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The EasyGluco® Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf or thigh as an aid in monitoring the effectiveness of diabetes management in the home by patients with diabetes. The EasyGluco® Plus Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared with any other person.

EasyGluco® Plus System is for self testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The EasyGluco® Plus Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The EasyGluco® Plus Blood Glucose Test Strips are for use with the EasyGluco® Plus Blood Glucose Monitor for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf or thigh.

The EasyGluco® Plus Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the EasyGluco® Plus Test Strips.

The test principle is:
This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.

The provided document does not contain detailed information about the acceptance criteria or a specific study that proves the device meets those criteria in a format allowing for direct extraction into the requested table and parameters.

The document is a 510(k) premarket notification summary for the EasyGluco® Plus Blood Glucose Monitoring System, which focuses on establishing substantial equivalence to a predicate device (G5 Infinity Blood Glucose Monitoring System, K082201). While it describes the device, its intended use, and claims substantial equivalence, it does not explicitly detail the performance acceptance criteria or the specifics of a study designed to demonstrate those criteria were met, such as accuracy metrics, sample sizes for testing sets, ground truth establishment, or expert involvement.

Therefore, it's not possible to populate the requested table and answer the specific questions based solely on the provided text. The document is primarily a regulatory submission for equivalence, not a detailed study report.

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