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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.

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.

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.

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