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

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.

NCT Number	NCT07307352
Lead Sponsor	Radiometer Medical ApS
Conditions	Diagnostic Tests
Enrollment	39 participants
Start Date	2026-01-20
Primary Completion	2026-01-30 (estimated)
Study Completion	2026-01-30 (estimated)
Updated on ClinicalTrials.gov	2026-03-04