EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008

K083099 · Eps Bio Technology Corp. · NBW · Jan 16, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083099
• Device Name: EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008
• Applicant: Eps Bio Technology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 16, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The EasyMax N Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm Testing 1s done outside the body (In Vitro diagnostic use) It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control

Device Story

EasyPlus mini EasyMax blood glucose monitoring system; modification of previously cleared device (K082121). Input: capillary whole blood sample via test strip. Transformation: electrochemical measurement of glucose concentration. Output: digital blood glucose reading on meter display. Modification: transition from manual code entry to 'no coding' technology. Used by patients for self-monitoring; provides quantitative glucose results to assist in 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

In vitro diagnostic glucose test system; capillary whole blood analysis; Class II device; Product Codes NBW, CGA.

Indications for Use

Indicated for self-monitoring of blood glucose levels in patients with diabetes.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

EPS B10 Technology Corp c/o Mr Y C Lei General Manager 2F, No 49-2, Lane 2, Guang Fu Rd , Sec 2 Hsinchu City, Tarwan, ROC

JAN 1 6 2009

Re k083099

Trade/Device Name EasyMax N Self-Monitoring Blood Glucose Meter Regulation Number 21 CFR 862 1345 Regulation Name Glucose test system Regulatory Class Class II Product Code NBW, CGA Dated December 19, 2008 Received December 22, 2008

Dear Mr Leı

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 regustration. Insting 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 Iogally marketed predicate device results in a classification for your device and thus, begine to repress 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, "Mısbranding 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 tolloffre and ber [phone] or [phone] or at 1ts Internet address http //www fda gov/cdrh/dsma/dsmamain html

Sincerely yours,

Cory C. Hill

Courtney C Harper, Ph D Acting Director DIVISIOn of Chemistry and Tox1cology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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## Indication for Use

510(k) Number (if known) k083099

Device Name EasyMax N Self Monitoring Blood Glucose Test System

Indication For Use

The EasyMax N Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm Testing 1s done outside the body (In Vitro diagnostic use) It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control

Prescription Use V (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use V (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 (OIVD)

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Division Sign-Off Office of In Vitro Diagnostic Device

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