EUKARE

K062892 · Eumed Biotechnology Co., Ltd. · CGA · Jan 22, 2007 · Clinical Chemistry

Device Facts

• Record ID: K062892
• Device Name: EUKARE
• Applicant: Eumed Biotechnology Co., Ltd.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jan 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The EUKARE® glucose test strip is intended to measure the glucose in whole blood with the EUKARE® glucose meter. It is suitable for a person with diabetes to monitor their blood glucose at home by themselves. The system can also be used at clinical sites by nurses or professional people to test patient's glucose level in whole blood. A 1UTION: The measurement of glucose in whole blood can be taken from the finger only, and this is not for neonatal use.

Device Story

EUKARE Blood Glucose Monitoring System; electrochemical biosensor; uses glucose oxidase enzyme on carbon electrode test strips. Input: capillary whole blood sample (3 µL) via capillary action into strip chamber. Operation: glucose oxidase catalyzes reaction with ferricyanide; meter measures resulting current; converts to glucose concentration. Output: digital display of blood glucose level (30-600 mg/dL). Used at home by patients or in clinical settings by professionals. Meter uses Check Code Card for calibration. Results aid diabetes management. System includes meter, test strips, and control solutions for accuracy verification.

Clinical Evidence

Pre-clinical and clinical data submitted per FDA Guidance for In Vitro Diagnostic Test Systems. No specific performance metrics (e.g., sensitivity, specificity) provided in summary.

Technological Characteristics

Electrochemical biosensor; glucose oxidase enzyme; carbon electrodes. 0.6V operating voltage. 3 µL sample volume. 15-second measurement time. Measuring range 30-600 mg/dL. Battery-powered (3V Lithium). Meter coding via Check Code Card. Operating temp 10-40°C. Connectivity: None (standalone).

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood. For OTC home use by diabetics or clinical use by healthcare professionals to monitor diabetes control. Fingerstick only. Not for neonatal use.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• EUSURE® glucosure blood glucose monitoring system (K040678)

Submission Summary (Full Text)

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

A. 510(k) Number:
k062892

B. Purpose for Submission:
New device

C. Measurand:
Glucose

D. Type of Test:
Quantitative electrochemical biosensor

E. Applicant:
Eumed Biotechnology Co. Ltd.

F. Proprietary and Established Names:
EUKARE Blood Glucose Monitoring System

G. Regulatory Information:

| Product Code | Classification | Regulation Number | Regulation Section | Panel |
| --- | --- | --- | --- | --- |
| NBW | II | 21 CFR 862.1345 | Blood Glucose Test System-Over the-counter | 75 Chemistry |
| CGA | II | 21 CFR 862.1345 | Glucose oxidase, glucose | 75 Chemistry |
| JJX | I, reserved | 21 CFR 862.1660 | Single analyte controls | 75 Chemistry |

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H. Intended Use:

1. Intended use(s):

See indication for use statement below.

2. Indication(s) for use:

The EUKARE Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.

The measurement of glucose in whole blood can be taken from the finger only, and this is not for neonatal use.

The EUKARE Blood Glucose Test Strips are intended to measure the glucose levels in whole blood with the EUKARE/EUSURE Blood Glucose Monitoring System. It is suitable for persons with diabetes to monitor their blood glucose levels at home by themselves. The system can also be used at clinical sites by health care professionals to test the blood glucose levels of patients.

The EUKARE Blood Glucose Control Solution level I, level II, and level III are used as quality control material to verify the accuracy of the EUKARE/ EUSURE Blood Glucose Monitoring System. If you are not sure about the strip quality or the previous storage condition, you are recommended to perform a quality control check. The control test results should always fall within the designed range listed on the box in use.

3. Special conditions for use statement(s):

The measurement of glucose in whole blood can be taken from the finger only, and this is not for neonatal use.

The EUKARE Blood Glucose Control Solution for use with EUKARE/EUSURE Blood Glucose Monitoring System only.

4. Special instrument requirements:

EUKARE/EUSURE Blood Glucose Monitoring System

I. Device Description:

The EUKARE/EUSURE Blood Glucose Monitoring System consists of the EUKARE Blood Glucose Test Strips, control solutions, and the EUKARE blood

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glucose meter. The sample is drawn into a small chamber on the strip based on capillary action. It will fill the chamber automatically and stop when it reaches the end of the chamber, so sample volume control is achieved.

