The US Food and Drug Administration (FDA) has granted 510(k) clearances to Qiagen's Rotor-Gene Q MDx and artus Infl A/B RG RT-PCR Kit, for in vitro diagnostic use (IVD).
The Rotor-Gene Q MDx instrument is an automated, real-time polymerase chain reaction (PCR) instrument based on real-time PCR technology.
The instrument uses a centrifugal rotary design to amplify and quantify DNA molecules, enabling a near-perfect well-to-well thermal and optical uniformity and a fast data acquisition rate.
The artus Infl A/B RG RT-PCR Kit is a multiplex real-time PCR IVD test which utilizes Rotor-Gene Q MDx instrument to qualitatively detect and identify Influenza A and B viral infections by using nasopharyngeal swab samples.
Qiagen chief executive officer Peer Schatz said the FDA clearances for the Rotor-Gene Q MDx along with the first assay for use on the system represent an important milestone for the company.
"The various Rotor-Gene Q models marketed by QIAGEN are not only an integral part of our revolutionary lab automation platform QIAsymphony RGQ, but are also among the most widely used stand-alone molecular detection platforms worldwide," Schatz added.
"The FDA clearances now pave the way to make this market-leading assay portfolio available to clinical laboratories in the U.S. as well."