EASYGLUCO, MODEL IGM0002

K031501 · American Healthcare, Inc. · NBW · Oct 16, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031501
• Device Name: EASYGLUCO, MODEL IGM0002
• Applicant: American Healthcare, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The EASYGLUCO™ Monitoring System is used by individuals with diabetes. It is for the quantitative measurement of glucose levels in whole blood, as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings.

Device Story

EASYGLUCO™ Monitor is an in vitro diagnostic device for quantitative whole blood glucose measurement. System uses EASYGLUCO™ Test Strips; glucose dehydrogenase in blood sample reacts with electrodes on strip; electrochemical signal generates electrical current proportional to glucose concentration. Meter measures current; displays result to user. Used by individuals with diabetes in home settings or by clinicians in clinical settings. Output provides glucose concentration data to assist in diabetes management.

Clinical Evidence

Bench testing included within-run and day-to-day precision (CVs 2.2-4.8%), linearity (R²=0.9991), and interference testing per NCCLS EP-7. Method comparison study performed on 416 blood samples (clinical centers) and 104 capillary samples (diabetic patients) against Hitachi 747 analyzer. Results showed high correlation (r=0.979 and r=0.978 respectively). No clinical sensitivity/specificity studies performed as device is an in vitro diagnostic glucose monitor.

Technological Characteristics

In vitro diagnostic blood glucose monitor; electrochemical sensing principle using glucose dehydrogenase; utilizes test strips; Class II device (21 CFR 862.1345).

Indications for Use

Indicated for individuals with diabetes for quantitative measurement of whole blood glucose levels to monitor diabetes management in home and clinical settings.

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

• OneTouch® Ultra® (K024194)
• SURESTEP® (K984261)
• Accu-Chek Advantage (K021513)

Submission Summary (Full Text)

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

A. 510(k) Number: K031501
B. Analyte: Whole Blood Glucose
C. Type of Test: Quantitative, utilizing Glucose Oxidase technology.
D. Applicant: American HealthCare, Inc.
E. Proprietary and Established Names: EASYGLUCO™ Monitoring System

F. Regulatory Information:
1. Regulation section:
21 CFR 862.1345 Glucose Test System
2. Classification:
Class II
3. Product Code:
NBW, System, Test, Blood Glucose, Over The Counter
CGA, Glucose Oxidase, Glucose
JJX, Single (Specified) Analyte Controls (Assayed and Unassayed) Class I
4. Panel:
Chemistry (75)

G. Intended Use:
1. Indication(s) for use:
The EASYGLUCO™ Monitoring System is used by individuals with diabetes. It is for the quantitative measurement of glucose levels in whole blood, as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings.
2. Special condition for use statement(s):
Provides plasma equivalent results.

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3. Special instrument Requirements:

N/A

## H. Device Description:

The EASYGLUCO™ Monitoring System consists of the EASYGLUCO meter, EASYGLUCO Test Strips, Auto-Lancet Device, Infopia Check Strip, Greenlan Lancets, and Control Solution.

## I. Substantial Equivalence Information:

1. Predicate device name(s):

LifeScan, Inc. One Touch ® Ultra ®

2. Predicate K number(s):

K024194

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | EASYGLUCO™ | ONE TOUCH® Ultra® |
| Detection method | Amperometry: current is generated by oxidation of reduced mediator. | Amperometry |
| Enzyme | Glucose Oxidase (Aspergillus niger) | Glucose Oxidase (Aspergillus niger) |
| Mediator | Potassium ferricyanide | Potassium ferricyanide |
| Electrode | Carbon electrode | Carbon electrode |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | EASYGLUCO™ | ONE TOUCH® ULTRA® |
| Test range | 10 – 600 mg/dL | 20 – 600 mg/ dL |
| Hematocrit Range | 30 – 55% | 30 – 55% |
| Test Time | 9 seconds | 5 seconds |
| Sample Volume | 3 uL | 1 uL |
| Temperature & Humidity range | 50 - 95° F | 43 - 111° F |
| | 10 - 35° C | 6 - 44° C |
| | 10 – 90% | 10 - 90% |
| Open use time | 3 months | 3 months |
| Coding | Button (C1 – C40) | Button (C1 – C49) |

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| Memory capability | From 7 to 90-day average and 200 tests in the memory | 14-day average and last 150 tests in the memory |
| --- | --- | --- |
| Power | 3v Li battery (CR2032) | 3V Li battery (CR2032) |
| Battery life | Running 5,000 test | Running 1,000 test |
| Size: LxWxH (mm) | 55x91x22 | 79x57x21 |
| Weight | 55g (with battery) | 42g (with battery) |
| Warranty | 3 years | 3 years |
| Software | EASYGLUCO™ diabetes management software | IN TOUCH® diabetes management software |

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

NCCLS EP-7

## K. Test Principle:

Electrochemical biosensor technology is used with glucose oxidase. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.

