The EasyPlus Self-Monitoring Blood Glucose System is used by individuals with diabetes. It is for the quantitative measurement of glucose levels in fresh capillary whole blood from fingerstick, as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings.

Device Description

The EasyPlus Self Monitoring Blood Glucose System is comprised of the EasyPlus Blood Glucose Meter, EasyPlus Glucose Test Strips, Auto Lancet, Check strip, code card and control solutions.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the EasyPlus Self Monitoring Glucose Test System:

Acceptance Criteria and Device Performance

The provided document does not explicitly state formal "acceptance criteria" with predefined thresholds that the device had to meet. Instead, it presents performance characteristics (precision, linearity, method comparison) and implies that these characteristics are acceptable because they are comparable to a predicate device and align with general guidelines (e.g., ISO 15197:2003, though the specific clauses for acceptance aren't detailed).

However, based on the performance data presented, here's a table summarizing the reported device performance, with an interpretation of what would generally be considered acceptable for a blood glucose monitor. Please note that the "Acceptance Criteria" column is a general interpretation based on industry standards for glucose meters, as the document itself does not explicitly list these as formal acceptance criteria.

Category	Performance Metric	Reported Device Performance (EasyPlus)	Interpreted Acceptance Criteria (General for BGMs)
Analytical Performance
Precision (Within-run)	CV (%) for various glucose ranges	30-50 mg/dL: 6.2%51-110 mg/dL: 4.5%111-150 mg/dL: 4.2%151-250 mg/dL: 2.7%251-400 mg/dL: 2.8%401-550 mg/dL: 2.2%	Typically ≤ 10% for concentrations < 75 mg/dL and ≤ 5% for concentrations ≥ 75 mg/dL applies to CV, or similar error grid requirements.
Precision (Day-to-day)	CV (%) for Low, Normal, High controls	Low: 5.1%Normal: 2.7%High: 3.2%	Similar to within-run; generally, CVs < 5% are considered excellent for controls.
Linearity/Reportable Range	Linear regression (y = mx + b, r²)	y = 0.9722x - 0.1682, r² = 0.9956	r² > 0.98, slopes close to 1, small y-intercepts.
	Detection Limit/Reportable Range	30-550 mg/dL	Clearly defined and clinically appropriate range.
Method Comparison	Linear regression (Patient vs. YSI)	y = 0.95x + 7.41, r² = 0.976	r² > 0.95, slopes close to 1, small y-intercepts. Typically, error grid analysis is used for clinical acceptance.
	Linear regression (HCP vs. YSI)	y = 0.95x + 7.91, r² = 0.971	r² > 0.95, slopes close to 1, small y-intercepts.
	Linear Regression (EasyPlus vs. Predicate)	Not explicitly detailed, but stated: "EasyPlus vs. predicate device: The linear regression was not explicitly stated, but it says "And compare with predicate device, the linear regressions was as follows:" implying a comparison was done.	Assumed to be very similar to the predicate device.

