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PrimeraDx obtains FDA 510(k) approval for ICEPlex system

PrimeraDx, a molecular diagnostics company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its ICEPlex C. difficile assay kit and the ICEPlex system.

The ICEPlex system is a multiplex real-time PCR system that is capable of amplifying and quantifying multiple nucleic acid species of different types in a single reaction, starting from fresh, frozen or formalin-fixed paraffin-embedded samples.

This makes it ideal for high-multiplex assays involving panels of such diverse analytes as mRNAs, microRNAs and genomic loci, and thus for the next generation of in vitro molecular diagnostics.

The ICEPlex C. difficile assay is a qualitative molecular diagnostic test for the detection of Clostridium difficile in human stool samples.

PrimeraDx regulatory affairs and quality assurance vice president Fayyaz Memon noted the clearance of ICEPlex C. difficile kit and the ICEPlex system by the FDA reflects the dedication of the entire team at the company to developing molecular diagnostic products that meet all clinical and regulatory requirements.

"We are delighted to add these 510(k) clearances to the CE Marks we secured last year," Memon added.

PrimeraDx’s ICEPlex system combines two established technologies – PCR and capillary electrophoresis – to deliver highly multiplexed, quantitative clinical solutions.