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# FDA Clears Roche 510(k) for Syphilis Assay
- URL: https://www.fdaweb.com/fda-clears-roche-510-k-for-syphilis-assay/
- Published: 2016-09-26T12:00:00.000Z
- Updated: 2026-09-14T21:34:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136908

FDA has cleared a Roche 510(k) for the Roche Syphilis treponemal antibody test, a fully automated assay for detecting antibodies to *Treponema pallidium* for use on all Roche immunoassay systems for low-, mid- and high-volume testing environments (including the **cobas e** 411, **cobas e** 601, **cobas e** 602 and **Modular** *Analytics* E170 analyzers). The assay, which is intended as an aid in diagnosing syphilis infection, produces results in about 18 minutes.