NCT07307352

25010 - ABL90 FLEX PLUS - Precision Capillary Adult - Clinical Study Protocol

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 39 (actual)
• Sponsor: Radiometer Medical ApS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Conducting the ABL90 FLEX PLUS Clinical Precision Study for 15 Parameters in Adult Whole Blood is to validate performance claims for precision in heparinized whole blood for 15 parameters: pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb, and FHHb, while being influenced by testing environment that is representative of intended use environment, site variability, and operator variability in a point-of-care (POC) setting. The investigational device is the ABL90 FLEX PLUS incl. consumables, running SW3.5 MR2, manufactured by Radiometer Medical ApS The study is being conducted in Denmark and in total, a minimum of 30 subjects are to be enrolled to provide successful measurement values from 2 sites.

Detailed description

Adult Whole Blood is to validate performance claims for precision in heparinized whole blood for 15 parameters: pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb, and FHHb, while being influenced by testing environment that is representative of intended use environment, site variability, and operator variability in a point-of-care (POC) setting. Capillary blood collected into 2 capillary tubes from 2 distinct finger sticks will be measured on ABL90 FLEX PLUS in the Capillary mode (C65). The study is designed to collect approximately 30 pairs of samples combined across sites.

Conditions

• Diagnostic Tests

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ABL90 FLEX PLUS analyser running SW3.5 MR2.	The ABL90 FLEX PLUS analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, metabolites, and oximetry in whole blood - utilizing 3 measuring modes (syringe, short probe, and capillary mode) to measure samples from a syringe, test tube or a capillary tube. The analyzer provides results for 17 parameters in 35 seconds using 65 μL heparinized whole blood.

Timeline

• Start date: 2026-01-20
• Primary completion: 2026-01-30
• Completion: 2026-01-30
• First posted: 2025-12-29
• Last updated: 2026-03-04

Locations

2 sites across 1 country: Denmark

Regulatory

• FDA-regulated device study