EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM

K043245 · Eps Bio Technology Corp. · CGA · Apr 29, 2005 · Clinical Chemistry

Device Facts

• Record ID: K043245
• Device Name: EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM
• Applicant: Eps Bio Technology Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Apr 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The Easy pain Supreme Self Monitoring Blood Glucose Test System is used by individuals with diabetes. It is for the quantitative measurement of glucose levels in fresh capillary whole blood, as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings.

Device Story

System comprises meter, test strips, auto-lancet, check strip, code card, and control solution. User applies fresh capillary whole blood to disposable test strip; glucose oxidase enzyme catalyzes oxidation of glucose to gluconic acid. Mediator transfers electrons to carbon electrode, generating current proportional to glucose concentration. Meter measures current and displays result after 25 seconds. Used by patients or clinicians for diabetes management. Provides plasma-equivalent results. Memory stores 100 test results with date/time. Powered by two AAA batteries.

Clinical Evidence

Method comparison study performed with 202 diabetic subjects comparing capillary blood results against YSI 2300 Analyzer. Results: slope 0.967, y-intercept 11.98 mg/dL, correlation coefficient (r) 0.972, range 33-514 mg/dL. Analytical precision testing (n=200 per level) showed CVs ranging from 3.1% to 4.3% for within-run and 2.6% to 5.6% for day-to-day precision.

Technological Characteristics

Amperometric glucose monitoring system. Uses disposable dry reagent strips with glucose oxidase (Aspergillus niger) and potassium ferricyanide mediator on carbon electrodes. Test range 40-600 mg/dL. Sample volume ≥2.0uL. Test time 25 seconds. Powered by 2x 1.5V AAA batteries. Memory capacity 100 tests. Coding via Code Card.

Indications for Use

Indicated for individuals with diabetes for quantitative measurement of glucose in fresh capillary whole blood 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

• Precision QID Blood Glucose Testing System (K971812)

Submission Summary (Full Text)

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# 510(K) SUMMARY

K043245

# APR 2 9 2005

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

| 1.0 Submitter's Name: | EPS Bio Technology Corp. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 2F, No.49-2, Lane 2, Guang Fu Rd., Sec. 2, Hsinchu City ,<br>Taiwan, R.O.C. |
| Phone: | 886-3-5752522 |
| Fax: | 886-3-5752552 |
| Contact: | Mr. Y.C. Lei, General Manager |
| 2.0 Device Name: | A. Easy Pain Supreme Self-Monitoring Blood Glucose System |
| 3.0 Classification: | Class II |
| 4.0 Predicate Device: | The predicate device is the Precision® QID Blood Glucose Testing<br>System (K 971812) marketed by Medisense Inc. |
| 5.0 Device Description: | The Easy Pain Supreme Self-Monitoring Blood Glucose System<br>consists of the Easy Pain Supreme meter, Easy Pain Supreme<br>Glucose Test Strips, Auto-Lancet Device, Check Strip, Code Card,<br>and Control Solution. |
| 6.0 Indication for Use: | The Easy Pain Supreme Self-Monitoring Blood Glucose System is<br>used by individuals with diabetes. It is for the quantitative<br>measurement of glucose levels in fresh capillary whole blood, as<br>an aid in monitoring the effectiveness of diabetes management in<br>the home and in clinical settings. |
| | Special condition for use statement(s) :<br>Provides plasma equivalent results. |
| | Special instrument Requirements : N/A |

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7.0 Comparison with predicate :

| Similarities | | |
|------------------|----------------------------------------------------------------------------|----------------------------------------|
| Item | Device | Predicated |
| | Easy Pain Supreme | Precision QID |
| Detection method | Amperometry : current is<br>generated by oxidation of<br>reduced mediator. | Amperometry |
| Enzyme | Glucose Oxidase<br>(Aspergillus niger) | Glucose Oxidase<br>(Aspergillus niger) |
| Mediator | Potassium ferricyanide | Potassium ferricyanide |
| Electrode | Carbon electrode | Carbon electrode |

