The EASY CHECK Blood Glucose Monitoring Systems is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and healthcare facilities as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Description

The EASY CHECK Blood Glucose Monitoring System is designed to provide an easy, accurate method for determining capillary blood glucose values. This analysis is based on amperometric technology using glucose oxidase that is specific for the blood glucose measurement. When the blood sample is applied to the test strip, electrons are formed by the reaction between glucose oxidase and blood glucose. The electrical current is measured by the meter and correlates with the concentration of glucose in the blood sample.

The EASY CHECK Blood Glucose Monitoring System consists of the Meter, Test strips with instructions, Lancing device with instructions, Lancets, Code card, 3-Volt Lithium Coin Battery, Users Guide, Log Book, Carrying case and EASY CHECK Control Solutions (level 1 and level 2)

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the EASY CHECK Blood Glucose Monitoring System:

This document primarily serves as a 510(k) summary for the FDA, focusing on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and the comprehensive study results in the format requested. While it mentions "clinical testing" for accuracy and comparability, the actual acceptance criteria along with their corresponding performance results are not explicitly laid out in a table in the provided text.

However, based on the general information provided for a blood glucose monitoring system, we can infer some aspects of what would likely constitute acceptance criteria and how performance was evaluated.

Response:

Based on the provided text, the report does not explicitly list a table of acceptance criteria with corresponding device performance results in the requested format. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a detailed breakdown of performance against predefined acceptance criteria.

However, it does state that "Sensitivity, precision, linearity and other tests were used to demonstrate the performance and reliability of EASY CHECK Blood Glucose Monitoring System." It also mentions "Consumer (field) testing was done to prove that the EASY CHECK Blood Glucose Monitoring System is easy to use by lay people and also that test results are accurate and comparable to a laboratory reference method and to the predicate device."

Without specific numerical targets for "sensitivity, precision, and linearity" and their achieved values, a direct table of acceptance criteria and reported device performance cannot be generated.

Given the context of a blood glucose meter, typical acceptance criteria would be based on ISO 15197 (or a similar standard in place at the time of submission) which outlines accuracy requirements. For example, for glucose concentrations < 75 mg/dL, 95% of results should be within ±15 mg/dL of the reference, and for glucose concentrations ≥ 75 mg/dL, 95% of results should be within ±20% of the reference. The document implies these types of tests were performed and met the necessary standards for clearance by stating, "Detailed testing has confirmed that the EASY CHECK Blood Glucose Monitoring System is substantially equivalent to the predicate device and that the differences do not bring up any new safety or effectiveness concerns."

Let's address the other points based on the available information:

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

As mentioned above, this table is not explicitly provided in the document. The document primarily focuses on demonstrating substantial equivalence to the predicate device (ASCENSIA ELITE DIABETES CARE SYSTEM) rather than presenting a performance report against specific numerical acceptance criteria.

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

Sample Size: The sample size for the clinical testing (consumer field testing) is not specified in the provided text.
Data Provenance: The document does not specify the country of origin. The testing appears to be prospective as it involves "consumer (field) testing" to prove usability and accuracy, implying newly collected data.

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)

The document states that "test results are accurate and comparable to a laboratory reference method." This implies that the ground truth was established by a laboratory reference method, which would be operated by trained laboratory personnel.
The number of experts or their specific qualifications (e.g., number of years of experience) are not specified.

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

The document does not describe any adjudication method. It refers to comparison against a "laboratory reference method," which typically serves as the gold standard, implying no adjudication among multiple human readers of the device results was necessary, as the comparison was to an established reference.

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 Multi-Reader Multi-Case (MRMC) study was done for AI assistance. This device is a standalone blood glucose monitoring system and does not involve AI assistance for human readers or interpretation of medical images. It's a direct measurement device.

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

Yes, in spirit. The "EASY CHECK Blood Glucose Monitoring System" itself is a standalone device. Its performance, specifically its "accuracy" when compared to a laboratory reference method, is a measure of its standalone algorithmic (or electrochemical) performance in converting a blood sample to a glucose value. While it's used by "lay people" at home, the core measurement and result generation is an automated process without human interpretation in the loop other than applying the sample and reading the digital display.

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

The ground truth used was a "laboratory reference method". For blood glucose meters, this typically refers to a highly accurate laboratory analyzer (e.g., a YSI analyzer) that uses an enzymatic or hexokinase method, considered the clinical gold standard.

8. The sample size for the training set

The document does not provide information regarding a separate "training set" or its sample size. This type of detail is usually more common for machine learning (AI) devices, which this blood glucose meter is not. For traditional medical devices like this, development and verification would involve internal testing, characterization, and then validation against a reference method.

