Molecular Designs Wins FDA 510(k) Clearance K262789 on November 13 for Its SimplicityDx Flu A, Flu B and RSV Panel
Birmingham, Alabama, United States. Molecular Designs said on November 13 that the U.S. Food and Drug Administration has granted 510(k) clearance, K262789, for its SimplicityDx Panel FluA/FluB/RSV, the company's first FDA-cleared assay.
The multiplex real-time RT-PCR test is designed to qualitatively detect and distinguish influenza A, influenza B and respiratory syncytial virus RNA from anterior nasal swabs collected from patients with signs and symptoms of respiratory infection. The panel includes an internal control and is intended to work with the company's Simplicity Dx Extraction products.
The company said the panel uses a breakaway format so laboratories can run only the number of tests needed, with minimal pipetting and support for batch processing, an approach it said may reduce reagent waste and inventory pressure when respiratory testing volumes fluctuate.
The clearance is limited to prescription use in CLIA-certified high-complexity laboratories. The release did not provide clinical performance tables, turnaround time, pricing or a commercial launch date.
Source: Molecular Designs
Published by GSM · USA (original Chinese edition)
Photo: 图：甲型流感病毒的透射电子显微镜图像。来源：美国疾病控制与预防中心／Erskine Palmer博士，公共领域，维基共享资源。 / Photo: Transmission electron micrograph of influenza A virus. Credit: CDC / Dr. Erskine Palmer, public domain, via Wikimedia Commons.
