(504 days)
The CONTOUR®NEXT EZ blood glucose nonitoring system is an over the counter (OTC) device utilized for self-esting by persons with diabetes at home for the quantiative measurement of glucose in whole patient use only, and should not be shared.
The CONTOUR® NEXT EZ blood glucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples. The clinical utility of this device is to aid in monitoring the effectiveness of your diabetes control program.
The CONTOUR® NEXT EZ blood glucose monitoring system is not intended for use for screening for diabetes mellitus and is not intended for use on neonates.
The CONTOUR® NEXT test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL.
The Contour Next EZ Blood Glucose Meter consists of a small handheld blood glucose meter that utilizes dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes. Liquid control solution is used to check the performance of the system. The meter, together with the test strips and control solutions, is referred to as the Contour Next EZ Blood Glucose Monitoring System.
The chemical principle utilized for both the predicate and modified devices 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. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed.
Here's a breakdown of the acceptance criteria and study information for the Contour Next EZ Blood Glucose Meter (K130265):
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Contour Next EZ Blood Glucose Monitoring System are based on ISO 15197:2003 standards for accuracy, repeatability, linearity, and intermediate precision. The provided document details the performance of the Contour Plus System as a proxy for the Contour Next EZ system, along with specific additional testing for the modified Contour Next EZ meter.
| Test Type | Acceptance Criteria | Reported Device Performance (Contour Plus System, unless otherwise noted) |
|---|---|---|
| Accuracy (Analytical) | **Glucose 1.0, meeting the acceptance criteria. | |
| EMC and Electrical Safety | Compliance with IEC 62316-2-6:2005, IEC 61010-1:2001, and IEC 61010-2-101:2002. | Evaluated and found to be compliant. |
| Hematocrit + Temp Study | Bias from YSI |
§ 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.