DIACHEX BLOOD GLUCOSE MONITORING SYSTEM

K062829 · Tyson Bioresearch, Inc. · NBW · Oct 10, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062829
• Device Name: DIACHEX BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Tyson Bioresearch, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The DIACHEX Blood Glucose Test Strips are used with the DIACHEX Blood Glucose Meter for quantitatively measuring glucose (sugar) in fresh capillary whole blood obtained from the fingertip. The DIACHEX Test Strips are for testing outside the body (in vitro diagnostic use). The DIACHEX Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels.

Device Story

Blood glucose meter modification; updates include meter name, physical size, memory capacity, date/time functionality, and 14-day average testing result calculation. Device operates as point-of-care diagnostic tool for glucose monitoring. Modifications verified via design control activities, risk analysis, and performance testing to ensure fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

No clinical data; substantial equivalence supported by design control activities, risk analysis, and verification/validation testing of device modifications.

Technological Characteristics

Electrochemical biosensor; glucose oxidase enzyme; potassium ferricyanide mediator. Measuring range 20-600 mg/dL. Sample volume ~1.5 uL. Powered by 3V Lithium CR 2032 battery. Meter dimensions 102x52x17 mm; weight 55g. Uses Glucode Chip for calibration.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from the fingertip for diabetes management. Intended for home and professional 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

• K052818

Submission Summary (Full Text)

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K062829

## 510(k) SUMMARY

#### 1. DATE PREPARED

September 18, 2006

OCT 1 0 2006

## 2. SPONSOR INFORMATION

Address

TYSON BIORESEARCH, INC. 5 F., # 22, KE TUNG RD., SCIENCE BASED INDUSTRIAL PARK CHUN-NAN, MIAO-LI COUNTY, CHINA (TAIWAN) 350

Contact Person: WEN-HAI TSAI

PHONE: [phone] FACSIMILE: 886-37-585996

### 3. NAME OF DEVICE:

Trade Name: Common Names/Descriptions: Classification Names:

DIACHEX Blood Glucose Monitoring System Blood Glucose Monitoring System Glucose test system, product code 75CGA and "System, test, blood glucose, over the counter", product code 75NBW, 21 CFR 862.1345

## 4. DEVICE DESCRIPTION:

The DIACHEX Blood Glucose Monitoring System designed by Tyson Bioresearch Inc., an amperometric biosensor, are adopted for its ease of use, its ability to process accurate results utilizing only a small volume of blood, and its quick response time. DIACHEX device provides a convenient and safe monitoring system for diabetes health care professionals, hospitals and most importantly, people with diabetes.

The DIACHEX Blood Glucose Test Strips are used with the DIACHEX Blood Glucose Meter to quantitatively measure glucose in capillary whole blood obtained from the fingertip. When the edge of the DIACHEX Test Strip is touched to a drop of blood, the test strip draws the blood into the sample chamber and the glucose reading is displayed

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on the meter after 10 seconds. The test measures glucose from 20 mg/dL (1.1mmol/L) to 600 mg/dL (33.3 mmol/L). The DIACHEX Test Strip is calibrated to display the equivalent of plasma glucose values to allow the comparison of results with laboratory methods.

## 5. INTENDED USE:

The DIACHEX Blood Glucose Test Strips are used with the DIACHEX Blood Glucose Meter for quantitatively measuring glucose (sugar) in fresh capillary whole blood obtained from the fingertip. The DIACHEX Test Strips are for testing outside the body (in vitro diagnostic use). The DIACHEX Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels.

### 6. TEST PRINCIPLE

The test principle is based on electrochemical biosensor technology using glucose oxidase. Glucose is oxidized to gluconic acid and electrons are produced from the reaction. The electrons are then trapped by a chemical mediator, potassium ferricyanide. Once the enzymatic reaction is complete, a potential is provided by the meter for a further electrochemical reaction in order to generate a current from the release of trapped electrons. This current is then measured and correlated to the glucose concentration in the whole-blood sample. The DIACHEX Test Strip is calibrated to display the equivalent of plasma glucose values to allow easy comparison of results with laboratory methods.

#### 7. PREDICATE DEVICE:

Predicate device name(s): EZ Smart - 168 Blood Glucose Monitoring System

Predicate 510(k) number(s): k052818

Comparison with predicate:

The Tyson Bioresearch Inc. DIACHEX Blood Glucose Monitoring System in this submission is equivalent to the Tyson Bioresearch Inc. EZ Smart-168 Blood Glucose Monitoring System previously cleared under (k052818). DIACHEX Blood Glucose Monitoring System is an amendment to the EZ Smart-168 Blood Glucose Monitoring System (K052818). This amendment addresses only small changes on the meter size, appearance, memory capacity, date, time and 14days average testing result. All main internal electronic components and meter functions remain as same as the EZ Smart-168

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Blood Glucose Meter. DIACHEX Test Strip also identical to the EZ Smart-168 Test Strip, only the size changed for more convenient use. Fundamental scientific technology of the DIACHEX device has not changed.

## Substantial Equivalence Comparison:

The Tyson Bioresearch Inc. DIACHEX Blood Glucose Monitoring System in this submission is equivalent to the Tyson Bioresearch Inc. EZ Smart-168 Blood Glucose Monitoring System previously cleared under (k052818). The table below lists the similarities and differences between the Predicate and Proposed device.

