The EUKARE® glucose test strip is intended to measure the glucose in whole blood with the EUKARE® glucose meter. It is suitable for a person with diabetes to monitor their blood glucose at home by themselves. The system can also be used at clinical sites by nurses or professional people to test patient's glucose level in whole blood.

CAUTION: The measurement of glucose in whole blood can be taken from the finger only, and this is not for neonatal use.

The EUKARE Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.

CAUTION: The measurement of glucose in whole blood can be taken from the finger only, and this is not for neonatal use.

The EUKARE Blood Glucose Test Strips are intended to measure the glucose levels in whole blood with the EUKARE / EUSURE® Blood Glucose Monitoring System. It is suitable for persons with diabetes to monitor their blood glucose levels at home by The system can also be used at clinical sites by health care professionals themselves. to test the blood glucose levels of patients.

CAUTION: The EUKARE Blood Glucose Test Strips for use with EUKARE® / EUSURE® Blood Glucose Monitoring System only.

The EUKARE Blood Glucose Control Solution level I, level II, and level III are used as quality control material to verify the accuracy of the EUKARE® / EUSURE® Blood Glucose Monitoring System. If you are not sure about the strip quality or the previous storage condition, you are recommended to perform a quality control check. The control test results should always fall within the designed range listed on the box in use.

CAUTION: The EUKARE Blood Glucose Control Solution for use with EUKARE® / EUSURE® Blood Glucose Monitoring System only.

Device Description

Based on an electrochemical biosensor technology and the principle of capillary action, EUKARE Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 15 seconds.

AI/ML Overview

This 510(k) submission (K062892) for the EUKARE® Blood Glucose Monitoring System, including the test strips and control solution, does not contain detailed information about a study proving device performance against specific acceptance criteria.

Instead, the submission relies on substantial equivalence to a predicate device, the EUSURE® glucosure blood glucose monitoring system (K040678). The core argument for substantial equivalence is that "Both of our devices (predicate device and subject device) use the same strip and have the same working principle and technologies." The differences mentioned (vision dimensions of the meter unit, weight, and memory storage) are deemed to "not have any safety and effectiveness aspects arising from the subject device."

Therefore, the requested information elements (acceptance criteria table, sample sizes, expert details, adjudication, MRMC studies, standalone performance, ground truth types, and training set details) are not explicitly provided or applicable in the context of this submission, which primarily focuses on demonstrating that the new device is fundamentally the same as its already-cleared predicate.

However, to answer the prompt as best as possible given the available information, here's what can be inferred or stated:

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

This information is not provided in the document. The submission hinges on the claim that the device (EUKARE®) is substantially equivalent to the predicate device (EUSURE® glucosure blood glucose monitoring system, K040678) because they share the "same strip and have the same working principle and technologies." Therefore, the presumed acceptance criteria and performance would be those established for the predicate device.

2. Sample size used for the test set and the data provenance:

Sample size: Not specified.
Data provenance: The document states "Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/ FDA." However, the details of these pre-clinical and clinical data, including their origin (e.g., country) or whether they are retrospective or prospective, are not provided. Given the manufacturer's location (China (Taiwan)), it is likely the data originated there.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. If clinical studies were performed for the predicate device to establish its performance, then experts (e.g., medical professionals for reference methods) would have been involved, but details are absent from this 510(k).

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

This information is not provided.

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:

This type of study is not applicable to a blood glucose monitoring system. MRMC studies are typically for image analysis or diagnostic interpretation tasks where human readers interpret medical images, and AI might assist in that interpretation. A blood glucose meter provides a numerical reading directly.

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

The device itself (the EUKARE® Blood Glucose Monitoring System) provides a standalone measurement. The comparison is implied to be against a laboratory reference method, but the details of such a comparison (if done for this specific device, rather than relying on the predicate's data) are not provided.

