ABL90 FLEX PLUS Method Comparison Neonatal Capillary

NCT07051278 | Completed FDA Device

• 1 other identifier: DC-083186
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Method Comparison for ABL90 FLEX PLUS in Neonatal Subjects

Keywords

Blood Gas; Method Comparison; Capillary; Neonates

Outcome Measures

Primary Outcomes (1)

• Primary Endpoints

  Bias between device under investigation and comparative device at medical decision level across sites; (unit is mg/dL)

  12 months

Secondary Outcomes (1)

• Secondary Endpoints

  12 months

Study Arms (2)

Investigational Device

ACTIVE COMPARATOR

The Investigational Device in this clinical study is the ABL90 FLEX PLUS running SW3.5 MR2 manufactured by Radiometer Medical ApS. The analyzer provides results for 17 parameters in 35 seconds using 65 μL heparinized whole blood. However, in this investigation only the data concerning the parameters ctBil and FHbF will be evaluated.

Device: Method Comparison

Predicate device

SHAM COMPARATOR

The predicate device for this study is the unmodified device ABL90 FLEX PLUS (k160153) running software SW 3.1 MR7 including sensor casettes and solution packs versions corresponding to 2016. ABL90 FLEX PLUS SW 3.1 MR7, has been selected as the predicate device because it has the appropriate 510(k) clearance, and the intended use matches the ABL90 FLEX PLUS SW. SW3.5 MR2 device.

Device: Method Comparison

Interventions

Method Comparison DEVICE

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).

Investigational Device; Predicate device

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Informed consent collected from legal representative able to understand information given and willing and able to voluntary give their consent to participate in this study.
• The age of the subject must be ≤28 days.
• Subject evaluated as suitable according to the protocol to enrol in the study by 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, who has an invalid written informed consent or has withdrawn consent.
• Subject who has already provided successful results from capillary samples, to cover both parameters.
• Subjects exposed to the substances listed in Appendix 1 with last dose within 72 hours, should be excluded due to risk of interference.

Sponsors & Collaborators

• Radiometer Medical ApS: lead

Study Sites (3)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: July 4, 2025
• Study Start: November 10, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-06

Locations

US (3)