EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM

K091481 · Eps Bio Technology Corp. · NBW · Aug 18, 2009 · Clinical Chemistry

Device Facts

• Record ID: K091481
• Device Name: EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM
• Applicant: Eps Bio Technology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 18, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The EasyPlus mini R13N SMBG Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is 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. The EasyPlus mini R13N Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini R13N Blood Glucose Test Strips must be used with the EasyPlus mini R13N Meter. Testing is 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. The EasyPlus mini R13N Blood Glucose Test Strips, are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini R13N Blood Glucose Test Strips must be used with the EasyPlus mini R13N Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are 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. EasyPlus mini R13N Glucose Control Solutions For the use with EasyPlus mini R13N meter and EasyPlus mini R13N Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Device Story

Modification to previously cleared Class II device (K083099); changes include physical appearance and addition of AC/PC icon setting function; fundamental scientific technology remains unchanged; device operates via established principles of previously cleared predicate; design control activities performed to assess modification impact; verification and validation activities confirmed predetermined acceptance criteria met.

Clinical Evidence

Bench testing only; no clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation testing confirming acceptance criteria met.

Technological Characteristics

Modification to physical appearance and addition of AC/PC icon setting function. Fundamental scientific technology remains consistent with predicate K083099. Design controls per 21 CFR 820.30 applied.

Indications for Use

Indicated for persons with diabetes for quantitative measurement of glucose in fresh capillary whole blood (fingertip or forearm) to monitor diabetes control effectiveness. For home (OTC) or clinical use.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features an abstract eagle design with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

## AUG 1 8 2009

EPS Bio Technology Corp. c/o Y.C. Lei General Manager 2F No. 49-2, Lane 2, Sec. 2, Guang Fu Road Hsinchu City, 300 Taiwan, R.O.C.

Re: k091481

> Trade Name: EasyPlus mini R13N Self-Monitoring Blood Glucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW. CGA Dated: July 31, 2009 Received: August 4, 2009

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 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

{1}------------------------------------------------

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 (OS) regulation (21 CFR Part 820).

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/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] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sanith acting

Courtney C. Harper. Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use Form

510(k) Number (if known): k091481 Device Name: EasyPlus mini R13N SMBG system Indications for Use:

#### EasyPlus mini R13N SMBG Test System

The EasyPlus mini R13N SMBG Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is 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.

#### EasyPlus mini R13N Meter

The EasyPlus mini R13N Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini R13N Blood Glucose Test Strips must be used with the EasyPlus mini R13N Meter. Testing is 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.

#### EasyPlus mini R13N Blood Glucose Test Strips

The EasyPlus mini R13N Blood Glucose Test Strips, are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini R13N Blood Glucose Test Strips must be used with the EasyPlus mini R13N Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are 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.

EasyPlus mini R13N Glucose Control Solutions

For the use with EasyPlus mini R13N meter and EasyPlus mini R13N Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K091481

Page 1 of 1