SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P

K992798 · Sigma Diagnostics, Inc. · CDO · Sep 28, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992798
• Device Name: SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P
• Applicant: Sigma Diagnostics, Inc.
• Product Code: CDO · Clinical Chemistry
• Decision Date: Sep 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1775
• Device Class: Class 1

Intended Use

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

Device Story

In vitro diagnostic reagent kit for quantitative uric acid measurement in human serum, plasma, or urine. Operates via modified Trinder peroxide assay: uricase oxidizes uric acid to allantoin and H2O2; peroxidase reacts H2O2 with 4-aminoantipyrine and 2,4,6-Tribromo-3-hydroxy benzoic acid (TBHB) to produce a quinoneimine dye. Absorbance measured at 520 nm (500-550 nm range). Used in clinical laboratories on automated or manual systems by laboratory technicians. Output is uric acid concentration, used by physicians to diagnose/monitor metabolic/renal disorders (e.g., gout, renal failure).

Clinical Evidence

Bench testing only. Correlation study performed using 126 plasma samples comparing subject device to Sigma Diagnostics Procedure No. 685 (K853357), yielding regression equation: INFINITY Uric Acid = 0.96 (Uric Acid 685) + 0.23.

Technological Characteristics

In vitro diagnostic reagent; enzymatic colorimetric assay (uricase/peroxidase). Reagents: uricase, peroxidase, 4-aminoantipyrine, 2,4,6-Tribromo-3-hydroxy benzoic acid (TBHB). Detection via spectrophotometry at 520 nm. Compatible with automated and manual clinical chemistry analyzers.

Indications for Use

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

• TRACE Scientific Uric Acid Reagent kit (K971485)

Reference Devices

• Sigma Diagnostics Uric Acid Reagent, Procedure No. 685 (K853357)

Submission Summary (Full Text)

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K992798

## 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, plasma 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 Kabasakalland with a modified Trinder 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.
HoOs + 4-AAP + TBHB Peroxidase \ Ouinoneimine + 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.

Correlation studies to Sigma Diagnostics Uric Acid Reagent, Procedure No. 685 (K853357) using plasma samples vielded a regression equation of:

INFINITY Uric Acid = 0.96 (Uric Acid 685) + 0.23 (N=126)

## References

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

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 8 1999

William R. Gilbert, Ph.D. Manager, Scientific Affairs Sigma Diagnostics® Clinical Technical Services 545 South Ewing Avenue St. Louis, Missouri 63103

Re: K992798

> Trade Name: Infinity™ URIC ACID Reagent (Procedure No. 684) Regulatory Class: II Product Code: CDO Dated: August 16, 1999 Received: August 19, 1999

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 action. In addition, FDA may publish further announcements 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 regulations.

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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/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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): K992718

Device Name: INFINITY™ Uric Acid Reagent

## Indications For Use:

The Sigma Diagnostics INFINJTY™ Uric Acid Reagent is a device intended to measure uric acid in serum, plasma or urine. 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.

in Cooper

(Division Sign-Off)
Division of Clinical Laboratoi vices
510(k) Number 1992798

(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)

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OR

Over-The-Counter Use __