Quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh
single person measurement only and should not be shared
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 system should not be used for the diagnosis of or screening for diabetes, or for neonatal use.
Alternative Site Testing (AST) should be done only during steady state times when glucose levels are not changing rapidly.
iHealth Blood Glucose Test Strips(AGS-1000I) are intended for use with the iHealth Align Mini Glucose meter (BG1) to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealth BG1 meter.

Device Description

The iHealth BG1 Align Mini Gluco-Monitoring System (BGMS) consists of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.
The new device iHealth BG1 is 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.
The appearance of iHealth BG1 is different from the predicate device. Both the iHealth BG1 and the predicate device BG3 need to connect to iOS device to display the rest results, however, iHealth BG1 connect to iOS device through the earphone kack, while BG3 connect to iOS device through the 30-pin dock interface.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the iHealth BG1 Align Mini Gluco-Monitoring System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary states that the device conforms to ISO 15197: "In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus."

Given that the document is a 510(k) summary, it does not explicitly detail the entire set of ISO 15197 acceptance criteria in a table format. However, it indicates compliance with the standard. For a Class II device like a blood glucose monitoring system, the key performance criteria from ISO 15197 (at the time this 510(k) was likely submitted) generally revolve around accuracy percentages relative to a reference method.

Based on the information provided, here's a representation of the acceptance criteria and implied performance:

Acceptance Criteria (Based on ISO 15197)	Reported Device Performance (Implied by compliance)
Accuracy (System Accuracy Evaluation):
- For glucose concentrations < 4.2 mmol/L (75 mg/dL), at least 95% of results shall fall within ±0.83 mmol/L (±15 mg/dL) of the reference measurement values.	The device would meet these criteria, as "Non-clinical test and the clinical test are done according to the above standard." Specific percentage agreement or bias values are not directly reported in this summary beyond the statement of conformity.
- For glucose concentrations ≥ 4.2 mmol/L (75 mg/dL), at least 95% of results shall fall within ±20% of the reference measurement values.	The device would meet these criteria.
Intermediate Precision (Repeatability): No explicit criteria or performance is given in the summary, but compliance with ISO 15197 implies that repeatability studies were conducted and met the standard's requirements for coefficient of variation (CV%) or standard deviation (SD) for various glucose concentration ranges, demonstrating consistent results under repeated testing.	Implied to meet ISO 15197 requirements.
Measurement Range: 20mg/dL-600mg/dL (1.1mmol/L~33.3mmol/L) (Typically, ISO 15197 requires that the system's claimed measurement range be verified and that the system performs accurately within this range).	Stated measurement range: 20mg/dL-600mg/dL (1.1mmol/L~33.3mmol/L). Implied to perform accurately within this range, as "Non-clinical test and the clinical test are done according to the above standard."
Hematocrit Range: 20-60% (ISO 15197 requires demonstration of accuracy across the claimed hematocrit range, as hematocrit can interfere with glucose measurements).	Stated hematocrit range: 20-60%. Implied to perform accurately within this range, as "Non-clinical test and the clinical test are done according to the above standard."
Interfering Substances: No explicit criteria or performance is given, but ISO 15197 requires testing for common interfering substances to ensure they do not significantly affect measurement accuracy.	Implied to meet ISO 15197 requirements.
Operating Temperature: $10℃~35℃(50°-95°F)$ (Systems must maintain accuracy within their specified operating temperature range).	Stated operating temperature: $10℃~35℃(50°-95°F)$. Implied to perform accurately within this range, as "Non-clinical test and the clinical test are done according to the above standard."
User Performance (Lay-user study): ISO 15197 typically includes criteria for lay-user performance, demonstrating that intended users can operate the device correctly and obtain accurate results. (e.g., specific percentages of readings within a defined accuracy range when performed by lay users).	Implied to meet ISO 15197 requirements for self-testing devices, as "Non-clinical test and the clinical test are done according to the above standard."

2. Sample Sizes and Data Provenance

Test Set Sample Size: The summary document explicitly states that "Non-clinical test and the clinical test are done according to the above standard [ISO 15197]". However, the specific sample sizes used for the clinical and non-clinical tests are not provided in this 510(k) summary. ISO 15197 outlines minimum sample sizes for system accuracy evaluation (e.g., at least 100 capillary blood samples for system accuracy, with specific distributions across the measuring range).
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the submitter's address in Tianjin, P.R. China, it's plausible the studies were conducted in China, but this is not stated. The studies would have been prospective to meet the requirements for clinical and non-clinical testing under ISO 15197.

