QuickMIC Instrument Certified for Research Use
Gradientech is pleased to announce that the QuickMIC® instrument, which is part of the antibiotic susceptibility testing system in development by Gradientech, is now approved for research use after extensive testing by Intertek. The QuickMIC instrument fulfils the IEC, UL and FCC standards for electrical safety, basic safety and electromagnetic compatibility (EMC), which certifies the instrument to be used by external customers within the European countries and the US.
“The certification proves our QuickMIC instrument to be safe for use according to regulatory requirements. This is a receipt for Gradientech that we have been successful in our development work so far and that our focus on quality has paid off,” says Sara Thorslund, CEO at Gradientech.
The QuickMIC system for ultra-rapid antibiotic susceptibility testing can be used for diagnostic purposes once the current certification is complemented with proven clinical performance according to regulatory requirements. The clinical performance study of the QuickMIC system, in collaboration with European clinical microbiology labs, is planned for 2021. Gradientech is ISO13485 certified since 2017, which is a requirement for placing a medical device product for diagnostic use on the market.
For further information, please contact:
Sara Thorslund, PhD, CEO Gradientech
Tel: +46 736 29 35 80
sara.thorslund@gradientech.se
About Gradientech
Gradientech is a diagnostics company developing the in vitro diagnostic QuickMIC® system, a new platform for antibiotic susceptibility testing based on phenotypic bacterial growth analysis. The system is expected to become the most rapid solution for determining appropriate antibiotic treatment of sepsis patients. Rapid antibiotic susceptibility testing is vital for increasing sepsis patient survival, reducing healthcare costs and lowering the spread of antibiotic resistance. www.gradientech.se