# J. Substantial Equivalence Information:

1. Predicate device name(s):

EUSURE Blood Glucose Monitoring System

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

k040678

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Subject Device EUKARE (Eumed) k062892 | Predicate Device EUSURE (Eumed) k040678 |
| Indications for Use | Intended for the quantitative measurement of glucose in fresh capillary whole blood. | Same |
| Test Principle | Electrochemical Biosensor with carbon electrodes | Same |
| Specimen | Capillary whole blood | Same |
| Sample Volume | ~3 ul | Same |
| Measuring Time | 15 sec | Same |
| Detecting Range | 30-600 mg/dl | Same |
| Calibration method | Control solution | Same |
| Battery Power | One 3V Lithium | Same |
| Meter Check | Resistor (embedded in Check Code Card) | Same |
| Test Strip | EUKARE/EUSURE Glucose Test Strips | Same |
| Voltage | 0.6V | Same |
| Button Design | 2 in one button | Same |
| Meter Coding | Check Code Card | Same |
| Operating Temp. | 10-40° C | Same |
| Strip Storage Temp. | 4-30° C | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| HCT Range | 20-55 mg/dl | 20-60 mg/dl |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Meter Dimension | 91 x 49x 21 mm | 80 x 45 x 15 mm |
| Meter Weight | 50 g | 45 g |
| Meter Memory Storage | 150 test results | 100 test results |

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

CLSI EP5-A Evaluation of Precision Performance of Clinical Chemistry Devices;

CLSI EP6-P2 Evaluation of the Linearity of Quantitative Analytical Methods;

CLSI EP7-A Interference testing in Clinical Chemistry;

CLSI EP9-A Method Comparison and Bias Estimation Using Patient Samples;

prEN 13640 Stability Testing of in vitro Diagnostic Medical Devices;

ISO 15197 In-vitro Diagnostic Test Systems-Requirements for Blood Glucose Monitoring Systems for Self-Testing;

IEC 61010 / EN 61010 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use;

IEC 60601 / EN 60601 Medical Electrical Equipment, General Requirements for Safety.

# L. Test Principle:

The test principal is based on electrochemical biosensor technology using glucose oxidase. The strip uses the enzyme glucose oxidase to produce a current that will stimulate a chemical reaction with ferricyanide. This reaction is measured by the meter and displayed as a blood glucose result.

# M. Performance Characteristics (if/when applicable):

# 1. Analytical performance:

# a. Precision/Reproducibility:

Precision studies were performed in the laboratory with EDTA venous whole blood. The blood glucose levels were adjusted to 5 different ranges by spiking the sample with glucose solution $(20\mathrm{g / dl})$ . Precision studies were conducted with ten EUKARE meters and 500 EUKARE/EUSURE strips for ten duplicates to obtain the following results (n=100 per level). All of the tests were conducted within 30 minutes.

| Concentration Range (mg/dl) | N | Total Mean (mg/dl) | Total SD (mg/dl) | Total CV% |
| --- | --- | --- | --- | --- |
| 30-50 | 100 | 39.61 | 2.66 | 6.68 |
| 51-110 | 100 | 81.88 | 3.24 | 3.96 |
| 111-150 | 100 | 124.98 | 2.91 | 2.33 |
| 151-250 | 100 | 161.51 | 5.71 | 3.53 |
| 251-400 | 100 | 310.85 | 9.74 | 3.13 |

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b. Linearity/assay reportable range:

Linearity studies were conducted in accordance to CLSI guideline EP6-P. A venous whole blood sample was collected from a healthy person (HCT~42%). Half of the collected sample was adjusted to about 30 mg/dl with glucose stock solution. The other half of the collected sample was spiked to about 600 mg/dl with glucose stock solution. Three intermediate concentrations were prepared by combining the two spiked initial samples. All five samples were measured by a YSI glucose analyzer for verification. The linear regression equation for the linear regression analysis of results from the EUKARE device and the YSI method was Y= 0.9996x-0.2571, R²=0.9995.

