EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM

K072441 · Tyson Bioresearch, Inc. · NBW · Mar 25, 2008 · Clinical Chemistry

Device Facts

• Record ID: K072441
• Device Name: EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Tyson Bioresearch, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The EZ Scan Plus Glucose Test Strips are used with the EZ Scan Plus Blood Glucose Meter for quantitatively measuring glucose (glucose) in fresh capillary whole blood drawn from the fingertip and the alternate sites: palm and forearm. The EZ Scan Plus Test Strips are for testing outside the body (in vitro diagnostic use). The EZ Scan Plus 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.

Device Story

EZ Scan Plus Blood Glucose Monitoring System uses electrochemical biosensor technology to measure glucose in capillary whole blood. User applies blood sample to test strip via capillary action; meter performs amperometric assay using glucose oxidase enzyme. Meter requires manual entry of calibration code found on test strip bottle. System displays glucose concentration in 10 seconds. Intended for home use by patients or clinical use by professionals. Output aids in monitoring diabetes control effectiveness. Device provides quantitative results to inform patient management decisions.

Clinical Evidence

Clinical alternate site testing performed to validate use of palm and forearm samples. Results compared to finger stick whole blood samples. Study demonstrated that alternate site results are similar to fingertip results with no effect on clinical action. Bench testing evaluated temperature, humidity, hematocrit levels, sensitivity, and linearity.

Technological Characteristics

Electrochemical biosensor; glucose oxidase enzyme; amperometric detection. Dimensions/form factor: handheld meter with single-use test strips. Connectivity: none. Calibration: manual code entry. Sterilization: not applicable. Software: embedded firmware.

Indications for Use

Indicated for persons with diabetes or clinical patients requiring blood glucose monitoring. Measures glucose in fresh capillary whole blood from fingertip, palm, or forearm. For in vitro diagnostic 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

• EZ Smart – 168 Blood Glucose Monitoring System (k052818)

Submission Summary (Full Text)

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K072441

## 510(k) SUMMARY

MAR 2 5 2008

#### 1. DATE PREPARED

August 18, 2007

#### 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: | EZ Scan Plus 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 EZ Scan Plus 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. EZ Scan Plus device provides a convenient and safe monitoring system for diabetes health care professionals, hospitals and most importantly, people with diabetes.

The EZ Scan Plus Blood Glucose Test Strips are used with the EZ Scan Plus Blood Glucose Meter to quantitatively measure glucose in capillary whole blood obtained from the fingertip and the alternate sites: palm and forearm. When the edge of the EZ Scan Plus Test Strip is touched to a drop of blood, the test strip draws the blood into the

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sample chamber and the glucose reading is displayed 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 EZ Scan Plus 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 EZ Scan Plus Blood Glucose Test Strips are used with the EZ Scan Plus Blood Glucose Meter for quantitatively measuring glucose (sugar) in fresh capillary whole blood drawn from the fingertip and the alternate sites: palm and forearm. The EZ Scan Plus Test Strips are for testing outside the body (in vitro diagnostic use). The EZ Scan Plus 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.

#### 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 EZ Scan Plus 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. EZ Scan Plus Blood Glucose Monitoring System in this submission is equivalent to the Tyson Bioresearch Inc. EZ Scan Plus Blood Glucose Monitoring System is the modification of EZ Smart-168 Blood Glucose Monitoring System. The modifications encompass the meter coding method, PCB size, meter

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appearance and new indication for use (Alternate Site Testing). All main meter internal electronic components, meter functions and detection algorithm remain the same. EZ Scan Plus Test Strip is also identical to the EZ Smart-168 Test Strip, only the size changed for more convenient use. Fundamental scientific technology of the EZ Scan Plus device has not changed.

#### Substantial Equivalence Comparison:

The Tyson Bioresearch Inc. EZ Scan Plus 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>EZ Scan Plus |
|---------------------------|----------------------------------------------------|---------------------------------|
| Test Principle | Electrochemical biosensor with<br>glucose oxidase. | identical |
| Test Strips | EZ Smart-168 Test Strip | EZ Scan Plus Test Strip |
| Specimen Type | Capillary whole blood | identical |
| Sample Volume | Around 1.5 uL | identical |
| Measuring Time | 10 sec | identical |
| Detecting Range | 20 ~ 600 mg/dL | identical |
| Unit of measurement | mg/dL or mmol/L | identical |
| HCT Range | 35 ~55 % | identical |
| Operating Temperature | 10 to 40 ℃ (50-104°F) | identical |
| Operating Humidity | 10 to 90% | identical |
| Average result | 28 tests average | identical |
| Memory capacity | 28 Test Results | identical |
| Strip Storage Temperature | 4 to 30 ℃ (40-86°F) | identical |
| Control Solution | 3 Levels available | identical |
| Button Design | one button | identical |
| Battery Power | One 3 V Lithium CR 2032 battery | identical |

