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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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The OneTouch Verio Sync Blood Glucose Monitoring System (BGMS) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The system is intended to be used by a single person and should not be shared.

The OneTouch Verio Sync BGMS 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 Sync BGMS should not 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 Sync Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

The OneTouch® Verio™ Sync 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™ Sync 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 an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for OneTouch Verio Sync Blood Glucose Monitoring System

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against the requirements of ISO 15197:2003(E) for system accuracy. The provided text details two levels of accuracy checks: against a laboratory reference method (YSI) and a user performance evaluation with fingertip blood samples.

System Accuracy (Against Laboratory Reference - YSI)

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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

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