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The OKmeter Direct Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper-arm, calf, thigh, or palm. The OKmeter Direct Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The OKmeter Direct Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The OKmeter Direct Blood Glucose Monitoring System should not be used for the diagnosis of 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 OKmeter Direct Test Strips are for use with the OKmeter Direct Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper-arm, calf, thigh, or palm.

Based on an electrochemical biosensor technology and the principle of capillary action, Okmeter Direct 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 is displayed in 6 seconds.

Here's a breakdown of the acceptance criteria and study details for the OKmeter Direct Blood Glucose Monitoring System, as extracted from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for glucose meters are typically defined by regulatory bodies like the FDA, often referring to standards like ISO 15197. While the document doesn't explicitly state "acceptance criteria" numbers as a separate table, it presents performance data in a way that implies these are the criteria against which the device is being tested for accuracy. The core criteria revolve around the percentage of results falling within specific deviation ranges from a reference method (YSI 2300).

The performance data is presented separately for two user groups: "Home Users" (lay users) and "Healthcare Professionals."

**For Glucose Concentration

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