(124 days)
The Element Blood Glucose Test 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.
Not Found
This letter is a 510(k) premarket notification decision from the FDA, not a study report. Therefore, it does not contain the specific details about acceptance criteria, device performance, or study methodology that you are requesting.
The document states that the FDA has reviewed the 510(k) premarket notification for the "Element Blood Glucose Monitoring System" and determined it to be substantially equivalent to legally marketed predicate devices. This determination is based on the information submitted in the 510(k), which would have included performance data, but that data is not detailed in this letter.
To fully answer your questions, you would need to refer to the actual 510(k) submission document (K060793) itself, which is typically a much more extensive report with detailed study results. The letter confirms the device name, regulation number, regulatory class, and product code, as well as its intended use.
§ 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.