EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS

K090629 · Tyson Bioresearch, Inc. · NBW · Jun 4, 2009 · Clinical Chemistry

Device Facts

• Record ID: K090629
• Device Name: EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS
• Applicant: Tyson Bioresearch, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 4, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Easy Step / DIACHEX PRO Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The Easy Step / DIACHEX* PRO Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System is intended for use at home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions. It is not intended for neonatal testing.

Device Story

Blood glucose monitoring system; measures glucose in capillary whole blood samples. Modifications include: addition of backlight; graphic indicator for pre/post-meal results; aesthetic changes; removal of hypo/hyperglycemic alarms; conversion to no-coding technology; automatic PC link mode activation upon USB connection. Used by patients at home for diabetes management. Output displayed on meter screen; used by patients to monitor glucose levels and adjust diabetes control programs. Data transferable to PC via USB.

Clinical Evidence

Clinical accuracy assessed in 129 participants (male/female) with glucose range 33.2–577 mg/dL and hematocrit 34%–53%. Results compared to YSI laboratory method. ISO 15197 compliance achieved: 98.4%–99.2% of fingertip results within ±15 mg/dL (<75 mg/dL) or ±20% (≥75 mg/dL). Bench testing included precision, linearity, and interference studies.

Technological Characteristics

Electrochemical biosensor; glucose oxidase enzyme; potassium ferricyanide mediator. Measures current generated by electron release. Range: 20–600 mg/dL. Connectivity: USB for PC link. Form factor: handheld meter with LCD. Power: battery-operated. Sterilization: not specified.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (finger, palm, forearm, upper arm, calf, thigh) for diabetes management by patients at home. Not for diabetes diagnosis/screening or 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

• Diachex Determine and Diachex Infinity blood glucose monitoring system (k073492)

Submission Summary (Full Text)

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K090629

### 510(k) SUMMARY

#### 1. DATE PREPARED

February 20, 2009

#### JUN - 4 2009 2. SPONSOR INFORMATION

## Address

TYSON BIORESEARCH. INC.

5 F., # 22, KE E. ROAD III., SCIENCE BASED INDUSTRIAL PARK CHUN-NAN, MIAO-LI COUNTY, CHINA (TAIWAN) 350

Contact Person: WEN-HAI TSAI

BHONE: 886-37-585988 FACSIMILE: 886-37-585996

### 3. NAME OF DEVICE:

Trade Name:

Easy Step Blood Glucose Monitoring System DIACHEX* PRO Blood Glucose Monitoring System

Common Names/Descriptions: Blood Glucose Monitoring System Classification Names: 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 Easy Step / DIACHEX* PRO Blood Glucose Monitoring System designed by Tyson Bioresearch Inc., an amperometric biosensor, is adopted for its ease of use, its ability to process accurate results utilizing only a small volume of blood, and its quick response time. Easy Step / DIACHEX* PRO provide a convenient and safe monitoring system for diabetes health care professionals, hospitals and most importantly, people with diabetes.

The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The Easy Step / DIACHEX* PRO Blood Glucose Test Strips are for testing outside the

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body (in vitro diagnostic use). When the edge of the 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 on the meter after 5 seconds. The test measures glucose from 20 mg/dL (1.1mmol/L) to 600 mg/dL (33.3 mmol/L). The 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 Easy Step / DIACHEX* PRO Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The Easy Step / DIACHEX* PRO Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System is intended for use at home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions. It is not intended for neonatal testing.

#### 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 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): DIACHEX* INFINITY Blood Glucose Monitoring System

Predicate 510(k) number(s): k073492

Comparison with predicate:

This 510(K) amendment addresses the changes of the DIACHEX* INFINITY Blood

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Glucose Monitoring System (k073492). The modifications encompass the change for operating process, addition of selectable backlight on/off function, addition of graphic indicator for pre-meal and post-meal test results on the LCD result display of Easy Step / DIACHEX* PRO meter and the removal of hypoglycemic and hyperglycemic alarm setting function and the change for meter outside looking of Easy Step Glucose meter only. All the main internal electronic component, function and detection algorithm of proposed devices remain the same as DIACHEX* INFINITY Blood Glucose Meter. The chemical formula and used enzyme of the Easy Step / DIACHEX* PRO test strip is identical to the original cleared device test strip (K062829) without ant change. The table below lists the differences between the Easy Step and DIACHEX* PRO device from the predicate DIACHEX* INFINITY device.

