NCT07051278

ABL90 FLEX PLUS Method Comparison Neonatal Capillary

ABL90 FLEX PLUS Method Comparison Study for ctBil and FHbF in Neonatal Capillary Whole Blood

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Radiometer Medical ApS · Industry
• Sex: All
• Age: 28 Days
• Healthy volunteers: Not accepted

Summary

The study is intended to validate performance claims for method comparison for ABL90 FLEX PLUS in heparinized neonatal capillary whole blood for ctBil and FHbF in a POC setting

Detailed description

The objective is to perform a method comparison study to quantify the relationship using comparison measurement from the same sample between ABL90 FLEX PLUS and the predicate device within the reportable range for ctBil and FHbF in heparinized capillary whole blood samples in capillary measuring mode (C65). This study will together with a method comparison study performed with surrogate capillary samples contribute to the overall validation of the performance of ABL90 FLEX for capillary whole blood with regards to the parameters ctBil and FHbF measured using the capillary mode. This study is anticipated to run for approximately 6-12 months from site initiation visit till close-out visit depending on patient enrollment.

Conditions

• Method Comparison for ABL90 FLEX PLUS in Neonatal Subjects

Interventions

Type	Name	Description
DEVICE	Method Comparison	Quantifying the relationship using comparison measurement from the same sample between ABL90 FLEX PLUS and the predicate device within the reportable range for ctBil and FHbF in heparinized capillary whole blood samples in capillary measuring mode (C65).

Timeline

• Start date: 2023-11-10
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2025-07-04
• Last updated: 2025-07-04

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study