NEW YORK (360Dx) — Medical device firm Kurin announced on Wednesday that it has received 510(k) clearance from the US Food and Drug Administration for its Kurin Lock blood culture collection product with a peripheral IV infusion set.
The FDA-cleared Kurin Lock is designed to divert a small volume of an initial blood sample from the main collection container to prevent skin contamination and false positives. The new 510(k) clearance permits the use of the Kurin Lock with the firm's PIV18 peripheral IV configuration and extension set, which can be used for infusion.
"Our Kurin PIV18 product was developed at the request of our customers who, after using the single-use Kurin Lock for blood culture collection, wanted to expand their use to include draws from infusion lines," Kurin CEO Bob Rogers said in a statement.
San Diego-based Kurin is currently involved in a lawsuit with Magnolia Medical Technologies over claims allegedly made about its rival blood culture collection system called Steripath.