Accuracy & Usability Study for Soberlink Cellular Device

Status Completed

Clinical Trial Summary

This study scope is to validate the accuracy and usability of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro.

Clinical Trial Description

The purpose of this accuracy and usability study is to validate the performance of Soberlink Cellular Device in the hands of the intended (lay) users - untrained study participants who have consumed alcohol and use the Soberlink Cellular Device to measure their blood alcohol content (BAC) in comparison to a predicate device.

The purpose of this document is to define how the human factors environment impacts the actual user interface design as well as how usability engineering evaluates user interface via usability objectives and usability tests. This accuracy and usability study will be performed on Soberlink Cellular Device in order to comply with FDA's Draft Guidance for Industry and Food and Drug Administration Staff, titled: Applying Human Factors and Usability Engineering to Optimize Medical Device Design, IEC 60601-1-6 (collateral standard for usability engineering of medical electrical equipment), and IEC 62366 (application of usability engineering to medical devices). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02794038
Study type	Interventional
Source	Soberlink Healthcare LLC
Contact
Status	Completed
Phase	N/A
Start date	June 2016
Completion date	June 2016

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