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The Diacheck Premium Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples from the fingertips by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Diacheck Premium Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The system is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates.

The Diacheck Premium Blood Glucose Test Strips are for use with the Diacheck Premium Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples from the fingertip. The test strip is intended for self testing outside the bod (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates.

The Diacheck Control solutions are intended for use with Diacheck Premium Blood Glucose Meter and Diacheck Premium Blood Glucose Test Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is being performed correctly.

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The provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria for the DiaCheck Premium Blood Glucose Monitoring System.

The document is a 510(k) premarket notification letter from the FDA to DELBio Incorporation, confirming that their DiaCheck Premium Blood Glucose Monitor System is substantially equivalent to legally marketed predicate devices. It also includes the "Indication for Use" for the device, test strips, and control solution.

Therefore, I cannot provide the requested information from the given input.

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