Medical Devices; Reclassification and Codification of Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices From Class III to Class II

The Food and Drug Administration (FDA) is reclassifying the fully automated short-term incubation cycle antimicrobial susceptibility device for use in determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens from class III to class II (special controls). The special control that will apply to this device is a guidance document entitled "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA." The agency is also announcing that it has issued an order in the form of a letter to BioMerieux Vitek, Inc., reclassifying the device. The agency is classifying this device into class II because special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device and there is sufficient information to establish special controls.