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The TheraSense Inc. FreeStyle™ Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh whole capillary blood. The FreeStyle System is intended for use outside the body (in vitro diagnostic use) by health care professionals and people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and it is not intended for use on neonates or with arterial blood samples.

The FreeStyle Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.

The FreeStyle Blood Glucose Monitoring System comprises an electrochemical biosensor glucose reagent test strip, a handheld meter, a quality control solution, a complete Owner's Booklet, a Quick Reference Guide and a "Getting Started" guide. A lancing device, lancets and a logbook for recording test results are also included with the system.

When the user inserts a test strip, the meter turns on. The user acquires a blood sample (with the test strip in the meter) by picking up the meter and touching the edge of the test strip at the sample target area, filling the chamber on the strip by capillary action. The meter sounds a tone (beeps) to let the user know that the sample chamber is full and the reaction has begun. When the test is complete, the meter displays the glucose reading on its liquid crystal display (LCD).

This document does not contain the information required to fulfill the request. The provided text is a 510(k) summary for the FreeStyle Blood Glucose Monitoring System, detailing its intended use and principle of operation, and stating that changes were made to product labeling regarding alternative site testing. However, it does not include a table of acceptance criteria, reported device performance data, information about sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), or a standalone algorithm performance study. It also lacks specifics on how ground truth was established beyond stating its intended use for "quantitative measurement of glucose."

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