AMDI™ Fast PCR System Receives FDA 510(k) Clearance and CLIA Waiver for Sub-10-Minute Respiratory Panel

The AMDI™ Mini Respiratory Panel delivers RT-PCR results in under 10 minutes, enabling clinical action in the Time of Care™

SANTA ANA, Calif., June 16, 2026 /PRNewswire/ -- 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.

About the AMDI Fast PCR System
The AMDI Fast PCR System is designed and manufactured in California to expand access to molecular diagnostics across decentralized care settings. The system is designed for urgent care, primary care, and retail clinics, delivering lab-quality molecular results in the Time of Care. Built on AMDI's proprietary HBH technology and an ultrafast PCR consumable architecture with scalability up to 32-plex, the platform supports future menu expansion. Cloud connectivity, enterprise-wide operational visibility, and broad EHR integration further support scalable deployment across distributed provider networks.

About Autonomous Medical Devices Incorporated (AMDI)
Autonomous Medical Devices Incorporated (AMDI) is a California-based diagnostics company developing next-generation point-of-care testing platforms for decentralized healthcare settings. Operating from its ISO 13485-certified, 110,000-square-foot facility in Santa Ana, California, AMDI combines in-house development and manufacturing capabilities with a focus on building differentiated, accessible technologies for the future of diagnostic care.

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Brian Miller

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SOURCE Autonomous Medical Devices Incorporated