Magnolia Medical Receives FDA 510(k) Clearance for Expanded Steripath Gen2 Product Family
Magnolia Medical today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of new configurations and the entire Steripath® Gen2 Initial Specimen Diversion Device® product family. Extensive clinical data demonstrating the performance achieved with Steripath was evaluated by the FDA. This data included peer-reviewed controlled studies published in leading medical journals including Clinical Infectious Diseases1 (CID) and the Journal of Emergency Nursing2 (JEN) demonstrating significant reductions in blood culture contamination with Steripath compared to standard method controls.
At the University of Nebraska Medical Center (UNMC), Steripath demonstrated an 88% reduction in blood culture contamination down to 0.2% in the Emergency Department compared to standard method controls sustained for the one-year study period. This performance represented a 92% reduction compared to the pre-intervention period. Steripath performance across four Lee Health Emergency Departments over a 7-month study period spanning 41,685 blood cultures demonstrated an 83% reduction in blood culture contamination compared to standard method controls with both venipuncture and IV-start configurations of Steripath Gen2. These clinical results supported Steripath’s FDA-cleared indications for use to reduce the frequency of blood culture contamination when contaminants are present, compared to standard method controls without diversion. Additionally, components of the Steripath Gen2 system may be used for infusion following sample collection, consistent with the Instructions for Use.3 Steripath is the first and only cleared device indicated to reduce blood culture contamination.