Study Information

Sample size used for the test set and the data provenance:
- Precision (Within-run): Total 1200 tests (6 glucose levels x 200 tests each for N). Data provenance is not specified, but the study was conducted internally by EPS Bio Technology Corp. (Taiwan, R.O.C.). It's a prospective internal lab study.
- Precision (Day-to-day): Total 1200 measurements (3 control solutions x 400 measurements each for n). Data provenance not specified; prospective internal lab study.
- Linearity: 630 tests (7 glucose ranges x 10 meters x 3 strip lots assumed, based on the text "among the seven glucose ranges per each strip lot."). This is an internal lab study.
- Method Comparison: 205 people with diabetes. Data provenance not specified, but given the company location, likely Taiwan, R.O.C. This is a prospective clinical study involving actual patient samples.
- Interference Testing: Not explicitly stated how many samples per interferent, but conducted internally.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Precision and Linearity: The ground truth or reference method was the preparation of specific glucose concentrations in blood samples. This does not involve human experts establishing ground truth in the traditional sense, but rather laboratory techniques with reference standards (NIST Traceability mentioned).
- Method Comparison: The YSI Glucose Analyzer was used as the reference method (ground truth) for blood glucose measurements. The YSI is a laboratory reference instrument, not a human expert.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No human adjudication method was used for establishing ground truth in these analytical performance studies. The ground truth was established by laboratory reference methods (YSI glucose analyzer, NIST traceable standards).
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 MRMC comparative effectiveness study was done. This device is a self-monitoring blood glucose system, which measures glucose levels directly, rather than relying on human interpretation of images or other subjective data that would necessitate an MRMC study.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance studies presented (precision, linearity, detection limit, analytical specificity) are all standalone performance evaluations of the device's accuracy and reliability in measuring glucose. The method comparison also evaluates the device's standalone performance against a gold standard (YSI). While a healthcare professional also used the device, this was to compare their use to the YSI, and the patient use was also standalone. The device is designed for independent use.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For precision, linearity, and analytical specificity, the ground truth was established using known concentrations of glucose (often prepared using NIST traceable standards) in blood or control solutions.
- For method comparison, the ground truth was established using a laboratory reference method, specifically the YSI Glucose Analyzer. The YSI is a highly accurate and widely accepted laboratory instrument for measuring blood glucose, often considered a "gold standard" for such comparisons.
The sample size for the training set:
- The document does not explicitly mention a "training set" in the context of machine learning or AI models. This device is an electrochemical biosensor. Its "training" is inherent in its design and calibration, not in a separate software training phase with a distinct dataset. The performance characteristics studies are for validation of the device, not for training.
How the ground truth for the training set was established:
- As there's no mention of a traditional "training set" for an AI/ML algorithm, this question isn't directly applicable. The device's calibration would be based on known glucose concentrations using highly accurate reference methods, presumably traceable to international standards (NIST traceability is mentioned for the device itself).

Summary

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510(k) SUMMARY

This Summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21CFR §807.81(a)(3).

The assigned 510(K) number is : K061992

A. Submitter's information

SEP 1 9 2006

Company: EPS Bio Technology Corp. 2F, No. 49-2, Lane 2, Guang Fu Rd., Sec.2 Hsinchu City, Taiwan, Address: R.O.C. Contact Name: Mr. Y.C. Lei, General Manager 886-3-5752522 Phone: 886-3-5752552 Fax: Date Prepared: June 30, 2006

B. Purpose for Submission:

The Indication for use and fundamental scientific technology of the modified device has not changed. The changes are modified mechanical appearance of device, test range, test time and the labeling.

C. Measurand:

Glucose

D. Type of Test: Quantitative; electrochemical biosensor

E. Proprietar y and Established Names:

EasyPlus Self Monitoring Glucose Test System

F. Common or Usual Name: Glucose Test System

G. Regulatory Information:

1. Regulation section: 21 CFR 862.1345, Glucose Test System 21 CFR 862.1660, Quality control material (assayed and unassayed).
1. Classification: Class II Class I. reserved
1. Product code: NBW, System Test, Blood Glucose, Over the Counter

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CGA, Glucose Oxidase, Glucose JJX, Single (Specified) Analyte Controls (Assayed and Unassayed)

1. Panel: Chemistry 75

H. Intended Use:

1. Intended use(s): see Indications for Use below
1. Indication(s) for use:

1. Special conditions for use statement(s): N/A
1. Special instrument requirements: N/A

Device Description: 1.

The EasyPlus Self Monitoring Blood Glucose System is comprised of the EasyPlus Blood Glucose Meter, EasyPlus Glucose Test Strips, Auto Lancet, Check strip, code card and control solutions.

J. Substantial Equivalence Information:

1. Predicate device name(s): Easy Pain Supreme Self Monitoring Blood Glucose System
1. Device Company EPS Bio Technology Corporation
1. Predicate 510(k) number(s): K043245
1. Comparison with predicate:

	Similarities
Item	Device	Predicate
Detection method	Amperometry	Amperometry
Enzyme	Glucose oxidase(Aspergillus niger)	Glucose oxidase(Aspergillus niger)
Mediator	Potassium ferricyanide	Potassium ferricyanide

