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Arlington Scientific Receives FDA Diagnostic Clearance for the ASI Evolution® Automated RPR Syphilis Analyzer

510(k) K173376

June 14, 2018 – Press Release

SPRINGVILLE, UTAH - Arlington Scientific, Inc. (ASI) announced today that it has received clearance from the US Food and Drug Administration (FDA) 510(k) for its ASI Evolution®—the only FDA cleared fully automated nontreponemal syphilis system for diagnostic testing and blood donor screening.

The release of the ASI Evolution, a low-cost analyzer for automating syphilis testing will increase efficiency, output and effectively reduce man hours in the lab. This instrument interprets the results of 190 samples per hour, while delivering consistent, dependable and objective results. A study found that the ASI Evolution reduced hands-on time by 92%, compared to a manual RPR test. With intuitive software, a single operator can run multiple analyzers simultaneously freeing up time for other laboratory tasks.

“We have always been focused on enhancing the quality and speed of diagnosing infectious diseases,” said Ben Card, President/CEO of Arlington Scientific.  “In 2010 we created the technology for a semi-automated analyzer designed for the objective interpretation of ASI’s RPR card test. We further developed a fully automated nontreponemal analyzer, taking the knowledge learned and applying it to an automated platform.”

The ASI Evolution allows laboratories to use the CDC recommended traditional nontreponemal screening algorithm with a fully automated assay, removing the need for a high-cost and complicated reverse algorithm. Screening with a treponemal test was previously only introduced because nontreponemal testing was not yet automated. Treponemal screening costs more, creates extra steps and complicates the testing process.

“The industry has needed a fully automated nontreponemal analyzer to efficiently use the traditional screening algorithm. The ASI Evolution delivers this standardization to the interpretation of syphilis testing, by removing the subjective visual reading and manual steps of RPR card tests.” (David Binks, COO of Arlington Scientific)

About

For over 30 years Arlington Scientific, Inc has been a leading global medical technology company that develops, manufactures and sells in-vitro diagnostics, medical devices, diagnostic analyzers and blood donor lounges. As the “Syphilis Authority”, manufacturing tens of millions of syphilis tests annually, ASI has an expertise in manufacturing diagnostic reagents for syphilis and innovative analyzers.

 

For additional information:

Arlington Scientific, Inc.

Mike LaDow, Director of Sales

800-654-0146

mladow@arlingtonscientific.com

www.arlingtonscientific.com

 

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Rev. 06_2018

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