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#### Differences:

| Item | Predicate Device<br>EZ Smart-168 (K052818) | Proposed Device<br>EZ Scan Plus |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intend Use | The EZ Smart-168 Blood Glucose Test<br>Strips are used with the EZ Smart-168<br>Blood Glucose Meter for quantitatively<br>measuring glucose (sugar) in fresh<br>capillary whole blood drawn from the<br>fingertip. Testing is done outside the<br>body (in vitro diagnostic use). It is<br>intended for use at home (over the<br>counter [OTC]) by persons with<br>diabetes, or in clinical setting by<br>healthcare professionals as an aid in<br>monitoring the effectiveness of diabetes<br>control. | The EZ Scan Plus Blood Glucose Test<br>Strips are used with the EZ Scan Plus<br>Blood Glucose Meter for quantitatively<br>measuring glucose (sugar) in fresh<br>capillary whole blood drawn from the<br>fingertip and the alternate sites: palm<br>and forearm. Testing is done outside the<br>body (in vitro diagnostic use). It is<br>intended for use at home (over the<br>counter [OTC]) by persons with<br>diabetes, or in clinical setting by<br>healthcare professionals as an aid in<br>monitoring the effectiveness of diabetes<br>control. |
| Blood source | fingertip | Fingertip, palm and forearm |
| Meter Coding | Glucode Chip | EZ Scan Plus Test Strip |
| Test Strips size | 33.5 x 5 (mm) | 33.5 x 7 (mm) |
| Meter Dimension | 76 x 47 x 16 (mm) | 102 x 52 x 17 (mm) |
| PCB Size | 72 x 42 (mm) | 92 x 44 (mm) |
| LCD Display | 40 x 21.5 (mm) | 37.5 x 34 (mm) |
| Meter Weight | 44 grams | 55 grams |

#### 8. PERFORMANCE CHARACTERISTIC SUMMARY

Based on the above information, we know the subject device, EZ Scan Plus Blood Glucose Monitoring System, and the predicate device have the same 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 EZ Scan Plus from EZ Smart-168 Blood Glucose Monitoring System are the meter coding method, meter dimension, weight, PCB size and new intended use - for alternate site testing. All internal electrical architectures and main electronic components as well as product functions and features remain unchanged. EZ Scan Plus 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.

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As we can see, the differences are due to the feature design aspects for more easy use of the EZ Scan Plus Blood Glucose Monitoring System, not relating to the safety or effectiveness aspects. Fundamental scientific technology of the EZ Scan Plus device has not changed. An evaluation of the EZ Scan Plus Blood Glucose Monitoring System was conducted under various conditions including temperature effects, humidity effects, hematocrit levels, sensitivity and linearity. The results of the evaluation demonstrate that EZ Scan Plus Blood Glucose Monitoring System is substantially equivalent to the originally cleared EZ Smart-168 Blood Glucose Monitoring System (K052818).

The results of clinical alternate site testing demonstrate that the results obtained from the alternate site sampling using EZ Scan Plus system, are similar to those obtained from finger stick whole blood with no effect on clinical action. EZ Scan Plus system provides the users an option to use the palm and forearm in addition to the fingertip to collect capillary blood for self monitoring of blood glucose within certain conditions as explained in product user's manual. EZ Scan Plus is suitable for its intended use.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Tyson BioResearch, Inc. c/o Mr. Wen-Hai Tsai 5F, #22, Ke E. Road III Science-Based Industrial Park Chu-Nan, Miao-Li County 350 Taiwan (ROC)

MAR 2 5 2008

Re: k072441

Trade Name: EZ Scan Plus Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA Dated: February 21, 2008 Received: February 25, 2008

Dear Mr. 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).

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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.

Yean 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

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# Indication for Use

510(k) Number (if known):

Device Name:

Indication For Use:

The EZ Scan Plus Blood Glucose Test Strips are used with the EZ Scan Plus Blood Glucose Meter for quantitatively measuring glucose (sugar) in fresh capillary whole blood drawn from the fingertip and the alternate sites: palm and forearm. The EZ Scan Plus Test Strips are for testing outside the body (in vitro diagnostic use). The EZ Scan Plus 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.

Prescription Use (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use _ X (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)

Carol C Benner

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K072441

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