(32 days)
The Achtung TD-4207 I Clever Chek TD-4209 / Clever Chek TD-4222 Glucose Test Systems are intended for use in the quantitative measurement of glucose in whole blood samples taken from the finger. They are intended for use by healthcare professionals and people with diabetes mellitus as an aid in monitoring the effectiveness of diabetes management. They are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.
Not Found
The provided text is related to a 510(k) premarket notification for a Glucose Test System and does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested. The document primarily focuses on the FDA's substantial equivalence determination for marketing the device.
Therefore, I cannot provide the requested table and study details based on the given input.
§ 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.