The iHealth Align Gluco-Monitoring System consists of the iHealth Align Glucose meter (BG1), iHealth Blood Glucose Test Strips (AGS-1000), and the iHealth Gluco-Smart App mobile application as the display component of the iHealth Align Gluco-Monitoring System. The iHealth Align Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Alian Gluco-Monitoring System is intended to be used by a single person and should not be shared.

The iHealth Align Gluco-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 iHealth Align Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The iHealth BG5 wireless Smart Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh. The iHealth BG5 wireless Smart Gluco-Monitoring System is intended to be used by a single person and should not be shared.

The iHealth BG5 wireless Smart Gluco-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 iHealth BG5 wireless Smart Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).

The AGS-1000I test strips are for use with the iHealth BG5 meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh.

The iHealth BG5L wireless Smart Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh. The iHealth BG5L wireless Smart Gluco-Monitoring System is intended to be used by a single person and should not be shared.

The iHealth BG5L wireless Smart Gluco-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 iHealth BG5L wireless Smart Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).

The AGS-1000I test strips are for use with the iHealth BG5L meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh.

Device Description

The iHealth Align Gluco-Monitoring System consists of a blood glucose meter, test strips, iHealth Gluco-Smart App, sterile lancets, lancing device and AGS-1000I Control Solutions (Level I. Level II and Level III). The iHealth Align Gluco-Monitoring System cannot display test results and must be used with an iPhone or iPod touch via an 3.5 mm auxiliary jack.

The iHealth BG5 wireless Smart and iHealth BG5L wireless Smart Gluco-Monitoring Systems consist of the BG5 and BG5L wireless Smart blood glucose meters, respectively, AGS-10001 Test Strips , sterile lancets, lancing device and the iHealth control solutions control solutions. (Control solutions provided are for Level 1, II, and III). iHealth BG5L uses Bluetooth 4.0 wireless radio technology; while iHealth BG5 uses Bluetooth 3.0 wireless radio technology. The iHealth BG5 and BG5L meters can display the test results and the test results can also be transmitted to an iPhone, iPod touch or iPad through blue tooth.

iHealth Gluco-Smart App is iOS- based software for use with the iHealth Align Glucose meter (BG1), iHealth BG5 meter, and iHealth BG5L meter. When used with these meters, iHealth Gluco-Smart App acts as a display and allows command and control of the meter. The App can transfer data from the device's memory, manage, and share the data.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and study details for the iHealth Gluco-Monitoring Systems:

The provided documents are a 510(k) premarket notification for the iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, and iHealth BG5L wireless Smart Gluco-Monitoring System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials typical of novel devices. Therefore, the "acceptance criteria" and "study" described are primarily focused on proving that the new devices perform comparably to the predicate device and meet relevant regulatory standards for glucose monitoring systems.

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not explicitly state a table of "acceptance criteria" in the format of specific thresholds for metrics like sensitivity, specificity, or accuracy (e.g., within X% of a reference standard for Z% of readings). Instead, the acceptance criteria are implicitly tied to the performance characteristics of the predicate device and general regulatory expectations for glucose monitoring systems.

The performance is primarily summarized by stating that the new devices share key characteristics with the predicate and that "Software validation and user study has been performed to establish the performance, the functionality and the reliability characteristics of the new device."

Here's an attempt to infer and present the information in a table format based on the textual evidence:

Characteristic/Criterion (Inferred)	Reported Device Performance
Intended Use	Same as predicate device: Quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, forearm, upper arm, calf, or thigh; for self-testing by people with diabetes at home as an aid to monitor effectiveness of diabetes control; not for diagnosis, screening, or neonatal use. Alternative site testing only during steady states.
Enzyme	Same as predicate device: Glucose oxidase
Measuring Range	Same as predicate device: 20-600 mg/dL
Hematocrit Range	Same as predicate device: 20-60%
Connectivity to Meter (for App)	iHealth Align: Earphone jack (same as predicate); BG5/BG5L: Bluetooth/Bluetooth low energy (new/improved, but functionally equivalent)
Display	iHealth Align: Connects to Apple platform (same as predicate); BG5/BG5L: Same as predicate AND LED meter display (new/improved, but functionally equivalent)
Test Strip Calibration	Same as predicate device: QR code scan
Software Performance	"Software validation and user study has been performed to establish the performance, the functionality and the reliability characteristics of the new device." The submission claims these differences "do not raise any new questions of safety and effectiveness." This implies that the software's ability to display results accurately, manage data, and connect with the meters was found to be acceptable and comparable to the predicate's functionality.
Safety and Effectiveness	Demonstrated that "these small differences do not raise any new questions of safety and effectiveness." (Implies meeting the same safety and effectiveness profile as the predicate). This is a core regulatory acceptance criterion for 510(k) submissions.

