BD Receives FDA 510(k) Clearance for Rapid Point-of-Care COVID-19 Test
核心洞察
BD (搜索) has received FDA 510(k) clearance for the BD Veritor™ System for SARS-CoV-2 (搜索), a digital test that detects COVID-19 (搜索) antigens in symptomatic individuals within 15 minutes.
The new clearance will replace the current Emergency Use Authorization version of the test, which has been available since September 2020, starting in early fall 2025.
The test is designed for use in CLIA-waived environments including doctors' offices, urgent care centers, and retail clinics, providing objective digital results from nasal swab specimens.
BD (搜索) (Becton, Dickinson and Company), a leading global medical technology company, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Veritor™ System for SARS-CoV-2 (搜索), a digital test designed to detect COVID-19 (搜索) antigens in symptomatic individuals in about 15 minutes at doctors' offices, urgent care centers, retail clinics and other convenient points of care.
The BD Veritor™ System for SARS-CoV-2 (搜索) 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.
Regulatory Milestone and Clinical Impact
"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 (搜索) Diagnostic Solutions. "The BD Veritor™ System for SARS-CoV-2 (搜索) has proven to be a reliable COVID-19 (搜索) test with a streamlined workflow and clear digital results, helping clinicians make confident and timely decisions that can help improve patient outcomes."
Technical Specifications and Design
The BD Veritor™ System for SARS-CoV-2 (搜索) is a chromatographic, digital lateral flow immunoassay that delivers objective, easy-to-read results using the BD (搜索) 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.
The system's digital format eliminates subjective interpretation of results, providing healthcare providers with clear, objective data to support clinical decision-making. The 15-minute turnaround time enables rapid diagnosis and treatment decisions in point-of-care settings.
Market Access and Support
BD (搜索) has established customer support infrastructure for the test, with customers able to contact BD Customer Service at 800-638-8663 for information or support. The company's extensive presence in virtually every country positions it to address global health challenges through close collaboration with healthcare organizations worldwide.