The Vitalab Uric Acid Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of uric acid in serum and plasma. Uric acid results may be used for 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

The Vitalab Uric Acid Reagent is a two-part for use with the Vitalab Selectra Analyzer. This reagent determines uric acid through enzymatic oxidation by uricase linked to a Trinder indicator reaction utilizing N-ethyl-N-(bydroxy-3sulfopropyl)-toluidine (TOOS) and 4-aminoantipyrine.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Vitalab Uric Acid Reagent, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Linear Range	Recovery of linearity standards that span the linear range, showing good correlation.	0.1 to at least 25 mg/dL. Regression: (Vitalab Recoveries) = 0 mg/dL + 1.027 x (Concentration), r = 0.999, s.y = 0.12 mg/dL, n = 40
Detection Limit	Mean + two standard deviations of normal saline measurements should be rounded up to the smallest reportable value.	0.1 mg/dL (mean + 2SD of normal saline measurements was 0.0 mg/dL, rounded up to the round-off error of the assay).
Precision	Replicate assay of commercially available control serum should demonstrate acceptable within-run and total precision (specific thresholds not explicitly stated but implied by acceptable results).	Serum 1 (2.5 mg/dL): Within Run: 1SD = 0.02, %CV = 0.7%; Total: 1SD = 0.04, %CV = 1.6% Serum 2 (6.8 mg/dL): Within Run: 1SD = 0.04, %CV = 0.7%; Total: 1SD = 0.09, %CV = 1.4% Serum 3 (11.1 mg/dL): Within Run: 1SD = 0.07, %CV = 0.6%; Total: 1SD = 0.13, %CV = 1.2%
Correlation	Good agreement with a "another commercially available method" (predicate device). Implied by a strong correlation coefficient and acceptable Deming regression statistics.	Serum: Selecta = 0.05 mg/dL + 0.995 x Competitive Reagent, r = 0.995, s.y = 0.08 mg/dL, n = 120 Plasma: Selecta = 0.05 mg/dL + 0.995 x Competitive Reagent, r = 0.995, s.y = 0.08 mg/dL, n = 120
Stability	All statistical estimates of total imprecision to be less than 0.2 mg/dL for claimed periods.	Onboard reagent stability: 14 days; Calibration stability: 7 days. Statistical estimates of total imprecision less than 0.2 mg/dL in all cases.

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

Linear Range: n = 40 (number of recovery samples for linearity standards)
Detection Limit: n = 30 (normal saline assays)
Precision: n = 60 for each of the 3 serum samples (total 180 individual measurements).
Correlation: n = 60 serum specimens and n = 60 heparinized plasma specimens (total n = 120 patient specimens).
Data Provenance: The text states, "Sixty serum specimens ranging from 3.6 to 10.2 mg/dL uric acid and 60 heparinized plasma specimens ranging from 2.1 to 10.6 mg/dL uric acid were collected from adult patients..." This indicates the data is prospective (collected for the study) from adult patients, but the country of origin is not specified.

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

This device is a reagent for diagnostic testing, not an imaging or AI system that requires expert interpretation to establish ground truth for performance evaluation.
The "ground truth" (or reference method) for the correlation study was "another commercially available method" (the predicate device). No human experts were explicitly involved in establishing "ground truth" in the manner of medical imaging interpretation.

4. Adjudication Method for the Test Set

Not applicable. This is a chemical reagent and an analytical performance study, not an imaging or diagnostics study requiring adjudication of interpretations. The performance is assessed by comparing results to a reference method (the predicate device) or by intrinsic analytical measures (precision, linearity).

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 study of a chemical reagent, not an AI-based diagnostic tool requiring human-in-the-loop evaluation or MRMC studies.

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

Not applicable. This is a study of a chemical reagent, not an algorithm. The performance described is the standalone analytical performance of the reagent on the Vitalab Selectra Analyzer.

7. The Type of Ground Truth Used

Linear Range: The ground truth was based on the known concentrations of "linearity standards."
Detection Limit: The ground truth was normal saline (assumed to have 0 mg/dL uric acid).
Precision: The ground truth was the known mean concentration of "commercially available control serum."
Correlation: The ground truth was established by the results from a "another commercially available method" (the predicate device). This serves as the reference method against which the new device's performance is compared.

