The Fast PCR Mini Respiratory Panel simultaneously detects Flu A, Flu B, RSV, and SARS-CoV-2 from nasal swab specimens.
Autonomous Medical Devices Incorporated (AMDI) has submitted to the US Food and Drug Administration a dual 510(k) and CLIA Waiver application for its Fast PCR Mini Respiratory Panel and Fast PCR Instrument.
The Fast PCR Mini Respiratory Panel is a multiplexed RT-PCR test that simultaneously detects flu A, flu B, RSV, and SARS-CoV-2 directly from anterior nasal swab specimens with a sample-to-answer time of under 10 minutes. 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,” says David Okrongly, CEO of AMDI, in a release. “The Fast PCR System and its proprietary technologies offer the ability to change clinical workflows wherever and whenever prompt access to test results is crucial for patient care.”
Regulatory Timeline and Market Plans
Based on historical FDA review times, AMDI anticipates US market clearance in late 2025 or early 2026. The company plans to file for registration in select markets outside the US in 2026.
“The regulatory submissions for the Fast PCR System required strong collaboration between AMDI and our numerous clinical and development partners,” says Aiying Sun, EVP of quality, regulatory, and clinical affairs, in a release. “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.”
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