AG-605 BLOOD GLUCOSE MONITORING SYSTEM

K073030 · Andon Health Co, Ltd. · NBW · Jul 21, 2008 · Clinical Chemistry

Device Facts

• Record ID: K073030
• Device Name: AG-605 BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Andon Health Co, Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

AG-605 & AG-606 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger only. 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. Not for use on neonates.

Device Story

System uses electrochemical biosensor technology to measure glucose in capillary whole blood. User applies blood to test strip; capillary action draws sample into chamber. Meter performs amperometric assay using glucose oxidase enzyme; current magnitude is proportional to glucose concentration. Results displayed in 5 seconds. Used by patients for self-monitoring or by clinicians in clinical settings. Requires manual entry of code number from test strip batch to calibrate meter. Output provides quantitative glucose concentration to aid diabetes management. Includes memory for result storage (160 for AG-605; 350 for AG-606).

Clinical Evidence

Clinical testing performed to verify accuracy requirements of ISO 15197. Results met or exceeded ISO 15197 accuracy standards. No specific sample size or statistical metrics provided in summary.

Technological Characteristics

Electrochemical biosensor; amperometric assay; glucose oxidase enzyme. Dimensions: AG-605 (112x50x22mm), AG-606 (82x59x20mm). Operates at 10-40°C, 25-85% relative humidity. Battery-powered. Code-chip/manual entry calibration. Single-use test strips.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from fingertips. For use by people with diabetes (lay users) and healthcare professionals in clinical settings to monitor diabetes mellitus. Contraindicated for neonates.

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

• One Touch Ultra Blood Glucose Monitoring system (K024194)

Submission Summary (Full Text)

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# 510(k) Summary

# JUL 2 1 2008

#### ldentification of the submitter:

| Submitter: | Andon Health Co., LTD<br>No 31, Changjiang Road, Nankai District, Tianjin,<br>P.R. China, 300193 |
|----------------------|--------------------------------------------------------------------------------------------------|
| Telephone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Application: | 08/10/07 |

#### Identification of the product:

| Trade name: | AG-605 Blood Glucose Monitoring System<br>AG-606 Blood Glucose Monitoring System | |
|-----------------|-----------------------------------------------------------------------------------------------|--|
| Common name: | Glucose test System | |
| Classification: | Blood Glucose Meter and test strip are Class II<br>devices (21 CFR 862.1345, Glucose Monitor) | |
| Product code: | CGA | |

#### Predicate Device:

One Touch Ultra Blood Glucose Monitoring system of Life Scan

K024194 510k number:

#### Device description:

AG-605 & AG-606 Blood Glucose Monitoring System consists of a blood glucose meter, test strips, two levels of control solutions, lancets and lancing device.

AG-605 & AG-606 Blood Glucose Monitoring System is designed to provide an easy, accurate method for determining capillary blood glucose values. This analysis is based on amperometric technology using glucose oxidase that is specific for the blood glucose measurement. When the blood sample is applied to the test strip, electrons are formed by the reaction between glucose oxidase and blood glucose. The electrical current is measured by the meter and correlates with the concentration of glucose in the blood sample.

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#### Intended use:

AG-605 & AG-606 Blood Glucose Monitoring System is intended for in vitro diagnostic use. The system is intended to be used for the quantitative measurement of capillary whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

## Comparison to Predicate Devices(s):

:

| CHARACTERISTICS | NEW DEVICE:<br>AG-605 & AG-606 Blood<br>Glucose Monitoring System | PREDICATE:<br>One Touch Ultra Blood<br>Glucose Monitoring system<br>(K024194) |
|-----------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Type of Meter | Biosensor (Electrode) | Biosensor (Electrode) |
| Intended Use | To quantitatively measure glucose<br>in fresh capillary whole blood. | To quantitatively measure glucose<br>in fresh capillary whole blood. |
| Sample Source | Capillary whole blood | Capillary whole blood |
| Sample Application | Blood sample is placed directly to<br>the test strip after finger is lanced. | Blood sample is placed directly to<br>the test strip after finger is lanced. |
| Hematocrit Range | 30-55% | 30-55% |
| Operating Temperature Range | 10℃~40℃(50°-104°F) | 6℃~44℃(43°-111°F) |
| Dimensions | AG-605: 50mmx 112mmx 22mm<br>AG-606: 82 mm×59mm × 20mm | 3.12" X2.25" X0.85" |
| Weight | AG-605: 60g (exclude batteries)<br>AG-606: 55g (exclude batteries) | 1.5 ounces (43g) with battery |
| Display | LCD | LCD |
| Result Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Memory Capabilities | AG-605: 160 times with time and<br>date displaying<br>AG-606: 350 times with time and<br>date displaying | 150 blood glucose and control<br>solution tests |
| Test Start | Automatic | Automatic |
| Test Time | 5 second | 5 second |
| Power Source | DC3V (2XAAA batteries) | One replaceable 3.0v lithium<br>battery |
| Battery Life | Approx. 1000 normal tests | 1000 tests |
| Measurement Range | 20mg/dL-600mg/dL<br>(1.1mmol/L~33.3mmol/L) | 20mg/dL-600mg/dL<br>(1.1mmol/L~33.3mmol/L) |
| Qualified Test Strip | AGS-600 Test Strip | ONETOUCH Ultra Test Strip |
| Sample Volume | Minimum 1 micro liter | Minimum 1 micro liter |

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#### Summary:

The information provided in this pre-market notification demonstrates that AG-605 & AG-606 Blood Glucose Monitoring System is substantially equivalent to One Touch Ultra Blood Glucose Monitoring system. Substantial equivalent was demonstrated through comparison of intended use and physical properties to the commercially available and analytical predicate devices. The information supplied in this pre-market notification provides reasonable assurance that the AG-605 &AG-606 Blood Glucose Monitoring System is safe and effective for its stated intended use.

#### Clinical Tests:

Clinical tests were performed and complied the accuracy requirements of ISO 15197. The results meet or exceed the accuracy requirements of ISO 15197.

#### Non-clinical Tests:

All non-clinical tests coincide the following standards, including Product Safety test and Electromagnetic Compatibility test.

#### IEC 61010-1-2001

Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General requirements

#### IEC 61010-2-101-2002

Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

#### EN 61326

Electrical equipment for measurement, control and laboratory use -EMC requirements

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings forming a curved shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Andon Health Co., Ltd. c/o Ms. Mona Technologi Department 7th Floor Hua Qiao Chuang Ye Plaza No. 10 JinPing Road, Ya An Road Nankai District, Tianjin, P.R. China 300193

JUL 2 1 2008

Re: k073030

Trade Name: AG-605 Blood Glucose Monitoring System, AG-606 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Monitoring System Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: July 9, 2008 Received: July 14, 2008

#### Dear Mona:

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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# Indication for Use

### 510(k) Number (if known): K073030

### Device Name: AG-605 Blood Glucose Monitoring System AG-606 Blood Glucose Monitoring System

#### Indication For Use:

AG-605 & AG-606 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for both lay uses by people with diabetes and in a clinical setting by health care professionals, as an aid to monitoring levels in Diabetes Mellitus. Not for use on neonates.

Prescription Use (21 CFR Part 801 Subpart D) Over the Counter Use Yes (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Sean Cooper
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K073036