EZ SMART-168 GLUCOSE MONITORING SYSTEM

K052818 · Tyson Bioresearch, Inc. · NBW · Jun 16, 2006 · Clinical Chemistry

Device Facts

• Record ID: K052818
• Device Name: EZ SMART-168 GLUCOSE MONITORING SYSTEM
• Applicant: Tyson Bioresearch, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The EZ SMART-168 Blood Glucose Test Strips are used with the EZ SMART-168 Meter to measure Glucose in whole blood. The EZ SMART-168 Test Strips are for testing outside the body ( in vitro diagnostic use ). The EZ SMART-168 Blood Glucose Monitoring System is intended for use in the home and in the professional settings to monitor blood glucose levels for better glucose level control among diabetics.

Device Story

System uses electrochemical biosensor technology and capillary action to draw small blood samples into a test strip chamber. Meter processes sample to provide glucose concentration results in 10 seconds. Device stores 28 results in memory. Used in home or professional settings by patients or healthcare providers to monitor blood glucose levels for diabetes management. Output displayed on meter screen; informs clinical decision-making regarding glucose control.

Clinical Evidence

Pre-clinical and clinical data were submitted in accordance with FDA guidance for In Vitro Diagnostic Test Systems. No specific performance metrics (e.g., sensitivity, specificity) were provided in the summary document.

Technological Characteristics

Electrochemical biosensor; glucose oxidase/potassium ferricyanide chemistry. Power: 3V Lithium CR 2032 battery. Dimensions: 76x47x16 mm. Weight: 44g. Calibration: Lot-specific via Glucode Chip. Operating range: 10-40°C, 10-90% RH. Standards: EN60601-1-2 (EMC), CLSI EP5-A2, EP6-A, EP7-A, EP9-A.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from the fingertip in persons with diabetes. Intended for home and professional use. In vitro diagnostic use only.

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

• VIP International EZ Smart Blood Glucose Monitoring System (k040848)

Submission Summary (Full Text)

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K052818

JUN 16 2006

# II. 510(K) Summary of Safety and Effectiveness

### (Per 21 CFR 807.92)

### 2.1. General Information Establishment

| Manufacturer: | TYSON BIORESEARCH, INC. |
|----------------------|--------------------------------------------------------------------------------------------------|
| Address: | 5F, No. 22, Ke Tung Rd., Science Based Industrial Park,<br>Chun-Nan, Miao-Li County, 350, Taiwan |
| Registration Number: | 3003132490 |
| Contact Person: | Dr. Jen, Ke-Min<br>Consultant<br>886-3-5208829 (Tel)<br>886-3-5209783 (Fax) |
| Date Submitted: | September 28, 2005 |
| | Device |
| Proprietary Name: | EZ SMART-168 Blood Glucose Monitoring System |
| Common Name: | Blood Glucose Monitoring System |
| Classification Name: | SYSTEM, TEST, BLOOD GLUCOSE, Class II |

### 2.2. Safety and Effectiveness Information

- . Predicate Device:
Claim of Substantial Equivalence (SE) is made to VIP International Wholesalers, Corp. --EZ SMART Blood Glucose Monitoring System ( K040848 ).

- Device Description: . Based on an electrochemical biosensor technology and the principle of capillary action, EZ SMART-168 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

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chamber and your blood glucose result is precisely and displayed in 10 seconds, and 28 blood glucose result memory.

#### Intended Use: ●

The EZ SMART-168 Blood Glucose Test Strips are used with the EZ SMART-168 Meter to measure Glucose in whole blood. The EZ SMART-168 Test Strips are for testing outside the body ( in vitro diagnostic use ). The EZ SMART-168 Blood Glucose Monitoring System is intended for use in the home and in the professional settings to monitor blood glucose levels for better glucose level control among diabetics.

#### 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 the predicate device VIP International Wholesalers, Corp. -- EZ SMART Blood Glucose Monitoring System ( K040848 ). Both of them have the same working principle and technologies. The EZ Smart-168 Test Strip is identical to the EZ Smart Test Strip. Only the meter coding method and memory size changes for more convenient operation of the EZ Smart Blood Glucose Monitoring System.

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Image /page/2/Picture/1 description: The image shows a logo with a circular border containing text that reads 'U.S. Department of Health & Human Services'. Inside the circle is a stylized symbol resembling an eagle or bird in flight, depicted with curved lines. The logo is in black and white and appears to be a standard emblem for the U.S. Department of Health & Human Services.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Tyson Bioresearch Inc. c/o Nathan A. Beaver, Esq. Foley and Lardner 3000 K Street NW Suite 500 Washington DC 20007

JUN 16 2006

Re: k052818

Trade/Device Name: EZ Smart-168 Blood Glucose Monitoring System Regulation Number: 21 CFR§862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: April 7, 2006 Received: April 11, 2006

Dear Mr. Beaver:

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

Sincerely yours,

Alberto Gutt

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

K052818 510(k) Number:

EZ Smart-168 Blood Glucose Monitoring System Device Name:

Indications For Use:

The EZ Smart-168 Blood Glucose Test Strips are used with the EZ Smart-168 Blood Glucose Meter for quantitatively measuring glucose (sugar) in fresh capillary whole blood obtained from the fingertip. The EZ Smart-168 Test Strips are for testing outside the body (in vitro diagnostic use). The EZ Smart-168 Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels in persons with diabetes.

Prescription Use X (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)

Carol C. Benam
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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