SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2

K043268 · Randox Laboratories, Ltd. · CEI · Feb 15, 2005 · Clinical Chemistry

Device Facts

• Record ID: K043268
• Device Name: SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2
• Applicant: Randox Laboratories, Ltd.
• Product Code: CEI · Clinical Chemistry
• Decision Date: Feb 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Intended Use

The Randox Laboratories Ltd. Sodium Test Kit is an in vitro diagnostic reagent for the quantitative determination of Sodium in serum. Sodium is determined enzymatically via Sodium dependant 9-galactosidase activity with ONPG as substrate. The absorbance at 405 nm of the product O-nitrophenyl is proportional to the sodium concentration. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hyper-tension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. This Application Sheet has been developed for the Hitachi 704, 717, 902 and 911/912 Analysers and must be used by suitable qualified laboratory personnel under appropriate laboratory conditions. Randox Electrolyte Cal 1 and 2 are liquid calibrators for in vitro diagnostic use in the calibration of NA+, K+ and CL- electrodes on Hitachi systems ISE modules and Randox Enzymatic Sodium kit. The Randox Electrolyte Cal 1 and 2 must only be used by suitable qualified laboratory personnel under appropriate laboratory conditions.

Device Story

The Randox Sodium Test Kit is an in vitro diagnostic reagent for quantitative serum sodium measurement. It utilizes an enzymatic method where sodium-dependent beta-galactosidase activity acts on an ONPG substrate; the resulting O-nitrophenyl product is measured via absorbance at 405 nm. The device is designed for use on Hitachi 704, 717, 902, and 911/912 analyzers. It is operated by qualified laboratory personnel in a clinical laboratory setting. The output is a sodium concentration value, which assists clinicians in diagnosing and managing electrolyte-related conditions such as dehydration, diabetes insipidus, and adrenal disorders. Randox Electrolyte Cal 1 and 2 are liquid calibrators used to calibrate sodium, potassium, and chloride electrodes on Hitachi ISE modules and the enzymatic sodium kit.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Enzymatic assay; reagents include buffer, β-galactosidase enzyme, and ONPG substrate. Aqueous calibrators contain NaCl and KCl. Designed for Hitachi 704, 717, 902, 911/912 analyzers. Photometric detection at 405nm. Two-point calibration.

Indications for Use

Indicated for the quantitative determination of sodium in serum to aid in the diagnosis and treatment of diseases involving electrolyte imbalance, including aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, and inappropriate antidiuretic hormone secretion. For use by qualified laboratory personnel.

Regulatory Classification

Identification

A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k043268

B. Purpose for Submission:
Notification of intent to manufacture and market the device: Sodium test kit and calibrator 1 and 2

C. Measurand:
Sodium

D. Type of Test:
Quantitative Enzymatic

E. Applicant:
Randox Laboratories Ltd.

F. Proprietary and Established Names:
Proprietary – Randox Sodium; Established – sodium

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1665 (Sodium) and 21 CFR 862.1150 (calibrator)
2. Classification:
Class 2
3. Product code:
CEI (Sodium) and JIT (Calibrator)

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4. Panel:
75 Chemistry

H. Intended Use:

1. Intended use(s):
See indications for use below.

2. Indication(s) for use:

Randox Sodium Test Kit: The Randox Laboratories Ltd. Sodium Test Kit is an in vitro diagnostic reagent for the quantitative determination of Sodium in serum. Sodium is determined enzymatically via Sodium dependant β-galactosidase activity with ONPG (o-nitrophenyl-β-D-galactopyranose) as substrate. The absorbance at 405nm of the product O-nitrophenyl is proportional to the sodium concentration.

Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hyper-tension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

This application sheet has been developed for the Hitachi 704, 717, 902, and 911/912 Analyzers and must be used by suitable qualified laboratory personnel under appropriate laboratory conditions.

Randox Electrolyte Calibrator 1 and 2: Randox Electrolyte Calibrator 1 and 2 are liquid calibrators for in vitro diagnostic use in the calibration of NA⁺, K⁺, and Cl⁻ electrodes on the Hitachi systems ISE modules and Randox Enzymatic Sodium kit.

The Randox Electrolyte calibrator 1 and 2 must only be used by suitable qualified laboratory personnel under appropriate laboratory conditions.

3. Special conditions for use statement(s):
For prescription use only

4. Special instrument requirements:
The Randox Sodium Test kit and calibrators are developed for the Hitachi 704, 717, 902, and 911/912 Analyzers.

