Diagnostic device

The phrase 'alone or in the context of other information' means that a device providing one input among several is still a diagnostic device. The term covers imaging, IVDs and software, and it shapes how FDA expects the clinical study to be designed.

A device that provides results that are intended to be used alone or in the context of other information to help assess a subject’s target condition.

FDA guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices (November 2013), Section 11, Glossary