ABL90 FLEX PLUS Method Comparison Neonatal Capillary
ABL90 FLEX PLUS Method Comparison Study for ctBil and FHbF in Neonatal Capillary Whole Blood
Study Overview
Status
Intervention / Treatment
Detailed Description
The objective is to perform a method comparison study to quantify 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).
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Bronx, New York, United States, 10461
- Albert Einstein College of Medicine
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke University
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Virginia
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Charlottesville, Virginia, United States, 22903
- University of Virginia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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- Subject, who has an invalid written informed consent or has withdrawn consent.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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Sham Comparator: 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. |
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).
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Active Comparator: 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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Primary Endpoints
Time Frame: 12 months
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Bias between device under investigation and comparative device at medical decision level across sites; (unit is mg/dL)
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Secondary Endpoints
Time Frame: 12 months
|
Bias between device under investigation and comparative device at a medical decision point in native capillary samples per site; (unit is mg/dL)
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DC-083186
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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