Universal Biosensors, Inc. announced that it has submitted its 510K application to the US Food & Drug Administration (FDA) to have Xprecia Prime approved for sale in the USA. The centrepiece of the 510K application is the 360 patient study (com completed 23 January, 2023) conducted over 4 sites in the USA which is designed to provide clinical evidence as to the performance and safety of Xprecia Prime.