3. Number of Experts and Qualifications

This information is not provided in the 510(k) summary. For blood glucose monitoring systems, "experts" typically refer to laboratory professionals or clinical staff who perform comparative reference measurements (e.g., using a YSI glucose analyzer). Their role is to establish the ground truth using a highly accurate laboratory method, not to interpret images or diagnose.

4. Adjudication Method

This information is not applicable/not provided for this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert review of medical images or complex diagnostic interpretations, where there might be disagreement in expert opinions. For a blood glucose meter, the "ground truth" is established by a highly accurate laboratory reference method, not by expert consensus on interpretation.

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

No, an MRMC comparative effectiveness study was not conducted (or at least not mentioned in this summary). MRMC studies are specific to evaluating the impact of AI on human reader performance, particularly in diagnostic imaging or similar fields where human interpretation is a key component. This device is a standalone measurement system, not an AI assistance tool for human readers.

6. Standalone Performance

Yes, a standalone performance study was done. The entire "Performance summary" section (section 8.0) and the statement that "Non-clinical test and the clinical test are done according to the above standard [ISO 15197]" refer to the performance of the algorithm/device itself. Blood glucose meters are inherently standalone devices that provide a measurement directly. The studies conducted would evaluate the meter's accuracy (agreement with a reference method), precision, and other analytical performance characteristics.

7. Type of Ground Truth Used

The ground truth used for performance evaluation of blood glucose monitoring systems is typically established by:

Reference Measurement System: This usually involves a highly accurate laboratory-based glucose analyzer (e.g., YSI 2300 STAT Plus Glucose & L-Lactate Analyzer, or similar enzymatic reference methods), which is regularly calibrated and subjected to stringent quality control. This is the standard "gold standard" for comparative studies for blood glucose meters.
Venous Plasma or Serum Samples: The reference measurements are usually performed on venous plasma or serum samples, which are then compared to the finger-prick capillary whole blood measurements from the device under evaluation, often after applying a conversion factor if comparing whole blood to plasma/serum.

8. Sample Size for the Training Set

This information is not provided and is largely not applicable in the context of this device. The iHealth BG1 Align Mini Gluco-Monitoring System likely uses a fixed algorithm based on electrochemical principles (amperometry with glucose oxidase). While there might be some calibration data used during manufacturing, it is not an AI/machine learning device that requires a "training set" in the sense of a deep learning model. Its performance is based on the inherent chemical and electrical properties of the test strip and meter design.

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

Since this device does not appear to be an AI/machine learning product that requires a "training set" in the conventional sense, this question is not applicable. The ground truth for calibration during development and manufacturing would typically be established similarly to the ground truth for performance testing – using highly accurate laboratory reference methods.

Summary

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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 Application:	12/03/2013

2.0 Device information

Trade name:	iHealth BG1 Align Mini Gluco-Monitoring System
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

Production code: JQP- calculator/data processing module, for clinical use. Regulation number: 862.2100 Classification: -Panel: Clinical Chemistry

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4.0 Predicate device information

Manufacturer: Andon Health Co., Ltd. Device: iHealth BG3 Smart Gluco-Monitoring System 510(k) number: K120813

5.0 Device description

101 - 101 -

The iHealth BG1 Align Mini Gluco-Monitoring System (BGMS) consists of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.

The new device iHealth BG1 is 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.

The appearance of iHealth BG1 is different from the predicate device. Both the iHealth BG1 and the predicate device BG3 need to connect to iOS device to display the rest results, however, iHealth BG1 connect to iOS device through the earphone kack, while BG3 connect to iOS device through the 30-pin dock interface.

6.0 Intended use

The iHealth Align Mini Gluco-Monitoring system(BG1) is intended to be used for:

· Quantitative measurement of glucose in fresh capillary whole blood
samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh
· single person measurement only and should not be shared

· 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

7- 2

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The iHealth system should not be used for the diagnosis of or screening for diabetes, or for neonatal use.

Alternative Site Testing (AST) should be done only during steady state times when glucose levels are not changing rapidly.

iHealth Blood Glucose Test Strips(AGS-1000I) are intended for use with the iHealth Align Mini Glucose meter (BG1) to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm,

forearm, upper arm, calf or thigh using the iHealth BG1 meter.

