NEW YORK (GenomeWeb) – Akonni Biosystems announced today it has submitted a molecular diagnostics system to the US Food and Drug Administration for 510(k) clearance. The system can perform multiplex testing using on-slide PCR and microarray technologies.
The system, called TruDiagnosis, consists of the TruDx imager, TruArray consumable test kit, and TruSpot software. The firm did not disclose whether a specific diagnostic assay was submitted along with the TruDiagnosis system.