Kurin Receives 510k from the FDA with Indication to Reduce Blood Culture Contaminations
Kurin, Inc., the inventor and manufacturer of the Kurin® blood culture collection sets, announced today that the Food and Drug Administration has issued a 510(k) clearance for the Kurin product line. Kurin now has four 510(k) clearances from the FDA. The recent clearance says, in part, that Kurin reduces the frequency of blood culture contaminations*.
“We are pleased that the FDA has provided clearance to say that Kurin reduces blood culture contaminations” said Bob Rogers, CEO of Kurin, Inc. “Kurin is the market leader because our device is simple to use and requires a minimal amount of blood. Our submission to the FDA included data demonstrating dramatic decreases in contaminations while using Kurin. The new 510(k) highlights Kurin’s growing list of accomplishments and underscores why Kurin continues to be the #1 company addressing blood culture contaminations. This is yet further proof that the myth that blood must be isolated to achieve contamination reduction is simply wrong.”
Kurin’s revolutionary approach to the contaminated blood culture problem is an elegantly simple, intuitive design that requires no additional user steps. Kurin passively sidelines potential contaminants during blood culture collection. Kurin is a simply better and more sustainable approach over conventional mechanical diversion. Contaminated blood cultures are a significant problem, as roughly one-third of the positive results are wrong, exposing these patients to unnecessary antibiotics, extending hospital stays and impacting larger community health issues, such as antimicrobial resistance and life-threatening C. diff. infections.
About Kurin, Inc.
Kurin Inc., a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing, and sale of products that help healthcare providers reduce contaminated blood cultures. San Diego-based Kurin has received FDA 510(k) market clearance. For more information, visit the website at www.kurin.com.
*Kurin Lock allows the specimen of blood from the patient to be sidelined prior to the collection of the test sample to reduce the frequency of blood culture contamination when contaminates are present in the initial blood sample compared to blood cultures drawn using standard practice without the Kurin Lock.