WAKO L-TYPE UA F TEST

K993469 · Wako Chemicals USA, Inc. · KNK · Nov 9, 1999 · Clinical Chemistry

Device Facts

• Record ID: K993469
• Device Name: WAKO L-TYPE UA F TEST
• Applicant: Wako Chemicals USA, Inc.
• Product Code: KNK · Clinical Chemistry
• Decision Date: Nov 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1775
• Device Class: Class 1

Intended Use

Intended formeasure unic acid in senum, plasma and are used in th obfair ad unne. Measurements and treatment of numerous renal and metabolic leukemia, disorders, induding venal failure, gout, conditions, psoriasis, starvation or other wasting and of patients veceiving cytotoxic drugs.

Device Story

In vitro diagnostic assay for quantitative uric acid measurement in serum, plasma, and urine. Principle: uricase-catalyzed oxidation of uric acid produces hydrogen peroxide; peroxidase-mediated oxidative condensation of F-DAOS and 4-aminoantipyrine forms a blue pigment. Absorbance of pigment measured to determine uric acid concentration. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing and monitoring renal and metabolic conditions, including gout and renal failure, and managing patients on cytotoxic therapy.

Clinical Evidence

Bench testing only. Comparison study against predicate assay yielded a correlation coefficient of 0.970 and regression equation y = 1.028x - 0.34. Precision studies demonstrated acceptable day-to-day performance. Minimum detectable level is 0.2 mg/dL.

Technological Characteristics

Enzymatic colorimetric assay. Reagents: uricase, N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxy-4-fluoroaniline (F-DAOS), and 4-aminoantipyrine. Detection via absorbance measurement of blue pigment. In vitro diagnostic reagent kit.

Indications for Use

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

• Wako UA 30R Uric Acid

Submission Summary (Full Text)

{0}------------------------------------------------

Wako Chemicals USA, Inc. 1600 Bellwood Road, Richmond, VA 23237 U.S.A

# 510(K) Summary of Safety and Effectiveness

The Wako L-Type UA F Test is an in vivo assay for the quantitative determination of uric acid in serum and plasma.

### Summary:

Wako

In human, uric acid is the major product of the catabolism of the purine necleosides. Purines are from catabolism of dietary nucleic acid and degradation of endogenous nucleic acid. Measurement of serum uric acid is largely of use 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 received cytotoxic drugs. There are several methods used for the measurement of uric acid concentration.

The Wako L-Type UA F is a method utilizing uricase, N-ethyl-N-(2-hydroxy-3sulfopropyl)-3,5-dimethoxy-4-fluoroaniline (F-DAOS) and 4-aminoantipyrine. 1,2

## Principle:

Uric acid in a specimen is oxidized in a reaction catalyzed by uricase that produces hydrogen peroxide. In the presence of peroxidase (POD), hydrogen peroxide participates in the oxidative condensation between F-DAOS and 4-aminoantipyrine to form a blue pigment. The amount of uric acid is determined by measuring the absorbance of this pigment.

The safety and effectiveness of the Wako L-Type UA F Test is demonstrated by its substantial equivalency to the Wako UA 30R Uric Acid product. Both test systems are used to measure to measure uric acid in the serum. In comparison studies against the predicate assay, a correlation coefficient of 0.970 and a regression equation of y = 1.028x - 0.34 was obtained. Precision studies indicate acceptable values can be obtained on a day-to-day basis. The minimum detectable level of this method is 0.2 md/dL.

### References:

1. Burtis, C.A. and Ashwood, E.R., Ed.: Tietz Textbook of Clinical Chemistry, 2nd Ed., Saunders, Philadelphia, 1994.

2. Kabasakalian, P. Kalliney, S. and Westcott, A .: Clin. Chem., 19, 522-524 (1973).

3. DG Klinische Chemie Mitteilungen 26 (1995) Heft 5.

Luiza Mallmann

Tonya Manory, Sr. Manager Wako Diagnostics September 22, 1999 1600 Bellwood Road Richmond, VA 23237

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a symbol that resembles three stylized human profiles facing to the right, with flowing lines connecting them. The symbol is meant to represent health and human services.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Nov - 9 1999

Ms. Tonya Mallory Senior Manager Wako Diagnostics 1600 Bellwood Road Richmond, Virginia 23237

Re: K993469 Trade Name: Wako L-Type UA F Test Regulatory Class: I Product Code: JHB Dated: September 28, 1999 Received: October 13, 1999

Dear Ms. Mallory:

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.

{2}------------------------------------------------

#### Page 2

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 Toutman

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

{3}------------------------------------------------

2002

Page of

| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|-------------------------|
| 510(k) Number (if known): | K99 3469 |
| Device Name: | Wako L-Type UAE Test |

# Indications For Use:

Intended formeasure unic acid in senum, plasma and are used in th obfair ad unne. Measurements and treatment of numerous renal and metabolic leukemia, disorders, induding venal failure, gout, conditions, psoriasis, starvation or other wasting and of patients veceiving cytotoxic drugs.

Jan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993469

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)