MAJOR III BLOOD GLUCOSE MONITORING SYSTEM

K072274 · Bestgen Biotech Corp. · NBW · Feb 29, 2008 · Clinical Chemistry

Device Facts

• Record ID: K072274
• Device Name: MAJOR III BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Bestgen Biotech Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 29, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Major III Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary blood from the fingertip. 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 setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.

Device Story

The MAJOR III Blood Glucose Monitoring System is an in vitro diagnostic device for quantitative glucose measurement. It utilizes an electrochemical biosensor and capillary action; a small blood sample is drawn into the test strip chamber. The system processes the sample and displays the glucose result in 8 seconds. It is intended for home use by patients with diabetes or clinical use by healthcare professionals. The device features memory storage, date/time settings, and auto-recall of 7, 14, and 30-day averages to assist in diabetes management.

Clinical Evidence

Pre-clinical and clinical data were submitted in accordance with FDA guidance for In Vitro Diagnostic Test Systems. No specific performance metrics (e.g., sensitivity, specificity) were provided in the summary document.

Technological Characteristics

Electrochemical biosensor; capillary action sample collection; 8-second measurement time; battery-powered; handheld form factor; memory storage for data; includes average calculation functionality.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from the fingertip. For use by individuals with diabetes (OTC) or healthcare professionals in clinical settings to monitor diabetes control effectiveness.

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

• EASY CHECK Blood Glucose Monitoring System (K062538)

Submission Summary (Full Text)

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

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

(Per 21 CFR 807.92)

| 2.1. General Information Establishment | FEB 29 2008 |
|----------------------------------------|--------------------------------------------------------------------------|
| Manufacturer: | BESTGEN Biotech Corp. |
| Address: | 7F, No.186, Jian 1st Rd. Jhonghe City, Taipei County, 23511, Taiwan, ROC |
| Owner Number: | 9102780 |
| 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: | August 13, 2007 |
| Device | |
| Proprietary Name: | MAJOR III Blood Glucose Monitoring System |
| Common Name: | Blood Glucose Monitoring System |
| Classification Name: | SYSTEM. TEST. BLOOD GLUCOSE. |
| | OVER THE COUNTER. Class II |
| Product Code: | NBW |

## 2.2. Safety and Effectiveness Information

#### ● Predicate Device:

Claim of Substantial Equivalence (SE) is made to EASY CHECK Blood Glucose Monitoring System (K062538)

- � Based on an electrochemical biosensor technology Device Description: and the principle of capillary action, MAJOR III 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 8 seconds.

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

#### Intended Use: .

The MAJOR III Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.

#### ● 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 Viro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/ FDA.

#### ● Substantial Equivalence (SE)

A claim of substantial equivalence is made to EASY CHECK Blood Glucose Monitoring System (K062538). 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 Zis Jen

Dr. Jen, Ke-Min official correspondent for BESTGEN BIOTECH CORP.

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

Image /page/2/Picture/1 description: The image shows the Department of Health and Human Services USA logo. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Bestgen Biotech Corporation c/o Dr. Ke-Min Jen 58 Fu Chuin Street Hsin Chu City, China (Taiwan) 30067

FEB 2 9 2008

Re: k072274

Trade/Device Name: Major III Blood Glucose Monitoring System Regulation Number: 21 CFR\$862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: February 20, 2008 Received: February 28, 2008

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).

{3}------------------------------------------------

## Page 2 –

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.

Jean 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

{4}------------------------------------------------

# Indications for Use

510 (K) Number ( If Known ): ___ K072274

Device Name: MAJOR III Blood Glucose Monitoring System

Indications for Use:

The MAJOR III Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary blood from the fingertip. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.

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 C. Benson
Sign.Ch

Page 1 of 1

e of In Vitro Diagnostic Device stion and Safety

Slol(k) K072274

7