AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM

K093755 · Andon Medical Co., Ltd. · NBW · Jul 15, 2011 · Clinical Chemistry

Device Facts

• Record ID: K093755
• Device Name: AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Andon Medical Co., Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The AG-695 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip.. The AG-695 Single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AG-695 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-695 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a qlucose test. The AGS-1000 single Blood Glucose Test Strips are for use with the AG-695 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample. The AG-695 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip.. The AG-695 MULT! Blood Glucose Monitoring System is intended for testing outside the body ( in vitro diagnostic use) and is intended to be used by healthcare professionals for multiple patients in a professional healthcare setting as an aid in monitoring the effectiveness of diabetes control. The AG-695 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a alucose test. The AGS-1000 MULTI Blood Glucose Test Strips are for use with the AG-695 MULT! Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample. This system should only be used with single-use, auto-disabling lancing devices. The AG-696 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip. The AG-696 Single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AG-696 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-696 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test. The AGS-1000 single Blood Glucose Test Strips are for use with the AG-696 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample. The AG-696 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip. The AG-696 MULTI Blood Glucose Monitoring System is intended for testing outside the body ( in vitro diagnostic use) and is intended to be used by healthcare professionals for multiple patients in a professional healthcare setting as an aid in monitoring the effectiveness of diabetes control. The AG-696 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test. The AGS-1000 MULTI Blood Glucose Test Strips are for use with the AG-696 MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample. This system should only be used with single-use, auto-disabling lancing devices.

Device Story

System uses electrochemical biosensor (glucose oxidase) to measure glucose in 0.7 µL capillary blood samples; 5-second measurement time. User applies blood to AGS-1000 test strip; meter measures electrical current proportional to glucose concentration. Devices include single-patient (AG-695/AG-696) and multi-patient (AG-695-Multi/AG-696-Multi) versions. Multi-patient versions require disinfection between uses with CaviWipes. Features include speaking function for visually impaired users, code card calibration, and memory for stored results. Used at home or in professional healthcare settings. Output displayed on screen and provided audibly. Assists healthcare providers and patients in monitoring diabetes control effectiveness.

Clinical Evidence

Clinical accuracy evaluated in 100 lay users and 100 visually impaired users across four hospitals. Results compared against YSI-2300 reference method. For lay users, 100% of results were within ±20% of YSI for glucose ≥75 mg/dL. Visually impaired study showed 98-100% of results within ±15-20% of YSI. Bench testing included precision (CV <6%), linearity (R² >0.99), interference testing, and hematocrit studies (30-55%).

Technological Characteristics

Electrochemical biosensor; glucose oxidase enzyme; capillary action. Dimensions: ~90x55x21mm. Power: 2xAAA batteries. Connectivity: None (standalone). Sterilization: N/A (disinfection via CaviWipes for multi-patient use). Standards: ISO 15197:2003, IEC 61326, IEC 61010.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from the fingertip by people with diabetes (home use) or healthcare professionals (professional setting) to monitor diabetes control. Contraindicated for neonatal use, diagnosis/screening of diabetes, and 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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JUL 1 5 2011

# 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.04-23-3 AIRPORT INDUSTRIAL PARK, TIANJIN |
| Phone number: | · 86-22-8761 2426 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Yi Liu |
| Date of Application: 09/30/2009 | |

#### 2.0 Device information

| Trade name: | AG-695 Single Blood Glucose Monitoring System<br>AG-695 Multi Blood Glucose Monitoring System<br>AG-696 Single Blood Glucose Monitoring System<br>AG-696 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 Health Co., Ltd. AG-606 Blood Glucose Monitoring System Device: 510(k) number: k073030

#### 5.0 Intended use

#### 5.1 AG-695 Single Blood Glucose Monitoring System

The AG-695 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip.. The AG-695 Single Blood Glucose

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Monitoring System is intended to be used by a single person and should not be shared.

The AG-695 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-695 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a qlucose test.

The AGS-1000 single Blood Glucose Test Strips are for use with the AG-695 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.

