Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543771
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-19
Brief Title:
Clinical Performance Study of Safety Test ABO Device
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Performance Study of Safety Test ABO Device
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 Safety Test ABO with the ABTest Card device
Detailed Description:
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 2 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
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 Safety Test ABO and ABTest Card are already CE marked under Directive 9879EC as List IIA product this study is part of the devices post-marketing performance monitoring
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 Safety Test ABO and ABTest Card are already CE marked under Directive 9879EC as List IIA product this study is part of the devices post-marketing performance monitoring
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