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 Description

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

AI/ML Overview

Here's an analysis of the AG-608N Single and AG-608N Multi Blood Glucose Monitoring System, focusing on its acceptance criteria and the study that proves its performance, based on the provided FDA 510(k) files:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the AG-608N Single and AG-608N MULTI Blood Glucose Monitoring System conforms to ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.

While the specific numeric acceptance criteria for bias, precision, and accuracy as defined by ISO 15197 are not explicitly detailed in the provided text, the standard itself outlines these requirements. For instance, the 2003 version of ISO 15197 (which would likely be applicable around the 2011 submission date) typically requires:

Accuracy: For glucose concentrations < 75 mg/dL (4.2 mmol/L), at least 95% of results must be within ±15 mg/dL (±0.83 mmol/L) of the reference value. For glucose concentrations ≥ 75 mg/dL (4.2 mmol/L), at least 95% of results must be within ±20% of the reference value.
Precision (repeatability/intermediate precision): Coefficients of variation (CVs) for within-day and between-day measurements should be within specified limits, generally less than 5% for higher glucose concentrations and within specified mg/dL values for lower concentrations.

The document doesn't provide the detailed reported performance data against these specific numeric criteria. It only states that "Non-clinical test and the clinical test are done according to the above standard." Without the actual performance tables, we cannot list the specific reported device performance values.

However, based on the statement that the device "conforms to" ISO 15197, we can infer that the device's performance met the general accuracy and precision requirements of that standard.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: The document explicitly states that "Non-clinical test and the clinical test are done according to the above standard," referring to ISO 15197. However, it does not specify the sample size used for these tests. ISO 15197 typically mandates a minimum number of subjects (e.g., 100 for accuracy evaluation) and a specific number of blood samples over a range of glucose concentrations for evaluating performance claims. Without the detailed study report, the exact sample size is unknown from this document.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the submitter's address (Tianjin, P.R. China), it is highly probable the studies were conducted in China. The statement about "clinical test" suggests a prospective study, but this is not explicitly confirmed.

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

The document does not specify the number of experts used to establish ground truth or their qualifications.
For blood glucose monitoring systems, the "ground truth" is typically established by laboratory reference methods (e.g., YSI analyzer) operated by trained laboratory personnel, rather than clinical experts for individual measurements. While these personnel are experts in operating the reference method, they are not medical experts in the sense of a radiologist interpreting images.

4. Adjudication Method for the Test Set:

The concept of an "adjudication method" (like 2+1 or 3+1) is not applicable to the performance evaluation of a blood glucose monitoring system where the ground truth is established by a quantitative laboratory reference method. The reference method provides a definitive numerical value, eliminating the need for expert consensus or adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically employed for diagnostic imaging devices where human interpretation plays a significant role and the AI's impact on human performance is being assessed.
This device is a standalone in vitro diagnostic system for direct glucose measurement. Its performance is evaluated against a laboratory reference method, not in conjunction with human readers or interpreters in an MRMC setting.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

Yes, a standalone performance study was done. The entire evaluation of the AG-608N system, as described by its conformity to ISO 15197, inherently involves testing the device's accuracy and precision as a standalone unit. The system measures glucose and displays a result directly; there is no "human-in-the-loop" interpretation in the measurement process itself, beyond physically performing the test. The "clinical test" refers to testing the device on actual patient samples, with the device running as an algorithm only to produce results compared to a reference standard.

7. The Type of Ground Truth Used:

The ground truth for blood glucose monitoring systems is typically established using a laboratory reference method (e.g., a YSI Glucose Analyzer). This method is considered the gold standard for accurately measuring glucose concentration in blood samples. While not explicitly stated as "YSI," the adherence to ISO 15197 implies such a high-accuracy laboratory method was used.

8. The Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. Blood glucose monitoring systems like the AG-608N generally operate on electrochemical principles rather than machine learning algorithms that require a distinct training phase in the same way an AI image analysis system would. Therefore, the concept of a "training set" for the device's core measurement algorithm is likely not applicable in the same context. Any "training" would be related to calibration and quality control during manufacturing.

9. How the Ground Truth for the Training Set Was Established:

As a training set in the AI/machine learning sense is not applicable, the question of how ground truth for it was established is also not applicable. The device's fundamental operational parameters and calibration are established through rigorous quality control procedures and calibrations against certified glucose standards, not through a "training set" of patient data.

Summary

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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,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 SystemAG-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

6.2 AG-608N MULTI BGMS

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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.

Similarities
CHARACTERISTICS	NEW DEVICE:AG-608N Single andMULTI Blood GlucoseMonitoring System	PREDICATE:AG-608 Blood GlucoseMonitoring System(K093262)
Detection Method	Amperometry	Amperometry
Enzyme	Glucose Oxidase	Glucose Oxidase
Type of Meter	Biosensor (Electrode)	Biosensor (Electrode)
Sample Source	Capillary whole blood fromAST(Alternative sitetesting) and finger	Capillary whole blood fromfinger
Sample Application	Blood sample is placeddirectly to the test stripafter finger or AST islanced.	Blood sample is placeddirectly to the test stripafter finger is lanced.
Hematocrit Range	20-60%	35-50%
Altitude	10744 feet(3275m)	11975 feet(3650m)
Operating TemperatureRange	10℃~40℃ (50°-104°F)	10℃~40℃ (50°-104°F)
Dimensions	87mmx 53mmx 9.9mm	85mm×53mm(W)×13.7mm(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(1.1mmol/L~33.3mmol/L)	20mg/dL-600mg/dL(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 (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 Biometrig'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/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 (800) 638-2041 or (301) 796-5680 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.

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

Page 1 of 2

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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).

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)

Page Dof 2

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.