	NEW DEVICE:	PREDICATE:
CHARACTERISTICS	iHealth BG1 Align MiniGluco-Monitoring System	iHealth BG3 SmartGluco-Monitoring System(K120813)
Indication for Use	The iHealth Align Mini Gluco-Monitoringsystem(BG1) is intended to be used for:• Quantitative measurement ofglucose in fresh capillary wholeblood samples drawn from thefingertip, palm, forearm, upperarm, calf, or thigh• single person measurement onlyand should not be shared• Self-testing outside the body (invitro diagnostic use) by peoplewith diabetes at home as an aid tomonitor the effectiveness ofdiabetes controlThe iHealth system should not be usedfor the diagnosis of or screening fordiabetes, or for neonatal use.Alternative Site Testing (AST) should bedone only during steady state timeswhen glucose levels are not changingrapidly.	iHealth BG3 Smart Gluco-MonitoringSystem is intended to be used for:• quantitative measurement ofglucose in fresh capillary wholeblood samples drawn from thefingertip, palm, forearm, upperarm, calf or thigh• single person measurementonly and should not be shared• self-testing outside the body(in vitro diagnostic use) bypeople with diabetes at home asan aid to monitor theeffectiveness of diabetes controlThe iHealth BG3 SmartGluco-Monitoring System should notbe used for the diagnosis of orscreening for diabetes, or for neonataluse.Alternative Site Testing (AST) shouldbe done only during steady state timeswhen glucose levels are not changingrapidly.

iHealth Blood Glucose TestStrips(AGS-1000I) are intended for usewith the iHealth Align Mini Glucose meter(BG1) to quantitatively measure glucosein fresh capillary whole blood samplesdrawn from the fingertips, palm, forearm,upper arm, calf or thigh using the iHealthBG1 meter.		The AGS1000I test strips are intendedfor use with the iHealth BG3 meter toquantitatively measure glucose in freshcapillary whole blood samples drawnfrom the fingertips, palm, forearm,upper arm, calf or thigh using theiHealthBG3 meter
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 site testing) and finger
Sample Application	Blood sample is placed directly to thetest strip after finger or AST is lanced.	Blood sample is placed directly to thetest strip after finger or AST is lanced.
Hematocrit Range	20-60%	20-60%
OperatingTemperature	$10℃~35℃(50°-95°F)$	$10℃~35℃(50°-95°F)$
Range
Dimensions	52mm×30mm×9.5mm	102mm×58mm ×22mm
Display	Connect to iOS device to displaymeasurement results	Connect to iOS device to displaymeasurement results
ResultPresentation	mg/dL or mmol/L	mg/dL or mmol/L
MemoryCapabilities	10000 times with time and datedisplaying	10000 times with time and datedisplaying
Test Start	Automatic	Automatic
Test Time	5 second	5 second
Power Source	DC3.0V (CR1620)	DC 3.3V (Powered by iOS deviceconnected to the meter)
Battery Life	200 times testing	N/A
MeasurementRange	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 throughEarphone jack	Connect to iOS device through 30-pindock interface

7.0 Summary comparing technological characteristics with predicate device

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8.0 Performance summary

The iHealth BG1 Align Mini Gluco-Monitoring System conforms to the following standards:

· ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
Non-clinical test and the clinical test are done according to the above standard.

9.0 Comparison to the predict device and the conclusion

The iHealth BG1 is similar with the predicate device iHealth BG3, the two devices 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. The appearance of the two device is different,and both the two devices have no LCD display, they must be connected with iOS device, however, the connect methods are different, BG1 connect to iOS device through earphone jack, while BG3 connect to iOS device through 30-pin dock interface. iHealth BG1 use battery as power source, this is different from the predicate device BG3 which is powered by iOS device connected to the meter.

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

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

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

May 22, 2014

ANDON HEALTH CO.. LTD MR YI LIU NO. 3 JIN PING STREET. YA AN ROAD. NANKAI DISTRICT TIANJIN. CHINA 300190

Re: K133790

Trade/Device Name: iHealth BG1 Align Mini Gluco-Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. CGA. JOP Dated: April 23, 2014 Received: April 25, 2014

Dear Mr. 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 docs 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 Liu

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, plcase note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

Sincercly yours.

Courtney H. Lias -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K133790

Device Name

iHealth Align Mini Gluco-Monitoring System

Indications for Use (Describe)

The iHealth Align Gluco-Monitoring system(BG1) is intended to be used for:

· Quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh

from the fingertip, palm, forearm, upper arm, calf, or thigh.
a single person measurement only and should not be shared.

· single person measurement only and should not be shared

· 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 system should not be used for the diagnosis of or screening for diabetes, or for neonatal use.

Alternative Site Testing (AST) should be done only during steady state times when glucose levels are not changing rapidly.

iHealth Blood Glucose Test Strips(AGS-1000!) are intended for use with the iHealth Align Glucose meter (BG1) to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealth BG1 meter.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Stavce Beck -S

. .

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.