K Number

Device Name

iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)

Manufacturer

Andon health Co., Ltd

Date Cleared

2017-09-15

(233 days)

Product Code

NBW

Regulation Number

862.1345

Intended Use

The iHealth® Align Gluco-Monitoring System (BG1) consists of the iHealth® Align Glucose meter (BG1), iHealth® Blood Glucose Test Strips (EGS-2003), 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. The iHealth® Align Gluco-Monitoring System (BG1) 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® Wireless Smart Gluco-Monitoring System (BC5) consists of the iHealth® Wireless Glucose meter (BC5), iHealth® Blood Glucose Test Strips (EGS-2003), and the iHealth® Gluco-Smart App mobile application. The iHealth® 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® Wireless Gluco-Monitoring System is intended to be used by a single person and should not be shared. The iHealth® Wireless Smart Gluco-Monitoring System (BG5) 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® 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).

Device Description

The iHealth® Align Gluco-Monitoring system(BG1) consist of BG1 glucose meter, EGS-2003 test strip, iHealth® control solution(Level I, Level II, Level III), lancet and lancing device. The BG1 glucose meter can be connected to iOS device and Android device through earphone jack, and display test result on iOS or Android device. The iHealth® wireless Smart Gluco-Monitoring System(BG5) consist of BG5 glucose meter, EGS-2003 test strip, iHealth® control solution(Level I, Level II, Level III), lancet and lancing device. The BG5 glucose meter can display test result on meter itself, and can also be connected to iOS device and Android device through bluetooth and display test result on iOS or Android device.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K153278

Reference Devices

K153278

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard glucose monitoring system and mobile app for displaying results. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No
The device is a gluco-monitoring system intended for the quantitative measurement of glucose, which aids in monitoring the effectiveness of diabetes control. It does not provide any therapy or treatment.

Diagnostic

Yes

The document states, "The iHealth® Align Gluco-Monitoring System (BG1) 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." and "The iHealth® Wireless Smart Gluco-Monitoring System (BG5) 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 term "in vitro diagnostic use" confirms its nature as a diagnostic device.

SaMD (Software as a Medical Device)

The device description explicitly states that the system consists of a glucose meter (hardware), test strips (hardware), control solution (hardware), lancet (hardware), and lancing device (hardware), in addition to the mobile application (software). Therefore, it is not a software-only medical device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The intended use statement explicitly states: "The iHealth® Align Gluco-Monitoring System (BG1) is intended for self testing outside the body (in vitro diagnostic use)..." and "The iHealth® Wireless Smart Gluco-Monitoring System (BG5) is intended for self-testing outside the body (in vitro diagnostic use)...".

This clearly indicates that the device is designed to be used for testing biological samples (blood) outside of the body to provide diagnostic information.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The iHealth® Align Gluco-Monitoring System (BG1) 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® Wireless Smart Gluco-Monitoring System (BC5) consists of the iHealth® Wireless Glucose meter (BC5), iHealth® Blood Glucose Test Strips (EGS-2003), and the iHealth® Gluco-Smart App mobile application. The iHealth® 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® Wireless Gluco-Monitoring System is intended to be used by a single person and should not be shared.

The iHealth® Wireless Smart Gluco-Monitoring System (BG5) 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® 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).

Product codes

NBW

Device Description

The iHealth® wireless Smart Gluco-Monitoring System(BG5) consist of BG5 glucose meter, EGS-2003 test strip, iHealth® control solution(Level I, Level II, Level III), lancet and lancing device. The BG5 glucose meter can display test result on meter itself, and can also be connected to iOS device and Android device through bluetooth and display test result on iOS or Android device.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Fingertip, palm, forearm, upper arm, calf, or thigh

Indicated Patient Age Range

Not Found

Intended User / Care Setting

People with diabetes at home.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

User Evaluation study include a total 350 participants was completed for the iHealth® Wireless Smart Gluco-Monitoring System (BG5) and iHealth® Align Gluco-Monitoring System(BG1). The study results demonstrate that the user accuracy and ease of use (via participant questionnaire scoring) confirmed the proposed device to be substantially equivalent to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K153278

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 15. 2017

ANDON HEALTH CO., LTD YI LIU PRESIDENT NO.3 JINPING STREET,YA AN ROAD, NANKAI DISTRICT TIANJIN, P.R. CHINA TIANJIN 300190. CHINA

Re: K170231

Trade/Device Name: iHealth Align Gluco-monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5) Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW Dated: August 14, 2017 Received: August 16, 2017

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

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/ResourcesforYou/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,

Kellie B. Kelm -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

Indications for Use

510(k) Number (if known) K170231

Device Name

iHealth® Align Gluco-Monitoring System (BG1) iHealth® Wireless Smart Gluco-Monitoring System (BG5)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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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 Street,Ya'an Road, Nankai District, Tianjin,
P.R. China
Phone number:	86-22-6052 6161
Fax number:	86-22-6052 6162
Contact:	Yi Liu
Date of Preparation:	9/14/2017

2.0 Device information

Trade name:	iHealth® Align Gluco-Monitoring system(BG1)
	iHealth®
System(BG5)	Wireless	Smart	Gluco-Monitoring
Common name:	Blood Glucose Monitoring System
Classification name:	Blood Glucose Monitoring System

3.0 Classification _

Product code	classification	Regulation section	Panel
NBW	II	862.1345	Chemistry(75)

4.0 Predicate device information

Manufacturer: Andon Health Co., Ltd.

