(281 days)
Not Found
No
The summary describes a standard electrochemical glucose monitoring system and its associated app, with no mention of AI or ML capabilities. The technology described is based on electrochemical biosensing and capillary action.
No.
The device is a gluco-monitoring system intended for measuring glucose levels, which is a diagnostic function to monitor diabetes control, not a therapeutic intervention.
No
The device is explicitly stated as "should not be used for the diagnosis of or screening of diabetes". It is intended for monitoring the effectiveness of diabetes control, not for diagnosis.
No
The device description explicitly states that the system consists of a blood glucose meter, test strips, lancets, lancing device, and control solutions, in addition to the mobile application. These are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states: "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."
This clearly indicates that the device is designed to be used outside of the body to test samples (blood) for diagnostic purposes (monitoring glucose levels).
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, 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).
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, JQP
Device Description
The iHealth Align Gluco-Monitoring System(BG1) 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. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. It uses the same technological characteristics for testing with its predicate device.
In order to use the iHealth Align Gluco-Monitoring system(BG1) , a compatible Android or iOS mobile device with the necessary mobile application installed is required.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, upper arm, calf, or thigh (Indications for Use text)
fingertip, palm, forearm, upper arm, calf, or thigh (Intended Use text)
Indicated Patient Age Range
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Intended User / Care Setting
by people with diabetes at home
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted with three parallel lines forming the staff and the snakes, giving it a modern and abstract appearance.
Auqust 19, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ANDON HEALTH CO., LTD LIU YI, PRESIDENT NO. 3 JINPING STREET, YA AN ROAD, NANKAI DISTRICT TIANJIN, P.R. CHINA
Re: K153286
Trade/Device Name: iHealth Align Gluco-Monitoring System (BG1) Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JQP Dated: August 11, 2016 Received: August 15, 2016
Dear Mr. Yi:
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.
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Page 2-Mr. Yi
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,
Stayce Beck -S
For :Courtney H. Lias Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K153286
Device Name
iHealth Align Gluco-Monitoring System (BG1)
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 fingertin, 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) |
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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: | 11/05/2015 |
2.0 Device information
| Trade name: | iHealth Align Gluco-Monitoring System (BG1 |
|---|---|
| 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
Production code: CGA- test, blood glucose, over the counter Regulation number: 862.1345 Classification: II Panel: Clinical Chemistry
JQP Production code: Regulation number: 862.2100 Classification: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Panel: Clinical Chemistry
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4.0 Predicate device information
| Manufacturer: | Andon Health Co., Ltd. |
|---|---|
| Device: | iHealth Align mini Gluco-Monitoring System(BG1) |
| 510(k) number: | K133790 |
5.0 Device description
The iHealth Align Gluco-Monitoring System(BG1) 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. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. It uses the same technological characteristics for testing with its predicate device.
In order to use the iHealth Align Gluco-Monitoring system(BG1) , a compatible Android or iOS mobile device with the necessary mobile application installed is required.
6.0 Intended 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
5
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).
| CHARACTERISTICS | NEW DEVICE:
iHealth Align
Gluco-Monitoring
System(BG1) | PREDICATE:
iHealth BG1 Align mini
Gluco-Monitoring System
(K133790) |
|--------------------------------|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Detection Method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase | Glucose Oxidase |
| Type of Meter | Biosensor (Electrode) | Biosensor (Electrode) |
| Sample Source | Capillary whole blood from
AST(Alternative site testing)
and finger | Capillary whole blood from
AST(Alternative site
testing) and finger |
| Sample Application | Blood sample is placed
directly to the test strip after
finger or AST is lanced. | Blood sample is placed
directly to the test strip
after finger or AST is
lanced. |
| Hematocrit Range | 20-60% | 20-60% |
| Operating
Temperature Range | 10℃35℃(50°-95°F) | 10℃33.3mmol/L) |35℃(50°-95°F) |33.3mmol/L) | 20mg/dL-600mg/dL
| Dimensions | 52mm×30mm×9.5mm | 52mm×30mm×9.5mm |
| Display | Connect to iOS device and
android device to display
measurement results | Connect to iOS device to
display measurement
results |
| Result Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Memory Capabilities | 10000 times with time and
date displaying | 10000 times with time and
date displaying |
| Test Start | Automatic | Automatic |
| Test Time | 5 second | 5 second |
| Power Source | DC3.0V (CR1620) | DC3.0V (CR1620) |
| Battery Life | N/A | N/A |
| Measurement Range | 20mg/dL-600mg/dL
(1.1mmol/L
(1.1mmol/L
| Qualified Test Strip | AGS-1000I Test Strip | AGS-1000I Test Strip |
| Sample Volume | Minimum 0.7 micro liter | Minimum 0.7 micro liter |
| Connect Method | Connect to iOS device and
Android device through
Earphone jack | Connect to iOS device
through Earphone jack |
7.0 Summary comparing technological characteristics with predicate device
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8.0 Comparison to the predict 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 device can be connected to not only the iOS device, but also the Android device.
However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.