The ATAC PAK Uric Acid Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of uric acid in serum and plasma. Unc acid results are for the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gour, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

Device Description

The ATAC PAK Uric Acid Reagent determines uric acid through the exzymatic oxidation coupled with a Trinder indicator reaction. The resulting increase in absorbance at 510 mm is proportional to the uric acid concentration of the sample.

AI/ML Overview

The provided text describes the ATAC PAK Uric Acid Reagent Kit and its performance studies as part of a 510(k) submission. It's important to note that this is a diagnostic reagent, not an AI-based device, so some of the requested categories (like "effect size of how much human readers improve with AI vs without AI assistance" or "adjudication method") are not applicable in the context of this product. I will address the relevant information as presented in the document.

Acceptance Criteria and Reported Device Performance for ATAC PAK Uric Acid Reagent Kit

The studies were conducted to demonstrate the substantial equivalence of the ATAC PAK Uric Acid Reagent Kit to a legally marketed predicate device (Roche Uric Acid Reagent Kit) on the ATAC 8000 Random Access Chemistry System.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Linearity/Recovery	Linear recovery across the usable range (0.2 to 25 mg/dL) with strong correlation to standard values.	The recovery of uric acid is linear from 0.2 to 25 mg/dL. Regression statistics: (ATAC Recoveries) = 0.996 x (Standard Value), r = 0.9998, sy.x = 0.18 mg/dL, n = 30.
Precision (Within Run)	Low coefficient of variation (CV) and standard deviation (1SD) for control samples.	Serum 1 (mean 2.3 mg/dL): 1SD = 0.12 mg/dL, %CV = 5.0% Serum 2 (mean 6.9 mg/dL): 1SD = 0.16 mg/dL, %CV = 2.3% Serum 3 (mean 11.3 mg/dL): 1SD = 0.19 mg/dL, %CV = 1.7%
Precision (Total)	Low coefficient of variation (CV) and standard deviation (1SD) for control samples across multiple runs/days.	Serum 1 (mean 2.3 mg/dL): 1SD = 0.23 mg/dL, %CV = 9.8% Serum 2 (mean 6.9 mg/dL): 1SD = 0.30 mg/dL, %CV = 4.4% Serum 3 (mean 11.3 mg/dL): 1SD = 0.38 mg/dL, %CV = 3.4%
Method Comparison	Strong correlation and agreement with a commercially available comparative method.	Regression statistics: ATAC 8000 = - 0.11 mg/dL + 0.987 x Competitive Reagent, syx = 0.29 mg/dL, n=120, range = 1.8 - 18.8 mg/dL.
Detection Limit	Low detection limit, accurately determined.	0.2 mg/dL. Documented by repetitive assay of a diluted serum pool; observed standard deviation of a 30-replicate within-run precision study was 0.1 mg/dL. The detection limit is reported as twice the round-off error of the assay (implying 0.1 mg/dL * 2 = 0.2 mg/dL).
Reagent Stability	Observed change in control recoveries less than 0.3 mg/dL over 14 days.	The observed change in control recoveries was less than 0.3 mg/dL over the claimed 14-day on-board reagent stability period.
Calibration Stability	Total imprecision of uric acid recoveries less than 0.3 mg/dL or 5% over 3 days.	The total imprecision of uric acid recoveries over the test periods was less than 0.3 mg/dL or 5% over the claimed 3-day calibration stability period.

2. Sample sizes used for the test set and the data provenance

Linearity/Recovery: n = 30 (for regression statistics, representing standard values/recoveries). No information on provenance (e.g., country of origin, retrospective/prospective) is provided, but it pertains to the behavior of the reagent with known standard concentrations.
Precision: n = 60 for each of the three serum control samples. This implies 60 replicate measurements for each control. No information on provenance for these commercially available control sera.
Method Comparison: n = 120 (mixed serum and plasma specimens). No information on country of origin. The data provenance is described as "collected from adult patients," suggesting prospective or freshly collected samples for the purpose of the study.
Detection Limit: n = 30 (for within-run precision study of a diluted serum pool).
Reagent Stability: "serum controls" assayed over the claimed periods. Specific 'n' not given, but likely multiple measurements of controls.
Calibration Stability: "serum controls" assayed over the claimed periods. Specific 'n' not given, but likely multiple measurements of controls.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a chemical assay, not an imaging device requiring expert interpretation. The "ground truth" for linearity and precision is based on known concentrations of standards and control materials. For method comparison, the "ground truth" is established by a "commercially available method" (the competitive reagent), and the goal is to show agreement between the two methods, rather than an expert ground truth.

4. Adjudication method for the test set

Not applicable. As noted above, this is a chemical assay.

