Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557031
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Clinical Performance Study of the ABTest Card Device
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Performance Study of the ABTest Card Device
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims to confirm the performance equivalence of the in vitro diagnostic device ABTest CardREF with the ABTest CardNEW device
Detailed Description:
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 2017746 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 2017746 IVDR on IVDMD has been effective since May 2022 with transitional periods The IVDR replaces the current EU Directive 9879EC 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 9879EC as List IIA product this study is part of the devices 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 CardNEW by comparing the results obtained with the ABTest CardREF already commercialised and used routinely by the study sites
According to the regulatory text Common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation EU 2017746 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 2017746 IVDR on IVDMD has been effective since May 2022 with transitional periods The IVDR replaces the current EU Directive 9879EC 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 9879EC as List IIA product this study is part of the devices 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 CardNEW by comparing the results obtained with the ABTest CardREF already commercialised and used routinely by the study sites
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None