Trials / Withdrawn
WithdrawnNCT00933764
Clinical Performance Evaluation of the Cholestech LDX Cardiac hsCRP Test (CLEAR)
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Abbott RDx Cardiometabolic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center study designed to assess the accuracy and precision of the Cholestech LDX Cardiac hsCRP test for the quantitative determination of C-reactive protein (CRP) in whole blood, serum and plasma from individuals being assessed for risk of cardiovascular disease. The Cholestech LDX Cardiac hsCRP test consists of the CRP cassette and LDX analyzer and measures CRP with high sensitivity on fingerstick or venous whole blood at the point-of-care (POC). The results of this study are intended to be used for regulatory 510k filings for use as an in vitro diagnostic test.
Conditions
Timeline
- Start date
- 2009-08-01
- Primary completion
- 2009-10-01
- Completion
- 2009-11-01
- First posted
- 2009-07-07
- Last updated
- 2015-07-21
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00933764. Inclusion in this directory is not an endorsement.