Devices

FDA Clears Luminex ARIES Bordetella Assay

FDA has cleared a Luminex Corp. 510(k) for the ARIES Bordetella Assay for detecting and identifying of Bordetella pertussis and Bordetella parapertussis nucleic acid in nasopharyngeal swab specimens obtained from individuals suspected of having a respiratory tract infection attributable to either organism. The assay works on the company’s ARIES Systems, which “automates all aspects of testing, from sample preparation through analysis, providing answers in less than two hours with minimal hands-on time,” Luminex says.

The molecular diagnostic uses internal barcode scanning and other “advanced features” to minimize operator errors. “Independent modules support from one to six cassettes, allowing for both STAT and batch testing of IVD assays and laboratory developed tests (LDTs) with MultiCode Reagents when using a universal assay protocol,” the company says.

FDA Clears Luminex ARIES Bordetella Assay

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