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Similarities
Item	Device	Predicate
Electrode	Carbon electrode	Carbon electrode
Hematocrit range	30-55%	30-55%
Sample volume	$\geq 2.0$ uL	$\geq 2.0$ uL
Temperature range	10-40°C	10-40°C
Humidity range	R.H. $\leq$ 90%	R.H. $\leq$ 90%
Coding	Code card	Code card
Memory capability	100 tests with date andtime	100 tests with date andtime
Power	1.5V (AAA) batteries	1.5V (AAA) batteries
Battery life	Approx. 1000 tests	Approx. 1000 tests

Item	Device	Predicate
Test range	30-550 mg/dL	40-600 mg/dL
Test time	5 seconds	25 seconds
Size L x W x H (inch)	3.2"x 2"x 0.7"	2.9"x 2.1"x 0.7"
Weight	1.6 oz (without batteries)	1.8 oz (without batteries)

K. Standard/Guidance Document Referenced (if applicable):

CLSI EP5-A, Precision Performance of Clinical Chemistry Devices 1.
1. CLSI EP6-P, Evaluation of the Linearity of Quantitative Analytical Methods; Proposed Guideline
1. CLSI EP7-P, Interference Testing in Clinical Chemistry; Proposed Guideline
1. ISO 15197:2003, In Vitro Diagnostic Test Systems - Requirements for Blood Glucose Monitoring Test Systems for Self Managing Diabetes Mellitus
1. IEC 60601-1-2, Medical Electrical Equipment – Part 1: General Requirement for Safety; Electromagnetic Compatibility - requirements and Tests
IEC 61010-1, Safety Requirements for Electrical Equipment for Measurement, 6. Control, and Laboratory Use - Part 1: General Requirements
1. IEC 60601-2-101, Safety Requirements For Electrical Equipment for Measurement, Control, and Laboratory Use - Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD) Medical Equipment
1. IEC 60068-2-64, Environmental Testing- Part 2: Test Methods- Test Fh: Vibration, Broad-band Random (Digital Control) and Guidance
IEC 61326 (2002-02) (for reference), Electrical Equipment for Measurement 9. Control, and Laboratory Use - EMC Requirements
1. ISO 14971:2000, Medical Devices Application of Risk Management to Medical Devices
1. ISO 15223:2000, Medical Devices Symbols to be Used With Medical Device Labels, Labeling, and Information to be Supplied
1. EN 376:2002, Information Supplied by the Manufacturer With In Vitro Diagnostic Reagents for Self Testing
1. ISO 10993-1, Biological Evaluation of Medical Devices Part 1:Evaluation and Testing

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14. EN 13640:2002 Stability Testing of In Vitro Diagnostic Reagents

L. Test Principle:

The EasyPlus Self Monitoring Blood Glucose System employs a disposable dry reagent strip technology, based on the glucose oxidase method for glucose determination. Each test strip features an electrode containing the enzyme glucose oxidase (Aspergillus niger). A blood sample is applied to the blood collection area at the tip of the strip and is automatically drawn into the reaction zone, where the glucose oxidase catalyzes the oxidation of glucose to produce qluconic acid. During the reaction, a mediator transfers electrons to the electrode surface and generates a current. The amount of the current is proportional to the amount of glucose present in the blood sample. The glucose concentration is displayed on the meter screen after 5 seconds.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
- a. Precision/Reproducibility:

Within-run - Testing was conducted by taking 4 mL of blood that was treated with heparin through a vacuum tube. Glucose was added to the 4 mL of blood to generate 6 different levels of glucose concentration for the test. Each of the samples was measured 10 times. The glucose concentration ranges were: 30-50 mg/dL, 51-110 mg/dL, 111-150 mg/dL, 151-250 mg/dL, 251-400 mg/dL, and 401~550 mg/dL.

Range(mg/dL)	N	EasyPlus
		mean(mg/dL) SD(mg/dL)		CV(%)
30~50 mg/dL	200	56.3	3.5	6.2
51~110 mg/dL	200	100.0	4.5	4.5
111~150 mg/dL	200	134.0	5.6	4.2
151~250 mg/dL	200	189.6	5.2	2.7
251~400 mg/dL	200	313.5	8.9	2.8
401~550 mg/dL	200	479.7	10.4	2.2

'Day to day - Three control solutions of Low, Normal and High were prepared. Each of the controls was measured twice a day, once in the morning and once in the afternoon for a month.

