The EasyPlus mini Self Monitoring Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or diabetics at home to measure glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from the fingertip, and forearm by using Easy Plus mini Monitoring Blood Glucose Monitoring System. The device is not intended for testing neonate blood samples.

The EasyPlus mini Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini Blood Glucose Test Strips must be used with the EasyPlus mini Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

The EasyPlus mini Blood Glucose Test Strips, are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini Blood Glucose Test Strips must be used with the EasyPlus mini Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

The EasyPlus Normal/High Control Solution is for use with the EasyPlus mini meter and EasyPlus mini Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Device Description

The EasyPlus mini Self Monitoring Blood Glucose System is comprised of the EasyPlus mini Meter, EasyPlus mini Blood Glucose Test Strips, Auto Lancet, Check strip, Code card and Normal/High Control solutions.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the EasyPlus mini Self Monitoring Blood Glucose Test System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state the specific numerical acceptance criteria used (e.g., minimum accuracy percentages, specific bias limits). However, it broadly indicates that "A full array of in-house and clinical testing was done consistent with relevant FDA guidances for blood glucose monitoring systems." This implies that the device met the generally understood accuracy and performance requirements for a glucose meter at the time of submission.

Therefore, the table below reflects what is reported in the summary against the implied or general expectation of acceptance for such devices.

Acceptance Criterion (Implied/General)	Reported Device Performance
Accuracy (Clinical Testing - Finger stick)	"Clinical testing included evaluation of accuracy for both finger stick..." (Implied: Met FDA guidance requirements for accuracy for capillary whole blood from the fingertip)
Accuracy (Clinical Testing - Alternate Site Testing)	"...and Alternate Site Testing." (Implied: Met FDA guidance requirements for accuracy for alternate site testing)
Interferences	"Bench testing included evaluation of interferences..." (Implied: Device demonstrated acceptable performance in the presence of common interfering substances or conditions as per FDA guidance.)
Sensitivity	"Bench testing included evaluation of ... sensitivity..." (Implied: Device was sufficiently sensitive to detect glucose within the relevant clinical range.)
Linearity	"Bench testing included evaluation of ... linearity..." (Implied: Device provided linear results across its intended measuring range.)
Reportable Range	"Bench testing included evaluation of ... reportable range..." (Implied: Device accurately measured glucose within its specified reportable range.)
Altitude Effects	"Bench testing included evaluation of ... altitude effects..." (Implied: Device maintained performance across tested altitude variations.)
Stability (Test Strips and System)	"Bench testing included evaluation of ... stability..." (Implied: Test strips and the overall system demonstrated acceptable stability over their shelf life and in-use period.)
Precision and Reproducibility	"Bench testing included evaluation of ... precision and reproducibility." (Implied: Device demonstrated acceptable levels of precision (repeatability) and reproducibility (between-device/operator variability) as per FDA guidance.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the exact sample size for the clinical test set. It only states that "Clinical testing included evaluation of accuracy for both finger stick and Alternate Site Testing."
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given the submitter's location (Taiwan), it's highly probable the studies were conducted there. The nature of clinical trials for blood glucose meters typically involves prospective data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide details on the number of experts, their qualifications, or how they established ground truth for the clinical test set. For blood glucose meters, the ground truth is typically established by a laboratory reference method (e.g., spectrophotometric method like YSI 2300 STAT Plus Glucose & Lactate Analyzer) rather than expert consensus.

4. Adjudication Method for the Test Set

Not applicable. As ground truth for blood glucose meters is typically established by a reference laboratory method, there is no need for expert adjudication.

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

No. The provided text does not mention an MRMC comparative effectiveness study where human readers improve with or without AI assistance. This type of study is more common for diagnostic imaging AI devices, not for a self-monitoring blood glucose system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, implicitly. The entire evaluation of the "EasyPlus mini Self Monitoring Blood Glucose Test System" as described (bench testing, clinical accuracy for finger stick and alternate site, etc.) represents the standalone performance of the device itself (meter + strips). There's no "human-in-the-loop" component in the sense of a diagnostic interpretation as there would be with an AI imaging tool. The device provides a quantitative measurement directly.

