BD Receives FDA 510(k) Clearance for Rapid Point-of-Care COVID-19 Test
BD (NYSE:BDX) has received FDA 510(k) clearance for its BD Veritor™ System for SARS-CoV-2, a rapid COVID-19 antigen test.
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Rhea-AI Summary
BD (NYSE:BDX) has received FDA 510(k) clearance for its BD Veritor™ System for SARS-CoV-2, a rapid COVID-19 antigen test. The digital test delivers results in approximately 15 minutes at various point-of-care locations including doctors' offices, urgent care centers, and retail clinics.
The test, previously available under Emergency Use Authorization since September 2020, will transition to the new FDA-cleared version in early fall 2025. The BD Veritor™ System uses chromatographic digital lateral flow immunoassay technology to provide objective results from nasal swab specimens taken within six days of symptom onset, and is designed for use in CLIA-waived environments.
Positive
- FDA 510(k) clearance represents a higher regulatory standard than the previous Emergency Use Authorization
- Rapid 15-minute result time enables quick clinical decision-making
- Wide accessibility through various point-of-care locations
- Digital results system reduces human interpretation errors
Negative
- Limited to testing symptomatic patients within 6 days of symptom onset
- Requires specific analyzer hardware (BD Veritor™ Plus Analyzer) to process results
Details
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New CLIA-Waived Test Delivers Digital Results to Support Timely Clinical Decision-Making
The BD Veritor™ System for SARS-CoV-2 has been available under Emergency Use Authorization (EUA) from the FDA since September 2020. The new 510(k) clearance will eventually replace the current EUA version of the test, starting in early fall 2025.
"This FDA clearance is part of our ongoing commitment to support health care providers with reliable, rapid diagnostic tools," said Nikos Pavlidis, worldwide president of BD Diagnostic Solutions. "The BD Veritor™ System for SARS-CoV-2 has proven to be a reliable COVID-19 test with a streamlined workflow and clear digital results, helping clinicians make confident and timely decisions that can help improve patient outcomes."
The BD Veritor™ System for SARS-CoV-2 is a chromatographic, digital lateral flow immunoassay that delivers objective, easy-to-read results using the BD Veritor™ Plus Analyzer. The test is intended for use in CLIA-waived environments and provides results from nasal swab specimens from patients within six days of symptom onset.
For more information or support, customers can contact BD Customer Service at 800-638-8663.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/, X (formerly Twitter) @BDandCo or Instagram @becton_dickinson
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SOURCE BD (Becton, Dickinson and Company)
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