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FDA clears ASI Evolution

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July 2018—Arlington Scientific announced it has received FDA 510(k) clearance for its ASI Evolution, a fully automated nontreponemal syphilis system for diagnostic testing and blood donor screening. The analyzer allows laboratories to use the CDC-recommended traditional nontreponemal screening algorithm with a fully automated assay and can process up to 190 samples per hour, reducing the amount of hands-on time as compared with a manual RPR test. The intuitive software enables one user to run up to four instruments at the same time.

“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, said in a press release.

Arlington Scientific, 801-489-8911