(434 days)
The OneTouch® Verio" 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, forearm or palm. The OneTouch® Verio" Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
The OneTouch® Verio" 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™ Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidlv).
The OneTouch® Verio™ Test Strips are for use with the OneTouch® Verio" Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The OneTouch® Verio" Control Solutions are for use with the OneTouch® Verio" Blood Glucose Meter and Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The OneTouch® Verio" Blood Glucose Monitoring System consists of the OneTouch® Verio" Meter, OneTouch® Verio™ Test Strips, OneTouch® Verio" Control Solutions (mid and high levels), the Lancing Device, Sterile Lancets and Clear Cap (sold separately). The OneTouch® Verio" 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.
Here's a breakdown of the acceptance criteria and study information for the OneTouch® Verio™ Blood Glucose Monitoring System, as extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to testing being done in accordance with ISO 15197:2003(E). While explicit numerical acceptance criteria for each category are not always stated outright, the results presented are the reported device performance and implicitly demonstrate that the device meets the standards of ISO 15197:2003(E).
| Test Category | Acceptance Criteria (Implied by ISO 15197:2003(E)) | Reported Device Performance (System Accuracy) |
|---|---|---|
| System Accuracy | **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.