An interventional study of Soberlink Cellular Device and BACtrack S80 Pro in Substance Abuse, sponsored by Soberlink Healthcare LLC. Completed. Open to participants aged 21 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-10.
Sponsored by Soberlink Healthcare LLC · Not applicable and Interventional
This study scope is to validate the accuracy and usability of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro.
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 This accuracy and usability study will be performed on Soberlink Cellular Device in order to comply with FDA's Draft Guidance for Industry and Food and Drug Administration Staff, titled: Applying Human Factors and Usability Engineering to Optimize Medical Device Design, IEC 60601-1-6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).
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 43 is below the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Soberlink Healthcare LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
BAC reading with Soberlink Cellular Device
Device: BACtrack S80 Pro
BAC reading with BACtrack S80 Pro
Device: Soberlink Cellular Device
BAC breath analyzer
BAC breath analyzer
Validate the accuracy of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro and assessed by linear regression.
Performance validation will occur by evaluating the accuracy of the Soberlink Cellular device in the hand of intended users - untrained study participants who have consumed alcohol and use the device to measure their blood alcohol content (BAC). 40 adults will be recruited who have recently consumed alcohol. The only assistance to be provided is the labeling. No additional coaching, either written or verbal, will be provided to study participants. Participants should obtain a BAC reading with the Soberlink Cellular device, and a second BAC reading with a comparator device. The second measurement will be taken within 5 minutes of the first. A linear regression line for the comparison between results of the Soberlink Cellular device and a comparator will be made.
Time frame: Day 1
Validate the usability of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro and assessed by Questionnaire.
Performance validation will occur by evaluating the usability of the Soberlink Cellular device in the hand of intended users - untrained study participants who have consumed alcohol and used the device to measure their blood alcohol content (BAC). 40 adults who have recently consumed alcohol will be asked to evaluate the Soberlink Cellular device. The only assistance provided is the labeling. No additional coaching, either written or verbal, will be provided to study participants. Participants should obtain a BAC reading with the Soberlink Cellular device, and a second BAC reading with a comparator device. The second measurement should be taken within 5 minutes of the first. Following the second measurement a questionnaire will be administered to study participants to evaluate the ease of use of the Soberlink Cellular device.
Time frame: Day 1
No study locations are listed for this record.
Plan to share: Yes — Participant will be aware of their own BAC result as the result is displayed on the LED screen of the device
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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