(219 days)
The GLUCOCARD W Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip or palm. Testing is done outside the body (in vitro diagnostic use). It is intended for use at home by persons with diabetes, as an aid in monitoring the effectiveness of a diabetes control program.
The GLUCOCARD W Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The GLUCOCARD® W Blood Glucose Monitoring System is designed to quantitatively determine glucose concentrations in fresh capillary whole blood samples. The GLUCOCARD® W Blood Glucose Monitoring System consists of a battery-powered GLUCOCARD® W Blood Glucose Meter, disposable GLUCOCARD® W Blood Glucose Test Strips and Assure® Control-Control Solution (Levels 1, 2, and 3). The GLUCOCARD® W Blood Glucose Monitoring System utilizes biosensor technology for the quantitative determination of glucose concentrations in capillary blood samples. Although capillary blood samples are used for measurement, the results displayed on the GLUCOCARD® W Blood Glucose Monitoring System are equivalent to plasma glucose levels.
The biosensor (GLUCOCARD® W Blood Glucose Test Strips) operates on the electrochemical detection of the reaction of glucose with the enzyme glucose oxidase.
Glucose in the blood reacts with the reagent in the test strip, and this produces a small electric current. The strength of this current is proportional to the concentration of glucose in the blood. The meter measures this current and calculates your glucose level.
The document describes the performance testing of the GLUCOCARD® W Blood Glucose Monitoring System, an in vitro diagnostic device. The acceptance criteria and supporting studies are detailed below, primarily focusing on the accuracy of blood glucose measurements.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the accuracy of blood glucose measurements are derived from the 2016 FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use. The reported device performance is based on the Finger-Stick Data Accuracy and Alternate Site (Palm) Data Accuracy studies.
| Criteria (Difference from True Blood Glucose Level) | Acceptance Criterion (FDA Guidance) | Reported Device Performance (Finger-stick) | Reported Device Performance (Alternate Site - Palm) |
|---|---|---|---|
| Within ± 5% | Not explicitly stated as a primary criterion for overall system accuracy in the provided text, but data is presented. | 63.7% (191/300) | 55.8% (134/240) |
| Within ± 10% | For glucose concentrations ≥ 100 mg/dL: ≥ 95% of results within ± 10%. For 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.