(79 days)
The CONTOUR® NEXT USB Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The CONTOUR® NEXT USB Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. The CONTOUR® NEXT USB Blood Glucose Monitoring System may be used as an aid to monitor the effectiveness of a diabetes control program and is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The Contour® NEXT Test Strips are for use with the CONTOUR® NEXT USB Blood Glucose Monitoring System for the quantitative measurement of glucose in whole blood. The Contour® NEXT Controls are for use with the CONTOUR® NEXT USB Blood Glucose Monitoring System to check that the meter and test strips are working properly.
Glucofacts® Deluxe Diabetes Management Software is an over-the-counter software program intended for use by health care professionals and patients with diabetes for viewing and printing reports that display blood sugar readings from Baver's Contour and Breeze families of meters.
The Contour NEXT USB Blood Glucose Monitoring System consists of a small handheld blood glucose meter that is substantially equivalent in look and feel to the predicate system. Contour Next Wireless Blood Glucose Meter, (K110894). The system also consists of dry reagent test strips used for the measurement of glucose in capillary whole blood and includes liquid controls to check the performance of the system.
The chemical principle of the system is based on measurement of electrical current caused by the reaction of glucose in the blood with chemicals on the reagent strip. The blood sample is drawn into the tip of the reagent strip through capillary action. Glucose in the sample reacts with FAD glucose dehydrogenase (FAD-GDH) enzyme on the reagent strip. The electrons generated by this reaction are shuttled to an electrode by a mediator chemical, producing a current that is proportional to the glucose in the sample.
The Bayer Contour NEXT USB Blood Glucose Monitoring System was tested and found to meet the system accuracy requirements of ISO 15197:2003 through analytical performance testing and a user performance evaluation.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from ISO 15197:2003 for system accuracy.
**System Accuracy - Glucose Concentrations
§ 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.