The diagnostics company Gradientech today announces that its QuickMIC[®] diagnostic test for ultra-rapid antibiotic susceptibility testing (AST) of sepsis samples, has been officially certified under the European Union’s In Vitro Diagnostic Medical Device Regulation (IVDR) - the new stringent regulatory framework for diagnostic devices.
The IVDR is aimed at enhancing quality and ensuring safety by introducing more rigorous requirements for clinical performance, safety, and post-market surveillance, replacing the former European directive for In vitro diagnostic medical devices.
The IVDR certification, granted by leading Notified Body BSI, applies to Gradientech’s Class B QuickMIC® GN AST panel for Gram-negative bacteria, along with its entire diagnostic platform - including the QuickMIC instrument, analysis software, and sample preparation kit. The entire QuickMIC system is now CE marked in accordance with the new IVDR.
“The IVDR certification marks a significant commercial milestone and reinforces Gradientech’s position at the forefront of next-generation diagnostics that bring real value to sepsis patients through faster, more precise treatment decisions,” says Sara Thorslund, CEO and co-founder of Gradientech. “ It is of course a major validation of the robustness and quality behind every aspect of our technology, but it also unlocks broader access across European markets, opening up for additional market-specific antibiotic panels to be added to the QuickMIC system.”
QuickMIC® and its Gram-negative panel are CE marked and commercially available in Europe. QuickMIC is classified as a Breakthrough Device by the U.S. Food and Drug Administration and available for Investigational Use Only in the U.S., but not 510(k) cleared.
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