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

As no "training set" is mentioned in the context of an AI/ML algorithm, this question is not applicable in the sense of establishing ground truth for machine learning. The device's underlying technology (amperometry using glucose oxidase) relies on well-established chemical principles, not machine learning trained on data sets.

Summary

{0}------------------------------------------------

Exhibit 3a
K062538

DIACARE CORP.

APR 3 0 2007

4977 E. La Palma Ave. Anaheim, CA 92807 Tel:(714) 970-7289

510(k) Summary

Administrative Information and Device Identification

Name and address of sponsor of the 510(k) submission:	Diacare Corp.4977 E. LA PALMA AVE.ANAHEIM, CA 92807
Official contact person for all correspondence:	Calvin Chang, calvin@evermed.comPhone: (714) 970-7289; Fax: (714) 777-9978
Date Prepared:	August 21, 2006
Device Name:	EASY CHECK Blood Glucose MonitoringSystem
Generic name of the device:	Blood Glucose Meter
Classification of new device:	Class II
Classification Panel:	Clinical Chemistry and Toxicology
Product Code and CFR Regulation Number:	NBW, CGA and 21 CFR 862.1345
Predicate Device Name and 510(k) Number:	ASCENSIA ELITE DIABETES CARE SYSTEMK043311

{1}------------------------------------------------

Description of Device:

Comparison of Device Technological Characteristics to Predicate Device:

EASY CHECK Blood Glucose Monitoring System and ASCENSIA ELITE DIABETES CARE SYSTEM are similar in many respects. Among other similarities, they use the same detection method, enzyme, mediator and basic electrode material.

Differences include the Hematocrit range, temperature range, test time and sample volume. Tests included in this 510(k) submission have incorporated these changes and results show that they introduce no new questions on the safety and effectiveness of the EASY CHECK Blood Glucose Monitoring System.

Item	Device	Predicate
	Easycheck	Bayer Elite
DetectionMethod	Amperometry	Amperometry
Enzyme	Glucose Oxidase	Glucose Oxidase
Mediator	Potassium Hexacyanoferrate	Potassium Hexacyanoferrate
Electrode	Carbon	Carbon
Coding	Code key	Code Key
Sample type	whole blood	whole blood
Humidity	20%-80%	20%-80%

Similarities:

{2}------------------------------------------------

Power Supply	3V lithium battery (CR2032)	3V lithium battery (CR2032)
Battery lifetime	Over 1000 tests	Over 1000 tests
Weight	50 g	50 g

Differences:

Temp. Range	2-30 □36-86 □	15-30 □60-86 □
Hct Range	30%-50%	20%-60%
Test Range	30-600 mg/dL	20-600 mg/dL
Test time	9 second	30 second
Sample volume	1.5 μL	3 μL
Test sample	fingertip, palm and forearm	fingertip
Memory	180 sets	20 sets
Meterdimension	58x80x19 mm	81x51x14 mm

Intended Use:

Non-Clinical Testing:

Sensitivity, precision, linearity and other tests were used to demonstrate the performance and reliability of EASY CHECK Blood Glucose Monitoring System. Meter also passed appropriate EMC requirements.

Clinical Testing:

{3}------------------------------------------------

Consumer (field) testing was done to prove that the EASY CHECK Blood Glucose Monitoring System is easy to use by lay people and also that test results are accurate and comparable to a laboratory reference method and to the predicate device.

Conclusion:

Detailed testing has confirmed that the EASY CHECK Blood Glucose Monitoring System is substantially equivalent to the predicate device and that the differences do not bring up any new safety or effectiveness concerns.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Diacare Corp. c/o Mr. Sid Mathur MDI Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021

APR 3 0 2007

K062538 Re:

Trade/Device Name: Easy Check Blood Glucose Monitoring System and Easy Check Glucose Control Solution Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: April 2, 2007 Received: April 3, 2007

Dear Mr. Mathur:

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), and 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).

{5}------------------------------------------------

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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., 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

{6}------------------------------------------------

Indications for Use

510(k) Number (if known): K062538

Device Name: EASY CHECK Blood Glucose Monitoring System

Indications for Use: The EASY CHECK Blood Glucose Monitoring Systems is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and healthcare facilities as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 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)

CFC

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

SK062538

{7}------------------------------------------------

Indications for Use

510(k) Number (if known): K062538

Device Name: EASY CHECK Glucose Control Solution

Indications for Use: The EASY CHECK Control Solution is intended for in vitro diagnostic use by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the EASY CHECK Blood Glucose Monitor System.

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

Over-The-Counter Use (21 CFR 801 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)

tion Sign-Off

Affice of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

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.