| Item | Predicate Device (K073492) | Proposed Device | |
|-----------------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------|
| | DIACHEX* INFINITY | Easy Step | DIACHEX* PRO |
| Hypoglycemic and<br>hyperglycemic alarm | 2 user setting alarms | none | 2 user setting alarms |
| Backlight | none | Selectable backlight on/off by user | |
| LCD Display | Image: DIACHEX INFINITY LCD Display | Increase pre/pro meal test result indicator<br>Image: DIACHEX PRO LCD Display | |
| Coding | Fixed code | Fixed code | Glucode chip |
| PC link mode | Enter PC link mode by setting meter | Automatically enter PC link mode when<br>plugging in the USB cable | |
| Memory mode | Press M button to read average and<br>300 test result memories | Press M button to read 300 test result<br>memories, press S button to read<br>average results | |
| Meter Appearance | Image: DIACHEX INFINITY Meter Appearance | Image: Easy Step Meter Appearance | Image: DIACHEX PRO Meter Appearance |
| Meter Size | 92 x 58 x 19 (mm) | 79 x 60 x 17 (mm) | 92 x 58 x 19 (mm) |
| Meter Weight | Appx. 60 grams | Appx. 55 grams | Appx. 60 grams |

Differences:

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### 8. PERFORMANCE CHARACTERISTIC SUMMARY

Within day precision test was performed with 5 levels of spiked whole blood each with one lot test strip. Samples were tested with 100 measurements obtained from 10 meters with each level of blood sample. Results are summarized below.

| Unit:mg/dL | | YSI | AVG | Bias % | Std | CV % |
|---------------------|----------------------|------|-------|--------|------|------|
| Proposed<br>Device | Easy Step | 43.8 | 42.6 | -2.8 | 2.47 | 5.80 |
| | | 87.8 | 85.1 | -3.1 | 2.92 | 3.43 |
| | | 132 | 135.7 | 2.8 | 4.65 | 3.42 |
| | | 206 | 209.2 | 1.5 | 4.98 | 2.38 |
| | | 320 | 323.4 | 1.0 | 6.72 | 2.08 |
| | DIACHEX*<br>PRO | 45.6 | 45.3 | -0.6 | 2.30 | 5.08 |
| | | 82.1 | 83.8 | 2.1 | 3.04 | 3.62 |
| | | 126 | 124.5 | -1.2 | 3.76 | 3.02 |
| | | 224 | 219.4 | -2.0 | 5.63 | 2.56 |
| | | 337 | 334.3 | -0.8 | 7.25 | 2.17 |
| Predicate<br>Device | DIACHEX*<br>INFINITY | 39.7 | 40.7 | 2.6 | 2.22 | 5.45 |
| | | | 92.4 | 89.3 | -3.4 | 2.45 |
| | | | 136 | 139.2 | 2.4 | 4.50 |
| | | | 243 | 240.0 | -1.2 | 5.49 |
| | | | 354 | 349.0 | -1.4 | 7.09 |

Linearity test was performed with 10 levels of spiked whole blood. Samples were tested with 10 measurements obtained from 10 meters with each level of blood sample using one lot test strip. The linear response range of proposed meter was defined from 20 to 600 mg/dL. and the actual studies were performed from ~25 to ~566 mg/dL. Linear regression results compared to YSI are summarized below.

| Device | Proposed Device | Predicate Device | |
|-----------|-----------------|------------------|-------------------|
| | Easy Step | DIACHEX* PRO | DIACHEX* INFINITY |
| Slope | 1.01 | 1.00 | 1.01 |
| Intercept | -1.11 | 0.41 | -0.23 |
| R2 | 0.9997 | 0.9996 | 0.9998 |
| sy.x | 5.45 | 6.66 | 6.77 |

To ensure that Easy Step, DIACHEX* PRO and DIACHEX* INFINITY system

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similarly, clinical accuracy was assessed in an in-house study performing by technician.129 participants both males and females ranged from age with sample ranged from 33.2 to 577mg/dL and hematocrit ranged from 34% to 53%. Values obtained from meters were compared to YSI results; linear results regression analysis yielded the following results:

| Fingertip | Proposed Devices | | Predicate Device |
|-----------|------------------|--------------|-------------------|
| | Easy Step | DIACHEX* PRO | DIACHEX* INFINITY |
| N | 129 | 129 | 129 |
| Slope | 1.03 | 1.01 | 1.02 |
| Intercept | 2.18 | 3.10 | 1.44 |
| R2 | 0.9887 | 0.9890 | 0.9871 |

