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# Diasorin Liaison Plex Assay Cleared
- URL: https://www.fdaweb.com/diasorin-liaison-plex-assay-cleared/
- Published: 2024-06-06T12:00:00.000Z
- Updated: 2026-09-14T14:32:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157133

FDA has cleared a Diasorin 510(k) for its Liaison Plex Yeast Blood Culture Assay for microbiological diagnosis of bloodstream infections. The device detects 16 pathogens commonly associated with fungemia (fungal bloodstream infections). “Fungal pathogens are often seen as an emerging threat and are of great concern due to the ease with which they can spread between patients in healthcare settings,” the company says.

Liaison Plex is intended to provide increased lab flexibility by testing only the pathogens noted on its Gram stain, which reduces common over-testing that can occur when labs must use the same broad syndromic panels for all patients, according to the company. “For ease of use, the fully automated, sample-to-answer system relies on a streamlined workflow and room-temperature consumables,” it says. “The hands-on time to operate the system is just two minutes, and results are produced in less than two hours.”