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# Akonni Biosystems’ TruDiagnosis System Cleared
- URL: https://www.fdaweb.com/akonni-biosystems-trudiagnosis-system-cleared/
- Published: 2019-06-06T12:00:00.000Z
- Updated: 2026-09-15T01:31:12.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144273

FDA has cleared an Akonni Biosystems 510(k) for its TruDiagnosis System, a compact point-of-service molecular diagnostic device which includes the TruDx 2000 Imager and the TruArray consumable test kit. The saliva test is intended to identify genetic signatures associated with patient metabolization of the drug Coumadin, which assists doctors in adjusting a patient’s therapeutic dose.