RANDOX URIC ACID

K033278 · Randox Laboratories, Ltd. · CDO · Feb 27, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033278
• Device Name: RANDOX URIC ACID
• Applicant: Randox Laboratories, Ltd.
• Product Code: CDO · Clinical Chemistry
• Decision Date: Feb 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1775
• Device Class: Class 1

Intended Use

The Randox Uric Acid Test Kit used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of uric acid in serum.

Device Story

Randox Uric Acid Test Kit is an in vitro diagnostic reagent set for use on the Dade Dimension clinical chemistry system. It utilizes two liquid reagents: Glycine buffer and bacterial Uricase. The device measures uric acid levels in serum samples via UV detection. It is intended for use in clinical laboratory settings by trained personnel. The output is a quantitative concentration of uric acid, which assists clinicians in assessing patient metabolic status. The device is designed to be functionally equivalent to the predicate Dade Behring Dimension Uric Acid Flex reagent cartridge.

Clinical Evidence

No clinical studies were performed. Evidence is based on analytical bench testing, including precision (within-run/total-run CVs 1.94-2.55%), linearity (up to 1145 μmol/l), and analytical specificity (interference testing for bilirubin, hemoglobin, and triglycerides). Method comparison against the predicate device using 40 patient samples showed a correlation coefficient of 1.00.

Technological Characteristics

Liquid, ready-to-use reagent kit containing Glycine buffer (pH 9.4) and bacterial Uricase (8 IU/L). Sensing principle: UV detection. Designed for use on the Dade Dimension clinical chemistry system. Storage: 2–8 °C.

Indications for Use

Indicated for the quantitative determination of uric acid in human serum for diagnostic purposes. No specific age or gender contraindications provided; reference ranges are provided for guidance for men and women.

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.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 27 2004

Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories Ltd. Ardmore, 55 Diamond Road Crumlin, Co. Antrim United Kingdom BT29 4QY

Re: k033278 Trade/Device Name: Uric Acid Regulation Number: 21 CFR 862.1775 Regulation Name: Uric acid test system Regulatory Class: Class I Product Code: CDO Dated: January 5, 2004 Received: January 8, 2004

Dear Dr. Armstrong:

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).

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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,

Jean M. Cooper MS, DVM.
Jean M. Cooper, MS, D.V.M.

Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known) | K033278 |
|--------------------------|-----------|
| Device Name | URIC ACID |

## Indications For Use :

The Randox Laboratories Limited Uric Acid Test Kit is an in vitro diagnostic reagent for the quantitative determination of uric acid in serum. The method used is based on UV detection. Uric acid, which absorbs light at 293nm, is converted by uricase to allantoin, which is nonabsorbing at 293nm. The change in absorbance at 293nm due to the disappearance of uric acid is indirectly proportional to the concentration of uric acid in the sample and is measured using a bichromatic (293, 700nm) end-point technique.

Uric acid measurements 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.

This application sheet has been developed for the Dade Dimension Clinical Chemistry Analyser and must be used by suitably qualified laboratory personnel under appropriate clinical laboratory conditions.

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109) ✓

OR

Over-The-Counter Use (Optional format 1-2-96)

Aclote Sins
Division Sign/Off

The Diagnostic

510(k) 6033278