URIC ACID MODEL 3P39

K102568 · Abbott Laboratories · KNK · May 6, 2011 · Clinical Chemistry

Device Facts

• Record ID: K102568
• Device Name: URIC ACID MODEL 3P39
• Applicant: Abbott Laboratories
• Product Code: KNK · Clinical Chemistry
• Decision Date: May 6, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1775
• Device Class: Class 1

Intended Use

The ARCHITECT 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.

Device Story

In vitro diagnostic assay for ARCHITECT c8000 System; measures uric acid in human serum, plasma, or urine. Uses two-part (R1/R2) uricase methodology. Uricase oxidizes uric acid to allantoin, producing hydrogen peroxide (H2O2). H2O2 reacts with 4-aminoantipyrine and HMMPS via peroxidase to form quinoneimine dye. Absorbance change at 604 nm proportional to uric acid concentration. R1 contains ascorbic oxidase to reduce ascorbic acid interference. Used in clinical laboratories; results interpreted by physicians to manage renal/metabolic conditions.

Clinical Evidence

Bench testing only. Performance evaluated per CLSI guidelines (EP5-A2, EP6-A, EP7-A2, EP9-A2, EP17-A). Precision studies (N=80) showed total CVs < 2.1% for urine and < 4.2% for serum. Linearity demonstrated across the measuring range (r > 0.999). Method comparison (N=103 serum, N=103 urine) against the predicate yielded slopes of 0.95 and correlation coefficients of 0.9955. Interference testing confirmed non-significant bias (within ±10%) for common endogenous substances including ascorbic acid, bilirubin, glucose, and hemoglobin.

Technological Characteristics

In vitro diagnostic reagent kit. Uricase-based enzymatic colorimetric assay. Two-part (R1/R2) liquid reagent configuration. Includes ascorbic oxidase for interference reduction. Photometric detection at 604 nm. Designed for use on ARCHITECT c8000 automated clinical chemistry analyzer.

Indications for Use

Indicated for the quantitative measurement of uric acid in serum, plasma, and urine to aid in the diagnosis and treatment of renal and metabolic disorders such as renal failure, gout, leukemia, psoriasis, and starvation, and for monitoring 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

• Abbott Uric Acid Assay (K981766)

Submission Summary (Full Text)

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#### Next Generation Uric Acid (k102568) Response Attachment H – 510(k) Summary

## Architect Uric Acid 510(k) Summary (Summary of Safety and Effectiveness)

MAY – 6 2011

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

## Applicant Name:

Linda Morris, Sr. Regulatory Specialist Regulatory Affairs Abbott Laboratories Diagnostics Division Dept. 2471 1921 Hurd Drive Irving, TX 75038

### Device Name:

## Reagents:

Classification Name: Acid, Uric, Uricase (U.V.) Trade Name: Architect Uric Acid Common Name: Uric Acid Governing Regulation: 862.1775 Device Classification: Class I Classification Panel: Clinical Chemistry Product Code: KNK

# Legally marketed device to which equivalency is claimed:

Abbott Uric Acid Assay (K981766)

### Intended Use of Device:

The Architect Uric Acid assay is used for the quantitation of uric acid in human serum, plasma, or urine.

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#### Next Generation Uric Acid (k102568) Response Attachment H – 510(k) Summary

## Description of Device:

The Uric Acid assay is an in vitro diagnostic assay for use on the ARCHITECT c8000 System for the quantitative determination of uric acid in human serum, plasma, or urine using a uricase methodology. The Uric Acid assay is a two-part reaction. Uric acid is oxidized to allantoin by uricase with the production of hydrogen peroxide (H2O2). The H2O2 reacts with 4-aminoantipyrine (4-AAP) and N-(3-sulfopropyl)-3-methoxy-5methylanaline (HMMPS) in the presence of peroxidase (POD) to yield a quinoneimine dye. The resulting change in absorbance at 604 nm is proportional to the uric acid concentration in the sample.

The two-part (R1/R2) configuration of this assay allows reduction of interference from ascorbic acid by inclusion of ascorbic oxidase in the R1 portion of the assay.

$$\begin{aligned} \text{Uric acid} + \text{O}_2 + 2\text{H}_2\text{O} &\xrightarrow{\text{Uricase}} \text{Allantoin} + \text{CO}_2 + \text{H}_2\text{O}_2\\ \text{H}_2\text{O}_2 + 4\text{-}\text{AAP} + \text{HMMPS} &\xrightarrow{\text{POD}} \text{Quinoelineine Dye} \end{aligned}$$

## Comparison of Technological Characteristics:

The Uric Acid assay uses a uricase methodology for the quantitative determination of uric acid in human serum, plasma, or urine. The Abbott On-Market Uric Acid assay also uses a uricase methodology for the quantitative measurement of uric acid in human serum, plasma, or urine.

# Summary of Non-Clinical Performance:

The Uric Acid assay is substantially equivalent to the Abbott On-Market Uric Acid assay. Both assays yield similar performance characteristics as demonstrated in the non-clinical performance data in this 510(k) submission.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/11 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

HAY 6 2011

Abbott Laboratories Diagnostics Division c/o Linda K. Morris Sr. Regulatory Specialist 1921 Hurd Drive Irving,TX 75038-4313

> Re: k102568 Trade Name: ARCHITECT Uric Acid Assay Regulation Number: CFR 862.1775 Regulation Name: Uric acid test system Regulatory Class: Class II Product Codes: KNK Dated: April 26, 2011 Received: April 27, 2011

Dear Ms. Morris:

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 levice is substantally equivalent (for the in interstate commerce problems 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 greneral 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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" (21 CFR Part 807.97). For questions regarding the reporting of pavense events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 the [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

C.C.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Enclosure

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## Next Generation Uric Acid (k102568) Response Attachment G - Indications for Use Form

Uric Acid Indication(s) for Use Form

K102568 510(k) Number (if known):

Device Name: ARCHITECT Uric Acid

Indication(s) for Use:

The ARCHITECT 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.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

ARS

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k102568