NCT06078956

ABL90 Flex Plus Method Comparison Study_Adults

ABL90 FLEX PLUS Method Comparison Study for pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb in Whole Blood in Adult Population.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 754 (actual)
• Sponsor: Radiometer Medical ApS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to validate performance claims for method comparison for the ABL90 FLEX PLUS for pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb in heparinized whole blood 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 ABL90 FLEX PLUS and the predicate device within the reportable range for all 15 parameters in heparinized arterial and venous patient whole blood in syringe measuring mode (S65, SP65) and heparinized capillary whole blood samples in capillary measuring mode (C65).

Conditions

• Diagnostic Test

Interventions

Type	Name	Description
DEVICE	Measuring of analytes	Method Comparison Study for pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb in whole blood in adult population.

Timeline

• Start date: 2023-07-08
• Primary completion: 2024-12-01
• Completion: 2025-01-31
• First posted: 2023-10-12
• Last updated: 2025-06-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study