> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Clears Covid Antigen Home Test
- URL: https://www.fdaweb.com/fda-clears-covid-antigen-home-test/
- Published: 2023-11-09T12:00:00.000Z
- Updated: 2026-09-14T14:15:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155759

FDA has cleared an ACON Laboratories 510(k) for its Flowflex Covid-19 Antigen Home Test, which was originally authorized for emergency use in 2021\. According to an FDA [news release](https://www.fda.gov/news-events/press-announcements/fda-clears-first-covid-19-home-antigen-test?ref=fdaweb.com), Flowflex is the second home Covid-19 test to successfully complete a traditional FDA premarket review pathway. Notably, it is also the first test indicated for use in children under 18.

Flowflex is designed for OTC home use by symptomatic individuals within six days of symptom onset, the agency says. It is cleared for individuals aged 14 years or older testing themselves, or adults testing individuals aged two years or older. A recent FDA-reviewed study found that the test correctly identified 89.8% of positive and 99.3% of negative samples in individuals with signs and symptoms of upper respiratory infection.