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Becton Dickinson Receives FDA 510(k) Clearance for Robotic Colony Picking and Sample Prep Kiestra Module

NEW YORK – Becton Dickinson announced on Friday it has received 510(k) clearance from the US Food and Drug Administration for the BD Kiestra IdentifA system, which automates the sample preparation component of microbiology bacterial identification.

Using the IdentifA, a technician can employ the BD Synapsys informatics to select bacterial colonies from a digital plate image.

"Sophisticated robotics then physically pick those selected organisms and prepare the sample for specific identification testing," BD said in a statement.

The firm noted that automating "cumbersome manual steps" may reduce the potential for human error when preparing samples for bacterial identification and thereby "produce more accurate diagnoses for patients." The process can then allow technicians to focus time and expertise on other tasks, BD also 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," noted Greg Miziolek, VP and general manager of the US region for BD integrated diagnostic solutions.

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