(187 days)
The OneTouch® Verio" "IQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The OneTouch® Verio" IQ Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
OneTouch® Verio" IQ Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The OneTouch® Verio" "IQ Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes, neonatal use.
The OneTouch® Verio" Test Strips are for use with the OneTouch® Verio" IQ Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.
The OneTouch® Verio" Verio" IQ Blood Glucose Monitoring System consists of the OneTouch Verio" " Q Blood Glucose Meter, OneTouch® Verio" Test Strips, OneTouch® Verio" Mid and High Control Solutions, Lancing Device, Sterile Lancets and Alternative Site testing Kit (available separately). The Alternative Site Testing Kit comprises the OneTouch® Lancing Device, OneTouch® UltraSoft" Sterile Lancets, OneTouch®, Clear Cap and Instructions for Use. The OneTouch® Verio" IQ Blood Glucose Monitoring System measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.
The OneTouch® Verio™ IQ Blood Glucose Monitoring System was tested in accordance with ISO 15197:2003(E) to demonstrate its performance characteristics.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for system accuracy are generally defined in ISO 15197:2003(E). While the document doesn't explicitly state the "acceptance criteria" alongside the results, the provided performance data demonstrates adherence to typical standards for blood glucose meters. Often, 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.