AMDI Submits 510(k) and CLIA Waiver Dual Submission to FDA

Autonomous Medical Devices Incorporated (AMDI) announced its submission to the US Food and Drug Administration (FDA) of a dual 510(k) and CLIA Waiver application for the AMDI™ Fast PCR Mini Respiratory Panel and AMDI™ Fast PCR Instrument. The Fast PCR Mini Respiratory Panel is a multiplexed RT-PCR test for the simultaneous detection of Flu A, Flu B, RSV, and SARS-CoV-2 directly from an anterior nasal swab specimen with a sample to answer time of under 10 minutes. The clinical studies for the Fast PCR System were completed at nine clinical testing sites across the US during the 2024-25 flu season.

Exhibitor Data Sheet