The test is available with a prescription, and is authorized for use at home with nasal swabs for those aged 14 and older whose doctor suspects they might be infected with COVID-19.
"While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home," FDA Commissioner Stephen Hahn said in a statement.
Designed to produce results in 30 minutes or less, the Lucira All-in-One has proven 100% efficacy with a rich enough sample, and a 94-98% positive-negative diagnosis accuracy with a limited sample.
The test is predicted to cost around $50, and generates results by swirling the test swab around in a vial included in the test.
Testing up until now has been done at a clinic, which can deter people due to the perceived risk of contracting the virus there, and even afterward the sample would have to be carefully handled, labeled, and tracked as it's sent to a lab for analysis.