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

SANTA ANA, Calif., Sept. 15, 2025 /PRNewswire/ -- Today, 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.

"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.

About AMDI 

Autonomous Medical Devices Incorporated (AMDI) is a California-based company employing a world class team of engineers, scientists, clinicians, manufacturing and quality/regulatory experts dedicated to the development and manufacture of best in class diagnostic devices using innovative technology, factory automation, and cloud connectivity. AMDI is headquartered in Santa Ana, CA where it manufactures the Fast PCR Mini Respiratory Panel in an ISO:13485 / MDSAP certified 110,000 square foot facility.

AMDI Media Contact:

Brian Miller

[email protected]

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SOURCE Autonomous Medical Devices Incorporated