7. Type of Ground Truth Used

The document doesn't explicitly state the type of ground truth (e.g., YSI reference method) but for blood glucose meters, the ground truth is universally established by a laboratory reference method (e.g., an FDA-cleared laboratory analyzer known for high accuracy and precision, like a hexokinase reference method). It is not expert consensus, pathology, or outcomes data for accuracy evaluations.

8. Sample Size for the Training Set

Not applicable. This device is a measurement system (hardware + chemical strips), not an AI/machine learning algorithm requiring a "training set" in the computational sense. The device is calibrated during manufacturing and validated through rigorous testing.

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

Not applicable, as there is no "training set" in the context of an AI algorithm for this device. The "ground truth" for calibration/development would be based on highly accurate reference solutions with known glucose concentrations.

Summary

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K070053

DEC 0 3 2007

510(k) Summary

Submitter:	EPS Bio Technology Corp.
Contact Person:	Mr. Y.C. Lei, General Manager
	EPS Bio Technology Corp.
	2F,No. 49-2, Lane 2, Guang Fu Rd.,Sec.2 Hsinchu City,
	Taiwan, R.O.C.
	Phone: 886-3-5752522
	Fax: 886-3-5752552
	E-mail: yclei@epsbio.com.tw
Date Prepared:	November 29, 2007
Trade Name:	EasyPlus mini Self Monitoring Blood Glucose Test System
Classification:	Glucose test system, 21 CFR 862.1345; Class II
Product Codes:	CGA, NBW, JJX
Predicate Device:	ACCU-CHEK advantage System (K032552)
Device	The EasyPlus mini Self Monitoring Blood Glucose System is
Description:	comprised of the EasyPlus mini Meter, EasyPlus mini Blood
	Glucose Test Strips, Auto Lancet, Check strip, Code card and
	Normal/High Control solutions.
Intended Use:	The EasyPlus mini Self Monitoring Blood Glucose Test System
	is intended for the quantitative measurement of glucose in
	fresh capillary whole blood samples drawn from the fingertips
	or forearm. Testing is done outside the body (In Vitro
	diagnostic use). It is indicated for use at home (over the
	counter [OTC]) by persons with diabetes, or in clinical settings
	by healthcare professionals, as an aid to monitor the
	effectiveness of diabetes control.
Functional and Safety Testing:	A full array of in-house and clinical testing was done consistent
	with relevant FDA guidances for blood glucose monitoring
	systems.Bench testing included evaluation of interferences, sensitivity,
	linearity, reportable range, altitude effects, stability, precision
	and reproducibility.
	Clinical testing included evaluation of accuracy for both finger
	stick and Alternate Site Testing.
Conclusion:	Labeling, bench testing results and clinical testing results
	support the Indications for Use and the claim of substantial
	equivalence to the predicate.

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Image /page/1/Picture/1 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" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 03 2007

EPS Biotechnology Corp. c/o Mr. Y. C. Lei General Manager 2F, No. 49-2, Lane 2 Guang Fu Road, Sec 2 Hsinchu City, Taiwan

Re: K070053

Trade/Device Name: EasyPlus Mini Self-Monitoring Blood Glucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: November 07, 2007 Received: November 13, 2007

Dear Mr. Lei:

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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Page 2 -

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 10gally 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 tollow the (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.

Sean 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

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Indication for Use

510(k) Number (if known): K070053

Device Name: EasyPlus min Self Monitoring Blood Glucose System

Indication For Use:

EasyPlus mini Meter

The EasyPlus mini Test Strips

The EasyPlus Normal/High Control Solution

For use with the EasyPlus mini meter and EasyPlus mini Blood Glucose Test Strips as a quality control check to yerify the accuracy of blood glucose test results. Prescription Use V And/Or

(21 CFR Part 801 Subpart D)

/Or

Over the Counter Use // (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K070053

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.