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

AMDI Submits a Dual 510(k) and CLIA Waiver Application

Autonomous Medical Devices Incorporated (AMDI) recently made headlines with its submission to the U.S. Food and Drug Administration (FDA) for a dual 510(k) and CLIA waiver application for its innovative products: the AMDI™ Fast PCR Mini Respiratory Panel and the AMDI™ Fast PCR Instrument. This submission promises to redefine rapid diagnostics in the medical field, particularly amid the growing need for timely testing in healthcare settings.

The Fast PCR Mini Respiratory Panel

The centerpiece of this submission is the Fast PCR Mini Respiratory Panel, an advanced multiplexed RT-PCR test capable of detecting several respiratory pathogens, including Flu A, Flu B, RSV (Respiratory Syncytial Virus), and SARS-CoV-2. What sets this product apart is its remarkable capability to provide results in under 10 minutes, using just an anterior nasal swab specimen. Such rapid response times can dramatically improve the clinical response during urgent healthcare visits, enabling healthcare providers to make informed decisions swiftly.

David Okrongly, CEO of AMDI, remarked, “The Fast PCR System was designed to deliver lab-quality molecular testing results during the time of an urgent healthcare visit.” This statement underscores the urgency and necessity of having swift diagnostic tools in the healthcare arsenal, particularly during peak seasons for respiratory illnesses.

Clinical Studies and Collaborative Success

The clinical studies validating the performance of the Fast PCR System were conducted at nine clinical testing sites across the United States during the 2024-2025 flu season. This extensive testing not only reinforces the reliability and effectiveness of the test but also highlights AMDI's commitment to rigorous scientific research and validation.

Aiying Sun, AMDI’s Executive Vice President of Quality, Regulatory and Clinical Affairs, emphasized the collaborative spirit required for this submission. “The regulatory submissions for the Fast PCR System required strong collaboration between AMDI and our numerous clinical and development partners,