EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM

K092894 · Eps Bio Technology Corp. · NBW · Feb 24, 2010 · Clinical Chemistry

Device Facts

• Record ID: K092894
• Device Name: EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM
• Applicant: Eps Bio Technology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 24, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The EasyMax V Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates.

Device Story

EasyMax V SMBG System measures glucose in fresh capillary whole blood via test strips. System includes meter, test strips, and control solutions. Used by patients at home or healthcare professionals in clinical settings to monitor diabetes management. Input is capillary blood sample; meter performs electrochemical analysis to quantify glucose concentration. Output is numerical blood glucose value displayed to user. Results assist in evaluating diabetes control effectiveness. Not intended for diagnostic screening or use by visually impaired individuals or neonates.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation testing confirming that modifications did not alter fundamental scientific technology or intended use.

Technological Characteristics

Electrochemical glucose test system. Consists of a handheld meter, disposable test strips, and liquid control solutions. Operates via enzymatic reaction on test strip to generate electrical signal proportional to glucose concentration. Standalone device.

Indications for Use

Indicated for self-monitoring of blood glucose levels in patients with diabetes.

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.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle. The eagle is depicted with three curved lines representing its body and wings. The logo is in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

EPS Bio Technology Corporation c/o Mr. Y.C. Lei General Manager 2F, No. 49-2, Lane 2, Sec. 2, Guang Fu Road Hsinchu City, China (Taiwan) 30071

FEB 2 L 2010

Re: k092894

Trade/Device Name: EasyMax V SMBG System Regulation Number: 21 CFR 8862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: January 21, 2010 Received: January 25, 2010

Dear Mr. Y.C. Lei:

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); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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

Page 2

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 adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

AC

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

### 510(k) Number (if known): K092894

#### Device Name: EasyMax V SMBG system

Indications for Use:

### EasyMax V SMBG Test System

The EasyMax V Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates.

### EasyMax V Meter

The EasyMax V Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (in Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by heatthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates.

### EasyMax V Blood Glucose Test Strips

The EasyMax V Blood Glucose Test Strips is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates.

## EasyMax V Glucose Control Solutions

For use with the EasyMax V meter and EasyMax V Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use V (21 CFR 801 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)

.

Livesion Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

v 092894 (; ' > '1 .. ' .. ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' '