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The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, and in venous and arterial whole blood.

The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for testing 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 a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices.

The system should not be used for the diagnosis of or screening for diabetes or for neonatal testing.

The Freestyle Precision Neo H Blood Glucose Test Strips are for use with the Freestyle Precision Neo H Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood from the finger, and from venous and arterial whole blood.

The FreeStyle Precision Neo H meter provides the following features:

• Quantitative measurement of glucose in capillary, venous and arterial whole blood samples
• Quality Control Reminder
• Out-of-Range Indicators

The FreeStyle Precision Neo H Meter is for use by healthcare professionals (HCPs) for multiple-patient use. The FreeStyle Precision Neo H Meter, in conjunction with the FreeStyle Precision Neo H 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 H System is compatible with the following components and accessories:

• FreeStyle Precision Neo H Blood Glucose Test Strips
• MediSense Glucose and Ketone Control Solutions
• FreeStyle Auto-Assist Neo Data Management System
• USB Cable

This document contains a 510(k) summary for the FreeStyle Precision Neo H Blood Glucose Monitoring System. The acceptance criteria and the study proving the device meets these criteria can be extracted from the performance data provided.

Here's the information requested, based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document references ISO 15197:2013 as the standard for accuracy. The acceptance criteria for glucose monitoring systems, according to ISO 15197:2013 for system accuracy, are typically:

• ≥95% of all measured glucose values shall fall within ±15 mg/dL of the reference measurement procedure for glucose concentrations

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