Evaluation of the Analytical Performance of ALLEGRO™ Instrument
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This page only displays public information reproduced from the official ClinicalTrials.gov record NCT04096313. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.
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Official title
Allegro Evaluation Study for FDA Submission
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To assess the performance of the Allegro in the hands of CLIA-Waived Point-of-Care users in at least three distinct Point-of-Care clinical settings and compare the performance characteristics to other accepted Point-of-Care methods and central laboratory reference methods. To assess the Ease of Use of the Allegro in the hands of the intended CLIA-Waived Point-of-Care users. CLIA-Waived operators will be provided with all package insert sheets, a Quick Reference Guide poster and Instructions for Use. No training, coaching, or prompting will be provided other than clarifying the protocol.
Study identification
- NCT ID
- NCT04096313
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 628 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 25, 2020 (Actual)
- Primary completion
- Nov 11, 2021 (Actual)
- Completion
- Dec 15, 2021 (Actual)
- Last update posted
- Dec 16, 2021
2020 – 2021
United States locations
- U.S. sites
- 3
- U.S. states
- 1
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Health Awareness, Inc | Jupiter | Florida | 33458 | — |
| South Florida Research Organization | Medley | Florida | 33166 | — |
| Health Awareness, Inc PSL | Port Saint Lucie | Florida | 34952 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04096313, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 16, 2021 · Synced Nov 15, 2026
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