EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

K112901 · Eps Bio Technology Corp. · LFR · Dec 23, 2011 · Clinical Chemistry

Device Facts

• Record ID: K112901
• Device Name: EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
• Applicant: Eps Bio Technology Corp.
• Product Code: LFR · Clinical Chemistry
• Decision Date: Dec 23, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The EME 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 EME meter and the EME test strips. The EME meter only is used with the EME test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm. The EME Glucose Control Solution For use with EME Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results. The EME 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 EME Pro meter and the EME Pro test strips. The EME Pro meter only is used with the EME Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip. The EME Glucose Control Solution For use with the EME Pro Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

Device Story

The EME and EME Pro systems are blood glucose monitoring devices. They utilize test strips to measure glucose concentrations in fresh capillary (fingertip, palm, forearm) or venous whole blood. The system consists of a meter and test strips, supported by a control solution for accuracy verification. The EME system is designed for single-patient home use, while the EME Pro is intended for multiple-patient use in professional clinical settings. Users apply a blood sample to the test strip, which the meter analyzes to provide a quantitative glucose reading. This output assists healthcare providers and patients in monitoring diabetes control. The devices are not intended for neonatal use or diabetes diagnosis.

Clinical Evidence

No clinical data. Bench testing only. Disinfection efficacy studies demonstrated complete inactivation of Hepatitis B Virus (HBV) using PDI Super SANI-CLOTH Germicidal wipes. Robustness testing confirmed no performance degradation after 20,000 disinfection cycles for the meter and 14,600 cycles for the lancing device.

Technological Characteristics

Glucose test system (21 CFR 862.1345). Consists of a meter, test strips, and control solution. Measures glucose in capillary or venous whole blood. Intended for in vitro diagnostic use.

Indications for Use

Indicated for single patient home use (EME Self Monitoring Blood Glucose System) and multiple patient use in a professional healthcare setting (EME Pro Self Monitoring Blood Glucose System) for blood glucose monitoring.

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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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a caduceus, which is a symbol often associated with healthcare.

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, 30077 Taiwan

DEC 2 3 2011

Re: k112901

Trade/Device Name: EME Self Monitoring Blood Glucose System, EME Pro Self Monitoring Blood Glucose System

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: LFR, NBW Dated: November 29, 2011 Received: December 1, 2011

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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.

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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 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/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 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/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Courtney 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: EME Self Monitoring Blood Glucose system

Indications for Use:

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

## The EME Glucose Control Solution

For use with EME 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)

signature

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

510(k) k 112901

Page 1 of 2

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## Indications for Use

510(k) Number (if known):

Device Name: EME Pro Self Monitoring Blood Glucose system

Indications for Use:

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

#### The EME Glucose Control Solution

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

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

Over-The-Counter Use X

(Part 21 CFR 801 Subpart D)

(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) K112901

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