(249 days)
No
The document describes a standard glucose monitoring system with a meter, test strips, and a mobile app for display and data management. There is no mention of AI or ML being used for data analysis, prediction, or any other function beyond basic data display and transfer.
No.
This device is a gluco-monitoring system used for measuring blood glucose levels, which aids in monitoring the effectiveness of diabetes control. It does not provide therapy or treatment for diabetes.
Yes
The device is explicitly stated to be for "in vitro diagnostic use" and assists in monitoring the effectiveness of diabetes control, which falls under the definition of a diagnostic device. However, it is also explicitly stated that it should not be used for diagnosis or screening of diabetes.
No
The device description explicitly states that the system consists of a blood glucose meter, test strips, lancets, lancing device, control solutions, and the iHealth Gluco-Smart App. While the app is a software component, it is part of a larger system that includes hardware (the meter, etc.).
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section for all three systems (iHealth Align, iHealth BG5, and iHealth BG5L) explicitly states: "The iHealth [System Name] 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."
This direct statement confirms that the device is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
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.
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, 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.
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.
Product codes
NBW, CGA, JOP
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.
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
self testing outside the body (in vitro diagnostic use) by 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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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.
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).
| 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."
3
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.
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."
4
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.
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."
5
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.
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.
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 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
7
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.
7.0 Summary comparing technological characteristics with predicate device
| Item | Predicate device | Candidate Devices | |
|---|---|---|---|
| Item | Predicate device | Candidate Devices | |
| Device name | iHealth Align Mini | ||
| Gluco-Monitoring | |||
| System | iHealth | ||
| wireless | |||
| Gluco-Monitoring | |||
| System and iHealth | |||
| BG5L wireless Smart | |||
| Gluco-Monitoring | |||
| System | BG5L iHealth Align | ||
| Smart Gluco-Monitoring | |||
| system | |||
| IFU | Quantitative | ||
| measurement of | |||
| glucose in fresh | |||
| capillary whole | |||
| blood samples drawn | |||
| from the fingertip | |||
| palm, forearm, upper | |||
| arm, calf, or thigh | Same | same | |
| Model | BG1 | BG5 (Bluetooth) | |
| BG5L (Bluetooth low | |||
| energy) | Same | ||
| Enzyme | Glucose oxidase | same | same |
| Measuring range | $20-600$ mg/dL | Same | Same |
| Hematocrit range | $20-60%$ | Same | same |
| Connectivity to | |||
| Meter | Earphone jack | Same and Bluetooth | |
| and Bluetooth low | |||
| energy | Earphone jack | ||
| Display | Connect to Apple | ||
| platform | Same and LED | ||
| meter display | Same | ||
| Test Strip | |||
| Calibration | QR code scan | Same | Same |
| Dimensions | 52 mmx30 mmx9.5 | ||
| mm | 9 mm x 34.5mm | ||
| x19mm | Same | ||
| Mobile App name | iHealth | ||
| Gluco-Smart App | Same | Same | |
| Mobile App version | V2.3 | V3.8.5 | V3.8.5 |
| Compatible iOS | |||
| version | 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 (4th | |||
| generation) | iPad3 | ||
| iPod touch (5th | |||
| generation) | 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.