NEW YORK — Magnolia Medical Technologies said on Thursday that it has received clearance from US regulators for its expanded Steripath Gen2 Initial Specimen Diversion Device line of blood contamination reduction products.
The Steripath Gen 2 ISDD is designed to divert and isolate a small volume of the initial blood collected for culture, which is the portion most likely to contain contaminants. According to Seattle-based Magnolia, the device has demonstrated as much as an 88 percent reduction in blood culture contamination compared to standard method controls in clinical testing.
Based on these and other data, the US Food and Drug Administration has granted 510(k) clearance to Steripath Gen 2 ISDD for use in reducing the frequency of blood culture contamination when contaminants are present and for infusion following sample collection, the company said.
In late 2019, Cardinal Health signed an agreement to distribute the Steripath device to hospitals. Magnolia is also currently involved in a patent infringement suit over the device with Kurin, which markets a rival product called Kurin Lock.