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Clinical Investigation for the Preview® hCG Urine/Serum Combo Pregnancy Test

NCT04207554 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 132

Last updated 2021-01-11

No results posted yet for this study

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

  • Pregnancy

Interventions

DEVICE

Test Device-Strip Format

Sponsor's investigational device

DEVICE

Test Device-Cassette Format

Sponsor's investigational device

DEVICE

Predicate Device

Commercially available device

Sponsors & Collaborators

  • Nova Clinical Solutions, Inc.

    collaborator UNKNOWN

  • Guangzhou Wondfo Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Rui Liu, Master · Guangzhou Wondfo Biotech Co., Ltd

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-05
Primary Completion
2020-12-29
Completion
2020-12-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04207554 on ClinicalTrials.gov