(356 days)
The FreeStyle Precision Neo Blood Glucose Monitoring System is for use outside the body only (in vitro diagnostic use) in the quantitative measurement of glucose in fresh whole blood for self-testing by lay users from the fingers. It is not intended to be used for testing neonatal blood samples or the diagnosis or screening of diabetes.
The FreeStyle Precision Neo System is indicated for home (lay user) in the management of patients with diabetes. It is intended to be used by a single person and should not be shared.
The FreeStyle Precision Neo Blood Glucose Test Strips are for use with the FreeStyle Precision Neo Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The FreeStyle Precision Neo Meter is for the quantitative measurement of glucose in capillary whole blood samples. The FreeStyle Precision Neo Meter, in conjunction with the FreeStyle Precision Neo Blood Glucose Test Strips, works on the principal of amperometric technology, measuring glucose by its reaction with Glucose Dehydrogenase (GDH) in blood samples or control solutions through electrical mediation.
The FreeStyle Precision Neo System is compatible with the following components and accessories:
- . FreeStyle Precision Neo Blood Glucose Test Strips (available separately)
- MediSense Glucose and Ketone Control Solutions (available separately) ●
- USB Cable (available separately) ●
- FreeStyle Lancing Device II ●
- Thin Lancets
The FreeStyle Precision Neo System also includes a hypoglycemia and hyperglycemia trend indicators feature. The hypoglycemia/hyperglycemia trend indicators feature alerts the user of low and high blood glucose patterns. The FreeStyle Precision Neo Meter displays a red arrow indicator light if the user's blood glucose is below the set target or a vellow arrow indicator light if their blood glucose is above the set target. The default indicator target values are 70 and 240 mg/dL but can be customized, if needed. The Meter will also use these ranges to determine blood glucose patterns.
The FreeStyle Precision Neo Blood Glucose Monitoring System is for quantitative measurement of glucose in fresh whole blood for self-testing by lay users from the fingers. It is not intended to be used for testing neonatal blood samples or the diagnosis or screening of diabetes.
Here is the information about the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Characteristics / Performance Study | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy (ISO 15197:2013) | **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.