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FDA Clears Automated Culture Screening, Interpretation System

NEW YORK (360Dx) – Clever Culture Systems announced that the US Food and Drug Administration has granted 510(k) clearance for its APAS Independence instrument and associated urine analysis module for culture-plate screening and interpretation.

The APAS Independence platform can process more than 200 culture plates at a time and automatically screen, interpret, and sort them in response to the growing demands of laboratories and the fast-growing automated pathology market, the firm said.

It noted that the APAS Independence walkaway system screens culture plates that show significant bacterial growth from those that do not.

The clearance, achieved ahead of schedule, paves the way for sales of the platform and associated urine analysis module, Clever Culture Systems General Manager Peter Bradley said in a statement.

With urine accounting for more than 50 percent of all types of specimens, a significant number of laboratories in the US has expressed interest in the product, and the firm expects to roll it out to targeted customers before the end of this year, he said.

Switzerland-based Clever Culture Systems, which is a joint venture of Australia's LBT Innovations and Germany's Hettich Holding Beteiligungs- und Verwaltungs, added that it plans to present information on the product at the American Society of Microbiology Microbe Meeting in San Francisco in June. Glen Hansen, a microbiologist at the Hennepin Healthcare System, Minneapolis, will present data there about the first US use of APAS Independence delivering artificial intelligence for clinical microbiology automation.