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The KetoSens BT Blood ß-Ketone Monitoring System is intended for the quantitative measurement of 0-Ketone (betahydroxybutyrate) level in capillary whole blood drawn from the fingertip. The KetoSens BT Blood β-Ketone Monitoring System is intended for self-testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of ketoacidosis control. The system is not intended for use in the diagnosis of or screening for ketoacidosis and is not intended for use on neonates. This system is intended to be used by a single person and should not be shared.

The KetoSens Blood 0-Ketone Test Strips work with the KetoSens BT Blood 0-Ketone Meter to quantitatively measure Blood ß-Ketone in capillary whole blood samples drawn from the finger.

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I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, validation studies, sample sizes, ground truth establishment, or expert involvement. The document primarily consists of an FDA 510(k) clearance letter for the KetoSens BT Blood $\beta$ -Ketone Monitoring System, outlining its indications for use and regulatory compliance. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given information.

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