Rheonix Inc. Files 510(k) Seeking FDA Clearance of Triplex Sexually Transmitted Infection Assay

ITHACA, N.Y. — Rheonix, Inc. Rheonix filed its first 510(k) on November 4, seeking to gain FDA clearance of its Rheonix STI TriPlex™ Assay (a PCR-based assay for the simultaneous detection for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis) as well as the Rheonix Encompass MDx® Workstation, a fully automated “sample-to-answer” system capable of taking untreated clinical specimens and extracting, purifying and PCR amplifying DNA targets.  In addition the 510(k) filing seeks clearance of the Rheonix Urine Specimen Collection Kit and the Rheonix Swab Specimen Collection Kit, both used to collect, store and transport the specimens needed to perform the testing.

Rheonix ran a multicenter clinical study with collection and testing sites located throughout the United States.  The external clinical studies were overseen by Dr. Barbara (Bobbie) Van Der Pol, University of Alabama at Birmingham, an internationally recognized expert in STIs.