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

NCT07307352 | Completed FDA Device

• 1 other identifier: 25010
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diagnostic Tests

Keywords

ABL90

Outcome Measures

Primary Outcomes (1)

• Within sample precision for each parameter measured in capillary mode pooled across sites.

  Within sample precision of each parameter (pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb) using replicate measurements from heparinized whole blood samples measured by intended users in a POC setting.

  1 hour

Secondary Outcomes (1)

• Within sample precision for each parameter measured in capillary mode per site, if applicable (at least 15 degrees of freedom shall be obtained for the estimate to be statistically meaningful).

  1 hour

Interventions

ABL90 FLEX PLUS analyser running SW3.5 MR2. DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients (≥18 years old ) admitted to the hospital with low (moderate hypo), normal, or elevated (moderate hyper) concentrations of the 15 parameters covering the reportable range as much as possible.

You may qualify if:

• The subject must be 18 years or older.
• Subjects must be able to understand given information and demonstrate willingness and ability to voluntarily give a signed, valid written informed consent to participate in the study.
• Subject evaluated as suitable according to the protocol to enroll in the study by the principal investigator or designee

You may not qualify if:

• Subject where sample collection is evaluated by principal investigator or designee to impose an unnecessary risk.
• Subject, with known pregnancy or breastfeeding.
• Subject, who has an invalid written informed consent or has withdrawn consent.
• Subjects who have been previously enrolled in the study.
• Subjects exposed to following substances within the last 72 hours:
• Acetylsalicylic Acid Sodium Salt at dose equal or above 1 gram/day
• N-acetylcysteine o Fluorescein dye o Patent Blue dye -

Sponsors & Collaborators

• Radiometer Medical ApS: lead

Study Sites (2)

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Sjællands Universitets Hospital Køge

Køge, 4600, Denmark

Location

Study Officials

• Klaus T Kristiansen, MD

  Hvidovre Hospital, ICU

  PRINCIPAL INVESTIGATOR

• Lars Peter k Andersen, MD

  Sjællands Universitetshospital Køge, Centre for Anaesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: January 20, 2026
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)