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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. The system is intended to be used by a single patient and should not be shared.
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 is not to be used for the diagnosis of or screening of diabetes or for neonatal use.
The OneTouch® Verio® Test Strips are for use with the OneTouch® Verio® Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.

The OneTouch® Verio® Blood Glucose Monitoring System consists of the OneTouch® Verio® Sync Blood Glucose Meter, OneTouch® Verio® Test Strips, OneTouch® Verio® Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch® Verio® 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.

Here's a breakdown of the acceptance criteria and study information for the OneTouch Verio Blood Glucose Monitoring System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document specifically refers to ISO 15197:2003(E) as the standard for performance testing. While ISO 15197:2003(E) has specific accuracy criteria (e.g., a certain percentage of results within ±X mg/dL or ±Y%), the summary text reports the device's performance against those criteria rather than explicitly stating the criteria as acceptance thresholds separate from the results. However, we can infer the acceptance criteria from the reported performance, as reaching 100% within certain thresholds implies these were the targets.

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