EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM

K113243 · Eps Bio Technology Corp. · LFR · Mar 28, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113243
• Device Name: EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
• Applicant: Eps Bio Technology Corp.
• Product Code: LFR · Clinical Chemistry
• Decision Date: Mar 28, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The EM50 Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood form 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 no the 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 EM50 meter and the EM50 test strips. The EM50 meter only is used with the EM50 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm. The EM50 Glucose Control Solution For use with EM50 Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

Device Story

EM50 Self Monitoring Blood Glucose System measures glucose in fresh capillary whole blood samples obtained from fingertip, palm, or forearm. System comprises EM50 meter and EM50 test strips; includes EM50 Glucose Control Solution for accuracy verification. Designed for home use (OTC) by single patients with diabetes to monitor effectiveness of diabetes control. Device provides quantitative glucose concentration output to user. Not for use on neonates or for diabetes diagnosis/screening. Alternative site testing limited to steady-state conditions.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Glucose test system consisting of a meter and test strips. Uses electrochemical sensing principle for quantitative glucose measurement in capillary whole blood. Designed for OTC home use.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (fingertip, palm, forearm) for home use by single patients with diabetes to monitor glycemic control. Contraindicated for neonates and for diagnosis or screening of diabetes mellitus. Alternative site testing restricted to steady-state glucose conditions.

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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three wing-like shapes suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

10903 New Hampshire Avenue Silver Spring, MD 20993

EPS Bio Technology Corp. c/o Cynthia Hung No.8 R&D Road III HSINCHU SCIENCE PARK Hsinchu City Taiwan 30077

MAR 2 8 2012

Re: k113243 Re: Trade Name: EM50 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: January 30, 2012 Received: January 31, 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 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/Resourcesfor You/Industry/default.htm

Sincerely yours,

N

Couriney 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: EM50 Self Monitoring Blood Glucose system

Indications for Use:

The EM50 Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood form 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 no the 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 EM50 meter and the EM50 test strips. The EM50 meter only is used with the EM50 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

The EM50 Glucose Control Solution For use with EM50 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__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)

Qnzs

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

510(k) K-113243

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