Food and Drug Administration (FDA)

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The page below is a sample from the LabCE course Microbial Identification Using MALDI-TOF MS. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

Learn more about Microbial Identification Using MALDI-TOF MS (online CE course)
Food and Drug Administration (FDA)

In the United States, the instruments discussed fall under the purview of the FDA for regulatory clearance. Both the VITEK® MS and the Bruker Microflex Biotyper™ have been granted clearance for select microorganisms.
The VITEK® MS was granted 510(k) clearance in August of 2013 for 192 microorganisms, including yeast (Candida, Cryptococcus, Malassezia groups) and bacteria from the Staphylococcaceae, Streptococcaceae, Enterobacteriaceae, Pseudomonadineae, and Bacteroidaceae families.
The Bruker Biotyper™ system was approved in November 2013 with a claim for identification of 40 gram-negative species or species groups. FDA clearance in April of 2015 heralded an additional 170 species and species groups, representing 180 clinically-relevant species of aerobic gram-positives, fastidious gram-negatives, Enterobacteriaceae, anaerobic bacteria, and yeasts. Both systems have expanded their databases since inception and interested readers are encouraged to consult the respective websites: