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January 10, 2022

FDA grants 510(k) clearance for BD’s Kiestra IdentifA system

BD Kiestra IdentifA can reduce human error while preparing samples as well as produce more accurate diagnoses.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Becton, Dickinson and Company’s (BD) Kiestra IdentifA system.

The BD Kiestra IdentifA automates the preparation of microbiology bacterial identification testing.

Using the new system, a laboratory technician can employ the BD Synapsys informatics for selecting discrete bacterial colonies from a digital plate image.

The selected organisms are then physically collected by robotics to prepare samples for further specific identification testing.

The company stated that the Kiestra IdentifA system has the potential to reduce human error while preparing samples as well as produce more accurate diagnoses.

BD integrated diagnostic solutions US region vice-president and general manager Greg Miziolek said: “The BD Kiestra IdentifA system transforms the manual workflow into one that is standardised, automated and digitised.

“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.

“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.”

According to the company, BD Kiestra IdentifA is the only solution cleared by the FDA that is available for lab automation to support sample preparation workflows for routine and challenging isolate types.

BD’s Synapsys Informatics solution combined with the Kiestra IdentifA system and matrix-assisted laser desorption/ionisation-time of flight (MALDI-ToF) mass spectrometry can help identify bacteria as well as yeasts rapidly and accurately.

Last month, BD acquired Tissuemed, adding advanced surgical sealant solutions to its portfolio.

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