AG-608N BLOOD GLUCOSE MONITORING SYSTEM

K110017 · Andon Medical Co., Ltd. · NBW · Jan 18, 2012 · Clinical Chemistry

Device Facts

• Record ID: K110017
• Device Name: AG-608N BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Andon Medical Co., Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The AG-608N single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AG-608N single Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AG-608N single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The AGS-1000N single Test Strips are for use with the AG-608N single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N control solutions are intended for use with the AG-608N single Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly and that you are doing the test correctly. These solutions contain a known range of glucose, as indicated on the bottles. The AG-608N MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N MULTI Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. The system is only used with single-use lancing devices. The AG-608N MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady - state times (when glucose is not changing rapidly). The AGS-1000N MULTI Test Strips are for use with the AG-608N MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N control solutions are intended for use with the AG-608N MULTI Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.

Device Story

System uses electrochemical biosensor technology; glucose oxidase enzyme reacts with capillary whole blood glucose to generate electrical current; meter measures current to calculate glucose concentration. Input: 0.7μL capillary blood sample on AGS-1000N test strip. Output: quantitative blood glucose level displayed on meter. Used in home (Single version) or professional healthcare settings (MULTI version). MULTI version validated for multiple-patient use with CaviWipes disinfection. Data transmission via USB to PC application. Results aid healthcare providers in monitoring diabetes control effectiveness. Benefits: provides rapid, point-of-care glucose monitoring for diabetes management.

Clinical Evidence

Clinical user performance study conducted with 100 lay-users. Glucose concentrations ranged 57-305 mg/dL. Results met ISO 15197 accuracy criteria: 95% of results within ±15 mg/dL for <75 mg/dL and within ±20% for ≥75 mg/dL across all test sites (finger, palm, forearm, upper arm, calf, thigh). Bench testing included precision (CV 2.07-3.48%), linearity (r²=0.9983), interference studies, altitude (up to 10,744 ft), and hematocrit (20-60%).

Technological Characteristics

Electrochemical biosensor; glucose oxidase enzyme; auto-coding; measuring range 20-600 mg/dL; reaction time 5 seconds; sample volume 0.7μL. Connectivity: USB for data transmission. Operating conditions: 50-104°F, <80% RH. Storage: 39-86°F, <80% RH. Complies with ISO 15197, ISO 14971, EN 60601-1-1, EN 60601-1-2, EN 61326-1, and IEC/EN 61010-2-101.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from fingertips, palm, forearm, upper arm, calf, and thigh. Intended for diabetes control monitoring in professional settings (MULTI version) or home self-testing (Single version). Contraindicated for neonatal use, diabetes diagnosis/screening, and critically ill patients. Not for use on patients with dehydration, hypotension, shock, or hyperglycemic-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-608 Blood Glucose Monitoring System (k093262)

Submission Summary (Full Text)

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AG-608N Single and AG-608N Multi Blood Glucose Monitoring System FDA 510(k) Files

# 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

| Name: | Andon Medical Co., Ltd. |
|----------------------|----------------------------------------------------------------------------|
| Address: | No.26 Hangn Yu Road, Tianjin Airport Economic Area,<br>Tianjin, P.R. China |
| Phone number: | 86-22-8761 2426 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Yi Liu |
| Date of Application: | 12/30/2010 |

# 2.0 Device information

| Trade name: | AG-608N Single Blood Glucose Monitoring System<br>AG-608N Multi 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. Regulation number: 862.1345 Classification: II Panel: Clinical Chemistry

# 4.0 Predict device information

Manufacturer: Andon Medical Co., Ltd. Device: AG-608 Blood Glucose Monitoring System 510(k) number: k093262

# 5.0 Device description

AG-608N Single Blood Glucose Monitoring System and AG-608N MULTI Blood Glucose Monitoring System measures the amount of sugar (glucose)

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AG-608N Single and AG-608N Multi Blood Clucose Monitoring System FDA 510(k) Files

in whole blood. The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. Your meter measures the current, calculates the blood qlucose level, and displays the result. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample.

# 6.0 Intended use

## 6.1 AG-608N Single BGMS

The AG-608N single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The AG-608N single Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AG-608N single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The AGS-1000N single Test Strips are for use with the AG-608N single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.

The AG-608N control solutions are intended for use with the AG-608N single Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly and that you are doing the test correctly. These solutions contain a known range of glucose, as indicated on the bottles.

# 6.2 AG-608N MULTI BGMS

The AG-608N MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N MULTI Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an

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# Additional information for K110017

AG-608N Single and AG-608N Multi Blood Glucose Monitoring System FDA 510(k) Files

aid to monitor the effectiveness of diabetes control program. The system is only used with single-use lancing devices.

