(281 days)
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).
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.
The provided text describes the iHealth Align Gluco-Monitoring System (BG1) and its substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested.
The document is a 510(k) summary for a glucose monitoring system, focusing on demonstrating substantial equivalence to a previously cleared device. It highlights the technological characteristics and intended use. While it mentions performance characteristics like measurement range and test time, it doesn't present a table of acceptance criteria with corresponding device performance for a specific study.
Therefore, I can extract information related to the device's characteristics and the submission's intent, but I cannot fulfill all sections of your request directly from the provided text as the specific clinical study data (including sample sizes, ground truth establishment, expert qualifications, and adjudication methods for acceptance criteria) is not present.
Here's a breakdown of what can be extracted and what cannot:
Information that CANNOT be extracted from the provided text:
- A table of acceptance criteria and the reported device performance because the document focuses on demonstrating substantial equivalence through technological comparison rather than presenting the results of a primary clinical validation study against predefined acceptance metrics.
- Sample sizes used for the test set and data provenance for a specific clinical validation study.
- Number of experts used to establish the ground truth and their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
- Whether a standalone (algorithm only) performance study was done. (This device is a physical glucose meter, not an AI algorithm.)
- The sample size for the training set. (This is a medical device, not an AI algorithm that typically has a "training set" in the machine learning sense.)
- How the ground truth for the training set was established.
Information that CAN be extracted or inferred:
1. Acceptance Criteria and Reported Device Performance:
While a formal "acceptance criteria" table is not provided, the document lists key performance characteristics assumed to meet regulatory expectations. The predicate device's performance, which the new device is compared against, indirectly sets the "acceptance criteria" for substantial equivalence.
| Characteristic | Reported Device Performance and Substantial Equivalence |
|---|---|
| Detection Method | Amperometry (Same as predicate) |
| Enzyme | Glucose Oxidase (Same as predicate) |
| Type of Meter | Biosensor (Electrode) (Same as predicate) |
| Sample Source | Capillary whole blood from AST and finger (Same as predicate) |
| Sample Application | Blood sample placed directly to test strip (Same as predicate) |
| Hematocrit Range | 20-60% (Same as predicate) |
| Operating Temperature Range | 10℃~35℃ (50°-95°F) (Same as predicate) |
| Display | Connect to iOS device and Android device to display measurement results (Predicate connected only to iOS; this is a difference noted, but considered not to raise new safety/effectiveness questions) |
| Result Presentation | mg/dL or mmol/L (Same as predicate) |
| Memory Capabilities | 10000 times with time and date displaying (Same as predicate) |
| Test Start | Automatic (Same as predicate) |
| Test Time | 5 seconds (Same as predicate) |
| Power Source | DC3.0V (CR1620) (Same as predicate) |
| Measurement Range | 20mg/dL-600mg/dL (1.1mmol/L~33.3mmol/L) (Same as predicate) |
| Qualified Test Strip | AGS-1000I Test Strip (Same as predicate) |
| Sample Volume | Minimum 0.7 microliter (Same as predicate) |
| Connect Method | Connect to iOS device and Android device through Earphone jack (Predicate connected only to iOS; this is a difference noted, but considered not to raise new safety/effectiveness questions) |
7. Type of Ground Truth Used:
The device measures chemical properties (glucose levels). The "ground truth" for such devices is typically established through a laboratory reference method (e.g., using a YSI glucose analyzer) on the same blood sample. While not explicitly stated, this is the standard for glucose meter validation.
The 510(k) summary explicitly states that the submission aims to demonstrate that "these small differences [referring to the expanded compatibility with Android devices] do not raise any new questions of safety and effectiveness," thus proving its substantial equivalence to the predicate device. This implies that the device performance for glucose measurement itself is considered equivalent to the predicate, which would have undergone its own rigorous testing against a reference standard.
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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
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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 AlignGluco-MonitoringSystem(BG1) | PREDICATE:iHealth BG1 Align miniGluco-Monitoring System(K133790) |
|---|---|---|
| Detection Method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase | Glucose Oxidase |
| Type of Meter | Biosensor (Electrode) | Biosensor (Electrode) |
| Sample Source | Capillary whole blood fromAST(Alternative site testing)and finger | Capillary whole blood fromAST(Alternative sitetesting) and finger |
| Sample Application | Blood sample is placeddirectly to the test strip afterfinger or AST is lanced. | Blood sample is placeddirectly to the test stripafter finger or AST islanced. |
| Hematocrit Range | 20-60% | 20-60% |
| OperatingTemperature Range | 10℃~35℃(50°-95°F) | 10℃~35℃(50°-95°F) |
| Dimensions | 52mm×30mm×9.5mm | 52mm×30mm×9.5mm |
| Display | Connect to iOS device andandroid device to displaymeasurement results | Connect to iOS device todisplay measurementresults |
| Result Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Memory Capabilities | 10000 times with time anddate displaying | 10000 times with time anddate 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~33.3mmol/L) | 20mg/dL-600mg/dL(1.1mmol/L~33.3mmol/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 andAndroid device throughEarphone jack | Connect to iOS devicethrough 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.
§ 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.