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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
200
Pre transfusional control with the ABTest Card®REF device (predicate device) and the ABTest Card®NEW device (investigational device).
CHU Orléans
Orléans, France
Concordance obtained on patient blood type between ABTest Card®NEW and ABTest Card®REF results.
Comparison of the "patient" blood type determined from the results of the ABTest Card®NEW device (A, B, AB, O) with the "patient" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O). There is concordance if the two "patient" blood types are identical.
Time frame: 1 day.
Concordance obtained on blood bag blood type between the ABTest Card®NEW and ABTest Card®REF results.
Comparison of the "donor" blood type determined from the results of the ABTest Card®NEW device (A, B, AB, O) with the "donor" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O). There is concordance if the two "donor" blood types are identical.
Time frame: 1 day.
Concordance obtained between blood type information from medical record and patient results obtained by ABTest Card®REF.
Comparison of the "patient" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O) with the "patient" blood type in the medical record (A, B, AB, O). There is concordance if the two "patient" blood types are identical.
Time frame: 1 day.
Concordance obtained between blood bag labelling information and blood bag results obtained by ABTest Card®REF.
Comparison of the "donor" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O) with the "donor" blood type shown on the blood bag label (A, B, AB, O). There is concordance if the two "donor" blood types are identical.
Time frame: 1 day.
Blood compatibility between the blood bag and the patient for the ABTest Card®NEW.
Comparison of the "patient" blood type determined from the results of the ABTest Card®NEW device (A, B, AB, O) with the "donor" blood type determined from the results of the ABTest Card®NEW device (A, B, AB, O). There is blood compatibility if the two blood types follow specific associations.
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Time frame: 1 day.
Blood compatibility between the blood bag and the patient for the ABTest Card®REF.
Comparison of the "patient" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O) with the "donor" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O). There is blood compatibility if the two blood types follow specific associations.
Time frame: 1 day.