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Sweden's Q-linea Gets 510(k) for Automated Sepsis Test System

The story has been updated to clarify the ASTar System consists of an instrument and kit, as well as what the US panel for the system comprises. 

NEW YORK – Uppsala, Sweden-based Q-linea announced Friday that it has obtained 510(k) clearance from the US Food and Drug Administration for its ASTar system.

The ASTar System consists of ASTar instrument and ASTar BC G- Kit for the analysis of Gram-negative bacteria directly from positive blood cultures.

The system and kit obtained the CE mark in 2021, and ASTar was designated a breakthrough device by the FDA in 2022.

"Feedback from hospitals that have had early access to ASTar has been very positive," Q-linea CEO Stuart Gander said in a statement. "We are excited to now be able to bring the system to labs across the US, which will make a real difference for patients with severe bloodstream infections," he added.

ASTar provides phenotypic antimicrobial susceptibility (AST) and minimum inhibitory concentration (MIC) results from positive blood cultures within 24 hours, according to the firm's website, at least one day faster than standard non-automated laboratory workflows.

The system uses a disc-based format, with more than 330 chambers available in each disc to contain antimicrobials. For the US, a single ASTar disc tests across a range of antimicrobials, antimicrobial dilutions, and pathogens. The disc design offers potential for additional antimicrobial expansion.

The ASTar system can analyze up to 12 samples simultaneously and offers random access, a user-friendly interface, and load-and-go operation requiring two minutes of hands-on time, according to Q-linea's website.

Q-linea and its collaborators previously developed a phenotypic pathogen ID method using padlock probes called ASTrID but opted to focus on AST after the rapid ID market began to emphasize molecular and MALDI methods, according to a financial report. 

The ASTar system can be combined with other systems or approaches for rapid pathogen identification, such as molecular techniques or MALDI-TOF mass spectrometry. In this way, the ASTar AST workflow can be started independently of the pathogen ID step, with the input of the ID information only required to create the final MIC results report, the firm said.