GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM

K062799 · Apex BioTechnology Corp. · CGA · Feb 6, 2007 · Clinical Chemistry

Device Facts

• Record ID: K062799
• Device Name: GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Apex BioTechnology Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Feb 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The Gluco Track Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary, fingerstick whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for both lay use by people with diabetes and in a clinical setting by health care professionals, as an aid to monitoring levels in Diabetes Mellitus.

Device Story

Gluco Track Blood Glucose Monitoring System uses electrochemical biosensor technology; capillary action draws small blood sample into test strip chamber. Device measures glucose concentration; displays result in 6 seconds. Used by patients (home) or healthcare professionals (clinical setting). Provides quantitative glucose readings to aid diabetes management. Differences from predicate include physical design, memory capacity, and user-interface features (e.g., 7, 14, 30-day averaging).

Clinical Evidence

Pre-clinical and clinical data provided in accordance with FDA Guidance for In Vitro Diagnostic Test Systems. No specific numerical performance metrics (e.g., sensitivity, specificity) are detailed in the provided summary.

Technological Characteristics

Electrochemical biosensor; glucose oxidase enzyme; amperometric detection. Dimensions/form factor: handheld meter. Connectivity: none (standalone). Calibration: batch-specific code strip. Sterilization: not specified. Software: embedded firmware for signal conversion and display.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary fingerstick whole blood for individuals with diabetes. Suitable for both lay use and clinical settings by healthcare professionals to monitor glucose levels.

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

• Glucosure Blood Glucose Monitoring System (k011233)

Submission Summary (Full Text)

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**APEX BIOTECHNOLOGY CORP**

Ka62799

No. 7, Li-Shin Rd. V, Hsinchu Science Park, Hsinchu, Taiwan, ROC TEL: [phone] FAX: [phone]

FEB -6 2007

### 510(K) Summary of Safety and Effectiveness II.

(Per 21 CFR 807.92)

| 2.1. General Information Establishment | | |
|----------------------------------------|----------------------|-------------------------------------------------------------------------|
| | Manufacturer: | APEX Biotechnology Corp. |
| | Address: | No. 7, Li-Shin Rd. V, Hsinchu Science Park, Hsinchu, 30078, Taiwan, ROC |
| | Registration Number: | 9616936 |
| | Contact Person: | Dr. Jen, Ke-Min E-mail: [e-mail] |
| | | 886-3-5208829 (Tel); 886-3-5209783 (Fax) |
| | Address: | No.58, Fu Chiun Street, Hsin Chu City, 30067, Taiwan, ROC |
| | Date Prepared: | September 15, 2006 |
| Device | | |
| ● | Proprietary Name: | Gluco Track® Blood Glucose Monitoring System |
| ● | Common Name: | Blood Glucose Monitoring System |
| ● | Classification Name: | SYSTEM, TEST, BLOOD GLUCOSE, |
| | | OVER THE COUNTER, Class II, |

## 2.2. Safety and Effectiveness Information

- Predicate Device:
Claim of Substantial Equivalence (SE) is made to GlucoSure Blood Glucose Monitoring System (K011233)

- Device Description: Based on an electrochemical biosensor technology and the principle of capillary action, Gluco Track Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 6 seconds.
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# X BIOTECHNOLOGY CORP

No. 7, Li-Shin Rd. V, Hsinchu Science Park, Hsinchu, Taiwan, ROC TEL: [phone] FAX: [phone]

#### Intended Use: .

The Gluco Track Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary, fingerstick whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for both lay use by people with diabetes and in a clinical setting by health care professionals, as an aid to monitoring levels in Diabetes Mellitus.

#### ● Synopsis of Test Methods and Results

Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/ FDA.

#### . Substantial Equivalence (SE)

A claim of substantial equivalence is made to GlucoSure Blood Glucose Monitoring System (K011233). Both of them have the same working principle and technologies. The differences are meter dimension, weight, power voltage, memory data number, date and time setting, auto recall the 7, 14 and 30 days average and some other user friendly designs on meter. As we can see, the differences are due to the feature design aspects, not relating to the safety or effectiveness aspects. They are substantially equivalent.

Ke. 22222

Л

Dr. Jen, Ke-Min 510k Contact Person for APEX BIOTECHNOLOGY CORP.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ke-Min Jen Apex Biotechnology Corp. No. 58, Fu Chium Street Hsin Chu City, 30067 Taiwan, R.O.C.

FEB - 6 2007

Re: k062799 Trade/Device Name: Gluco Track Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: January 28, 2007 Received: January 30, 2007

Dear Dr. Jen:

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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Yean 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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# Indications for Use

#### 510 (K) Number ( If Known ):____ K062799

Device Name: Gluco Track Blood Glucose Monitoring System

# Indications for Use:

The Gluco Track Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary, fingerstick whole blood. Testing is done outside the body ( in vitro diagnostic use). It is indicated for both lay use by people with diabetes and in a clinical setting by health care professionals, as an aid to monitoring levels in Diabetes Mellitus.

Prescription Use

AND/OR

Over-The-Counter Use √

(Part 21 CFR 801 Subpart D)

(21 CFR 807 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)

Carol Benson
Vision Sign-Off

fifice of In Vitro Diagnostic Device baluation and Safety

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K062799