#### Similarities:

| Item | Predicate Device<br>EZ Smart-168 (K052818) | Proposed Device<br>DIACHEX |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intend Use | The EZ Smart-168 Blood Glucose<br>Test Strips are used with the EZ<br>Smart-168 Blood Glucose Meter to<br>measure glucose (sugar) in<br>capillary whole blood from<br>fingertip. The EZ Smart-168 Test<br>Strips are for testing outside the<br>body (in vitro diagnostic use). The<br>EZ Smart-168 Blood Glucose<br>Monitoring System provides a<br>convenient and safe monitoring<br>system for diabetes health care<br>professionals, hospitals and most<br>importantly people with diabetes. | The DIACHEX Blood Glucose<br>Test Strips are used with the<br>DIACHEX Blood Glucose Meter<br>to measure glucose (sugar) in<br>capillary whole blood from<br>fingertip. The DIACHEX Test<br>Strips are for testing outside the<br>body (in vitro diagnostic use). The<br>DIACHEX Blood Glucose<br>Monitoring System provides a<br>convenient and safe monitoring<br>system for diabetes health care<br>professionals, hospitals and most<br>importantly people with diabetes. |
| Test Principle | Electrochemical biosensor with<br>glucose oxidase. | Electrochemical biosensor with<br>glucose oxidase. |
| Test Strips | EZ Smart-168 Test Strip | DIACHEX Test Strip |
| Specimen Type | Capillary whole blood from<br>fingertip | Same |
| Sample Volume | Around 1.5 uL | Same |
| Measuring Time | 10 sec | Same |
| Detecting Range | 20 ~ 600 mg/dL | Same |
| HCT Range | 35 ~55 % | Same |
| Operating<br>Temperature | 10 to 40 °C (50-104°F) | Same |

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| Item | Predicate Device<br>EZ Smart-168 (K052818) | Proposed Device<br>DIACHEX |
|------------------------------|--------------------------------------------|----------------------------|
| Strip Storage<br>Temperature | 4 to 30 ℃ (40-86°F) | Same |
| Battery Power | One 3 V Lithium CR 2032 battery | Same |
| Meter Coding | Glucode Chip | Same |

Differences:

| Item | Predicate Device<br>EZ Smart-168 (K052818) | Proposed Device<br>DIACHEX |
|------------------|--------------------------------------------|----------------------------|
| Test Strips size | 33.5 x 5 (mm) | 33.5 x 7 (mm) |
| Average result | Only 28 tests average | 14-Day Average |
| Memory capacity | 28 Test Results | 300 Test Results |
| Button Design | one button | Two buttons |
| PCB Size | 72 x 42 (mm) | 92 x 44 (mm) |
| Meter Dimension | 76 x 47 x 16 (mm) | 102 x 52 x 17 (mm) |
| Meter Weight | 44 grams | 55 grams |
| LCD Display | 40 x 21.5 (mm) | 37.5 x 34 (mm) |

# 8. PERFORMANCE CHARACTERISTIC SUMMARY

Based on the above information, we know the subject device, DIACHEX Blood Glucose Monitoring System, and the predicate device have functioning principle and using the same technologies. The detection ranges for both devices are similar. HCT ranges are the same. The strip storage environments and the operating temperature are similar.

The differences between DIACHEX from EZ Smart-168 Blood Glucose Monitoring System are meter dimension, weight, memory capacity, 14 days average result, date and time display, all internal electrical architectures and main electronic components as well as product functions and features remain unchanged. DIACHEX Test Strip is also identical to the EZ Smart-168 Blood Glucose Monitoring System, only the size changed for more convenient use. No physical changes of EZ Smart-168 Test Strips were made.

As we can see, the differences are due to the feature design aspects for more convenience

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use of the DIACHEX Blood Glucose Monitoring System, not relating to the safety or effectiveness aspects. Fundamental scientific technology of the DIACHEX device has not changed. DIACHEX Blood Glucose Monitoring System is substantially equivalent to the originally cleared EZ Smart-168 Blood Glucose Monitoring System (K052818).

An evaluation of the DIACHEX Blood Glucose Monitoring System was conducted under various conditions including temperature effects, hematocrit levels, sensitivity and linearity. The results of the evaluation demonstrate that the DIACHEX Blood Glucose Monitoring System is equivalent in performance to the predicate device and suitable for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## OCT 1 0 2006

Mr. Wen-Hai Tsai Tyson Bioresearch, Inc. 5F., #22, Ke Tung Rd., Science Based Industrial Park Chun-Nan, Miao-Li County, China (Taiwan) 350

k062829 Trade/Device Name: DIACHEX Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: September 19, 2006 Received: September 20, 2006

Dear Mr. Tsai:

Re:

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).

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This letter will allow you to begin marketing your device as described in your Section 510(k) rus lotter will and will you to begin and equivalence of your device of your device to a legally promation notification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or you costs on the promotion and advertising of your device, please contact the Office of In of tro 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 I ba may of annoutics griticional 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,

Alberto Guti

Alberto Gutierrez, Ph.D. 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:

K062829

Device Name:

DIACHEX Blood Glucose Monitoring System

Indications For Use:

The DIACHEX Blood Glucose Test Strips are used with the DIACHEX Blood Glucose Meter for quantitatively measuring glucose (sugar) in fresh capillary whole blood obtained from the fingertip. The DIACHEX Strips are for testing outside the body (in vitro diagnostic use). The DIACHEX Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels for better glucose control among diabetics.

Division Sign-Off

Office of In Vitro Diganost Device Evaluation and Safety

510(k) K062829

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use X (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)