BG5/BG5L WIRELESS SMART GLUCOSE iHealth® Device: MONITORING SYSTEM

510(k) number: K153278

5.0 Test principle

The blood glucose Monitoring System consist of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.

They are based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. For EGS-2003 test strip, the reactive enzyme is glucose dehydrogenase.

Capillary action at the end of the test strip draws the blood into the action chamber and the glucose in blood will take electrochemical reaction with the enzyme, the blood glucose result is displayed in 5 seconds.

6.0 Device description

7.0 Intended use

For BG1

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).

For BG5

The iHealth® Wireless Smart Gluco-Monitoring System (BG5) consists of the iHealth® Wireless Glucose meter (BG5), iHealth® Blood Glucose Test Strips (EGS-2003), and the iHealth® Gluco-Smart App mobile application. The iHealth® 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® Wireless Gluco-Monitoring System is intended to be used by a single person and should not be shared.

The iHealth® 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® 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).

8.0 Summary comparing technological characteristics with predicate device

CHARACTERISTICS	PREDICATE	NEW DEVICE:
TICS	BG5 BGMS (K153278)	BG1 BGMS	BG5 BGMS
Detection
Method	Amperometry	Same as predicate	Same as predicate
Enzyme	Glucose Oxidase	Glucose Oxidase
and Glucose
dehydrogenase	Glucose Oxidase
and Glucose
dehydrogenase
Type of Meter	Biosensor (Electrode)	Same as predicate	Same as predicate

Sample Source	Capillary whole blood from AST(Alternative site testing) and finger	Same as predicate	Same as predicate
Sample Application	Blood sample is placed directly to the test strip after finger or AST is lanced.	Same as predicate	Same as predicate
Hematocrit Range	20-60%	Same as predicate	Same as predicate
Operating Temperature Range	$10℃~35℃(50°-95°F)$	Same as predicate	Same as predicate
Dimensions	9mm x 34.5mm x19mm	52mm×30mm×9.5 mm	9mm x 34.5mm x19mm
Display	Connect to iOS device and android device to display measurement results
Display on the meter	Connect to iOS device and android device to display measurement results	Connect to iOS device and android device to display measurement results
Display on the meter
Result Presentation	mg/dL or mmol/L	mg/dL or mmol/L	mg/dL or mmol/L
Memory Capabilities	500 times with time and date displaying	1000 times with time and date displaying	500 times with time and date displaying
Test Start	Automatic	Automatic	Automatic
Test Time	5 second	5 second	5 second
Power Source	DC 3.7V d.c.
li-ion 250mAh	DC3.0V (CR1620)	DC 3.7V d.c.
li-ion 250mAh
Battery Life	N/A	N/A	N/A
Measurement Range	20mg/dL-600mg/dL
(1.1mmol/L~33.3mmol/L)	20mg/dL-600mg/dL
(1.1mmol/L~33.3m mol/L)	20mg/dL-600mg/dL
(1.1mmol/L~33.3m mol/L)
Qualified Test Strip	AGS-1000l Test Strip	EGS-2003 and
AGS-1000l Test Strip	EGS-2003 and
AGS-1000l Test Strip
Sample Volume	Minimum 0.7 micro liter	Minimum 0.7 micro liter	Minimum 0.7 micro liter
Connect Method	Connect to iOS device	Connect to iOS	Connect to iOS

Specification Comparison

	through bluetooth	device through	device through
		earphone jack	bluetooth

Discussion of Non-Clinical Tests Performed

· Performance, functionality, and reliability of the proposed device has been evaluated. The performance evaluation include precision, altitude, temperature & humidity, linearity, interference, sample volume and hematocrit.

• Software: documentation was prepared and submitted for a moderate level of concern device in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices;

Discussion of Clinical Tests Performed

9.0 Comparison to the predicate device and the conclusion

The proposed device is similar with the predicate device, they are both for single patient use, can test the blood glucose at the alternative site. The hematocrit range, the altitude and the use function are all the same, and all the proposed device can be connected to not only the iOS device, but also the Android device. The only difference is the new device added new test strips.

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