The EASYGLUCO Blood Glucose Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. The EASYGLUCO Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm, palm, thigh, and calf.

Device Description

The EASYGLUCO Blood Glucose Monitoring System is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the EASYGLUCO Test Strips. The test principle is: This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.

AI/ML Overview

The provided text is a 510(k) summary for the EASYGLUCO Blood Glucose Monitoring System. It does not contain the detailed study information required to answer all the questions. The document focuses on establishing substantial equivalence to predicate devices and provides basic device description and intended use.

Therefore, I can only address the questions for which information is available in the provided text.

Here's a breakdown of the information that cannot be provided from the given document:

A table of acceptance criteria and the reported device performance: This detailed information is typically found in the full submission, not the summary.
Sample sized used for the test set and the data provenance: Not mentioned in the summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned in the summary.
Adjudication method for the test set: Not mentioned in the summary.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a blood glucose monitor, not an AI-assisted diagnostic imaging device, so an MRMC study is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As a blood glucose monitor, its primary function is standalone measurement, but the specific performance study details are not provided.
The type of ground truth used: While the principle of "in vitro diagnostic product intended for the measurement of glucose concentration in human blood" implies comparison to a reference method, the specific ground truth used in a validation study is not detailed.
The sample size for the training set: Not mentioned in the summary. The device's operation doesn't suggest a traditional "training set" in the context of machine learning, but rather calibration/validation data.
How the ground truth for the training set was established: Not mentioned in the summary.

Based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

The provided text does not contain a table of acceptance criteria or reported device performance data. The 510(k) summary states that the submission provides "sufficient data to understand the basis for a determination of substantial equivalence," implying that such data would be in the full submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided 510(k) summary. Given that this is an in vitro diagnostic device for glucose measurement, "experts" in this context would likely be reference laboratory personnel performing comparative measurements, rather than medical specialists interpreting images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not available in the context of an in vitro diagnostic blood glucose monitor. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation of medical images or other diagnostic tests where there's potential for inter-observer variability. For a quantitative device like a blood glucose meter, validation involves comparing its output against a reference method, not expert adjudication of its readings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done, as this device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging system that involves human readers interpreting results.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The EASYGLUCO Blood Glucose Monitoring System is designed as a standalone device for measuring glucose concentration. The device itself performs the measurement and displays the result without direct human intervention in the measurement process beyond sample application. The 510(k) summary implies that its performance was validated in this standalone capacity, but the details of such a study are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document doesn't explicitly state the specific "ground truth" used. However, for a blood glucose monitoring system, the ground truth would typically be established by a highly accurate laboratory reference method for glucose measurement (e.g., hexokinase method or isotope dilution-mass spectrometry) on the same blood samples used for device testing.

8. The sample size for the training set

This information is not available in the provided 510(k) summary.

9. How the ground truth for the training set was established

This information is not available in the provided 510(k) summary.

Summary

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K0435/2

American HealthCare, Inc. 510(k) for In Vitro Diagnostic Device

510(k) SUMMARY

(As required by 21.CFR.807.92)

Introduction:	According to the requirements of 21 CFR.807.92, the followinginformation provides sufficient data to understand the basis for adetermination of substantial equivalence.
Submitted By:	American HealthCare, Inc.304 Park Avenue SouthSuite 218New York, NY 10010
Contact Person:	Edward LetkoPhone: 917-402-5900Fax: 212-202-5173
Date Summary,Prepared:	December 14, 2004
Device Name:	Propriety Name: EASYGLUCO Blood Glucose MonitoringSystemCommon Name: Blood Glucose Test SystemClassification Name: Class II, 862.1345 Glucose Blood Tester
Predicate Device:	We claim substantial equivalence to the LifeScan, Inc.,OneTouch® Ultra®.
DeviceDescription:	The EASYGLUCO Blood Glucose Monitoring System is an invitro diagnostic device designed for measuring the concentration ofglucose in whole blood, which is used with the EASYGLUCOTest Strips.The test principle is:This device is an in vitro diagnostic product intended for themeasurement of glucose concentration in human blood. Theprinciple of the test relies upon a specific type of glucose in theblood sample, the dehydrogenase glucose that reacts to electrodesin the test strip. The test strip employs an electrochemical signalgenerating an electrical current that will stimulate a chemicalreaction. This reaction is measured by the Meter and displayed asyour blood glucose result.
Intended Use:	The EASYGLUCO Blood Glucose Monitoring System is used forthe quantitative measurement of glucose level in whole blood as an
	aid in monitoring the effectiveness of diabetes management in thehome and in clinical settings. EASYGLUCO Blood MonitoringSystem is for testing outside the body (in vitro diagnostic useonly). Testing sites include the traditional fingertip testing alongwith alternate site testing on the arm, palm, thigh and calf.
Comparison toPredicate Device:	The US Diagnostics, Inc. EASYGLUCO Blood GlucoseMonitoring System is substantially equivalent to the other productsin commercial distribution intended for similar use. The mostnotable, it is substantially equivalent to the currently marketeditem, the OneTouch® Ultra® by LifeScan, Inc.
Conclusion:	The EASYGLUCO Blood Glucose Monitoring System issubstantially equivalent to the following predicate devices:K024194 – LifeScan, Inc. OneTouch® Ultra®K984261 – LifeScan, Inc. SURESTEP®K021513 – Roche Diagnostics Corp. Accu-Chek Advantage

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American HealthCare, Inc.

510(k) for In Vitro Diagnostic Device

510(k) Summary, Continued

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

APR 8 2005 Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Edward Letko Managing Director American HealthCare Inc. 304 Park Avenue South Suite 218 New York, NY 10010

Re: K043512

Trade/Device Name: EASYGLUCO Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: March 9 2005 Received: March 10, 2005

Dear Mr. Letko

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Jean M. Cooper, MS, DVM

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K043512

Device Name: EASYGLUCO Blood Glucose Monitoring System

Indications For Use: The EASYGLUCO Blood Glucose Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. The EASYGLUCO Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm, palm, thigh, and calf.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-off

lice of in Vitro Digar

Page 1 of

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.