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# FDA Clears Quidel’s Solana C. difficile Assay
- URL: https://www.fdaweb.com/fda-clears-quidels-solana-c-difficile-assay/
- Published: 2017-05-12T12:00:00.000Z
- Updated: 2026-09-14T22:23:25.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138677

FDA has cleared a Quidel 510(k) to market its Solana *C. difficile* Assay for the direct, qualitative detection of the *Clostridium difficile* DNA in unformed stool specimens from patients suspected of having such an infection. Unlike traditional methods for diagnosing *C. difficile*, such as glutamate dehydrogenase or toxin antigen tests, that can lack sensitivity and increase lab costs due to additional confirmation testing, the Solana assay provides fast and sensitive results generated by molecular methods, without an upfront nucleic acid extraction step, according to the company. Results are generated in about 35 minutes.

  
The Solana molecular platform relies on the company’s Helicase-Dependent Amplification technology that is part of its AmpliVue molecular product line. It can process up to 12 different assays or patient samples in each batched run.