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The EM40 Pro Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingerip. Testing is done outside use). It is intended for multiple-patient use in professional healthcare schings 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 EM40 Pro meter and the EM40 Pro meter only is used with the EM40 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.

The EM40 Glucose Control Solution For use with the EM40 Pro Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.

The EM40 Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forcarn. Testing is done outside the body (In Vitro diagnosic 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 system consists of the EM40 meter and the EM40 meter only is used with the EM40 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm,

The EM40 Glucose Control Solution is for use with EM40 Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

The system consists of the EM40 Pro meter and the EM40 Pro meter only is used with the EM40 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.

The system consists of the EM40 meter and the EM40 meter only is used with the EM40 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm,

This document is an FDA 510(k) clearance letter for the EM40 Self-monitoring Blood Glucose System and EM40 Pro Blood Glucose System. While it acknowledges the device's substantial equivalence to predicates and outlines its intended use, it does not contain the specific acceptance criteria, study details, or performance results requested.

Therefore, I cannot provide the information you requested based on the provided text. The document focuses on regulatory approval, not on the detailed technical study results that demonstrate how the device meets specific acceptance criteria.

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