BD said on Wednesday that its BD Veritor System Flu A+B, a digital immunoassay for the rapid detection of influenza, meets the new Food and Drug Administration’s (FDA’s) performance requirements.
As BD said, the FDA has reclassified antigen based rapid influenza virus antigen detection systems (RIDTs) intended to detect influenza virus directly from clinical specimens from Class I devices into Class II devices subject to special controls.
With the new FDA requirements, rapid flu tests, which are used by health care providers and laboratory personnel, must now attain a higher level of performance.
“The change to the new performance standards may help improve the overall quality of testing for influenza,” said Dr. Charles Cooper, vice president of medical affairs at BD.