VITALAB URIC ACID REAGENT

K040467 · Clinical Data, Inc. · KNK · Mar 8, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040467
• Device Name: VITALAB URIC ACID REAGENT
• Applicant: Clinical Data, Inc.
• Product Code: KNK · Clinical Chemistry
• Decision Date: Mar 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1775
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

Vitalab Uric Acid Reagent 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 Story

Vitalab Uric Acid Reagent is a two-part enzymatic reagent kit used with the Vitalab Selectra Analyzer. It measures uric acid in serum and plasma samples via enzymatic oxidation using uricase linked to a Trinder indicator reaction (TOOS and 4-aminoantipyrine). The analyzer performs the assay, providing quantitative results to clinicians. Used in clinical laboratory settings to assist in diagnosing and monitoring renal and metabolic disorders, including gout and conditions requiring cytotoxic therapy. The device provides objective biochemical data to support clinical decision-making regarding patient metabolic status and treatment efficacy.

Clinical Evidence

Bench testing only. Precision evaluated over 10 days (n=60 per sample) with total CVs 1.2-1.6%. Linearity confirmed from 0.1 to 25.0 mg/dL (max residual 0.1 mg/dL). Method comparison (n=120) against predicate showed strong correlation (slope 0.9954, intercept -0.05 mg/dL). Interference studies assessed ascorbic acid, bilirubin, hemoglobin, and triglycerides; specific suppression effects noted for bilirubin and high triglycerides.

Technological Characteristics

Two-part liquid reagent; enzymatic colorimetric assay (uricase/Trinder indicator: TOOS and 4-aminoantipyrine). Designed for use on the Vitalab Selectra Analyzer. Linear range 0.1-25 mg/dL. Analytical method follows standard enzymatic oxidation principles.

Indications for Use

Indicated for the quantitative determination of uric acid in serum and plasma for the diagnosis and treatment of renal and metabolic disorders (e.g., renal failure, gout, leukemia, psoriasis, starvation, wasting conditions) and for patients receiving cytotoxic drugs.

Regulatory Classification

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.

Predicate Devices

• Roche Uric Acid Plus Reagent Kit (k873363)

Submission Summary (Full Text)

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MAR - 8 2004

Brea. CA 92821 T [phone] F [phone]

> 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.<br>1075 West Lambert Road, Building D<br>Brea, California 92861 | | | |
|-----------------|-------------------------------------------------------------------------------------|--|--|--|
| Contact Person: | Wynn Stocking<br>Regulatory 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:

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.

# Intended Use:

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.

## 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 [phone]. 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 [phone] or [phone] 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:

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(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