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.

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.

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.

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.

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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the AG-695/AG-696 Blood Glucose Monitoring Systems:

The provided document is a 510(k) Summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of accuracy, sensitivity, and specificity in the way one might for a diagnostic imaging AI. For blood glucose monitoring systems (BGMS), the primary acceptance criteria revolve around the accuracy of glucose measurements compared to a laboratory reference method, as defined by standards like ISO 15197.

1. Table of Acceptance Criteria and Reported Device Performance

The document references compliance with ISO 15197 and FDA Draft Guidance Document "Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems: October 24, 2006." These standards set forth the acceptance criteria for accuracy. While the document mentions compliance, it does not explicitly present a table of acceptance criteria or detailed device performance statistics (e.g., mean absolute relative difference, percentage of results within specific error margins) in the provided text.

However, based on typical ISO 15197 (2003) guidelines (the likely version for a 2011 submission), common acceptance criteria for accuracy are:

Acceptance Criteria (Typical ISO 15197:2003)	Reported Device Performance
For glucose concentrations < 75 mg/dL (4.2 mmol/L): All results within ±15 mg/dL (±0.83 mmol/L) of the reference method.	Not explicitly detailed in the provided text. The document states the device "conform to ... ISO 15197".
For glucose concentrations ≥ 75 mg/dL (4.2 mmol/L): All results within ±20% of the reference method.	Not explicitly detailed in the provided text. The document states the device "conform to ... ISO 15197".
All glucose concentrations: At least 95% of results within specific error margins (e.g., ±15 mg/dL or ±20%).	Not explicitly detailed in the provided text. The document states the device "conform to ... ISO 15197".

2. Sample Size for the Test Set and Data Provenance

Sample Size for the Test Set: Not explicitly stated in the provided text. The document only mentions "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness."
Data Provenance: Not explicitly stated. Given that Andon Medical Co., Ltd. is based in Tianjin, China, and the application date is 2009, it's highly probable the testing was conducted in China, though this is not confirmed. The document does not specify if the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable and not typically found in 510(k) submissions for blood glucose monitoring systems. The "ground truth" for these devices is established by a laboratory reference method, not by expert consensus (like radiologists for imaging studies).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used when multiple human readers interpret data to establish a ground truth or resolve discrepancies. For blood glucose monitors, the reference method provides the objective truth, and there is no human adjudication process involved in comparing device readings to the reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a standalone blood glucose monitoring system, not an AI-powered diagnostic imaging tool or an AI assistant for human readers. Therefore, MRMC studies and "human reader improvement with AI" are not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the studies would have been conducted as a standalone performance assessment of the device (meter and test strips) against a laboratory reference method. The device's electrochemical biosensor technology and capillary action principle are essentially the "algorithm" that converts the electrochemical signal into a glucose reading. The performance assessment outlined by ISO 15197 and FDA guidance focuses on this standalone accuracy without human interpretation influencing the numerical result.

7. The Type of Ground Truth Used

The ground truth used for blood glucose monitoring systems is typically established by a laboratory reference method for glucose measurement (e.g., hexokinase method, glucose oxidase method) performed on venous plasma or serum samples. This is considered the gold standard for glucose concentration.

8. The Sample Size for the Training Set

Not applicable in the context of this device and report. This is a traditional electrochemical biosensor device, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The device's "training" and calibration would involve manufacturing processes to ensure sensor consistency and calibration against known glucose concentrations.

9. How the Ground Truth for the Training Set was Established

Not applicable for the reasons stated in point 8.

Summary

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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 SystemAG-695 Multi Blood Glucose Monitoring SystemAG-696 Single Blood Glucose Monitoring SystemAG-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

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

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 should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

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 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 should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

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

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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:AG-695 Single andAG-695 MULTI BloodGlucose MonitoringSystem	PREDICATE:AG-606 Blood GlucoseMonitoring System(K073030)
Detection Method	Amperometry	Amperometry
Enzyme	Glucose Oxidase	Glucose Oxidase
Type of Meter	Biosensor (Electrode)	Biosensor (Electrode)
Intended Use	To quantitatively measureglucose in fresh capillarywhole blood.	To quantitatively measureglucose in fresh capillarywhole blood.
Sample Source	Capillary whole blood	Capillary whole blood
Sample Application	Blood sample is placeddirectly to the test strip afterfinger is lanced.	Blood sample is placeddirectly to the test strip afterfinger is lanced.
Hematocrit Range	30-55%	30-55%
Operating TemperatureRange	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 datedisplaying	350 times with time and datedisplaying
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(1.1mmol/L~33.3mmol/L)	20mg/dL-600mg/dL(1.1mmol/L~33.3mmol/L)
Qualified Test Strip	AGS-1000 Single Test Stripfor AG-695 Single BGMSAGS-1000 MULTI Test stripfor 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:AG-696 Single andAG-696 MULTI BloodGlucose MonitoringSystem	PREDICATE:AG-606 Blood GlucoseMonitoring System(K073030)
Detection Method	Amperometry	Amperometry
Enzyme	Glucose Oxidase	Glucose Oxidase
Type of Meter	Biosensor (Electrode)	Biosensor (Electrode)
Intended Use	To quantitatively measureglucose in fresh capillarywhole blood.	To quantitatively measureglucose in fresh capillarywhole blood.
Sample Source	Capillary whole blood	Capillary whole blood
Sample Application	Blood sample is placeddirectly to the test strip afterfinger is lanced.	Blood sample is placeddirectly to the test strip afterfinger 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 datedisplaying	350 times with time and datedisplaying
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(1.1mmol/L~33.3mmol/L)	20mg/dL-600mg/dL(1.1mmol/L~33.3mmol/L)
Qualified Test Strip	AGS-1000 Single Test Strip forAG-696 Single BGMSAGS-1000 MULTI Test stripfor 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 (301) 796-5450. 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 (301) 796-5760. 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 (800) 638-2041 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 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✓	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)

. �

િ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.

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 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

{12}------------------------------------------------

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 should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

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

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
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.(b)
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.