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)

{0}------------------------------------------------

K062892

Image /page/0/Picture/1 description: The image shows the word "EUMED" in bold, black letters. The letters are capitalized and sans-serif. The word is enclosed in a black rectangle, with the top and bottom lines of the rectangle being thicker than the side lines. The image appears to be a logo or a stylized wordmark.

# 510(K) Summary of Safety and Effectiveness

(Per 21 CFR 807.92)

General Information Establishment ■ EUMED BIOTECHNOLOGY CO., LTD. Manufacturer: . Address: 3F, NO. 789, BOAI ST. HSIN CHU HSIEN, China (Taiwan) 30265 li Registration Number: 3004379419 . Contact Person: Dr. Jen Ke-Min, Official Correspondent 886-3-5208829 (Tel) 886-3-5209783 (Fax) . Date Prepared: September 23, 2006 Device . Proprietary Name: EUKARE® . Common Name: Blood Glucose Monitoring System ● Classification Name: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER, Class II,

### Safety and Effectiveness Information

#### ● Predicate Device:

Claim of Substantial Equivalence (SE) is made to EUMED Biotechnology Co., Ltd. EUSURE® glucosure blood glucose monitoring system (K040678)

- . Device Description: Based on an electrochemical biosensor technology and the principle of capillary action, EUKARE Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 15 seconds.
JAN 2 2 2007

{1}------------------------------------------------

#### . 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.

#### . Synopsis of Test Methods and Results

Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/ FDA.

#### ● Substantial Equivalence (SE)

A claim of substantial equivalence is made to EUMED Biotechnology Co., Ltd., EUSURE® glucosure blood glucose monitoring system (K040678). Both of our devices (predicate device and subject device) use the same strip and have the same working principle and technologies. The differences are vision dimensions of the meter unit, weight and memory storage. There are no safety and effectiveness aspects arising from the subject device. They are substantially equivalent.

> Ke-Min Jen, Dr. Official Correspondent for EUMED BIOTECHNOLOGY CO., LTD.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, line-art style. The eagle is facing to the right.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ke-Min Jen Eumed Biotechnology Co., Ltd. 3F, No. 789, Boai Street Jubei City, Hsinchu County, Taiwan 30265, R.O.C.

Received: December 7, 2006

JAN 2 2 2007

k062892 Re: Trade/Device Name: EUKARE Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Blood Glucose Test System-Over the counter Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: December 3, 2006

Dear Dr. Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{3}------------------------------------------------

Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., 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

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the word "EUMED" in bold, black letters inside of a black rectangle. The letters are large and blocky, filling most of the space within the rectangle. The font is sans-serif. The rectangle is thin and outlines the word closely.

### Indications for Use

510 (K) Number:_______________________________________________________________________________________________________________________________________________________________

Device Name: EUKARE Blood Glucose Monitoring System

Indications 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.

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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) |
|-------------------------------------------------------------------|
|-------------------------------------------------------------------|

Division Sign-Off

| Office of In Vitro Diagnostic Device Evaluation and Safety |
|------------------------------------------------------------|
|------------------------------------------------------------|

K062892

| Page 1 of 3 |
|-------------|
|-------------|

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "EUMED" in bold, black letters inside of a black rectangle. The letters are large and take up most of the space inside the rectangle. The letters are sans-serif and appear to be a standard font. The background of the rectangle is white.

# Indications for Use

| 510 (K) Number: | K062892 |
|-----------------|---------|
|-----------------|---------|

Device Name: EUKARE Blood Glucose Test Strips

Indications for 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 The system can also be used at clinical sites by health care professionals themselves. to test the blood glucose levels of patients.

CAUTION: The EUKARE Blood Glucose Test Strips for use with EUKARE® / EUSURE® Blood Glucose Monitoring System only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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) | |
|-------------------------------------------------------------------|--|
| Division Sign-Off | |
| Page 1 of 3 | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
| K062892 | |

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the word "EUMED" in bold, black letters inside of a black rectangle. The letters are large and take up most of the space inside the rectangle. The letters are sans-serif and appear to be a standard font. The rectangle is a simple, thin line.

## Indications for Use

#### K062892 510 (K) Number:

Device Name: EUKARE Blood Glucose Control Solution

Indications for Use:

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.

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

Prescription Use

AND/OR

Over-The-Counter Use

e-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

| Division Sign-Off | |
|-------------------|--|
|-------------------|--|

Office of In Vitro Diagnostic Device
Evaluation and Safety

| | K062892 |
|--|---------|
|--|---------|

| | Page 1 of 3 |
|--|-------------|
|--|-------------|