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The SureChek Edge Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The alternative site testing in the SureChek Edge Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

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This document is a 510(k) clearance letter for a blood glucose monitoring system and does not contain detailed information about acceptance criteria or specific study designs to prove device performance. It primarily focuses on the regulatory aspects of substantial equivalence.

Therefore, I cannot provide the requested information about acceptance criteria and the study proving device performance using only the provided text. The document states "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...", which implies that studies were submitted to the FDA, but the details of those studies and their results are not included in this letter.

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