EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

K112272 · Eps Bio Technology Corp. · LFR · Sep 7, 2011 · Clinical Chemistry

Device Facts

• Record ID: K112272
• Device Name: EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
• Applicant: Eps Bio Technology Corp.
• Product Code: LFR · Clinical Chemistry
• Decision Date: Sep 7, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The devices are intended for single (EM44) and multiple patient use (EM44 Pro).

Device Story

System measures glucose in fresh capillary (fingertip, palm, forearm) or venous whole blood; utilizes electrochemical biosensor technology via test strips; meter provides quantitative glucose concentration readout. EM44 intended for home use by patients; EM44 Pro intended for professional use in clinical settings. Healthcare providers/patients use output to monitor diabetes control effectiveness. System includes glucose control solution for accuracy verification. Benefits include rapid, point-of-care glucose assessment for diabetes management.

Clinical Evidence

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

Technological Characteristics

Electrochemical glucose test system; consists of meter, test strips, and control solution. Quantitative measurement of glucose in whole blood. Designed for in vitro diagnostic use.

Indications for Use

Indicated for patients with diabetes requiring blood glucose monitoring. EM44 (OTC) for single-patient home use; EM44 Pro for professional healthcare settings (multiple-patient use). Not for neonates, diagnosis, or screening of diabetes mellitus. Alternative site testing restricted to steady-state 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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Public Health Service

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

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EPS Bio Technology Corp. c/o Y.C. Lei General Manager No.8 R&D Rd III. Hsinchu Science Park Hsinchu City, Hsinchu China (Taiwan) 300

Re: k112272

Trade Name: EM44 Pro and EM44 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: August 2, 2011 Received: August 8, 2011

Dear Mr. 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 111 (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 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 Viro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 800 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 regoring 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] for ( 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/or You/Industry/default.htm.

Sincerely yours,

jz

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

510(k) Number (if known): k112272

### Device Name: EM44 Self Monitoring Blood Glucose System

Indications For Use:

The EM44 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 EM44 meter and the EM44 test strips. The EM44 meter only is used with the EM44 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

### The EM44 Glucose Control Solution

For use with EM44 Self Monitoring Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use X (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE: CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Division Sign-Off

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

510(k) K112272

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# Indications for Use

510(k) Number (if known): k112272

Device Name: EM44 Pro Self Monitoring Blood Glucose System

Indications For Use:

The EM44 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. Alternative site testing can be only used during steady-state blood glucose conditions.

The system consists of the EM44 Pro meter and the EM44 Pro test strips. The EM44 Pro meter only is used with the EM44 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.

#### The EM44 Glucose Control Solution

For use with EM44 Pro Self Monitoring Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.

Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use X (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

signature

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

510(k) K112272