FDA Approves First OTC COVID-19 Home Antigen Test

ACON Laboratories’ Flowflex approved for home use.

COVID-19 Virus Microscopy Image
COVID-19 Virus

On November 9, 2923, the U.S. Food and Drug Administration FDA approved ACON Laboratories’ Flowflex COVID-19 Antigen Home Test as the first over-the-counter (OTC) antigen test for home use.The Flowflex COVID-19 Antigen Home Test is a visually-read test. It is cleared for individuals aged 14 years or older or for adults testing individuals aged two years or older.

San-Diego based ACON Laboratories is a manufacturer of multiple point-of-care medical diagnostics including it’s On Call Diabetes, Kidney Disease, and Personal Care Tests.

It’s Flowflex COVID-19 Antigen Home Test is a visually read device. As a medical device which the FDA approved through it’s 510(k) premarket review pathway used for medical device. A 510(k) is a premarket submission made to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.