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Q-linea ASTar System receives US FDA 510(k) clearance

Q-linea

ASTar enables rapid therapeutic response to sepsis directly from a positive blood culture

9 May 2024
Will Thompson
Editorial Assistant

Product news

ASTar
ASTar from Q-Linea enables rapid therapeutic response to sepsis

Q-linea has announced that the US Food and Drug Administration (FDA) has granted 510(k) market clearance for the company’s ASTar® System, enabling market launch to hospitals and laboratories in the United States.

According to the Centers for Disease Control and Prevention, at least 1.7 million adults in the United States develop sepsis each year and nearly 270,000 die as a result. ASTar enables rapid therapeutic response to sepsis directly from a positive blood culture in approximately six hours, giving physicians the tool needed to improve patient outcomes and reduce mortality.

Stuart Gander, CEO of Q-linea, says, “The approval is a significant step for Q-linea in the infectious disease diagnostics field in the U.S. Feedback from hospitals that have had early access to ASTar has been very positive, and 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 blood stream infections. We are pleased with the panel of drug-bug combinations which has been approved.”

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ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Point-of-CarePoint-of-Care Testing (POCT) or Near Patient Testing (NPT) products are available for urine, blood and other clinical chemistry analyses. POCT includes: blood glucose testing, blood gas and electrolytes analysis, rapid coagulation testing (PT / INR), rapid cardiac markers diagnostics, drugs of abuse screening, urine strips testing, pregnancy testing, fecal occult blood analysis, food pathogens screening, hemoglobin diagnostics, infectious disease testing and cholesterol screening.FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices. SepsisSepsis is a life-threatening response to infection causing organ dysfunction. Research focuses on early detection, biomarkers, and therapies to reduce mortality. Explore tools for sepsis diagnostics and analysis in our peer-reviewed product directory, including detection kits and biomarkers.Infectious DiseasesInfectious diseases are caused by pathogens such as bacteria, viruses, and fungi. Effective detection, prevention, and treatment are crucial to control outbreaks and improve public health. Diagnostic tools, vaccines, and antimicrobial treatments are essential components of managing these diseases. Research into emerging pathogens and resistance patterns continues to evolve. Browse our peer-reviewed product directory to find the best diagnostic tools, prevention solutions, and treatment options; compare products, read customer reviews, and get pricing directly from manufacturers.

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Q-linea ASTar System receives US FDA 510(k) clearance