EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

K121207 · Eps Bio Technology Corp. · LFR · May 18, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121207
• Device Name: EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
• Applicant: Eps Bio Technology Corp.
• Product Code: LFR · Clinical Chemistry
• Decision Date: May 18, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is intended for single patient home use (EASYMAX MU Self-monitoring Blood Glucose System) and multiple patient use in a professional healthcare setting (EASYMAX MU Pro Self-monitoring Blood Glucose System).

Device Story

EasyMax MU/MU Pro systems measure glucose in whole blood samples; electrochemical biosensor technology; test strips inserted into handheld meter; meter displays quantitative glucose concentration; used by patients (home) or healthcare professionals (clinical); aids diabetes management; results inform glycemic control decisions; control solution verifies accuracy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrochemical glucose biosensor; handheld meter with disposable test strips; quantitative measurement; battery-powered; non-sterile.

Indications for Use

Indicated for the quantitative measurement of glucose in fresh capillary whole blood from the finger, palm, or forearm by people with diabetes at home or by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control.

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

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#### Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

EPS Bio Technology Corp c/o Cynthia Hung No.8 R & D Rd III Hsinchu Science Park Hsinchu City, China (Taiwan) 30077

MAY 1 8 2012

Re: k121207

> Trade Name: EasyMax MU Self Monitoring Blood Glucose System, EasyMax MU Pro Self Monitoring Blood Glucose System

Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: LFR, NBW, JJX Dated: April 16, 2012 Received: April 20, 2012

Dear Ms Hung:

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 (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).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice so: your stic Device Evaluation and Safety at [phone]. Also, common the office of in 1 reso Diage Misbranding by reference to premarket notification" (21 productions increations regarding postmarket surveillance, please contact CDRH is Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) Office of Surveinance and Drolling of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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 Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address [phone] 00 v/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Courney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices 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):

Device Name: EasyMax MU Self Monitoring Blood Glucose system

Indications for Use:

The EasyMax MU Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

The system consists of the EasyMax MU meter and the EasyMax MU test strips. The EasyMax MU meter only is used with the EasyMax MU test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

#### The EasyMax MU Glucose Control Solution

For use with EasyMax MU Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (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)

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

510(k) K12120

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# Indications for Use

510(k) Number (if known):

Device Name: EasyMax MU Pro Self Monitoring Blood Glucose system

Indications for Use:

The EasyMax MU Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.

The system consists of the EasyMax MU Pro meter and the EasyMax MU Pro test strips. The EasyMax MU Pro meter only is used with the EasyMax MU Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.

### The EasyMax MU Glucose Control Solution

For use with the EasyMax MU Pro Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood qlucose test results.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use

(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)

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

510(k) K121207

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