EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005

K082121 · Eps Bio Technology Corp. · CGA · Sep 17, 2008 · Clinical Chemistry

Device Facts

• Record ID: K082121
• Device Name: EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005
• Applicant: Eps Bio Technology Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Sep 17, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The EasyPlus mini EasyMax 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. The EasyPlus mini EasyMax Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini EasyMax Blood Glucose Test Strips must be used with the EasyPlus mini EasyMax Meter. 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. The EasyPlus mini EasyMax Blood Glucose Test Strips , are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini EasyMax Blood Glucose Test Strips must be used with the EasyPlus mini EasyMax Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter IOTCI) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. The EasyPlus mini EasyMax Glucose Normal/High Control Solution For use with the EasyPlus mini EasyMax meter and EasyPlus mini EasyMax Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Device Story

System measures glucose in capillary whole blood via electrochemical test strips and handheld meter; used by patients (home) or clinicians (clinical settings) to monitor diabetes control. Input: fresh capillary blood sample applied to test strip. Operation: electrochemical reaction on strip analyzed by meter. Output: quantitative blood glucose concentration displayed on meter screen. Benefit: provides real-time glucose data to assist in diabetes management.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and performance verification of the glucose monitoring system.

Technological Characteristics

Electrochemical glucose test system; handheld meter with disposable test strips; capillary blood sample; quantitative measurement; in vitro diagnostic use.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (fingertip/forearm) for persons with diabetes (home/OTC) or clinical settings to monitor diabetes control effectiveness.

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)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - (U.S.)" are arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

SEP 1 7 2008

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k082121

Trade Name: EasyPlus Mini Easy Max Self-Monitoring Blood Glucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA, JJY Dated: September 09, 2008 Received: September 12, 2008

Dear 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); 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.

Sincercly 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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# Indications for Use

## 510(k) Number (if known): K082121

### Device Name: EasyPlus mini EasyMax Self-Monitoring Blood Glucose System

#### Indications For Use:

The EasyPlus mini EasyMax Self Monitoring Blood Glucose Test System The EasyPlus mini EasyMax 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.

#### The EasyPlus mini EasyMax Meter

The EasyPlus mini EasyMax Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini EasyMax Blood Glucose Test Strips must be used with the EasyPlus mini EasyMax Meter. 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.

#### The EasyPlus mini EasyMax Blood Glucose Test Strips

The EasyPlus mini EasyMax Blood Glucose Test Strips , are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini EasyMax Blood Glucose Test Strips must be used with the EasyPlus mini EasyMax Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter IOTCI) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

#### The EasyPlus mini EasyMax Glucose Normal/High Control Solution

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

V Prescription Use

Over-The-Counter Use _ AND/OR

V

(Part 21 CFR 801 Subpart D)

(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) IVISIOn Sign-Off

# Office of In Vitro Diagnostic Device

Evaluation and Sefety

KO82121