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

For blood glucose monitoring systems, the "ground truth" or reference method typically involves a laboratory-based glucose analysis method (e.g., hexokinase method, glucose oxidase method) performed on venous blood samples. This information is not explicitly stated for the EUKARE® system within this 510(k), as it defers to the predicate's established performance.

8. The sample size for the training set:

This information is not provided. Blood glucose meters typically do not have a "training set" in the machine learning sense. Their electrochemical biosensor technology is based on established chemical reactions, and the calibration would be done during manufacturing.

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

Not applicable, as there's no "training set" in this context. The calibration and validation of the device would rely on comparison to recognized reference methods.

Summary

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K062892

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510(K) Summary of Safety and Effectiveness

(Per 21 CFR 807.92)

General Information Establishment ■ EUMED BIOTECHNOLOGY CO., LTD. Manufacturer: . Address: 3F, NO. 789, BOAI ST. HSIN CHU HSIEN, China (Taiwan) 30265 li Registration Number: 3004379419 . Contact Person: Dr. Jen Ke-Min, Official Correspondent 886-3-5208829 (Tel) 886-3-5209783 (Fax) . Date Prepared: September 23, 2006 Device . Proprietary Name: EUKARE® . Common Name: Blood Glucose Monitoring System ● Classification Name: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER, Class II,

Safety and Effectiveness Information

● Predicate Device:

Claim of Substantial Equivalence (SE) is made to EUMED Biotechnology Co., Ltd. EUSURE® glucosure blood glucose monitoring system (K040678)

. Device Description: Based on an electrochemical biosensor technology and the principle of capillary action, EUKARE Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 15 seconds.
JAN 2 2 2007

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. Intended Use:

A 1UTION: The measurement of glucose in whole blood can be taken from the finger only, and this is not for neonatal use.

. Synopsis of Test Methods and Results

Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/ FDA.

● Substantial Equivalence (SE)

A claim of substantial equivalence is made to EUMED Biotechnology Co., Ltd., EUSURE® glucosure blood glucose monitoring system (K040678). Both of our devices (predicate device and subject device) use the same strip and have the same working principle and technologies. The differences are vision dimensions of the meter unit, weight and memory storage. There are no safety and effectiveness aspects arising from the subject device. They are substantially equivalent.

Ke-Min Jen, Dr. Official Correspondent for EUMED BIOTECHNOLOGY CO., LTD.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ke-Min Jen Eumed Biotechnology Co., Ltd. 3F, No. 789, Boai Street Jubei City, Hsinchu County, Taiwan 30265, R.O.C.

Received: December 7, 2006

JAN 2 2 2007

K062892 Re: Trade/Device Name: EUKARE Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Blood Glucose Test System-Over the counter Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: December 3, 2006

Dear Dr. Jen:

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) 276-0490. 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

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Indications for Use

510 (K) Number:_______________________________________________________________________________________________________________________________________________________________

Device Name: EUKARE Blood Glucose Monitoring System

Indications for Use:

CAUTION: The measurement of glucose in whole blood can be taken from the finger only, and this is not for neonatal use.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)
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Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety
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K062892

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Indications for Use

510 (K) Number:	K062892
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Device Name: EUKARE Blood Glucose Test Strips

Indications for Use:

CAUTION: The EUKARE Blood Glucose Test Strips for use with EUKARE® / EUSURE® Blood Glucose Monitoring System only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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
Page 1 of 3
Office of In Vitro Diagnostic Device Evaluation and Safety
K062892

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Indications for Use

K062892 510 (K) Number:

Device Name: EUKARE Blood Glucose Control Solution

Indications for Use:

CAUTION: The EUKARE Blood Glucose Control Solution for use with EUKARE® / EUSURE® Blood Glucose Monitoring System only.

Prescription Use

AND/OR

Over-The-Counter Use

e-Counter Use

(Part 21 CFR 801 Subpart D)

(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
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Office of In Vitro Diagnostic Device
Evaluation and Safety

	K062892
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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.