EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2

K070053 · Eps Bio Technology Corp. · NBW · Dec 3, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070053
• Device Name: EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2
• Applicant: Eps Bio Technology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The EasyPlus mini 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 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.

Device Story

System consists of meter, disposable glucose oxidase test strips, code card, check strip, and control solutions. User inserts test strip into meter; applies capillary whole blood sample (fingertip or forearm) to strip. Device uses electrochemical biosensor (amperometry) to measure current generated by glucose oxidation; calculates glucose concentration. Result displayed on meter screen in 5 seconds. Used by diabetics for self-monitoring or healthcare professionals in clinical settings. Provides quantitative glucose data to aid diabetes management decisions. Alternate site testing (forearm) restricted to steady-state glucose conditions.

Clinical Evidence

Clinical testing evaluated accuracy for both finger stick and alternate site testing. Bench testing included evaluation of interferences, sensitivity, linearity, reportable range, altitude effects, stability, precision, and reproducibility. Results support substantial equivalence.

Technological Characteristics

System includes meter, test strips, auto lancet, check strip, code card, and control solutions. Quantitative measurement of glucose in capillary whole blood. In vitro diagnostic use. Class II device under 21 CFR 862.1345.

Indications for Use

Indicated for professional healthcare personnel or diabetics at home to measure glucose concentration in fresh capillary whole blood from fingertips or forearm to aid diabetes management. Not intended for neonate blood samples.

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.

Predicate Devices

• Roche Accu-Chek Advantage System (k032552)

Submission Summary (Full Text)

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K070053

DEC 0 3 2007

# 510(k) Summary

| Submitter: | EPS Bio Technology Corp. |
|--------------------------------|------------------------------------------------------------------------------|
| Contact Person: | Mr. Y.C. Lei, General Manager |
| | EPS Bio Technology Corp. |
| | 2F,No. 49-2, Lane 2, Guang Fu Rd.,Sec.2 Hsinchu City, |
| | Taiwan, R.O.C. |
| | Phone: [phone] |
| | Fax: [phone] |
| | E-mail: [e-mail] |
| Date Prepared: | November 29, 2007 |
| Trade Name: | EasyPlus mini Self Monitoring Blood Glucose Test System |
| Classification: | Glucose test system, 21 CFR 862.1345; Class II |
| Product Codes: | CGA, NBW, JJX |
| Predicate Device: | ACCU-CHEK advantage System (k032552) |
| Device | The EasyPlus mini Self Monitoring Blood Glucose System is |
| Description: | comprised of the EasyPlus mini Meter, EasyPlus mini Blood |
| | Glucose Test Strips, Auto Lancet, Check strip, Code card and |
| | Normal/High Control solutions. |
| Intended Use: | The EasyPlus mini 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 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. |
| Functional and Safety Testing: | A full array of in-house and clinical testing was done consistent |
| | with relevant FDA guidances for blood glucose monitoring |
| | systems.<br>Bench testing included evaluation of interferences, sensitivity, |
| | linearity, reportable range, altitude effects, stability, precision |
| | and reproducibility. |
| | Clinical testing included evaluation of accuracy for both finger |
| | stick and Alternate Site Testing. |
| Conclusion: | Labeling, bench testing results and clinical testing results |
| | support the Indications for Use and the claim of substantial |
| | equivalence to the predicate. |

.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 03 2007

EPS Biotechnology Corp. c/o Mr. Y. C. Lei General Manager 2F, No. 49-2, Lane 2 Guang Fu Road, Sec 2 Hsinchu City, Taiwan

Re: k070053

Trade/Device Name: EasyPlus Mini Self-Monitoring Blood Glucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: November 07, 2007 Received: November 13, 2007

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); 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 10gally 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 tollow the [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Sean M. Cooper, M.S., D.V.M. 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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## Indication for Use

## 510(k) Number (if known): k070053

Device Name: EasyPlus min Self Monitoring Blood Glucose System

## Indication For Use:

The EasyPlus mini Self Monitoring Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or diabetics at home to measure glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from the fingertip, and forearm by using Easy Plus mini Monitoring Blood Glucose Monitoring System. The device is not intended for testing neonate blood samples.

### EasyPlus mini Meter

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

The EasyPlus mini 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 Blood Glucose Test Strips must be used with the EasyPlus mini 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.

## The EasyPlus Normal/High Control Solution

For use with the EasyPlus mini meter and EasyPlus mini Blood Glucose Test Strips as a quality control check to yerify the accuracy of blood glucose test results. Prescription Use V And/Or

(21 CFR Part 801 Subpart D)

/Or

Over the Counter Use // (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)

Carol C. Benson

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

510(k) K070053