenneth T. Edds Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue, Tarrytown, NY 10591.

6/21/02
Date

Date

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

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

Re: K022096

Trade/Device Name: Uric Acid Assay for the ADVIA Integrated Modular System (IMS) Regulation Number: 21 CFR § 862.1775 Regulation Name: Uric acid test system Regulatory Class: I Product Code: KNK Dated: January 17, 2003 Received: January 21, 2003

MAR 1 8 2003

Dear Dr. Edds:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.

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

Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

Page 1 of 1

Koa 2-096 510(k) Number:

Device Name: Uric Acid Assay for the ADVIA IMS

Indications for Use:

(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)

Over-The-CounterUse

(Optional Format 1-2-96)

Carl Simon for Jean Cooper, DUM

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022096

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.