SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT

K982251 · Sigma Diagnostics, Inc. · CDO · Aug 18, 1998 · Clinical Chemistry

Device Facts

• Record ID: K982251
• Device Name: SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT
• Applicant: Sigma Diagnostics, Inc.
• Product Code: CDO · Clinical Chemistry
• Decision Date: Aug 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1775
• Device Class: Class 1

Intended Use

The Sigma Diagnostics INFINITY™ Uric Acid Reagent is a device intended to measure uric acid in serum. Measurements obtained by the 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

INFINITY™ Uric Acid Reagent is an in vitro diagnostic chemical assay for measuring uric acid levels in human serum or urine. The device utilizes a modified Trinder peroxide assay based on the methods of Trivedi and Kabasakallan. The biochemical process involves two steps: 1) Uricase oxidizes uric acid to allantoin, producing hydrogen peroxide (H2O2); 2) Peroxidase catalyzes a reaction between H2O2, 4-aminoantipyrine (4-AAP), and 2,4,6-Tribromo-3-hydroxy benzoic acid (TBHB) to form a quinoneimine dye. The resulting change in absorbance at 520 nm is measured via automated or manual spectrophotometric systems. The intensity of the color change is directly proportional to the uric acid concentration in the sample. Clinicians use these quantitative results to assess purine metabolism and diagnose conditions like gout, renal dysfunction, and metabolic disorders. The reagent is intended for professional laboratory use.

Clinical Evidence

Bench testing only. The device relies on established biochemical assay principles (modified Trinder peroxide assay) and equivalence to a previously cleared predicate device.

Technological Characteristics

In vitro diagnostic reagent kit. Chemistry: Uricase/peroxidase enzymatic assay using 2,4,6-Tribromo-3-hydroxy benzoic acid (TBHB) as a chromogen. Detection: Spectrophotometric absorbance at 520 nm (range 500-550 nm). Compatible with automated and manual clinical chemistry analyzers.

Indications for Use

Indicated for the quantitative determination of uric acid in human serum or urine to aid in the diagnosis and treatment of renal and metabolic disorders such as renal failure, gout, leukemia, psoriasis, starvation, wasting conditions, and monitoring patients on 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

• TRACE Scientific Uric Acid Reagent kit (K971485)

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

INFINITY™ Uric Acid Reagent, Procedure 684

Sigma Diagnostics INFINITY™ Uric Acid Reagent is intended for the in vitro quantitative, diagnostic determination of uric acid in human serum or urine on both automated and manual systems.

Uric acid is a metabolite of purines, nucleic acids and nucleoproteins. Consequently, abnormal levels may be indicative of a disorder in the metabolism of these substances. Hyperuricaemia may be observed in renal dysfunction, gout, leukemia, polycythaemia, atherosclerosis, diabetes, hypothyroidism, or in some genetic diseases. Decreased levels are present in patients with Wilson's Disease.1-3

This reagent is based upon the methods of Trivedi and Kabasakallan45 with a modified Trinder8 peroxide assay using 2,4,6-Tribromo-3-hydroxy benzoic acid (TBHB).

The series of reactions involved in the assay system is as follows:

- Uric Acid is oxidized to allantoin by uricase with the production of H2O2. 1.
Uric Acid + O2 + H2O Uricase > Allantoin + CO2 + H2O2

- The peroxide reacts with 4-aminoantipyrine (4-AAP) and TBHB in the presence of 2. peroxidase to yield a quinoneimine dye. The resulting change in absorbance at 520 nm (500-550 nm) is proportional to uric acid concentration in the sample.
H2O2 + 4-AAP + TBHB Peroxidase > Quinoneimine + H2O

The Sigma Diagnostics INFINITY™ Uric Acid Reagent (Procedure No. 684) is substantially equivalent to, and is the same product as the TRACE Scientific Uric Acid Reagent kit cleared by the FDA as K971485.

## References

- Searcy RL: Diagnostic Biochemistry. McGraw-Hill, New York, NY, 1969 】.
- Henry RJ, Common C, Winkelman JW (eds), Clinical Chemistry: Principles and 2. Techniques. Harper & Row, Hagerstown, MD, 1974
- 3. Balls ME: Adv Clin Chem 18:213, 1976
- Trivedi R, Berta E, Rebar L: Clin Chem, 22:1223, 1976 4.
- Kabasakallan P, Kalliney S, Wescott A: Clin Chem, 19:522, 1973 న.
- Trinder P: J Clin Pathol, 22:246, 1949 6.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

AUG 1 8 1998

William Gilbert, Ph.D. Manager, Scientific Affairs Sigma Diagnostics Inc. 545 South Ewing Avenue St. Louis, Missouri 63103

Re : K982251 INFINITY™ Uric Acid Reagent (Procedure No. 684) Requlatory Class: I Product Code: CDO Dated: June 23, 1998 Received: June 26, 1998

Dear Dr. Gilbert:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: INFINITY ™ Uric Acid Reagent ___

## Indications For Use:

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The Sigma Diagnostics INFINITY™ Uric Acid Reagent is a device intended to measure uric acid in serum. Measurements obtained by the 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)
Division of Clinical Laboratory Devices

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