NCT02794038

Accuracy & Usability Study for Soberlink Cellular Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Soberlink Healthcare LLC · Industry
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Accepted

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.

Detailed 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 This accuracy and usability study will be performed on Soberlink Cellular Device in order to comply with FDA's Draft Guidance for Industry and Food and Drug Administration Staff, titled: Applying Human Factors and Usability Engineering to Optimize Medical Device Design, IEC 60601-1-6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).

Conditions

• Substance Abuse

Interventions

Type	Name	Description
DEVICE	Soberlink Cellular Device	BAC breath analyzer
DEVICE	BACtrack S80 Pro	BAC breath analyzer

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-06-08
• Last updated: 2016-06-10