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# Roche 510(k) for Syphilis Assay
- URL: https://www.fdaweb.com/roche-510-k-for-syphilis-assay/
- Published: 2016-05-18T12:00:00.000Z
- Updated: 2026-09-14T21:03:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135708

Roche has filed a 510 (k) for a fully automated assay for detecting antibodies to *Treponema pallidium* for use on all Roche immunoassay systems for low-, mid- and high-volume testing systems, including the cobas e 411, cobas e 601, cobas e 602 and Modular *Analytics* E170 analyzers. The assay is intended as an aid in diagnosing syphilis infection, and a positive treponemal antibody test result indicates prior exposure to syphilis, according to the company. The test provides results within 18 minutes.