2. Sample Size for the Test Set and Data Provenance

The document mentions "user study" but does not specify the sample size for any clinical or test set. It also does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given the nature of a 510(k) for a glucose monitoring system, user studies often involve a diverse cohort to assess performance across various glucose levels and user demographics. However, these specific details are absent from the provided text.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish ground truth for a test set. For glucose monitoring systems, "ground truth" is typically established by comparing the device's readings against a highly accurate laboratory reference method (e.g., YSI glucose analyzer), rather than expert adjudication of images or clinical reports. The general term "user study" is used, which implies participants used the device and its performance was evaluated against a reference.

4. Adjudication Method for the Test Set

As the document does not describe a process involving experts to establish ground truth for a test set in the traditional sense, there is no mention of an adjudication method like 2+1 or 3+1. Performance is likely assessed against a laboratory reference.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The provided text does not describe an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. This type of study is more common in diagnostic imaging or clinical decision support AI devices where human interpretation is a key component. The iHealth devices are standalone glucose meters; while an app is involved, it primarily acts as a display and data management tool, not an AI for interpretation.

6. Standalone (Algorithm Only) Performance Study

Yes, implicitly. The core performance of the glucose measurement algorithm itself (i.e., the meter and test strip system) is evaluated. The 510(k) process for glucose meters typically requires studies demonstrating the accuracy of the device's readings against a laboratory reference method. Although the document uses the broad term "performance summary," this usually entails standalone accuracy data. The phrase "Software validation and user study has been performed to establish the performance, the functionality and the reliability characteristics of the new device" suggests that the device's ability to accurately measure glucose without a human in the interpretative loop was a key part of the validation.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. However, for glucose monitoring systems, the ground truth is almost universally established using a laboratory reference method (e.g., a YSI glucose analyzer) that is considered the gold standard for glucose measurement.

8. Sample Size for the Training Set

The document does not mention a "training set" sample size. This is expected because the iHealth Gluco-Monitoring Systems, as described, do not appear to be AI/Machine Learning devices that require a "training set" in the context of learning algorithms. They are likely electrochemical biosensors with pre-defined algorithms for glucose calculation. The app primarily handles data display and management.

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

As there is no mention of a training set, there is no information on how its ground truth was established. The device likely relies on established physical and chemical principles of glucose measurement rather than a trained AI model.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 4, 2015

ANDON HEALTH CO., LTD YI LIU, PRESIDENT NO 3, JINPING RD, YA AN ST NANKAI DISTRICT TIANJIN 300193 CHINA

Re: K150833

Trade/Device Name: iHealth Align Gluco-Monitoring System iHealth BG5L wireless Smart Gluco-Monitoring System iHealth BG5 wireless Smart Gluco-Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JOP Dated: November 2, 2015 Received: November 4, 2015

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -S

For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150833

Device Name iHealth Align Gluco-Monitoring System

Indications for Use (Describe)

The iHealth Align Gluco-Monitoring System consists of the iHealth Align Glucose meter (BG1), iHealth Blood Glucose Test Strips (AGS-1000), and the iHealth Gluco-Smart App mobile application as the display component of the iHealth Align Gluco-Monitoring System. The iHealth Align Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Align Gluco-Monitoring System is intended to be used by a single person and should not be shared.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K150833

Device Name

iHealth BG5 wireless Smart Gluco-Monitoring System

Indications for Use (Describe)

The iHealth BG5 wireless Smart Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, calf or thigh. The iHealth BG5 wireless Smart Gluco-Monitoring System is intended to be used by a single person and should not be shared.

The iHealth BG5 wireless Smart Gluco-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 iHealth BG5 wireless Smart Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The AGS1000I test strips are for use with the iHealth BG5 meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh,

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K150833

Device Name

iHealth BG5L wireless Smart Gluco-Monitoring System

Indications for Use (Describe)

The iHealth BG5L wireless Smart Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, calf or thigh. The iHealth BG5L wireless Smart Gluco-Monitoring System is intended to be used by a single person and should not be shared.

