Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05747274
Status:
COMPLETED
Last Update Posted:
2023-11-09
First Post:
2023-02-17
Brief Title:
SRDK0921_ Analytical Performance Study
Sponsor:
BioMAdvanced Diagnostics
Organization:
BioMAdvanced Diagnostics
Study Overview
Official Title:
Retrospective Study to Validate the Analytical Performance of an In Vitro Diagnostic IVD Medical Device in Patients With Kidney Transplant
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SRDK0921_APS
Brief Summary:
Analytical Performance Study of the SRDK0921 IVD medical device Kit and Software
Detailed Description:
It is a retrospective observational non-randomised study using clinical data and samples from DIVAT biocollection
The aim of this study is to validate the analytical performance of the SRDK0921 In Vitro Diagnostic Medical Device IVD
The SRDK0921 system kit and software is intended
to calculate a score of subclinical rejection in kidney transplant patients
as an aid in diagnosis of subclinical rejections absence in kidney transplant recipients in conjunction with other clinical information
The aim of this study is to validate the analytical performance of the SRDK0921 In Vitro Diagnostic Medical Device IVD
The SRDK0921 system kit and software is intended
to calculate a score of subclinical rejection in kidney transplant patients
as an aid in diagnosis of subclinical rejections absence in kidney transplant recipients in conjunction with other clinical information
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None