EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031

K101457 · Eps Bio Technology Corp. · NBW · Jul 1, 2010 · Clinical Chemistry

Device Facts

• Record ID: K101457
• Device Name: EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031
• Applicant: Eps Bio Technology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 1, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The EasyPlus mini R9N 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. This device is not intended for the diagnosis or screening of diabetes mellitus and is not intended for use in neonates. Alternate Site Testing (AST) in the EasyPlus mini R9N Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Device Story

EasyPlus mini R9N SMBG system measures glucose in fresh capillary whole blood; samples obtained via fingerstick or forearm. System comprises meter, test strips, and control solutions. Used by patients at home or healthcare professionals in clinical settings to monitor diabetes management. Principle of operation involves electrochemical measurement of glucose concentration in blood sample applied to test strip. Meter processes electrical signal to calculate glucose level; displays result on screen. Provides quantitative data to assist in diabetes control; not for diagnostic or screening purposes. Requires steady-state conditions for alternate site testing.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by design control activities, risk analysis (FMEA), and verification/validation testing of the modified hardware components.

Technological Characteristics

Electrochemical glucose monitoring system; consists of handheld meter, disposable test strips, and control solutions. Operates via enzymatic reaction on test strip; electrical signal measured by meter. Battery-powered. No connectivity features described.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (finger, palm, forearm, upper arm, calf, thigh) for home use by individuals with diabetes to monitor glycemic control. Not for diabetes diagnosis, screening, or neonatal 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)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.

| 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 |

| | Food & Drug Administration |
|--|----------------------------|
| | 10903 New Hampshire Avenue |
| | Building 66 |
| | Silver Spring, MD 20993 |

| | JUL 1 2010 |
|--|------------|
|--|------------|

| Re: | k101457 |
|-------------|--------------------------------------------------------|
| Trade Name: | EasyPlus mini R9N Self Monitoring Blood Glucose System |

Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: CGA, NBW, JJX Dated: May 21, 2010

Received: June 3, 2010

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 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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## Page 2

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

CA

Courtney C. Harper, 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):

(II KNOWN). R. VS. T.

Device Name:

### EasyPlus mini R9N SMBG system

Indications for Use:

#### EasyPlus mini R9N SMBG Test System

The EasyPlus mini R9N 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. This device is not intended for the diagnosis or screening of diabetes mellitus and is not intended for use in neonates. Alternate Site Testing (AST) in the EasyPlus mini R9N Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

#### EasyPlus mini R9N Meter

The EasyPlus mini R9N Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini R9N Blood Glucose Test Strips must be used with the EasyPlus mini R9N 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. This device is not intended for the diagnosis or screening of diabetes mellitus and is not intended for use in neonates. Alternate Site Testing (AST) in the EasyPlus mini R9N Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

#### EasyPlus mini R9N Blood Glucose Test Strips

The EasyPlus mini R9N 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 R9N Blood Glucose Test Strips must be used with the EasyPlus mini R9N 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. This device is not intended for the diagnosis or screening of diabetes mellitus and is not intended for use in neonates. Alternate Site Testing (AST) in the EasyPlus mini R9N Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

#### EasyPlus mini R9N Glucose Control Solutions

For use with the EasyPlus mini R9N meter and EasyPlus mini R9N Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Prescription Use V (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)

Division Sian-C

**Office of In Vitro Diagnostic**
**Device Evaluation and Safety**

510(k) k10145