Q-linea submits US market application to FDA
Q-linea submits US market application to FDA
Q-linea AB (publ) (OMX: QLINEA) today announces that the company has submitted a 510(k) application to the FDA to gain US market authorization.
“This is a major milestone for us and an important step towards the US market. The next step will be the review of our clinical study data by the FDA, and I hope that the breakthrough designation we received in April 2022 could enable a prioritized review. We are encouraged about the results in the study, and I am looking forward to our future launch of ASTar in the USA,” said Jonas Jarvius, CEO of Q-linea.
About ASTar Instrument and ASTar BC G-Kit
ASTar Instrument and ASTar BC G-Kit already deliver the broadest answer regarding the combination of the number of antibiotics and the number of double dilution steps of each antibiotic, in a single analysis for gram-negative bacteria. The test enables the analysis of gram-negative bacteria, including difficult-to-grow so-called fastidious bacteria, which satisfies the need for rapid and comprehensive results to support optimal treatment decisions.
ASTar Instrument and ASTar BC G- Kit are CE-marked but not FDA 510(k)-cleared and not available for sale in the United States.