(162 days)
The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The LabonaCheck® Gluppy Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for neonatal use.
The LabonaCheck® Gluppy Blood Glucose Test Strips are for use with the LabonaCheck® Gluppy Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
The system consists of Test Meter, Test Strips, Lancing Device, lancets, 3 V battery and Carrying Case. The system measures the amount of glucose (sugar) in whole blood. Blood is applied to the absorbent hole of the test strip and automatically drawn into the reaction zone where reaction between reagent and glucose occurs.
The provided text is a 510(k) summary for the LabonaCheck® Gluppy Blood Glucose Monitoring System. It does not contain information about the specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes for training/test sets, ground truth establishment, or expert involvement as requested.
The document primarily focuses on establishing substantial equivalence to a predicate device (K102751) by comparing various features and performance characteristics. It states that the "Performance Characteristics" are the same as the predicate and refers to "N. Performance Characteristics on 6 page" which is not provided in the input text.
Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, study design, and performance results. This document is a regulatory submission for premarket notification, not a detailed scientific study report.
§ 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.