Autonomous Medical Devices Incorporated (AMDI) today announced that the U.S. Food and Drug Administration has granted both 510(k) clearance and CLIA waiver for the AMDI Fast PCR Instrument and Mini Respiratory Panel, a multiplex RT-PCR test for the simultaneous detection and differentiation of Respiratory Syncytial Virus (RSV), Influenza A, Influenza B, and SARS-CoV-2 from anterior nasal swab specimens. The Fast PCR System delivers sample-to-answer RT-PCR results in under 10 minutes, helping providers act within the Time of Care™ during urgent care and physician office visits.
“This milestone reflects the coordinated work of teams across AMDI,” said Aiying Sun, EVP, Quality, Regulatory and Clinical Affairs at AMDI. “Pursuing the FDA’s dual 510(k) clearance and CLIA waiver pathway was a deliberate strategy to bring this innovation to market with the validation needed for clinical use in the urgent care setting. It shows that Fast PCR combines strong RT-PCR performance with the simplicity needed for confident molecular testing at the point of care.”
“AMDI has scaled manufacturing for both instruments and consumables to support broad deployment,” said Frank Gill, COO of AMDI. “We have the capacity, quality systems, and supply discipline required to support long-term adoption with confidence.”
“The AMDI Fast PCR System combines streamlined workflow with lab-quality molecular testing during the office visit, making it an ideal solution for urgent care and physician offices particularly those requiring RSV testing results,” said Brian Miller, EVP of Marketing at AMDI. “With results available while the patient is still present, providers can make timely diagnostic and treatment decisions with greater confidence while improving the patient experience. That is what Time of Care is all about.”
“At the clinical site level, ease of use matters just as much as performance,” said Christopher Price, MD, Clinical Investigator at ERA Health Research. “The AMDI Fast PCR fits naturally into the clinic workflow. Staff can run the test without adding complexity, and getting a molecular result during the visit helps us make decisions while the patient is still in front of us instead of chasing follow-up later.”
The AMDI Mini Respiratory Panel is a 4-plex molecular panel that detects key upper respiratory viruses, including RSV. RSV remains an important target because it can cause significant disease, particularly in infants, older adults, and patients with underlying risk factors. In point-of-care settings, rapid detection of RSV alongside other common respiratory pathogens can support more informed clinical decision-making during the visit.