| Differences | | |
|-----------------------|-----------------------------------|-----------------------------------|
| Item | Device | Predicated |
| | Easy Pain Supreme | Precision QID |
| Test range | 40-600 mg/dL | 20-600 mg/dL |
| Hematocrit Range | 30-55% | 20-70% |
| Test Time | 25 seconds | 20 seconds |
| Sample Volume | ≥2.0uL | ≥3.5uL |
| Operating Range | | |
| Temperature | 10-40°C | 18-30°C |
| Humidity range | R.H.≤90% | R.H. : 10% to 90% |
| Open use time | 3 months | 3 months |
| Coding | Code Card | Calibrator |
| Memory | 100 blood glucose tests with | NA |
| Capability | Date and time | |
| Power | 1.5V (AAA)*2 batteries | Non-replaceable cell 3.0 V/DC |
| Battery life | Approximately 1,000 glucose tests | Approximately 4,000 glucose tests |
| Size : L x W x H (cm) | 7.5 x 5.4 x 1.9 | 9.7 x 4.80 x 1.45 |
| Weight | 50g (without batteries) | 39.35gram |

The Easy Pain Supreme Self-Monitoring Blood Glucose System employs 8.0 Test Principle a disposable dry reagent strip technology, based on the glucose oxidase method for glucose determination. Each test strip features an electrode containing the enzyme glucose oxidase (Aspergillus niger). A blood sample is applied to the blood collection area at the tip of the strip and is automatically drawn into the reaction zone, where the glucose oxidase catalyzes the oxidation of glucose to produce gluconic acid. During the reaction, a mediator transfers electrons to the electrode surface and generates a current. The amount of the current is proportional to the amount of glucose present in the blood sample the glucose concentration is measured by the Easy Pain Supreme Glucose Meter and displayed on the screen after 25 seconds.

FDA 510(K) SUMMARY

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#### 9.0 Performance Characteristics

## 1. Analytical performance :

#### Precision / Reproducibility :

Testing was conducted by taking 4 mL of blood that was treated with Heparin 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 | 40-50 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. (Table I (below) shows a summary of the Within-Run Precision and the Day-to-Day Precision Tests.)

#### Table I : Summary of Test Results

| Control<br>Samples | No. Of Assay | Mean<br>(mg/dL) | SD(mg/dL) | CV(%) |
|--------------------|--------------|-----------------|-----------|-------|
| Level 1 | 200 | 43 | 2.4 | 4.3 |
| Level 2 | 200 | 95 | 5.3 | 3.5 |
| Level 3 | 200 | 144 | 8.0 | 3.3 |
| Level 4 | 200 | 246 | 13.7 | 3.1 |
| Level 5 | 200 | 398 | 22.1 | 3.3 |

# Within-Run Precision

| Day-to-Day Precision | | |
|----------------------|--|--|
| | | |

| Control<br>Samples | No. Of Assay | Mean<br>(mg/dL) | SD(mg/dL) | CV(%) |
|--------------------|--------------|-----------------|-----------|-------|
| Low | 400 | 56 | 3.10 | 5.6 |
| Normal | 400 | 129 | 4.49 | 3.5 |
| High | 400 | 388 | 10.21 | 2.6 |

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### 9.0 Performance Characteristics(Cont.)

# a. Linearity / assay reportable range :

- A blood sample of 25 mL was taken, treated with Heparin vacuum tube, to be set for a day, Testing was performed using whole blood tube, to be set for a Gay, 188.ing to provide samples at seven different supplemented within a total of 210 tests were preformed using 5 meters among the seven glucose ranges per each strip lot. The melers among the coven gide demonstrated the following regression

| mmol/L | mg/dL |
|-----------|---------|
| 2.2- 2.8 | 40- 50 |
| 2.8-4.3 | 51-80 |
| 4.4-6.7 | 81-120 |
| 6.7-11.1 | 121-200 |
| 11.2-16.6 | 201-300 |
| 16.7-22.2 | 301-400 |
| 22.3-33.3 | 400-600 |

Y=0.9589x + 6.1617

R2=0.9958; Syx=10.14; N=630

- b. 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
- c. Detection limit : 40-600 mq/dL 2.2-33.3 mmol/L
- d. Analytical Specifiecity :

Interference testing was conducted to determine the effect of select intonoronoo could 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. at the substances and concentrations of the interferents are recommended at NCCLS EP7-P.