### 5.2 AG-695 MULTI Blood Glucose Monitoring System

The AG-695 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip.. The AG-695 MULT! Blood Glucose Monitoring System is intended for testing outside the body ( in vitro diagnostic use) and is intended to be used by healthcare professionals for multiple patients in a professional healthcare setting as an aid in monitoring the effectiveness of diabetes control.

The AG-695 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a alucose test.

The AGS-1000 MULTI Blood Glucose Test Strips are for use with the AG-695 MULT! Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.

This system should only be used with single-use, auto-disabling lancing devices.

#### 5.3 AG-696 Single Blood Glucose Monitoring System

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The AG-696 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip. The AG-696 Single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The AG-696 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-696 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.

The AGS-1000 single Blood Glucose Test Strips are for use with the AG-696 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.

### 5.4 AG-696 MULTI Blood Glucose Monitoring System

The AG-696 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip. The AG-696 MULTI Blood Glucose Monitoring System is intended for testing outside the body ( in vitro diagnostic use) and is intended to be used by healthcare professionals for multiple patients in a professional healthcare setting as an aid in monitoring the effectiveness of diabetes control.

The AG-696 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.

The AGS-1000 MULTI Blood Glucose Test Strips are for use with the AG-696 MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.

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This system should only be used with single-use, auto-disabling lancing devices.

#### 6.0 Device description

The four blood Glucose Monitoring system AG-695 Single, AG-695 MULTI, AG-696 Single and AG-696 MILTI are all 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 into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. All of them use the same technological characteristics for testing but the appearance is different from their predicate device. More over, all of the four systems have a voice function.

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### 7.0 Summary comparing technological characteristics with predicate device

### 7.1AG-695 Single and AG-695 MULTI Blood Glucose Monitoring System

| Similarities | | |
|--------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| CHARACTERISTICS | NEW DEVICE:<br>AG-695 Single and<br>AG-695 MULTI Blood<br>Glucose Monitoring<br>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<br>glucose in fresh capillary<br>whole blood. | To quantitatively measure<br>glucose in fresh capillary<br>whole blood. |
| Sample Source | Capillary whole blood | Capillary whole blood |
| Sample Application | Blood sample is placed<br>directly to the test strip after<br>finger is lanced. | Blood sample is placed<br>directly to the test strip after<br>finger is lanced. |
| Hematocrit Range | 30-55% | 30-55% |
| Operating Temperature<br>Range | 10℃~40℃(50°-104°F) | 10℃~40℃(50°-104°F) |
| Dimensions | 52mmx 92mmx 21mm | 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 (2 AAA) | 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 Single Test Strip<br>for AG-695 Single BGMS<br>AGS-1000 MULTI Test strip<br>for AG-695 MULTI BGMS | AGS-600 Test Strip |
| Sample Volume | Minimum 0.7 microliter | Minimum 1 microliter |
| Other function | Voice function | N/A |

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### 7.2 AG-696 Single and MULTI Blood Glucose Monitoring System

| CHARACTERISTICS | NEW DEVICE:<br>AG-696 Single and<br>AG-696 MULTI Blood<br>Glucose Monitoring<br>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<br>glucose in fresh capillary<br>whole blood. | To quantitatively measure<br>glucose in fresh capillary<br>whole blood. |
| Sample Source | Capillary whole blood | Capillary whole blood |
| Sample Application | Blood sample is placed<br>directly to the test strip after<br>finger is lanced. | Blood sample is placed<br>directly to the test strip after<br>finger is lanced. |
| Hematocrit Range | 30-55% | 30-55% |
| Operating Temperature Range | 10℃~40℃(50°-104°F) | 10℃~40℃(50°-104°F) |
| Dimensions | 90mmx 59mmx 22mm | 82mmx 59mmx 20mm |
| Display | LCD | LCD |
| Result Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Memory Capabilities | 500 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 Single Test Strip for<br>AG-696 Single BGMS<br>AGS-1000 MULTI Test strip<br>for AG-696 MULTI BGMS | AGS-600 Test Strip |
| Sample Volume | Minimum 0.7 micro liter | Minimum 1 microliter |
| Other function | voice function | N/A |

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#### 8.0 Performance summary

AG-695 Single BGMS, AG-695 MULTI BGMS, AG-696 Single BGMS and AG-696 MULTI BGMS 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.
- · FDA Draft Guidance Document-Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems: October 24, 2006
- · Disinfectant CaviWipes with the EPA registration number of 46781-8 has been validated to clean and disinfect the BGMS, and the performance and material will not be effected by the disinfection during the BGMS' lifetime.

