NEW YORK – The US Food and Drug Administration said Thursday that it has granted Acon Laboratories 510(k) clearance for its Flowflex COVI-19 Antigen Home Test.
The test, which was originally authorized by FDA for emergency use in 2021, is the second at-home COVID-19 test to successfully go through traditional FDA premarket review, following FDA's authorization of Cue's COVID-19 Molecular Test in June.
It is the first cleared antigen home test for COVID-19 and the first indicated for use in children under 18.
The test in intended for home use by symptomatic individuals within six days of symptom onset and is cleared for use in people 14 or older when testing themselves, and two and older when an adult conducts the testing, the FDA said. It is meant to be used serially, with at least two tests conducted over three days with at least 48 hours between tests.
In a study reviewed by the FDA, the Acon test correctly identified 90 percent of positive and 99 percent of negative samples in symptomatic individuals.