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 diagnostic reagent, not an AI-based system or an imaging device requiring human reader interpretation. No AI component is described.

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

The performance data presented are for the "ATAC PAK Uric Acid Reagent Kit on the ATAC 8000 Random Access Chemistry System." This represents the standalone performance of the reagent kit and analyzer system in determining uric acid levels in samples. Human involvement is limited to operating the instrument, performing calibration/quality control, and interpreting quantitative numerical results provided by the system.

7. The type of ground truth used

Linearity/Recovery: Known concentrations of "linearity standards."
Precision: Assays of "commercially available control serum" with expected target ranges/values.
Method Comparison: Results from a "commercially available method" (predicate device or similar). This serves as the reference for comparison, rather than an absolute "ground truth" in the sense of pathology or outcome data.
Detection Limit: A "diluted serum pool" and its statistical properties.
Stability Studies: "Serum controls" with known target values.

8. The sample size for the training set

Not applicable. This is a chemical reagent and analyzer system, not an algorithm that requires a "training set." The system's operation is based on established chemical principles and pre-programmed instrument parameters, not machine learning.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for this type of device.

Summary

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JUL 15 2003

K 031044

Brea, CA 92821 T (714) 672-3553 F (714) 672-3554

SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS INFORMATION

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 ATAC PAK Uric Acid Reagent Kit is intended for the quantitative determination of uric acid in serum and plasma. Uric acid results are for the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gou, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. The ATAC PAK Uric Acid Reagent determines uric acid through the exzymatic oxidation coupled with a Trinder indicator reaction. The resulting increase in absorbance at 510 mm is proportional to the uric acid concentration of the sample.

The ATAC PAK Uric Acid Reagent Kit and ATAC Calibrator are substantially equivalent to the Roche Uric Acid Reagent Kit, product no. 908241 callbrated with the C.f.a.s. Calibrator, product no. 759350, which are marked by Roche Diagnostics of Indianapolis, IN. The effectiveness of ATAC PAK Uric Acid Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown by the following studies.

The recovery of uric acid using the ATAC PAK Uric Acid Reagent is linear from 0.2 to 25 mg/dL, as shown by the recovery of linearity standards that span the usable range. Regression statistics, which are forced through the origin, compare standard recoveries to standard values. These statistics are shown below.

(ATAC Recoveries) = 0.996 x (Standard Value), r = 0.9998, sy.x = 0.18 mg/dL, n = 30

Precision is demonstrated by the replicate assay of commercially available control serum on two separate instruments. Precision statistics, calculated analogous to the method described in NCCLS Guideline EP3-T, are shown below.

Sample	n	mean	Within Run		Total
			1SD	%CV	1SD	%CV
Serum 1	60	2.3	0.12	5.0%	0.23	9.8%
Serum 2	60	6.9	0.16	2.3%	0.30	4.4%
Serum 3	60	11.3	0.19	1.7%	0.38	3.4%

Precision of Uric Acid Recoveries in mg/dr

Mixed serum and plasma speciments collected from adult patients were assayed for uric acid using the ATAC 8000 Random Access Chemistry System and another commercially available method. Results were compared by least squares linear regression and the following statistics were obtained.

ATAC 8000 = - 0.11 mg/dL + 0.987 x Competitive Reagent syx = 0.29 mg/dL n=120 range = 1.8 - 18.8 mg/dL

The detection limit of 0.2 mg/dL is documented the repetitive assay of a diluted serum pool. The observed standard deviation of a 30 replicate within run precision study was 0.1 mg/dL. Consequently, the detection limit is reported as twice the round-off error of the assay.

The 14 day on board reagent stablity claim is documented through the assay of serum controls over the claimed periods. In all cases, the observed change in control recoveries was less than 0.3 mg/dL.

The 3 day calibration stability claim is documented through the assay of serum controls over the claimed periods. In all cases, the total imprecision of wic acid recoveries over the test periods are less than 0.3 mg/dL or 5%.

Wynn Stocking

Manager of Regulatory Affairs July 11, 2003

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JUL 15 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Wynn Stocking Manager, Regulatory Affairs Elan Diagnostics 1075 W. Lambert Road - Building D Brea. CA 92821

Re: K031044

Trade/Device Name: ATAC PAK Uric Acid Reagent Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: KNK: JIX Dated: March 31, 2003 Received: April 30, 2003

Dear Mr. Stocking:

We have reviewed vour 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. Iisting 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).

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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 vours.

Steven Putman

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

ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ �

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Kosioitt

510(k) Number (if known):

Device Name:

ATAC PAK Uric Acid Reagent

Indications for Use:

This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k) K031014

Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k)

(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-Counter Use

(Optional Format 1-2-96)

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.