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

### 1. Analytical performance:

#### a. Precision/Reproducibility:

Testing was conducted by taking 4 mL of blood that was treated with EDTA through a vacuum tube. Glucose was added to the 4 mL of blood to generate 5 different levels of glucose concentration for the test. Each of the samples was measured 5 times. Below are the glucose concentration ranges for each level that were measured. (See Table I for Summary of Test Results)

| Level | Glucose Concentration Range |
| --- | --- |
| 1 | 30 – 50 mg/dL |
| 2 | 51 – 110 mg/dL |
| 3 | 111 – 150 mg/dL |
| 4 | 151 – 250 mg/dL |
| 5 | 251 – 400 mg/dL |

Three control solutions of Low, Normal and High were prepared. Each of the controls was measured twice a day, once in the morning and once in the afternoon for a month.

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(Table I (below) shows a summary of the Within-Run Precision and the Day-to-Day Precision Tests.)

Table I: Summary of Test Results
Within-Run Precision

| Control Samples | No. Of Assay | Mean (mg/dL) | SD (mg/dL) | CV (%) |
| --- | --- | --- | --- | --- |
| Level 1 | 5 | 47.2 | 1.6 | 3.5 |
| Level 2 | 5 | 94.2 | 2.3 | 2.4 |
| Level 3 | 5 | 131 | 4.5 | 3.4 |
| Level 4 | 5 | 221 | 6.0 | 2.7 |
| Level 5 | 5 | 339.8 | 7.4 | 2.2 |

Day-to-Day Precision

| Control Samples | No. Of Assay | Mean (mg/dL) | SD (mg/dL) | CV (%) |
| --- | --- | --- | --- | --- |
| Low | 80 | 74.2 | 2.8 | 3.7 |
| Normal | 80 | 128.8 | 6.2 | 4.8 |
| High | 80 | 252.9 | 9.9 | 3.9 |

# b. Linearity/assay reportable range:

A blood sample of $25~\mathrm{mL}$ was taken, treated with EDTA vacuum tube, to be set for a day. Two glucose concentrations of $10~\mathrm{mL}$ (high and low concentrations) were prepared. Each of the glucose levels was measured 5 times to test for precision. The glucose linearity dilution study demonstrated the following regression:

$\mathrm{Y} = 62.553\mathrm{x} - 30.078\mathrm{R}^2 = 0.9991$

c. Traceability (controls, calibrators, or method):

CAS# (Chemical Abstract Service)

MDL# (MDL, inc. formerly Molecular Design Laboratories)

Glucose # 492615 SigmaUltra MFCD00063989

Traceability referenced to NBS, NIST Standards

d. Detection limit:

$10 - 600\mathrm{mg / dL}$

$0.6 - 33.3\mathrm{mmol / L}$

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e. Analytical specificity:

Interference testing was conducted to determine the effect of select endogenous and exogenous substances. A series of test samples, systematically varying in the concentration of the interferents, was prepared by making quantitative, volumetric mixtures of two pools: one at the highest concentration to be tested and the other at the lowest. The substances and concentrations of the interferents are recommended at NCCLS EP7-P.

f. Assay cut-off: N/A

2. Comparison studies:

a. Method comparison with predicate device:

The accuracy of the EASYGLUCO™ System was assessed by comparing blood glucose results obtained by patients with those obtained using the Hitachi 747 Chemistry Analyzer. Glucose levels were measured on 416 blood samples, and 104 fresh capillary blood specimens by 104 diabetic patients and three healthcare professionals at three different clinical centers.

A direct correlation between The Hitachi 747 and EASYGLUCO™ were confirmed in the 416 blood samples. Results obtained by Healthcare Professionals in Clinical Centers presented the following regression:

Slope = 0.957
y- intercept 5.4
Correlation coefficient (r) 0.979
No. of samples 416
Range tested 68 – 430 mg/dL

The Linear regression of the 104 diabetic patients – Hitachi 747 vs. EASYGLUCO™ System presented the following regression:

Slope = 0.957
y- intercept 12.1
Correlation coefficient (r) 0.978
No. of samples 104
Range tested 81 – 425 mg/dL

b. Matrix comparison: N/A

3. Clinical studies:

a. Clinical sensitivity: N/A

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b. Clinical specificity:
N/A

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

4. Clinical cut-off:
N/A

5. Expected values/Reference range:

Expected blood glucose levels for people without diabetes:

| Time | Range (mg/dL) | Range (mmol/L) |
| --- | --- | --- |
| Before Breakfast: | 70 – 105 | 3.9 – 5.8 |
| Before Lunch or Dinner: | 70 – 110 | 3.9 – 6.1 |
| 1 hour after meals: | less than 160 | less than 8.9 |
| 2 hours after meals: | less than 120 | less than 6.7 |
| Between 2 and 4 AM | Greater than 70 | Greater than 3.9 |

- referenced from Joslin Diabetes Manual

M. Conclusion:
Based upon review of the information and labeling provided, this device is Substantially Equivalent to 21 CFR 862.1345, 75 NBW, System, Test, Blood Glucose, Over the Counter and 75 CGA Glucose Oxidase, Glucose