Clinical Performance Study of the ABTest Card® Device.

The study aims to confirm the performance equivalence of the in vitro diagnostic device ABTest Card®REF with the ABTest Card®NEW device.

Following some changes in the ABTest Card® raw materials, a new validation of the associated clinical performances is required. Raw materials of the ABTest Card® are : Triton, Cleanis, Tween, Yellow, Blue dye and the blood segment opener device. According to the regulatory text "Common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council", 90% of the results will be derived from the performance study carried out at the DIAGAST laboratory on tube left over and blood bag, and 10% of the results will be derived from the use of the device in a real situation ("at the bedside"). The Regulation 2017/746 (IVDR) on IVDMD, has been effective since May 2022 with transitional periods. The IVDR replaces the current EU Directive (98/79/EC) to ensure a higher level of health and safety for the making available and putting into service of medical devices on the EU market. As the ABTest Card® is already CE marked under Directive 98/79/EC as List IIA product, this study is part of the device's post-marketing performance monitoring. The purpose of this study is to document and verify the clinical performance of the ABTest Card® device in combination with the new raw materials used for manufacturing (ABTest Card®NEW), by comparing the results obtained with the ABTest Card®REF, already commercialised and used routinely by the study sites.