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The EME Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

The EME Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.

The system consists of the EME meter and the EME test strips. The EME meter only is used with the EME test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

The system consists of the EME Pro meter and the EME Pro test strips. The EME Pro meter only is used with the EME Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.

The EME Glucose Control Solution is for use with EME Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

The EME Glucose Control Solution is for use with the EME Pro Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The text provided is a 510(k) clearance letter from the FDA for two devices: EME Self Monitoring Blood Glucose System and EME Pro Self Monitoring Blood Glucose System. It outlines the regulatory classification, indications for use, and general compliance requirements, but it does not detail specific performance studies or acceptance criteria that were met to achieve this clearance.

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