#### 9.0 Comparison to the predict device and the conclusion

The four blood glucose monitor AG-695 Single AG-695 MULTI, AG-696 Single and AG-696 MULTI are very similar with the predicate device AG-606, their appearance is different from AG-606, they use the different test strips, they also has a new voice function. And the intended use of AG-695 MULTI and AG-696 MULTI are also different from their predicate device.

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

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

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

Jul 1 5 2011

Re: k093755

AG-695 Single Blood Glucose Monitoring System Trade name: AG-695 Multi Blood Glucose Monitoring System AG-696 Single Blood Glucose Monitoring System AG-696 Multi Blood Glucose Monitoring System

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: July 13, 2011 Received: July 13, 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 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Signature

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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AG-695 Blood Glucose Monitoring System FDA 510(k) Files

## Indication for Use

510(k) Number (if known): K093755 Device Name: AG-695 Single Blood Glucose Monitoring System Indication for Use:

The AG-695 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip.. The AG-695 Single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The AG-695 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-695 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.

The AGS-1000 single Blood Glucose Test Strips are for use with the AG-695 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.

| Prescription Use<br>✓ | And/Or | Over the Counter Use<br>✓ |
|-----------------------------|--------|-----------------------------|
| (21 CFR Part 801 Subpart D) | | (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)

. �

િન્દ

Page 1 of _

Ruth Chuber

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

510(K) 长 o 8 37 5 5

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AG-695 MULTI Blood Glucose Monitoring System FDA 510(k) Files

## Indication for Use

510(k) Number (if known): K093755

Device Name: AG-695 MULTI Blood Glucose Monitoring System Indication for Use:

The AG-695 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip.. The AG-695 MULTI Blood Glucose Monitoring System is intended for testing outside the body ( in vitro diagnostic use) and is intended to be used by healthcare professionals for multiple patients in a professional healthcare setting as an aid in monitoring the effectiveness of diabetes control.

The AG-695 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.

The AGS-1000 MULTI Blood Glucose Test Strips are for use with the AG-695 MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.

This system should only be used with single-use, auto-disabling lancing devices.

Over the Counter Use Prescription Use And/Or (21 CFR Part 801 Subpart C) (21 CFR Part 801 Subpart D) (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)

(ONVD)

Ruth Chuse

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

510(k) k093758

{11}------------------------------------------------

AG-696 single Blood Glucose Monitoring System FDA 510(k) Files

## Indication for Use

K093755 510(k) Number (if known): Device Name: AG-696 Single Blood Glucose Monitoring System Indication for Use:

The AG-696 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of qlucose (sugar) in fresh capillary whole blood sample from the fingertip. The AG-696 Single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The AG-696 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-696 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.

The AGS-1000 single Blood Glucose Test Strips are for use with the AG-696 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.

| Prescription Use ✓ | And/Or | Over the Counter Use ✓ |
|-----------------------------|--------|-----------------------------|
| (21 CFR Part 801 Subpart D) | | (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)

Ruth Chester

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

510(k) k093755

Page 3 of 4

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AG-696 MULTI Blood Glucose Monitoring System FDA 510(k) Files

## Indication for Use

510(k) Number (if known): K093755

Device Name: AG-696 MULTI Blood Glucose Monitoring System Indication for Use:

The AG-696 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip. The AG-696 MULTI Blood Glucose Monitoring System is intended for testing outside the body ( in vitro diagnostic use) and is intended to be used by healthcare professionals for multiple patients in a professional healthcare setting as an aid in monitoring the effectiveness of diabetes control.

The AG-696 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.

The AGS-1000 MULTI Blood Glucose Test Strips are for use with the AG-696 MULT! Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.

This system should only be used with single-use, auto-disabling lancing devices.

Prescription Use J J And/Or . Over the Counter Use J (21 CFR Part 801 Subpart D) (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)

Qute Chula

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

510(k) 093755

Page 4 of 4