Devices

Akonni Biosystems 510(k) for TruDiagnosis System

Akonni Biosystems has filed a 510(k) to market the TruDiagnosis system, its proprietary microarray-based technology. The company says the in vitro diagnostic device is intended for genotyping multiple genes in a DNA sample using on-slide polymerase chain reaction gel-drop microarray technology to help detect clinically relevant genotypes for pharmacogenomics, human chronic diseases, and genotypes for infectious diseases such as multidrug-resistant tuberculosis, upper respiratory infections, viral encephalitis, and hospital-acquired infections. It comprises the TruDx 2000 Imager, TruSpot Software, and the TruArray consumable test kit, according to Akonni. This is the first 510(k) for the company, which was founded in 2003 and says it has been issued 21 U.S. and 37 international patents primarily covering sample preparation, microfluidic devices, bioinstrumentation, and integrated systems.

Akonni Biosystems 510(k) for TruDiagnosis System

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