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The TrueTrack Smart System Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

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The provided document is an FDA 510(k) clearance letter for the TrueTrack Smart System Blood Glucose Monitoring System dated July 11, 2003. This document confirms the device's substantial equivalence to a legally marketed predicate device but does not contain the detailed study information needed to answer the questions about acceptance criteria and device performance.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act." This indicates that the detailed study results and performance data would have been part of the original 510(k) submission, not typically included in the clearance letter itself.

Therefore, I cannot provide the requested information based on the given input. To answer these questions, the actual 510(k) submission document or a summary of its contents would be required.

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