(127 days)
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.
Not Found
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.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.