FDA allows marketing of VITEK MS

The FDA announced it will allow the marketing of a mass spectrometer system for the automated identification of 193 different pathogenic microorganisms known to cause serious infections, according to a press release.

The system works by using a laser to break the yeast and bacteria specimens down into small particles for improved identification. The test can begin within 18 to 24 hours of exposure to the yeast or bacterial growth, according to the press release.

“The ability for laboratories to use one device to identify almost 200 different microorganisms is a significant advance in the timely identification of pathogenic microorganisms,” Alberto Gutierrez, PhD, director of the office of in vitro diagnostics and radiologic health at the FDA’s Center for Devices and Radiological Health, said in the press release. “Rapid identification of harmful microorganisms can improve the care of critically ill patients.”

Alberto Gutierrez

The VITEK MS (bioMerieux, Inc.) can identify yeasts such as those from the Candida, Cryptococcus and Malassezia groups; bacteria from the Staphylococcaceae, Streptococcaceae, Enterobacteriaceae, Pseudomonadaceae and Bacteroidaceae families – all of which are associated with skin infections, pneumonia, meningitis and blood stream infections, according to the press release.

For more information:

FDA News Release. Accessed August 23, 2013.