Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
129 participants
INTERVENTIONAL
2023-11-10
2025-01-31
Brief Summary
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Detailed Description
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This study will together with a method comparison study performed with surrogate capillary samples contribute to the overall validation of the performance of ABL90 FLEX for capillary whole blood with regards to the parameters ctBil and FHbF measured using the capillary mode.
This study is anticipated to run for approximately 6-12 months from site initiation visit till close-out visit depending on patient enrollment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Investigational Device
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.
Method Comparison
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).
Predicate device
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.
Method Comparison
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).
Interventions
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Method Comparison
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).
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
28 Days
ALL
No
Sponsors
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Radiometer Medical ApS
INDUSTRY
Responsible Party
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Locations
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Albert Einstein College of Medicine
The Bronx, New York, United States
Duke University
Durham, North Carolina, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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DC-083186
Identifier Type: -
Identifier Source: org_study_id
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