- e. Assay cut-off : N/A

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## 2. Comparison studies :

# a. Method comparison with predicate device :

The accuracy of the Easy Pain Supreme Self-Monitoring Blood The accuracy of the Easy Part by comparing blood glucose results. Glucose System was accosse obtained using the YSI 2300 Analyzer. The results below were obtained by 202 subjects with diabetes at The results below were obtained by ssion statistics are derived from a three intoporis capillary data versus YSI plasma data.

The Linear regression of the 202 diabetic patients - YSI 2300 vs. easy Pain Supreme System presented the following regression :

| Slope= | 0.967 |
|----------------------------|--------------|
| y-intercept | 11.98 mg/dL |
| Correlation coefficient(r) | 0.972 |
| No. of samples | 202 |
| Range tested | 33-514 mg/dL |
| Matrix comparison: | N/A |

## b. Matrix compariso

## 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) : See Attachment 12
- N/A 4. Clinical cut-off :

# 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<br>Dinner : | 70 - 110 | 3.9 - 6.1 |
| 1 hour after meals : | Less than 160 | Less than 8.9 |
| 2 hour after meals : | Less than 120 | Less than 6.7 |
| Between 2 and 4 AM | Greater than 70 | Greater than 3. |

Where the above Expected Values is referenced from Joslin Diabetes Manual

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#### 8. Conclusions:

The Easy Pain Supreme Self-Monitoring Blood Glucose System have the same intended use and similar technological characteristics as Precision ® QID Blood Glucose Testing System (K 971812) marketed by Medisense Inc.. Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness. Thus, the Easy Pain Supreme Self-Monitoring Blood Glucose System is substantially equivalent to the predicate devices.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three flowing lines representing the body and head. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.

Food and Drug Adrninistration 2098 Gaither Road Rockville MD 20850

APR 2 9 2005

EPS Bio Technology Corp. c/o Ms. Jennifer Reich US Agent Harvest Consulting Corporation 3892 South America West Trail Flagstaff, AZ 86001

k043245 Re:

K043243
Trade/Device Name: Easy Pain Supreme Self-Monitoring Blood Glucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: March 18, 2005 Received: March 25, 2005

Dear Ms. Reich:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becasil 3 ro(i) fan device is substantially equivalent (for the indications felerenced above and nave determined and marketed predicate devices marketed in interstate for use stated in the Cherosure) to regars actment date of the Medical Device Amendments, or to commence prov to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been reclassified in accessfired in assessor al of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvine of the general controls provisions of the Act. The You may, merclore, market the device, solo, connual registration, listing of general controls provisions of the rict mercials comments of and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), II your device is classified (300 above) into 5. Existing major regulations affecting your device
it may be subject to such additional controls. Existing major regulation i It may be subject to such adultional controllar Enting Cargo, Co. 9
can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in Thie 21, Coub of I caeral suggest in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualled of a backers.
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a decemmation the Journer Federal agencies. You must or any Federal statutes and regulations as annuding, but not limited to: registration and listing (21 comply with an the Ave 3 requirements 801 and 809); and good manufacturing practice and CI'K I all 807), laoching (21 CF ruality systems (QS) regulation (21 CFR Part 820).

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#### Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin manteang your and equivalence of your device to a legally premained notification. "The I D'A manig of ousleasification 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, If you destions on the promotion and advertising of your device, please contact the Office of In of questions on the promotion and Safety at [phone]. Also, please note the Pill o Diagnostic Dovies Brance to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may outlif one getierers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Jean M. Cooper, MS, DUM

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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# Indications for Use

510(k) Number (if known): K043245

Easy Pain Supreme Self-Monitoring Blood Glucose System Device Name:

Indications For Use:

The Easy Pain Supreme Self-Monitoring Blood Glucose System is used by The Easy Pain Supreme Scir Monitonia Breakurement of glucose levels
individuals with diabetes. It is for the quantitative the offectiveness of diabete individuals with diabetes. It is for the quantitiation the effectiveness of diabetes
in fresh capillary whole blood, as an aid in monitoring the effectiveness of diabetes in froom oupliary on the home and in clinical settings.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Albeto Caz

**Division Sign-Off**

Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) K043245

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