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First To Know Pregnancy Test - Clinical Evaluation Protocol

NCT07304531 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1705

Last updated 2025-12-26

No results posted yet for this study

Summary

This study is evaluating the ADEXUSDx® hCG CLIA moderately complex, FDA-cleared test for potential over the counter (OTC) use and marketing as the First To Know® (FTK) Pregnancy test. The investigational FTK Pregnancy test will be used to assess its clinical performance in the intended use population (i.e., lay users) through self-testing in a simulated home setting.

Conditions

  • Pregnancy Detection

Interventions

DEVICE

Diagnostic Test

For this observational trial , the Intervention of interest is the First To Know Pregnancy Test

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • NOWDiagnostics, Inc.

    lead INDUSTRY

Eligibility

Min Age
14 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-14
Primary Completion
2026-04-30
Completion
2026-05-31
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 NCT07304531 on ClinicalTrials.gov