Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06078943
Status:
RECRUITING
Last Update Posted:
2023-10-12
First Post:
2023-02-14
Brief Title:
ABL90 FP MC Neonatal Arterial Venous Capillary Blood
Sponsor:
Radiometer Medical ApS
Organization:
Radiometer Medical ApS
Study Overview
Official Title:
ABL90 Flex Plus Method Comparison Neonatal Arterial Venous Capillary Blood
Status:
RECRUITING
Status Verified Date:
2023-01
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:
None
Brief Summary:
The goal of this clinical trial is to validate performance claims for method comparison for ABL90 FLEX PLUS in heparinized neonatal arterial venous and capillary whole blood for ctBil and FHbF in a Point of Care POC setting
Detailed Description:
The main question it aims to answer is
To quantify the relationship using comparison measurement from the same sample between the test device and the predicate device within the reportable range for ctBil and FHbF in heparinized arterial and venous neonatal whole blood in syringe measuring mode S65 SP65 and heparinized mixed venousarterial whole blood samples in capillary measuring mode C65
To quantify the relationship using comparison measurement from the same sample between the test device and the predicate device within the reportable range for ctBil and FHbF in heparinized arterial and venous neonatal whole blood in syringe measuring mode S65 SP65 and heparinized mixed venousarterial whole blood samples in capillary measuring mode C65
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None