EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

K111728 · Eps Bio Technology Corp. · CGA · Sep 16, 2011 · Clinical Chemistry

Device Facts

• Record ID: K111728
• Device Name: EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
• Applicant: Eps Bio Technology Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Sep 16, 2011
• 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 (EMV3 Self Monitoring Blood Glucose Test System) and multiple patient use in a professional healthcare setting (EMV3 Pro Self Monitoring Blood Glucose System).

Device Story

The EMV3 and EMV3 Pro are blood glucose monitoring systems used for quantitative glucose measurement in capillary whole blood. These devices are modifications of the EasyMax V system (k092894), featuring updated physical appearance, modified power button, and new trade names. The systems are intended for home use by patients or professional use in healthcare settings. The device utilizes disinfection protocols validated with PDI Super SANI-CLOTH Germicidal wipes to prevent bloodborne pathogen transmission, specifically HBV. Robustness testing confirmed performance stability after 10,000 cleaning and disinfection cycles, simulating over 4 years of home use or 3 years of professional use. The output is a blood glucose concentration value, which assists healthcare providers and patients in monitoring diabetes management.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and performance verification of the glucose measurement system.

Technological Characteristics

Electrochemical glucose test system; consists of meter and test strips. Measures glucose in capillary whole blood. Includes quality control solution. Professional version (EMV3 Pro) restricted to fingertip; home version (EMV3) supports fingertip and forearm (alternative site testing).

Indications for Use

Indicated for quantitative measurement of glucose in capillary whole blood as an aid in monitoring the effectiveness of diabetes control programs.

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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

8 1 8 2017

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

Re: k111728

> Trade Name: EMV3 Self Monitoring Blood Glucose System EMV3 Pro Self Monitoring Blood Glucose System

Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System. Regulatory Class: Class II Product Codes: NBW : CGA Dated: July 22, 2011 Received: August 19, 2011

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); medical device reporting (reporting of medical device-related adverse events) (21 CIFR 803): and good manufacturing practice requirements as set forth in the quality svstems (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 contact the Office of In Viro Diagnostic Device Evaluation and Safety at [phone]. Also, please con 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 revoring 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 (1 01 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/des/11/11/1

Sincerely yours,

j

Courtney H. Lias, 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 Form

510(k) Number (if known): k111728

## Device Name: EMV3 Pro Self Monitoring Blood Glucose system

Indications for Use:

The EMV3 Pro Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in 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 EMV3 Pro meter and the EMV3 Pro test strips. The EMV3 Pro meter only is used with the EMV3 Pro test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip.

#### The EMV3 Glucose Control Solution

For use with the EMV3 Pro 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 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)

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

510(k) K111728

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# Indications for Use Form

510(k) Number (if known): k111728

#### Device Name: EMV3 Self Monitoring Blood Glucose system

Indications for Use:

The EMV3 Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip 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 EMV3 meter and the EMV3 test strips. The EMV3 meter only is used with the EMV3 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip or forearm.

#### The EMV3 Glucose Control Solution

For use with EMV3 Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

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

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)

Signature

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

510(k) k-111728

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