EUA-ACONlab-flowflexAg-Rev-2023-03-15

1. March 15, 2023 Qiyi Xie ACON Laboratories, Inc. 5850 Oberlin Drive, #340 San Diego, CA 92121 Re: EUA2 104 94 /S0 22 Trade/Device Name: Flow flex COVID - 19 Antigen Home Test Dated: February 6, 2023 Received: February 6, 2023 Dear Qiyi Xie : This is to notify you that your request to update the Flow flex COVID - 19 Antigen Home Test to extend the shelf - life expiration date to 2 4 months , when stored at 2 o C – 30 o C , based on the results of your completed stability studies , is granted . Upon review, we concur that the data and information submitted in EUA 2 104 94 /S0 22 support the requested update for the Flow flex COVID - 19 Antigen Home Test . By submitting this EUA revision for review by the Food and Drug Administration (FDA), you have complied with the Conditions of Authorization stated in the letter authorizing the emergency use of the Flow flex COVID - 19 Antigen Home Test re - issued on March 7, 2023 . Sincerely yours, ___ _________________________ Uwe Scherf, M.Sc., Ph.D. Director, Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health