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Magnolia Medical Nabs 510(k) for Steripath Blood Collection Configurations

NEW YORK – Magnolia Medical Technologies said Tuesday that the firm had secured US Food and Drug Administration 510(k) clearance for 19 new configurations of its Steripath Micro blood culture collection instruments.

The instrument is used to reduce blood culture contamination during sample collection by diverting and sequestering the initial 0.5-1.0 mL of collected blood, which can improve the accuracy of tests for sepsis and other infections, the firm said. Magnolia Medical noted that it developed the Steripath Micro system with hospital-based clinicians to allow for fast, easy, effective diversion and test sample collection.

In October 2022, Becton Dickinson and Magnolia Medical inked a collaboration deal to co-sell and comarket Magnolia Medical's Steripath and Steripath Micro Initial Specimen Diversion Device instruments, which work with Becton Dickinson's BD Vacutainer specimen collection products. BD said at the time that Steripath provides the only all-in-one devices proven to meet the Clinical and Laboratory Standards Institute's 1 percent blood culture contamination goal and the US Centers for Disease Control and Prevention's guidelines on reducing blood culture contamination.

Magnolia Medical CEO Greg Bullington said in a statement on Tuesday that "The availability of these configurations will further accelerate our co-selling and comarketing activities with BD as all Steripath Micro needle configurations come standard with BD's best-in-class UltraTouch needle innovation."