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# FDA Clears Diazyme Sepsis Assay
- URL: https://www.fdaweb.com/fda-clears-diazyme-sepsis-assay/
- Published: 2017-04-25T12:00:00.000Z
- Updated: 2026-09-14T22:19:27.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138541

FDA has cleared a Diazyme Laboratories 510(k) for the Procalcitonin (PCT) assay. Procalcitonin, a propeptide synthesized in the C-cells of the thyroid, has been identified to be more clinically useful than currently used common clinical variables and laboratory tests in diagnosing sepsis, according to the company. “In healthy conditions, PCT levels in circulation are very low,” it says. “Rising PCT concentrations can be detected within two to six hours after infectious challenges and peak within six to 24 hours.” The test can be used to measure PCT levels in both serum and plasma samples.