URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

K022096 · Bayer Diagnostics Corp. · KNK · Mar 18, 2003 · Clinical Chemistry

Device Facts

• Record ID: K022096
• Device Name: URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
• Applicant: Bayer Diagnostics Corp.
• Product Code: KNK · Clinical Chemistry
• Decision Date: Mar 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1775
• Device Class: Class 1

Intended Use

The Bayer ADVIA IMS Uric Acid (UA) method is an in vitro diagnostic device intended to measure uric acid in human serum, plasma and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation and other wasting conditions and of patients receiving cytotoxic drugs.

Device Story

In vitro diagnostic assay for quantitative measurement of uric acid in human serum, plasma, and urine; used on ADVIA Integrated Modular System (IMS). Device utilizes chemical reagents to produce measurable signals proportional to uric acid concentration. Operated by laboratory personnel in clinical settings. Output provides uric acid levels to clinicians to assist in diagnosing and monitoring renal and metabolic disorders. Results facilitate clinical decision-making regarding patient treatment for conditions like gout or renal failure.

Clinical Evidence

Bench testing only. Performance evaluated via imprecision studies and method comparison. Imprecision (serum) showed total CVs of 1.1-2.3%; (urine) 2.6-5.2%. Correlation studies (N=10-117) against CDC Uricase and ADVIA 1650 yielded R values of 0.998-0.999. Interference testing conducted for bilirubin, hemoglobin, lipids, acetaminophen, ascorbic acid, and salicylate, showing minimal effect (<7% change). Analytical range established as 0-26 mg/dL for serum and 0-230 mg/dL for urine.

Technological Characteristics

In vitro diagnostic reagent system for use on the ADVIA IMS platform. Quantitative colorimetric/enzymatic assay principle. Analytical range: 0-26 mg/dL (serum), 0-230 mg/dL (urine). System is designed for clinical laboratory use.

Indications for Use

Indicated for the measurement of uric acid in human serum, plasma, and urine to aid in the diagnosis and treatment of renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation, other 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

• ADVIA 1650 Uric Acid (K022096)

Submission Summary (Full Text)

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MAR 1 8 2003

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Uric Acid Method for ADVIA IMS

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

The assigned 510(k) number is: HOA2096 (leave blank)

#### 1. Intended Use

The Bayer ADVIA IMS Uric Acid (UA) method is an in vitro diagnostic device intended to measure uric acid in human serum, plasma and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation and other wasting conditions and of patients receiving cytotoxic drugs.

#### 2. Predicate Device

| Product Name | Reagent Part # | Calibrator Part # |
|----------------------|----------------|-------------------|
| ADVIA 1650 Uric Acid | B01-4131-01 | T03-1291-62 |

#### 3. Device / Method

| Product Name | Reagent BAN # | Calibrator BAN # |
|---------------------|---------------|------------------|
| ADVIA IMS Uric Acid | 07383256 | 06798711 |

#### A. Imprecision (serum)

| ADVIA IMS | Advia 1650 | | |
|------------------|-----------------|------------------|----------------|
| Level<br>(mg/dL) | Total<br>CV (%) | Level<br>(mg/dL) | Total<br>CV(%) |
| 3.7 | 2.3 | 3.9 | 1.9 |
| 7.7 | 1.6 | 8.6 | 1.6 |
| 9.9 | 1.1 | 10.0 | 2.3 |

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## Imprecision (urine)

| ADVIA IMS | | Advia 1650 | |
|---------------|--------------|---------------|--------------|
| Level (mg/dL) | Total CV (%) | Level (mg/dL) | Total CV (%) |
| 20.2 | 5.2 | 12.4 | 2.3 |
| 28.9 | 3.6 | 23.9 | 5.2 |
| 38.4 | 2.6 | | |

# B. Correlation (Y=ADVIA IMS, X=Comparison system)

| Specimen type | Comparison System (X) | N | Regression Equation | Syx (mg/dL) | R | Sample Range (mg/dL) |
|-----------------------|-----------------------|-----|---------------------|-------------|-------|----------------------|
| Serum | CDC Uricase | 117 | Y=0.98X+0.11 | 0.27 | 0.999 | 1.5-26.2 |
| Serum | Advia 1650 | 100 | Y=0.96X+0.29 | 0.37 | 0.998 | 1.5-23.6 |
| Plasma (y), Serum (x) | Advia 1650 | 54 | Y=1.01X-0.05 | 0.08 | 0.998 | 2.8-7.3 |
| Urine | CDC Uricase | 10 | Y=1.035X-0.37 | 1.11 | 0.999 | 3.8-182.8 |
| Urine | Advia 1650 | 63 | Y=0.96X-1.08 | 2.70 | 0.998 | 5.7-198.7 |

## C. Interfering Substances

| Interfering | Interfering Sub.<br>Conc. (mg/dL) | Uric Acid<br>Conc. (mg/dL) | Effect<br>(% change) |
|-----------------------------|-----------------------------------|----------------------------|----------------------|
| Bilirubin<br>(unconjugated) | 30 | 7.6 | -5 |
| Bilirubin<br>(conjugated) | 30 | 7.6 | -6 |
| Hemoglobin | 750 | 7.5 | -7 |
| Lipids (Intralipid) | 1000 | 7.0 | -1 |
| Acetaminophen | 280 µg/mL | 20.9 | -5 |
| Ascorbic Acid | 200 | 21.1 | -5 |
| Salicylate | 500 | 21.3 | -5 |

Analytical Range (serum): 0-26 mg/dL

Analytical Range (urine): 0-230 mg/dL

Laure S. Adli

Kenneth T. Edds Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue, Tarrytown, NY 10591.

6/21/02
Date

Date

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

Re: k022096

Trade/Device Name: Uric Acid Assay for the ADVIA Integrated Modular System (IMS) Regulation Number: 21 CFR § 862.1775 Regulation Name: Uric acid test system Regulatory Class: I Product Code: KNK Dated: January 17, 2003 Received: January 21, 2003

MAR 1 8 2003

Dear Dr. Edds:

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 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, 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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.

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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 yours,

Steven Sutman

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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#### Koa 2-096 510(k) Number:

Device Name: Uric Acid Assay for the ADVIA IMS

### Indications for Use:

The Bayer ADVIA IMS Uric Acid (UA) method is an in vitro diagnostic device intended to measure uric acid in human serum, plasma and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation and other wasting conditions and of patients receiving cytotoxic drugs.

### (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)

OR

Over-The-CounterUse

(Optional Format 1-2-96)

Carl Simon for Jean Cooper, DUM

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022096