(60 days)
The OneTouch Verio Reflect Blood Glucose Monitoring System is composed of the OneTouch Verio Reflect Meter and OneTouch Verio Test Strips. The OneTouch Verio Reflect 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 Reflect Blood Glucose Monitoring System is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended to be used by a single person and should not be shared. The system should not be used for the diagnosis of, or screening for diabetes or for neonatal use.
The OneTouch Verio Reflect Blood Glucose Monitoring System consists of the OneTouch Verio Reflect Blood Glucose Meter, OneTouch Verio Test Strips, OneTouch Verio Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch Verio Reflect 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 Reflect meter also contains tools to aid diabetes management which include a dynamic range indicator, test tracker, blood sugar mentor, trend90 average blood glucose and meal and advanced tagging.
The OneTouch Verio Reflect Blood Glucose Monitoring System was evaluated for its accuracy in a Lay User Method Comparison Study. The study assessed the device's performance against a laboratory reference method, the Yellow Springs Instrument (YSI 2300 STAT PLUS glucose analyzer).
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (October 2016)) | Reported Device Performance (OneTouch Verio Reflect Blood Glucose Monitoring System) |
|---|---|
| For glucose concentrations ≥ 75 mg/dL: At least 95% of results must be within ±15% of the reference method. | 99.2% of results were within ±15% of the YSI 2300 reference instrument. |
| 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.