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Kurin Nabs FDA 510(k) Clearance for Blood Culture Collection Set

NEW YORK – Kurin said Tuesday that the firm has secured US Food and Drug Administration 510(k) clearance for a blood culture collection kit intended to reduce blood culture contamination compared to blood drawn using standard practices.

An FDA document identifies the cleared instrument as the Kurin Blood Culture Collection Set with Kurin Lock Technology. The San Diego-based firm said its recently cleared instrument diverts a small amount of an initial blood sample to reduce the risk of contamination from skin and false-positive test results. It said the collection set sidelines potential contaminants during collection with a simple, intuitive design that improves on conventional mechanical diversion methods.

Kurin CEO Bob Rogers said in a statement, "Kurin is the market leader because our device is simple to use and requires a minimal amount of blood. Our submission to the FDA included data demonstrating dramatic decreases in contaminations while using Kurin."

The firm said contaminated blood cultures are a significant problem and erroneous positive results can expose patients to unnecessary antibiotic treatments and increase the risks of selection for antimicrobial resistance and life-threatening Clostridioides difficile infections.