Control	n	mean (mg/dL)	SD (mg/dL)	CV (%)
Low	400	59.3	3.0	5.1
Normal	400	131.6	3.5	2.7
High	400	389.3	12.4	3.2

b. Linearity/assay reportable range:

A blood sample of 25 mL was taken, treated with heparin vacuum tube, to be set

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for a day. Testing was performed using whole blood supplemented with B-Dglucose to provide samples at seven different blood glucose levels (30-50 mg/dL, 51-80 mg/dL, 81-120 mg/dL, 121-200 mg/dL, 201-300 mg/dL, 301-400 mg/dL, and 400-550 mg/dL). A total of 210 tests were performed using 10 meters among the seven glucose ranges per each strip lot.

The linear regression was as follows: v = 0.9722x -0.1682, 2 = 0.9956, Svx = 9.38, N = 630

Traceability, Stability, Expected values (controls, calibrators, or methods): C. Traceability referenced to NIST Standards, and it cleared with predicate device.
d. Detection limit:

Data was provided to support a reportable range of 30-550 mg/dL.

e. Analytical specificity:
Interference testing was conducted to determine the effect of select endogenous and exogenous substances. A series of test samples, systematically varying in the concentration of the interferents, was prepared by making quantitative, volumetric mixtures of two pools: one at the highest concentration to be tested and the other at the lowest. The substances and concentrations of the interferents are recommended in CLSI EP7-P.

Interference from dopamine and L-dopa was observed when the recommended concentration of these drugs was reached in the blood. Interference was also observed in higher than therapeutic dosages of acetaminophen, gentisic acid, and methvidopa.

f. Assay cut-off: N/A

2. Comparison studies:

a. Method comparison with predicate device:
Two hundred and five people with diabetes performed a finger stick using the EasyPlus system. A healthcare professional then performed the test on the EasyPlus and the YSI. The range of tested values for these samples was 30-550 ma/dL.

The linear regressions were as follows:
Patient vs. YSI:	$y = 0.95x + 7.41, r^2= 0.976$
Healthcare professional vs. YSI:	$y = 0.95x + 7.91, r^2= 0.971$

And compare with predicate device, the linear regressions was as follows: EasyPlus vs. predicate device:

b. Matrix comparison: N/A

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3. Clinical studies:

a. Clinical Sensitivity: N/A
b. Clinical specificity: N/A
c. Other clinical supportive data (when a. and b. are not applicable): see section 2.a.
1. Clinical cut-off: N/A

5. Expected values/Reference range: Expected blood glucose levels for people without diabetes (refereced from Joslin Diabetes Manual):

Time	Range (mg/dL)	Range (mmol/L)
before breakfast	70-105	3.9-5.8
before lunch or dinner	70-110	3.9-6.1
one hour after meals	less than 160	less than 8.9
two hours after meal	less than 120	less than 6.7
between 2 and 4 AM	greater than 70	greater than 3.9

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

The EasyPlus Self Monitoring Blood Glucose System has the same intended use and similar technological characteristics as the Easy Pain Supreme Self Monitoring Blood Glucose System (K043245) marketed by EPS Bio Technology Corp., Moreover, bench testing contained in the submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the EasyPlus Self-Monitoring Blood Glucose System is substantially equivalent to the predicate devise.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is positioned to the right of the department's name, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 9 2006

General Manager EPS Bio Technology Corp. 2F, No. 49-2, Lane 2, Guang Fu Rd., Sec 2 Hsinchu City, Taiwan, China

Re: K061992

Mr. Y.C. Lei

Trade/Device Name: EasyPlus 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: August 18, 2006 Received: August 21, 2006

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 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,

Alberto Garcia, Ph.D.

Alberto Gutierrez, Ph.D. 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 (if known): K061992

Device Name: EasyPlus Self-Monitoring Blood Glucose System ·

Indications For Use:

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

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

t C)

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

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

C.H.

Division Sign-Off

Divise of In Vitro Diagnostic Device
Office of In Vitro Diagnostic Device
In Coloral Cafety Office tion and Safety

510(k) K061992

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.