(30 days)
The TRUEbalance Blood Glucose System is intended for the quantitative determination of glucose in human capillary 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.
The alternative site (forearm) testing for the TRUEbalance Blood Clucose System can be used only during steady-state blood glucose conditions.
The TRUEbalance Blood Glucose System is not intended for the diagnosis of or screening for diabetes mellitus.
TRUEbalance Blood Glucose System
This document is a 510(k) clearance letter for the TRUEbalance Blood Glucose System. It primarily addresses the FDA's determination of substantial equivalence, and therefore, does not contain the detailed information required to answer your prompt regarding acceptance criteria and a study proving 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."
The accompanying "Indication for Use" statement (page 2 of the document) describes the intended use of the device but offers no performance data or study details.
Therefore, based solely on the provided text, I cannot extract the information required to populate the table or answer the specific questions about the device's acceptance criteria and the study that proves performance.
To answer your prompt, I would need access to the full 510(k) submission or at least the performance study section of that submission.
§ 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.