The AMDI 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 in under 10 minutes.

RT’s Three Key Takeaways:

  1. Rapid Respiratory Testing — AMDI submitted its Fast PCR Mini Respiratory Panel and Instrument to the FDA, offering under-10-minute molecular detection of Flu A, Flu B, RSV, and SARS-CoV-2 from a nasal swab.
  2. Transforming Care Workflows — The system is designed to deliver lab-quality results during urgent healthcare visits, streamlining decision-making and improving patient care.
  3. Regulatory Pathway — Pending FDA review, AMDI anticipates US clearance by late 2025 or early 2026, with international registrations to follow.


Autonomous Medical Devices Inc (AMDI) announced its submission to the US 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.

“The Fast PCR System was designed to deliver lab quality molecular testing results during the time of an urgent healthcare visit,” said David Okrongly, CEO of AMDI. “The Fast PCR System and its proprietary technologies offer the ability to transform clinical workflows wherever and whenever prompt access to test results is crucial for patient care.”

“The regulatory submissions for the Fast PCR System required strong collaboration between AMDI and our numerous clinical and development partners,” said Aiying Sun, EVP of Quality, Regulatory & Clinical Affairs. “Today’s filing demonstrates the company’s ability to develop novel automated diagnostic systems and execute IVD clinical studies from a strong foundation of competence and compliance.”

Based on historical FDA review times, AMDI anticipates US market clearance in late 2025 or early 2026 and will file for registration in select markets outside the US in 2026.