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

Control materials are traceable to YSI standards which are traceable to NIST SRM #965a (Glucose in frozen human serum: 4 glucose levels). Real-time shelf life studies performed by the manufacturer indicate that control solutions and the unopened test strips have a shelf life of 18 months. Once the control solution or strip containers are opened, they have been shown to be stable for 3 months.

d. Detection limit:

The measuring range is from 30 to 600 mg/dL (1.6 to 33.33 mmol/L). If the blood glucose value is below 30 mg/dl, "Lo" is displayed on the screen. If the blood glucose value is above 600 mg/dl, "Hi" is displayed on the screen. See precision and linearity studies above for validation of the measuring range.

e. Analytical specificity:

Interference testing was conducted to determine the effect of endogenous and exogenous substances according to CLSI EP7-P. According to this study, the sponsor determined that acetaminophen, ascorbic acid, dopamine, bilirubin and uric acid may lead to inaccurate glucose readings with the EUKARE/EUSURE blood glucose monitoring system to the extent shown below. The sponsor also determined the sodium fluoride should not be used with the EUKARE Blood Glucose Monitoring System.

Acetaminophen- will interfere with test results, each acetaminophen unit (mg/dl) will contribute about 3.86 mg/dL glucose for the EUKARE/EUSURE strip. The labeling contains a warning that patients taking acetaminophen should not use the meter.

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Ascorbic Acid- levels lower than 1.5 mg/dl will not affect the glucose reading of the device. However, levels higher than 2 mg/dl will interfere with the EUKARE/EUSURE strip.

Dopamine-if a patient was treated with dopamine, the measurement results will be increased. The labeling contains a warning that patients taking dopamine should not use the meter.

Bilirubin- results up to 1.22 mg/dL do not interfere.

Uric Acid- concentrations higher than 7 mg/dL will have an effect on measurements of EUKARE/EUSURE Blood Glucose Monitoring System for the normal uric acid users.

Sodium Fluoride will interfere with the EUKARE Blood Glucose Monitoring System. This system is for fresh capillary whole blood only.

## Altitude Effect

Six glucose devices, controls (4 levels) and strips (3 lots) were tested at 5 altitudes (up to 3000 meters). No effect on performance was found when the 4 control solutions were tested up to 9842 feet (3000 meters). Higher elevations were not tested.

## Hematocrit Effect

The effect of hematocrit variation on the EUKARE Blood Glucose Monitoring System was tested by comparing results of different whole blood samples with hematocrit values ranging from 60% to 20% (increments of 10%). The samples were tested in replicates of four and the YSI 2300 Stat Plus served as the reference instrument. The sponsor used the ISO 15197 document system accuracy section to validate their high percent deviations from the average hematocrit (40%) values. The study supported a hematocrit range of 20 to 55%.

## Temperature and Humidity Effect

The sponsor submitted data to support that the test system can be used between 56.3° -98.6° degrees Fahrenheit (12° and 37° C) and a relative humidity up to 93%.

f. Assay cut-off:

Not applicable

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2. Comparison studies:

a. Method comparison with predicate device:

A clinical investigation was conducted to evaluate the system accuracy of the EUKARE meter. 146 volunteer samples (6 were excluded due to high hematocrit levels) consisting of 126 real samples and 20 spiked samples to obtain higher values were tested with the EUKARE meter, EUSURE meter and compared to YSI values. The samples ranged from 71 to 498 mg/dl and the hematocrit ranged from 34 to 55%. The agreement of the EUKARE capillary reading between the technician and lay user found that the lay user variability was less than +/- 20% of the technicians obtained values. The Error-Grid analysis to compare the capillary test result measured by EUKARE was plotted against the EUSURE reading obtained with the same volunteers' samples. 98% of all the data fell within the Zone A acceptance area. The device was compared to YSI values and yielded the following regression equation:

$$
\mathrm{Y} = 1.0029\mathrm{x} - 0.607
$$

$$
\mathrm{R}^2 = 0.9941
$$

$$
N = 146
$$

The sponsor also conducted a consumer questionnaire to investigate the consumers' ability to understand the use of the EUKARE Blood Glucose Monitoring System and strips. The results revealed a consumer average usability score of 96% and a consumer's ability to read and understand the insert had a score of 98%.

b. Matrix comparison:

Not applicable

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

b. Clinical specificity:

Not applicable

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

The sponsor's labeling was evaluated for readability via Flesh-Kincaid software and was given a 7.9 grade reading level score.

4. Clinical cut-off:

Not applicable

5. Expected values/Reference range:

The sponsor quotes Tietz N.: Fundamentals of Clinical Chemistry 3rd Ed., W.B. Saunders Co., Philadelphia, PA, 1987, pg. 427.

Fasting Glucose: 90-130 mg/dl

Bedtime Glucose: 110-150 mg/dl

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.

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