The company's test allows users to swab themselves to collect a nasal sample. The sample is then swirled in a vial that plugs into a portable device that interprets the results and displays whether the person tested positive or negative for coronavirus.
To date, the agency has authorised nearly 300 tests for coronavirus. The vast majority require a nasal swab performed by a health professional and must be processed at laboratories using high-tech testing equipment.
A handful allow people to collect their own sample at home - a nasal swab or saliva - that's then shipped to a lab, which usually means waiting days for results.
Health experts have for months called for options to allow people to test themselves at home, reducing turnaround times and the potential spread of the virus to health care workers.
Lucira did not immediately respond to request for additional details.