(241 days)
The GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM is intended for the quantitative measurement of glucose in capillary whole blood.
Not Found
The provided text does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for the Glucochek Pocketlab II Blood Glucose System, indicating that the device has been determined to be substantially equivalent to previously marketed devices.
This type of document typically does not include the detailed study results, acceptance criteria, or performance metrics. It primarily confirms the FDA's decision regarding market clearance.
Therefore, I cannot provide the requested information based on the given text.
§ 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.