(166 days)
The TRUEresult Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and Healthcare Professional in the management of diabetes. Healthcare Professionals may use the device to test venous whole blood; home-use is limited to capillary whole blood testing. Not for neonatal use.
TRUEresult Blood Glucose Monitoring System
The provided document is an FDA 510(k) clearance letter for the TRUEresult Blood Glucose Monitoring System. It does not contain the acceptance criteria, reported device performance, or details of the study used to establish substantial equivalence.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications based on this document. This letter only states that the device is substantially equivalent to a predicate device for its stated indications for use.
To answer your questions, I would need access to the actual 510(k) submission, which would include the study reports and validation data.
§ 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.