The iHealth BG5L wireless Smart Gluco-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 iHealth BG5L wireless Smart Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The AGS1000I test strips are for use with the iHealth BG5L meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh,

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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 Health Co., Ltd.
Address:	No 3, Jinping Road, Ya'an street TIANJIN,300193
Phone number:	86-22-60526161
Fax number:	86-22-6052 6162
Contact:	Yi Liu
Date of Application:	3/20/2015

2.0 Device information

Device name: iHealth Align Gluco-Monitoring System iHealth BG5 wireless Smart Gluco-Monitoring System iHealth BG5L wireless Smart Gluco-Monitoring System
Classification name: Blood Glucose Monitoring System

3.0 Classification

Product code	Classification	Regulation Section	Panel
NBW	II	21 CFR 862.1345	Chemistry (75)
CGA	II	21 CFR 862.1345	Chemistry (75)
JQP	I	21 CFR 862.2100	Chemistry (75)

4.0 Predicate device information

Manufacturer:	Andon Health Co., Ltd.
Device:	iHealth Align Mini Gluco-Monitoring System
510(k) number:	K133790

5.0 Device description

The iHealth Align Gluco-Monitoring System consists of a blood glucose

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meter, test strips, iHealth Gluco-Smart App, sterile lancets, lancing device and AGS-1000I Control Solutions (Level I. Level II and Level The iHealth Align Gluco-Monitoring System cannot display test III). results and must be used with an iPhone or iPod touch via an 3.5 mm auxiliary jack.

6.0 Intended use

The iHealth Align Gluco-Monitoring System consists of the iHealth Align Glucose meter (BG1), iHealth Blood Glucose Test Strips (AGS-1000I), and the iHealth Gluco-Smart App mobile application as the display component of the iHealth Align Gluco-Monitoring System. The iHealth Align Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Alian Gluco-Monitoring System is intended to be used by a single person and should not be shared.

The iHealth BG5 wireless Smart Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh

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capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh. The iHealth BG5 wireless Smart Gluco-Monitoring System is intended to be used by a single person and should not be shared.

7.0 Summary comparing technological characteristics with predicate device

Item	Predicate device	Candidate Devices
Item	Predicate device	Candidate Devices
Device name	iHealth Align MiniGluco-MonitoringSystem	iHealthwirelessGluco-MonitoringSystem and iHealthBG5L wireless SmartGluco-MonitoringSystem	BG5L iHealth AlignSmart Gluco-Monitoringsystem
IFU	Quantitativemeasurement ofglucose in freshcapillary wholeblood samples drawnfrom the fingertippalm, forearm, upperarm, calf, or thigh	Same	same
Model	BG1	BG5 (Bluetooth)BG5L (Bluetooth lowenergy)	Same
Enzyme	Glucose oxidase	same	same
Measuring range	$20-600$ mg/dL	Same	Same
Hematocrit range	$20-60%$	Same	same
Connectivity toMeter	Earphone jack	Same and Bluetoothand Bluetooth lowenergy	Earphone jack
Display	Connect to Appleplatform	Same and LEDmeter display	Same
Test StripCalibration	QR code scan	Same	Same
Dimensions	52 mmx30 mmx9.5mm	9 mm x 34.5mmx19mm	Same
Mobile App name	iHealthGluco-Smart App	Same	Same
Mobile App version	V2.3	V3.8.5	V3.8.5
Compatible iOSversion	5,6,7	7,8,9	7,8,9
Item	Predicate device	Candidate Devices
Phone Platform	iPhone 5s	Same and	Same and
	iPhone 5c	iPhone 6S	iPhone 6S
	iPhone 5	iPhone 6S Plus	iPhone 6S Plus
	iPhone 4S	iPhone 6	iPhone 6
	iPhone 4	iPhone 6 PLUS	iPhone 6 PLUS
	iPhone 3GS	iPad2
	iPod touch (4thgeneration)	iPad3
	iPod touch (5thgeneration)	iPad4
		iPad Mini
		iPad mini 2
		iPad Air
		iPad Air 2

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8.0 Performance summary

Software validation and user study has been performed to establish the performance, the functionality and the reliability characteristics of the new device. Testing of iHealth Gluco-Smart App included system test and unit test.

9.0 Comparison to the predicate device and the conclusion

The proposed device is similar with the predicate device iHealth BG1, they are both for single patient use, they use the same test strip, and can test the blood glucose at the alternative site. The hematocrit range, the altitude and the use function are all the same. However, the proposed devices, BG1, BG5/BG5L systems can be operated with the claimed platforms.

iHealth Gluco-Smart App can operate with both iHealth BG1 Align Gluco-Monitoring System and iHealth BG5/BG5L wireless Smart Gluco-Monitoring System, The style of the app are also changed. Some new function are added ,such as A Blood Glucose summary according to the data saved in database should be displayed, People can share the data by Facebook.

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

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.