BD wins FDA clearance for microbiology bacterial identification testing automation platform

BD (NYSE:BDX) announced today that it received FDA 510(k) clearance for its Kiestra IdentifA system for testing automation.

Franklin Lakes, N.J.-based BD designed its Kiestra IdentifA system to automate sample preparation for microbiology bacterial identification testing, using BD Synapsys informatics to select discrete bacterial colonies from a digital plate image.

According to a news release, BD’s Kiestra automates typically cumbersome manual steps and reduces the potential for human error when preparing samples for bacterial identification, producing more accurate diagnoses for patients and streamlining processes to increase efficiency and time management.

BD promotes Kiestra IdentifA as the only FDA-cleared solution available as part of a track-connected system for lab automation to support specimen preparation workflows for routine and challenging isolate types.

“The BD Kiestra IdentifA system transforms the manual workflow into one that is standardized, automated and digitized,” Greg Miziolek, VP and GM of the U.S. region for BD Integrated Diagnostic Solutions, said in the release.

“Mass spectrometry methods, including MALDI-ToF technology, have innovated and advanced microbial identification in clinical microbiology but often require a significant number of process steps and hands-on-time.,” Miziolek said. “The BD Kiestra IdentifA system uses automated colony picking and MALDI-ToF spotting to reduce time to pathogen identification, which in turn can help improve patient management.”

Original Article: (https://www.massdevice.com/bd-wins-fda-clearance-for-microbiology-bacterial-identification-testing-automation-platform/)