(109 days)
The FREEDOM Blood Glucose Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. The FREEDOM Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm, palm, thigh and calf.
The FREEDOM Blood Glucose Monitoring System is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the FREEDOM Test Strips.
The test principle is:
This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
This is an in vitro diagnostic device, not an AI/ML device, so many of the requested categories (e.g., number of experts, adjudication method, MRMC study, sample size for training set) are not applicable. The information provided focuses on the device's accuracy against established references, which is typical for this type of device.
Acceptance Criteria and Device Performance
The provided 510(k) summary does not explicitly state acceptance criteria in a quantitative table format nor reported device performance in a similar table. However, based on the nature of blood glucose monitoring systems and the reference to substantial equivalence to predicate devices, the acceptance criteria would implicitly involve the device demonstrating accuracy and precision comparable to or better than the predicate devices and meeting relevant ISO standards for blood glucose monitoring.
From the information provided, it states that the device measures "the concentration of glucose in whole blood" and is "an aid in monitoring the effectiveness of diabetes management." The device claims "substantial equivalence to the LifeScan, Inc., OneTouch® Ultra®" and others. This implies that the performance (accuracy, precision) of the FREEDOM Blood Glucose Monitoring System must be within acceptable limits relative to these established predicate devices.
Implicit Acceptance Criteria (based on common standards for IVD blood glucose meters) & Reported Device Performance:
| Acceptance Criteria (Inferred from industry standards for IVD Blood Glucose Meters) | Reported Device Performance (Inferred from "substantial equivalence") |
|---|---|
| Accuracy: Results within a certain percentage/absolute difference of reference (e.g., 75 mg/dL, |
§ 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.