(306 days)
The EasyMax T1 Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for multiple-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood qlucose conditions.
The system consists of the EasyMax T1 Pro Meter and the EasyMax T1 Pro Blood Glucose Test Strips. The EasyMax T1 Pro Meter is only used with the EasyMax T1 Pro Blood Glucose Test Strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips.
The EasyMax T1 Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
The system consists of the EasyMax T1 Meter and the EasyMax T1 Blood Glucose Test Strips. The EasyMax T1 Meter is only used with the EasyMax T1 test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips or forearm.
The system consists of the EasyMax T1 Pro Meter and the EasyMax T1 Pro Blood Glucose Test Strips. The EasyMax T1 Pro Meter is only used with the EasyMax T1 Pro Blood Glucose Test Strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips.
The system consists of the EasyMax T1 Meter and the EasyMax T1 Blood Glucose Test Strips. The EasyMax T1 Meter is only used with the EasyMax T1 test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips or forearm.
Acceptance Criteria and Study for EasyMax TI Self Monitoring Blood Glucose System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (CliniLabs Guidelines) | Reported Device Performance (EasyMax TI System) |
|---|---|
| ≥ 95% of results within ± 15 mg/dL or ± 15% of reference 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.