Trials / Completed
CompletedNCT05467449
DxFLEX 10C Clinical Study
DxFLEX ClearLLab 10C US-IVD Clinical Study Protocol - Clinical Laboratory
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 527 (actual)
- Sponsor
- Beckman Coulter, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
A multi-center method comparison study is designed per CLSI-EP09 A3. This study compares the qualitative immunophenotype agreement between DxFLEX and Navios EX to demonstrate the accuracy of the DxFLEX-10C system. A series of precision studies will be conducted with each focusing on different aspects of the DxFLEX-10C system.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | DxFLEX 10C | A device combining flow cytometry and reagents for immunophenotyping analysis |
Timeline
- Start date
- 2022-04-12
- Primary completion
- 2023-05-31
- Completion
- 2023-08-31
- First posted
- 2022-07-20
- Last updated
- 2024-02-13
Locations
6 sites across 3 countries: United States, Canada, Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05467449. Inclusion in this directory is not an endorsement.