(872 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 of or screening for 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 LabonaCheck Gluppy Control Solution is for use with the LabonaCheck Gluppy Blood Glucose Monitoring System as a quality control check to verify that the meter and test strips are working together properly.
The system consists of Test Meter, Test Strips, Code key, Lancing Device, lancets, 3V 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 describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not contain any information about acceptance criteria, a specific study proving the device meets those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details.
The document is a regulatory submission for premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed device rather than providing detailed performance study results with specific acceptance criteria and statistical analysis.
Therefore, I cannot fulfill your request for the specific points about acceptance criteria and detailed study information based on the provided text. The document primarily focuses on:
- Device Name: LabonaCheck Gluppy Blood Glucose Monitoring System
- Manufacturer: CERAGEM Medisys Inc.
- Submission Date: February 11, 2013
- Predicate Device: RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, Model GM 100 (K081451)
- Indication for Use: Quantitative measurement of glucose in fresh capillary whole blood samples from the fingertip for self-testing by people with diabetes at home (not for diagnosis, screening, or neonatal use).
- Similarities to Predicate: Amperometry detection method, Glucose Oxidase enzyme, Potassium ferricyanide mediator, test range (20-600 mg/dL), temperature range (10-40°C), noble metal electrode, 3-year warranty, CR2032 battery.
- Differences from Predicate: Sample volume (1.0 uL vs 1.4 uL), humidity range (Below 80% vs 10-90%), open use time for test strips (4 months vs 3 months), coding (Code Key vs No coding), test time (5 seconds vs 8 seconds), hematocrit range (20-60% vs 30-55%), memory (500 results vs 10 results).
To answer your questions, a different type of document, such as a validation study report or a more detailed performance specification document, would be required.
§ 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.