(241 days)
The ActiveCare TD-4121 Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood taken from the finger. It is intended to be used by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. The ActiveCare TD-4121 Blood Glucose Monitoring System is comprised of the ActiveCare TD-4121 glucose meter and the ActiveCare TD-4121 blood glucose test strip. The ActiveCare TD-4121 Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The ActiveCare TD-4121 Blood Glucose Monitoring System is not intended for the diagnosis of, or screening of diabetes. It is not intended for use on neonates.
The ActiveCare TD-4121 Blood Glucose Monitoring System is comprised of the ActiveCare TD-4121 glucose meter and the ActiveCare TD-4121 blood glucose test strip. They have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only ActiveCare TD-4121 blood glucose test strip with ActiveCare TD-4121 Blood Glucose Monitoring System.
The document describes the ActiveCare TD-4121 Blood Glucose Monitoring System, an over-the-counter device intended for quantitative measurement of glucose in fresh capillary whole blood from the finger. It is used by people with diabetes mellitus at home to monitor their diabetes control program but is not for diagnosis or screening of diabetes, nor for use on neonates.
The device's acceptance criteria are based on its performance compared to a predicate device (TD-4277 Blood Glucose Monitoring System) and its conformance to established accuracy standards for blood glucose meters.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly references ISO 15197 for accuracy standards, as is common for blood glucose monitoring systems. Although a specific table of acceptance criteria with numerical targets is not explicitly provided in the excerpt, the typical acceptance criteria for accuracy of blood glucose meters, as per ISO 15197:2013, are:
| Acceptance Criteria (typically ISO 15197:2013) | Reported Device Performance (from the context of SE determination) |
|---|---|
| Accuracy relative to laboratory reference method: | Demonstrated to be accurate. |
| - 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.