The alternate site testing was also been evaluated.

| Easy Step | Finger vs YSI | Palm vs YSI | Palm vs Finger | Forearm vs YSI | Forearm vs Finger |
|-----------|---------------|-------------|----------------|----------------|-------------------|
| N | 113 | 113 | 113 | 113 | 113 |
| Slope | 1.03 | 1.01 | 0.98 | 1.01 | 0.97 |
| Intercept | 2.99 | 3.06 | 1.92 | 0.81 | 0.43 |
| R2 | 0.9797 | 0.9767 | 0.9871 | 0.9734 | 0.9753 |

| DIACHEX*<br>PRO | Finger vs YSI | Palm vs YSI | Palm vs Finger | Forearm vs YSI | Forearm vs Finger |
|-----------------|---------------|-------------|----------------|----------------|-------------------|
| N | 113 | 113 | 113 | 113 | 113 |
| Slope | 1.02 | 1.01 | 0.99 | 1.03 | 1.00 |
| Intercept | 4.92 | 3.02 | 0.58 | -2.72 | -3.97 |
| R2 | 0.9815 | 0.9769 | 0.9856 | 0.9705 | 0.9659 |

| DIACHEX*<br>INFINITY | Finger vs YSI | Palm vs YSI | Palm vs Finger | Forearm vs YSI | Forearm vs Finger |
|----------------------|---------------|-------------|----------------|----------------|-------------------|
| N | 113 | 113 | 113 | 113 | 113 |
| Slope | 1.02 | 1.02 | 0.98 | 1.02 | 0.99 |
| Intercept | 2.53 | -0.40 | -0.45 | -1.08 | -1.42 |
| R2 | 0.9770 | 0.9763 | 0.9739 | 0.9759 | 0.9766 |

The acceptable criteria is the ISO 15197 requirement of 95% of individual glucose results falling within ±15mg/dL at glucose concentration for samples <75mg/dL and within ±20% at glucose concentrations≥75mg/dL. The samples that met the ISO 15197 requirement were summarized in the table below.

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| Device | Proposed device | | Predicate device |
|-------------|-----------------------|-----------------------|----------------------|
| Sample Site | Easy Step | DIACHEX* PRO | DIACHEX* INFINITY |
| Finger | 98.4%<br>(127 / 129) | 99.2%<br>(128 / 129 ) | 100%<br>(129 / 129) |
| Palm | 100.0%<br>(113 / 113) | 98.2%<br>(111 / 113 ) | 98.2%<br>(111 / 113) |
| Forearm | 98.2%<br>(111 / 113) | 96.5%<br>(109 / 113 ) | 97.3%<br>(110 / 113) |

From the above test results, we conclude that the modification of the DIACHEX* INFINITY Meter do not affect the effectiveness and safety of the device. The proposed device Easy Step / DIACHEX* PRO Blood Glucose Monitoring System is substantial equivalent to the original cleared device. The performance characteristics of the proposed system under various conditions including temperature effect, altitude effect, hematocrit levels, interference study, sensitivity and linearity has been established in the previously device cleared under k073492. Easy Step / DIACHEX* PRO system are suitable for its intended use. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a caduceus or a staff with a snake winding around it.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

k090629 Re:

> Trade/Device Name: Easy Step/DIACHEX PRO Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: May 4, 2009 Received: May 5, 2009

Dear Dr. Tsai:

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).

JUN - 4 2009

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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 advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr.

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 http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

At. H.

Courtney C. Harper, Ph.D. Acting 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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# Indication for Use

11090629 510(k) Number (if known):

Device Name: Easy Step / DIACHEX* PRO Blood Glucose Monitoring System

Indication for Use:

The Easy Step / DIACHEX PRO Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The Easy Step / DIACHEX* PRO Blood Glucose Test Strips are for testing outside the body (in vitro . diagnostic use). The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System is intended for use at home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions. It is not intended for neonatal testing.

Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k090629