The AG-608N MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady - state times (when glucose is not changing rapidly).

The AGS-1000N MULTI Test Strips are for use with the AG-608N MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.

The AG-608N control solutions are intended for use with the AG-608N MULTI Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.

| Similarities | | |
|--------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| CHARACTERISTICS | NEW DEVICE:<br>AG-608N Single and<br>MULTI Blood Glucose<br>Monitoring System | PREDICATE:<br>AG-608 Blood Glucose<br>Monitoring System<br>(K093262) |
| Detection Method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase | Glucose Oxidase |
| Type of Meter | Biosensor (Electrode) | Biosensor (Electrode) |
| Sample Source | Capillary whole blood from<br>AST(Alternative site<br>testing) and finger | Capillary whole blood from<br>finger |
| Sample Application | Blood sample is placed<br>directly to the test strip<br>after finger or AST is<br>lanced. | Blood sample is placed<br>directly to the test strip<br>after finger is lanced. |
| Hematocrit Range | 20-60% | 35-50% |
| Altitude | 10744 feet(3275m) | 11975 feet(3650m) |
| Operating Temperature<br>Range | 10℃~40℃ (50°-104°F) | 10℃~40℃ (50°-104°F) |
| Dimensions | 87mmx 53mmx 9.9mm | 85mm×53mm(W)×13.7mm<br>(H) |

# 7.0 Summary comparing technological characteristics with predicate device

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·

. .

| Display | LCD | LCD |
|----------------------|--------------------------------------------|--------------------------------------------|
| Result Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Memory Capabilities | 500 times with time and date displaying | 350 times with time and date displaying |
| Test Start | Automatic | Automatic |
| Test Time | 5 second | 5 second |
| Power Source | DC 3V (CR2032) | DC 3V (CR2032) |
| Battery Life | Approx. 500 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-1000N Test Strip | AGS-1000 Test Strip |
| Sample Volume | Minimum 0.7 micro liter | Minimum 0.7 micro liter |
| Other function | USB function. | N/A |

.

AG-608N Single and AG-608N Multi Blood Glucose Monitoring System FDA 510(k) Files

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# 8.0 Performance summary

AG-608N Single and AG-608N MULT! blood glucose monitoring system conforms 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-608N Single and AG-608N MULTI are similar with the predicate device AG-608, however, the appearance is different from AG-608, it uses the different test strips, AG-608N Single and AG-608N MULTI can test the blood glucose at the alternative site other than the finger, it also has the USB function. The hematocrit range is different, the altitude, the memory capability, the Battery Life are also changed. AG-608N Single and AG-608N MULTI also has a USB function.

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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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Andon Medical Co, Ltd c/o Yi Liu No. 04-23-3 Airport Industrial Park, Tianjin Tianjin China 300381

JAN 1 8 2012

Re: k110017

Trade Name: AG-608N MULTI Blood Glucose Monitoring System, AG-608N single Blood Glucose Monitoring System Regulation Number: 21 CFR §866.1345 Regulation Name:' Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: December 19, 2011 Received: December 19, 2011

Dear Yi 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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# Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire 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 Biometrig'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/Medical

Devices/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 Tou inay of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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AG-608N single Blood Glucose Monitoring System FDA 510(k) Files

# Indication for Use

# 510/k) Number (if known):

# Device Name: AG-608N Single Blood Glucose Monitoring System

## Indication For Use:

The AG-608N Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thiah. The AG-608N single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The AG-608N single Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AG-608N single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The AGS-1000N single Test Strips are for use with the AG-608N single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.

The AG-608N control solutions are intended for use with the AG-608N single Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly and that you are doing the test correctly. These solutions contain a known range of glucose, as indicated on the bottles.

Prescription Use (21 CFR Part 801 Subpart D) And/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)

Division Sign-Off

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

510(k) < 11001

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AG-608N Blood Glucose Monitoring System FDA 510(k) Files

# Indication for Use

510(k) Number (if known):

Device Name: AG-608N MULTI Blood Glucose Monitoring System

## Indication For Use:

The AG-608N MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thiah. The AG-608N MULTI Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiplepatient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. The system is only used with singleuse lancing devices.

The AG-608N MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady -- state times (when glucose is not changing rapidly).

The AGS-1000N MULTI Test Strips are for use with the AG-608N MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.

The AG-608N control solutions are intended for use with the AG-608N MULTI Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.

And/Or

Prescription Use (21 CFR Part 801 Subpart D) 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)

Signature

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

510(k)

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