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# FDA Clears Quidel’s Solana Bordetella Assay
- URL: https://www.fdaweb.com/fda-clears-quidels-solana-bordetella-assay/
- Published: 2018-07-16T12:00:00.000Z
- Updated: 2026-09-15T00:19:34.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141872

FDA has cleared a Quidel Corp. 510(k) for the Solana Bordetella Complete Assay, a molecular diagnostic assay to be used with the Solana molecular diagnostic instrument for the qualitative detection and differentiation of *Bordetella pertussis* and *Bordetella parapertussis* nucleic acids isolated from nasopharyngeal swab specimens obtained from patients suspected of having a respiratory tract infection. The test uses the company’s Helicase-Dependent Amplification (HDA) technology to generate a fast and accurate test result. It targets the IS481 and IS1001 sequence of the *Bordetella pertussis* and *Bordetella pertussis* genomes, according to the company. The instrument can process up to 12 patient samples in each batched run.