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

Indications for 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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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE ONLY TEMPLATE

A. 510(k) Number: K033278
B. Analyte: Uric Acid
C. Type of Test: Method used is based on UV detection.
D. Applicant: Randox Laboratories Ltd.
E. Proprietary and Established Names: Randox Uric Acid

F. Regulatory Information:

1. Regulation section: 21 CFR §862.1775 Uric acid test system
2. Classification: Class I
3. Product Code: CDO
4. Panel: 75

G. Intended Use:

1. Intended use(s):

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.

2. Special condition for use statement(s): None

3. Special instrument Requirements:

Dade Dimension Clinical Chemistry Analyzer.

H. Device Description:

The Randox Uric Acid Test Kit used on the Dimension Clinical Chemistry System consists of two liquid reagents ready for use. The reagents provided are Glycine Buffer (0.1 mmol/L pH 9.4) and Uricase Reagent (Bacterial) 8 IU/L. Store reagents at +2 to +8 °C.

I. Substantial Equivalence Information:

1. Predicate device name(s):

The Randox Uric Acid Test Kit is substantially equivalent to the currently marketed Dade Behring Dimension clinical chemistry system Uric Acid Flex reagent cartridge (K862359).

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2. Predicate K number(s): K862359
3. Comparison with predicate:

Similarities between Predicate Device and Proposed Randox Uric Acid

| Characteristics | Predicate Device (K862359) | Proposed Product |
| --- | --- | --- |
| Device Brand Name | Dade Behring Dimension®
Uric Acid Flex reagent
cartridge | Randox Uric Acid Test Kit |
| Immunoassay System | Dade Dimension clinical
chemistry system | Dade Dimension ® clinical
chemistry system |
| Format | Liquid and ready to use. | Liquid and ready-to-use. |
| Storage Conditions | 2 – 8 °C | 2 – 8 °C |
| Intended Use | The Dade Uric Acid method
used on the Dimension clinical
chemistry system is an in vitro
diagnostic test intended for the
quantitative determination of
uric acid in serum. | The Randox Uric Acid
method used on the
Dimension clinical chemistry
system is an in vitro
diagnostic test intended for the
quantitative determination of
uric acid in serum. |

J. Standard/Guidance Document Referenced (if applicable): N/A
K. Test Principle: UV Detection.

L. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

The within run and total run precision was determined by testing 20 replicates of 3 different control sera or patient samples in one assay. Where possible, control sera or patient samples within the normal range and at the decision making level were used. The mean concentration, the number of determinations, the standard deviation and the percentage coefficient of variation are listed below:

| | Level 1 | Level II | Level III |
| --- | --- | --- | --- |
| Mean | 165.1 | 328 | 522.2 |
| SD | 4.217 | 6.358 | 10.370 |
| % CV | 2.55% | 1.94% | 1.99% |
| n | 20 | 20 | 20 |

b. Linearity/assay reportable range:

The linearity of this method was evaluated by comparing the recovery of serial diluted linearity sera and the observed value was compared to the known expected or calculated expected result. The linearity claim is based on a percentage

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deviation of ≤5% at the 2 highest analyte concentrations. The uric acid assay was found to be linear up to 1145 μmol/l.

c. Traceability (controls, calibrators, or method): N/A

d. Detection limit:

The minimum detectable level has been determined as 23 μmol/l (0.39 mg/dl). Sensitivity is determined for each analyte and is expressed as the lowest measurable concentration that can be distinguished from zero with a %CV ≤ 20.

e. Analytical specificity:

Interference was evaluated by spiking human serum pools with hemoglobin, unconjugated bilirubin, conjugated bilirubin, and triglycerides concentrate, and triglyceride intralipid.

The following interferents were tested up to the indicated levels and found not to interfere:

| Bilirubin (conjugated and unconjugated) | 152 μmol/l |
| --- | --- |
| Hemoglobin | 1000 mg/dl |
| Triglyceride (concentrate) | 834 mg/dl |
| Triglyceride (intralipid) | 1600 mg/dl |

f. Assay cut-off: N/A

2. Comparison studies:

a. Method comparison with predicate device:

A comparison of 40 normal and abnormal patient samples, which span the analytical range, is made using the Randox method and a comparable, commercially available test kit- the Predicate Device. The results obtained are correlated using least-squares regression analysis.

Linear regression analysis of the data resulted in the equation:

$$Y = 1.01 X + 3.9$$, with a correlation coefficient r = 1.00

Matrix comparison: Only Serum Samples were evaluated

3. Clinical studies:

a. Clinical sensitivity:

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Clinical studies are not typically submitted for this device type.

b. Clinical specificity:

Clinical studies are not typically submitted for this device type.

c. Other clinical supportive data (when a and b are not applicable): NA

4. Clinical cut-off: Not Applicable

5. Expected values/Reference range:

Reference ranges provided are cited from those quoted in the appropriate literature. A warning statement accompanies all reference ranges to indicate that they are provided for GUIDANCE ONLY and that individual laboratories are advised to establish their own reference range to reflect the age, sex, diet and geographical location of the specific population encountered in the daily course of laboratory operation.

| Normal Values | Serum: (5) | Men | 208 - 428 μmol/l |
| --- | --- | --- | --- |
| | | | 3.5 - 7.2 mg/dl |
| | Women | | 155 - 357 μmol/l |
| | | | 2.6 – 6.0 mg/dl |

M. Conclusion:

Based on the information provided in this 510(k) submission, I recommend that the Randox Uric Acid Test Kit for use on the Dade Dimension® clinical chemistry system is substantially equivalent to the currently marketed Dade Behring Dimension clinical chemistry system Uric Acid Flex reagent cartridge (K862359).