Trials / Completed
CompletedNCT03595501
Analytical and Clinical Performance Testing Plan
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 679 (actual)
- Sponsor
- Sight Diagnostics · Industry
- Sex
- All
- Age
- 3 Months
- Healthy volunteers
- Accepted
Summary
Clinical and analytical tests will be performed based on risk assessment and system specifications to verify that the performance of the investigational device is in accordance with its specifications.
Detailed description
Comparison and precision studies will be conducted in up to 5 clinical sites in Israel and the US, and include: * Precision * Sample Matrix Comparison * Method comparison study and flagging analysis * Reference interval range
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hematology Analyzer - OLO | Complete blood counts from OLO will be determined from analysis of whole blood samples |
| DEVICE | Hematology Analyzer - Predicate | Complete blood counts from Predicate will be determined from analysis of whole blood samples |
Timeline
- Start date
- 2018-06-20
- Primary completion
- 2019-03-06
- Completion
- 2019-08-25
- First posted
- 2018-07-23
- Last updated
- 2021-03-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03595501. Inclusion in this directory is not an endorsement.