8. The Sample Size for the Training Set

Not applicable. This is a chemical reagent, not a machine learning algorithm that requires a "training set." The performance characteristics are determined through analytical testing.

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

Not applicable, as there is no "training set" for a chemical reagent.

Summary

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MAR - 8 2004

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

Summary of 510(k) Safety and Effectiveness Information Vitalab Uric Acid Reagent

<040467

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.

Submitted by:

	Clinical Data, Inc.1075 West Lambert Road, Building DBrea, California 92861
Contact Person:	Wynn StockingRegulatory Affairs Manager
Date Submitted:	February 4, 2004

Device Names:

Proprietary name:	Vitalab Uric Acid Reagent
Common name:	Uric acid reagent
Classification Name:	Acid, uric, uricase (colorimetric)

Device Description:

Intended Use:

Predicate Device:

Vitalab Uric Acid Reagent Kit is substantially equivalent to the Roche Uric Acid Plus Reagent, product no. 1661850, which is currently marketed by Roche Diagnostics Corp. of Indianapolis, IN.

Summary of Performance Data:

The linear range of the Vitalab Uric Acid Reagent is from 0.1 to at least 25 mg/dL, as shown by the Usable Range: recovery of linearity standards that span the linear range. Least squares regression statistics, forced through the origin, compare recoveries to standard concentrations.

(Vitalab Recoveries) = 0 mg/dL + 1.027 x (Concentration), r = 0.999, s.y = 0.12 mg/dL, n = 40

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Detection Limit: Normal saline was assayed thirty times in a single analytical run. The mean and standard deviation of the results are both 0.0 mg/dL. The minimum detection limit, calculated as the mean plus two stadard deviations of the recovery values, is rounded up to 0.1 mg/dL, which is the round-off error of the assay.

Precision is demonstrated by the replicate assay of commercially available control serum. Precision 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	2.5	0.02	0.7%	0.04	1.6%
Serum 2	60	6.8	0.04	0.7%	0.09	1.4%
Serum 3	60	11.1	0.07	0.6%	0.13	1.2%

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Correlation:

Sixty serum specimens ranging from 3.6 to 10.2 mg/dL uric acid and 60 heparinized plasma specimens ranging from 2.1 to 10.6 mg/dL uric acid were collected from adult patients and were assayed for unc ranguig the Vitalab Selectra E Analyzer and another commercially available method. Results were compared by Deming regression and the following statistics were obtained.

Selecta == 0:05 mg/dL + 0:995 x Competitive Reagent
Selecta == 0:05 mg/dL + 0:995 x Competitive Reagent
Competent == 0:05 mg/dL + 0:.995 x Competitive Reagent
Competent == 0: s = 0.08 mg/dL = n = 120 = 120 = 120 = 10.6 mg/dL

Stability:

The 14 day onboard reagent stability and 7 day calibration stability claims are documented through the I ho 1 directively resgues the claimed periods. In all cases, statistical estimates of total imprecision are less than 0.2 mg/dL.

: 上一篇:

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR - 8 2004

Clinical Data, Inc. c/o: Mr. Ned E. Devine, Jr. Entela, Inc 3033 Madison Avenue, SE Grand Rapids, MI 49548

K040467 Re:

Trade/Device Name: Vitalab Uric Acid Reagent Regulation Number: 21 CFR 862.1775 Regulation Name: Uric acid test system Regulatory Class: Class I Product Code: KNK Dated: February 24, 2004 Received: February 24, 2004

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave 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 10 too stated in the 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 or any I vith 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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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,

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K040467

510(k) Number (if known):

Device Name:

Vitalab> Uric Acid Reagent

Indications for Use:

The Vitalab Uric Acid Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a ystem or the quantituives of symmer I he Vilalab Offic Acid Reagent Kirls internet for with and be used for the diagnosis and treatment of themselves and treatment of them detection of the and in south and plains. "Off and the reals may be niss , starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

✓ prescription use

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

Carol C Benam
Division Sign-Off

Office of In Vitro Diagnostic Office Evaluation and Safe

510(k) K040167

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.