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The FreeStyle Precision Neo Blood Glucose Monitoring System is for use outside the body only (in vitro diagnostic use) in the quantitative measurement of glucose in fresh whole blood for self-testing by lay users from the fingers. It is not intended to be used for testing neonatal blood samples or the diagnosis or screening of diabetes.
The FreeStyle Precision Neo System is indicated for home (lay user) in the management of patients with diabetes. It is intended to be used by a single person and should not be shared.
The FreeStyle Precision Neo Blood Glucose Test Strips are for use with theFreeStyle Precision Neo Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

The FreeStyle Precision Neo Meter is for the quantitative measurement of glucose in capillary whole blood samples. The FreeStyle Precision Neo Meter, in conjunction with the FreeStyle Precision Neo Blood Glucose Test Strips, works on the principal of amperometric technology, measuring glucose by its reaction with Glucose Dehydrogenase (GDH) in blood samples or control solutions through electrical mediation.
The FreeStyle Precision Neo System is compatible with the following components and accessories:

• . FreeStyle Precision Neo Blood Glucose Test Strips (available separately)
• MediSense Glucose and Ketone Control Solutions (available separately)
• . USB Cable (available separately)
• FreeStyle Lancing Device II ●
• Thin Lancets ●

The provided text describes the FreeStyle Precision Neo Blood Glucose Monitoring System and its substantial equivalence to a predicate device. It includes performance study information for glucose measurements.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details the performance of the FreeStyle Precision Neo Blood Glucose Monitoring System against specific criteria. The key performance metrics revolve around the accuracy of glucose measurements.

Acceptance Criteria for Blood Glucose Monitoring Systems (as per ISO 15197:2003, which is commonly referenced for such devices):

• **For glucose concentrations

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