EASYMATE BLOOD GLUCOSE MONITORING SYSTEM

K053312 · Bioptik Technology, Inc. · NBW · Mar 1, 2006 · Clinical Chemistry

Device Facts

• Record ID: K053312
• Device Name: EASYMATE BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Bioptik Technology, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The self-testing EasyMate Blood Glucose Monitoring System is indicated for use by healthcare professionals and persons with diabetes to measure glucose values in capillary, finger stick whole blood. Frequent monitoring of whole blood glucose is an adjunct to the care of persons with diabetes.

Device Story

EasyMate Blood Glucose Monitoring System is an in vitro diagnostic device for quantitative glucose measurement in capillary whole blood. Used by healthcare professionals and patients with diabetes for self-testing. System consists of a meter and test strips. Operates via electrochemical biosensor technology; blood sample applied to test strip; meter measures electrical current proportional to glucose concentration. Provides digital readout of blood glucose levels. Assists in diabetes management by providing frequent monitoring data. Used in clinical settings or home environments.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on technological characteristics and performance typical of glucose test systems.

Technological Characteristics

Electrochemical biosensor; glucose oxidase (Aspergillus niger) enzyme. Hand-held meter with electronic calibration key for lot-specific data. Measures glucose 20-600 mg/dL; hematocrit range 30-55%. Operating temperature 57.2°F–104°F; altitude up to 8000 ft. Connectivity: standalone device with 70-measurement memory. Software-based current-to-glucose conversion algorithm.

Indications for Use

Indicated for healthcare professionals and persons with diabetes for self-testing of capillary fingerstick whole blood glucose. No specific age or gender restrictions provided. Contraindicated for use with therapeutic agents L-Dopa and Dopamine due to interference.

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/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing right. The eagle is composed of three curved lines. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" in a circular arrangement.

Public Health Service

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

MAR I 2006

Bioptik Technology, Inc. c/o Mr. Eric Luo. Ph.D. 6833 St. Lawrence Street Plano, TX 75024

> k053312 Trade/Device Name: EasyMate Blood Glucose Monitoring System Regulation Number: 21 CFR§862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, JJY Dated: January 27, 2006 Received: January 30, 2006

Dear Dr. Luo:

Re:

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).

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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.

If you desire specific information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97), 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/cdrh/industry/support/index.html.

Sincerely yours,

Alberto G. A.

Alberto Gutierrez, 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):_K053312

Device Name: EasyMate Blood Glucose Monitoring System

Indications For Use:

The self-testing EasyMate Blood Glucose Monitoring System is indicated for use by healthcare professionals and persons with diabetes to measure glucose values in capillary, finger stick whole blood. Frequent monitoring of whole blood glucose is an adjunct to the care of persons with diabetes.

Prescription Use (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)

C.A.C.

Division Bign-Off

Office of In Vitro Diagnostic Device Ev-luation and Safety

0533/2

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