ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR

K031044 · Clinical Data, Inc. · KNK · Jul 15, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031044
• Device Name: ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
• Applicant: Clinical Data, Inc.
• Product Code: KNK · Clinical Chemistry
• Decision Date: Jul 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1775
• Device Class: Class 1

Intended Use

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 Story

ATAC PAK Uric Acid Reagent Kit used with ATAC 8000 Random Access Chemistry System; performs quantitative uric acid determination in serum/plasma samples. Principle: enzymatic oxidation coupled with Trinder indicator reaction; increase in absorbance at 510 nm proportional to uric acid concentration. Operated by trained personnel in professional clinical settings. Output: uric acid concentration values used by clinicians to diagnose/monitor renal and metabolic disorders. Benefits: provides diagnostic data for clinical decision-making regarding patient metabolic status.

Clinical Evidence

Bench testing only. Linearity established from 0.2 to 25 mg/dL (r=0.9998). Precision studies (n=60 per sample) showed within-run CVs of 1.7-5.0% and total CVs of 3.4-9.8%. Method comparison against a commercially available reagent (n=120) yielded a regression slope of 0.987 and sy.x of 0.29 mg/dL. Detection limit documented at 0.2 mg/dL. Stability claims supported by 14-day on-board reagent stability and 3-day calibration stability testing.

Technological Characteristics

Enzymatic oxidation/Trinder indicator chemistry; photometric detection at 510 nm. System includes reagent kit, calibrator, and ATAC 8000 analyzer. Quantitative, automated chemistry system. No specific material standards or software architecture details provided.

Indications for Use

Indicated for quantitative determination of uric acid in serum and plasma for diagnosis and treatment of renal and metabolic disorders (e.g., renal failure, gout, leukemia, psoriasis, starvation, wasting conditions, patients on cytotoxic drugs). For professional use only; not for home use.

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 Reagent Kit (product no. 908241) calibrated with C.f.a.s. Calibrator (product no. 759350)

Submission Summary (Full Text)

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JUL 15 2003

K 031044

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

## 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 [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 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

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# Kosioitt

510(k) Number (if known):

Device Name:

ATAC PAK Uric Acid Reagent

Indications for Use:

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.

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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)