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The eBcarryon Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. The eBcarryon Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not for use on neonates. 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.

Based on an electrochemical biosensor technology and the principle of capillary action, eBcarryon 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 10 seconds.

The provided document focuses on the eBcarryon Blood Glucose Monitoring System and its 510(k) submission (K091765). The summary of the device, its intended use, and the declaration of substantial equivalence to a predicate device are included. However, the document does not contain the specific details about acceptance criteria, device performance results, study design, or ground truth establishment that you've requested.

This document is a regulatory submission for premarket notification, primarily asserting substantial equivalence to a previously cleared device (eBsensor Blood Glucose Monitoring System, K062555). It outlines general information about the device and its intended use but lacks the detailed performance study information.

Therefore, I cannot provide the requested information from the given text. A typical 510(k) submission might include a detailed section on performance data to support claims, but that specific content is not present in the provided snippets.

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