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The EGV1.1 Pro 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 EGV1.1 Pro meter and the EGV1.1 Pro meter only is used with the EGV1.1 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.

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

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The provided document is an FDA 510(k) clearance letter for two blood glucose monitoring systems: EGV1.1 Pro Monitoring Blood Glucose System and EGV1.1 Self Monitoring Blood Glucose System. While it states the devices are substantially equivalent to legally marketed predicate devices, it does not contain the detailed acceptance criteria or the study results that demonstrate the device meets those criteria.

FDA 510(k) clearance evaluates substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device. The detailed performance data and acceptance criteria are typically part of the 510(k) submission, which is not fully included here. The provided text primarily focuses on regulatory information, indications for use, and administrative details.

Therefore, I cannot provide the requested information based on the input text alone. The document explicitly avoids detailed technical specifications and performance data.

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