Trials / Completed
CompletedNCT04207554
Clinical Investigation for the Preview® hCG Urine/Serum Combo Pregnancy Test
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 132 (actual)
- Sponsor
- Guangzhou Wondfo Biotech Co., Ltd · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study is to evaluate the agreement of the test device (Preview® hCG Urine/Serum Combo Pregnancy Test) with the predicate device, the QuickVue+ hCG Combo Test.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Test Device-Strip Format | Sponsor's investigational device |
| DEVICE | Test Device-Cassette Format | Sponsor's investigational device |
| DEVICE | Predicate Device | Commercially available device |
Timeline
- Start date
- 2019-12-05
- Primary completion
- 2020-12-29
- Completion
- 2020-12-29
- First posted
- 2019-12-23
- Last updated
- 2021-01-11
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04207554. Inclusion in this directory is not an endorsement.