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I. Device Description:

The Randox Laboratories Ltd. Sodium Test Kit is an in vitro diagnostic reagent for the quantitative determination of Sodium in serum. The test kit comprises two reagent pack components: Reagent 1 is buffer and Enzyme substrate, Reagent 2 is diluent and Enzyme. Prior to loading the reagent onto the instrument, the reagent components are mixed according to directions. The test kit is also comprised of two calibrators labeled Calibrator 1 and Calibrator 2 which are composed of aqueous solutions containing electrolyte salts containing Sodium Chloride, Potassium Chloride and preservatives.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Olympus ISE Sodium

2. Predicate 510(k) number(s):

k961274

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Matrix | Serum | Plasma, serum, urine |
| Calibration | 2 point serum
Calibration | 2 point serum
Calibration |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Stability | Stable 2 weeks at 2° to 8°C or 5 days at 15° to 25°C | Once opened, stable 90 days at 15° to 25°C |
| Test Method | Enzymatic | Ion Selective Electrode |

K. Standard/Guidance Document Referenced (if applicable):

No Standard or Guidance Document was referenced in this submission.

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L. Test Principle:

This is an enzymatic method via sodium dependant $\beta$-galactosidase activity with ONPG as substrate. Assay is calibrated via a two point calibration.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Intra assay precision was determined by testing at least 2 different control sera or patient samples in one assay 20 times using the Hitachi 717 analyzer. Where possible, control sera or patient sample within normal range and at the decision making level are used. Acceptance criteria: %CV ≤ 7.5. The value may vary depending upon analyte concentration and analyzer used.

Intra Assay Precision

| | Level 1 | Level 2 | Level 3 |
| --- | --- | --- | --- |
| Mean (mmol/L) | 125 | 142 | 159 |
| SD | 1.23 | 1.39 | 1.73 |
| CV (%) | 0.98 | 0.98 | 1.09 |
| N | 20 | 20 | 20 |

Inter assay precision was determined by testing at least 2 different control sera or patient samples in 20 assays using the Hitachi 717 analyzer. Where possible, control sera or patient sample within normal range and at the decision making level were used. Acceptance criteria: %CV ≤ 10. The value may vary depending upon analyte concentration and analyzer used.

Inter Assay Precision

| | Level 1 | Level 2 | Level 3 |
| --- | --- | --- | --- |
| Mean (mmol/L) | 130 | 149 | 166 |
| SD | 2.89 | 2.29 | 2.36 |
| CV (%) | 2.23 | 1.54 | 1.42 |
| N | 20 | 20 | 20 |

b. Linearity/assay reportable range:

The reportable range of the test kit is based on the sensitivity (lower detection limit) and the linearity of the method. The method is linear for sodium values between 80 and 180 mmol/L.

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To establish the range of an assay, where the reported result is a linear function of the analyte concentration, serial dilutions of a suitable control were tested and the observed value is compared to the known expected or calculated expected result. Percentage deviations were calculated. The linearity claim is based on a percentage deviation of ≤5% at the 2 highest analyte concentrations. The samples tested ranged in concentration from 52 to 199 mmol/L.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Calibrator values are assigned from internal testing at Randox Laboratories Ltd and compared to a master lot stored at -80°C.

The calibrator materials are stable until the printed expiration date when stored at 2 to 5 °C.

d. Detection limit:

The minimum detectable concentration of sodium with an acceptable level of precision, ≤20% was 58 mmol/L. This value was determined by testing 10 replicates of a sample targeted at 51 mmol/L.

e. Analytical specificity:

The following analytes were tested up to the following levels and found not to interfere more than 10% or less than 10% at a sodium concentration of 169 mmol/L.:

| Bilirubin | 665.125μmol/L |
| --- | --- |
| Hemoglobin | 10g/L |
| Triglycerides | 13.185mmol/L |

f. Assay cut-off:

N/A

2. Comparison studies:

a. Method comparison with predicate device:

A comparison of 70 samples, ranging in concentration from <80 to 157 mmol/L, was performed using the Randox method and a comparable, commercially available test kit – the Predicate Device. The results obtained are correlated using least-squares regression analysis. The regression equation and correlation coefficient, r are quoted along with the

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number and range of samples tested. The results obtained yielded a linear regression equation of $Y = 0.94X + 5.75$ , $r = 0.99$ .

b. Matrix comparison:

N/A

3. Clinical studies:

a. Clinical Sensitivity:

N/A

b. Clinical specificity:

N/A

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

N/A

4. Clinical cut-off:

N/A

5. Expected values/Reference range:

The expected values stated in package insert are 136 to 146 mmol/L. These ranges are cited from those quoted in the appropriate literature. A warning statement accompanies the reference ranges to indicate that they are provided for guidance only and that individual laboratories are advised to establish the own reference range to reflect the age, sex, diet, and geographical location of the specific population encountered in the daily course of laboratory operation.

# N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

# O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.