AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM

K093262 · Andon Medical Co., Ltd. · NBW · Jul 13, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093262
• Device Name: AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Andon Medical Co., Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The AG-608 and AG-610 Blood Glucose Monitoring Systems are 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 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. Not for use on neonates. It is not intended for the diagnosis of or screening for diabetes mellitus.

Device Story

AG-608 and AG-610 are blood glucose monitoring systems consisting of a meter, test strips, lancets, lancing device, and optional control solutions. Device uses electrochemical biosensor technology; capillary action draws blood into test strip chamber. Meter performs amperometric measurement of glucose; displays results in 5 seconds. Used by patients at home or healthcare professionals in clinical settings. Output (mg/dL or mmol/L) aids in monitoring diabetes control programs. Features include code button for strip calibration and memory for 350 test results with date/time. Provides quantitative data to assist clinical decision-making regarding diabetes management.

Clinical Evidence

Clinical accuracy evaluated in 100 lay users and technicians at two hospitals. Samples ranged from 51.6 to 356 mg/dL (AG-608) and 53.4 to 347 mg/dL (AG-610). Results compared against YSI-2300 reference. For concentrations ≥75 mg/dL, 96-100% of results were within ±20% of reference. Regression analysis showed high correlation (R² 0.9724–0.9818). Bench testing included precision, linearity, interference, hematocrit (30-55%), altitude (up to 11,975 ft), and temperature/humidity studies.

Technological Characteristics

Electrochemical biosensor; glucose oxidase enzyme; capillary action sample intake. Measurement range 20-600 mg/dL. AG-608: 85x53x13.7mm, CR2032 battery. AG-610: 134x64x43mm, 2xAAA batteries. Connectivity: None (standalone). Calibration: Code bottle. ISO 15197:2003 compliant.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from the fingertip. Intended for use by healthcare professionals and people with diabetes mellitus for monitoring diabetes control programs. Contraindicated for neonates, patients who are dehydrated, hypotensive, in shock, critically ill, or in a hyperosmolar state.

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

• AG-606 Blood Glucose Monitoring System (k073030)

Submission Summary (Full Text)

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K09 3262

JUL 1 3 2010

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.

#### 1.0 submitter's information

Andon Medical Co., Ltd. Name: No.04-23-3 AIRPORT INDUSTRIAL PARK, TIANJIN Address: 86-22-8761 2426 Phone number: Fax number: 86-22-6052 6162 Contact: Yi Liu Date of Application: 09/30/2009

#### 2.0 Device information

| Trade name: | AG-608 Blood Glucose Monitoring System<br>AG-610 Blood Glucose Monitoring System |
|----------------------|----------------------------------------------------------------------------------|
| Common name: | Blood Glucose Monitoring System |
| Classification name: | Blood Glucose Monitoring System |

#### 3.0 Classification

Production code: NBW- Blood Glucose Monitoring System. Requlation number: 862.1345 Classification: II Panel: Clinical Chemistry

#### 4.0 Predict device information

Manufacturer: Andon Health Co., Ltd. Device: AG-606 Blood Glucose Monitoring System 510(k) number: k073030

# 5.0 Device description

AG-608, AG-610 Blood Glucose Monitoring System consists of a blood glucose meter, test strips, lancets, lancing device and the control solutions (available if user requests).

The AG-608, AG-610 blood Glucose Monitoring system is based on an electrochemical biosensor technology(electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood

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into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available are used to test the performance of the device.

#### 6.0 Intended use

AG-608, AG-610 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 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. It is not intended for the diagnosis of or screening for diabetes mellitus.

# 7.0 Summary comparing technological characteristics with predicate device

| Similarities | | |
|--------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| CHARACTERISTICS | NEW DEVICE:<br>AG-608 Blood Glucose<br>Monitoring System | PREDICATE:<br>AG-606 Blood Glucose<br>Monitoring System<br>(K073030) |
| Detection Method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase | Glucose Oxidase |
| 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<br>Range | 10℃~40℃(50°-104°F) | 10℃~40℃(50°-104°F) |
| Dimensions | 85mmx 53mmx 13. 7mm | 82mmx 59mmx 20mm |
| Display | LCD | LCD |
| Result Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Memory Capabilities | 350 times with time and date<br>displaying | 350 times with time and date<br>displaying |
| Test Start | Automatic | Automatic |
| Test Time | 5 second | 5 second |
| Power Source | DC 3V (CR2032) | DC 3V (2 AAA) |
| Battery Life | Approx. 1000 normal tests | Approx. 1000 normal tests |

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| 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-1000 Test Strip | AGS-600 Test Strip |
| Sample Volume | Minimum 0.7 microliter | Minimum 1 microliter |
| Other function | Code bottle | N/A |

| | NEW DEVICE:. | PREDICATE: |
|-----------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| CHARACTERISTICS | AG-610 Blood Glucose<br>Monitoring System | AG-606 Blood Glucose<br>Monitoring System<br>(K073030) |
| Detection Method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase | Glucose Oxidase |
| 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) | 10℃~40℃(50°-104°F) |
| Dimensions | 134mmx 64mmx 43mm | 82mmx 59mmx 20mm |
| Display | LCD | LCD |
| Result Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Memory Capabilities | 350 times with time and date<br>displaying | 350 times with time and date<br>displaying |
| Test Start | Automatic | Automatic |
| Test Time | 5 second | 5 second |
| Power Source | DC3V (2XAAA batteries) | DC 3V (2 AAA) |
| Battery Life | Approx. 1000 normal tests | Approx. 1000 normal 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-1000 Test Strip | AGS-600 Test Strip |
| Sample Volume | Minimum 0.7 micro liter | Minimum 1 microliter |
| Other function | Code bottle | N/A |

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#### 8.0 Performance summary

AG-608, AG-610 blood glucose monitoring system conform to the following standards:

- · ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
Non-clinical test and the clinical test are done according to the above standard.

## 9.0 Comparison to the predict device and the conclusion

AG-608 and AG-610 is very similar with the predicted device AG-606, However, their appearance is different from AG-606, they use the different test strips, they also has a code button.

However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name arranged in a circular pattern around the perimeter. In the center is a stylized symbol, possibly representing human services or health, with three abstract figures connected in a flowing design.

Andon Medical Co., Ltd c/o Mr. Yi Liu 156 Floor Building C No.3 Jin Ping Street Nankai District Tianjin, China 300190

Re: k093262

> Trade name: AG-608 Blood Glucose Monitoring System AG-610 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: June 25, 2010 Received: June 25, 2010

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

JUL 1 3 2010

Dear Mr. Liu:

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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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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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# Indication for Use

# 510(k) Number (if known): K 093 2 ماء

Device Name: AG-608 Blood Glucose Monitoring System AG-610 Blood Glucose Monitoring System

#### Indication For Use:

AG-608, AG-610 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 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. Not for use on neonates. It is not intended for the diagnosis of or screening for diabetes mellitus.

Prescription Use Yes (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)

Carol C Benam

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

510(k) K093262

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