Biocartis Group said on Wednesday that on the day before, July 11, 2017 the US FDA published a final list of devices that it has exempted from 510(k) premarket notification requirements in accordance with the US 21st Century Cures Act (signed into US law 13 December 2016).
Biocartis noted that the product code applicable to the Biocartis Idylla(TM) Instrument and Idylla Console is included on this list. As a result, Biocartis’ Idylla Instrument and Idylla(TM) Console are no longer subject to 510(k) notification requirements prior to being placed on the US market for in vitro diagnostic use with FDA approved or cleared assays, Biocartis said. All other US 510(k) requirements, including current Good Manufacturing Practices (cGMP) and vigilance reporting, remain in effect. With this exemption in place, Biocartis is complying with the instructions in the publication and can now withdraw the pending 510(k) submission for the Idylla Instrument and Idylla Console.
Vishal Sikri, General Manager of Biocartis US, said: “The publication of this list by the US FDA will allow us to speed up the introduction of our fully automated Idylla platform in the US. This positive news is one more step towards our vision of bringing high value, rapid molecular diagnostic testing to hospitals in the US.”