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Evaluation of the BD OneFlow Acute Leukemia Panel on the BD FACSLyric Flow Cytometer

NCT05035615 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 332

Last updated 2024-08-06

No results posted yet for this study

Summary

This study is a multi-site, prospective performance study to determine equivalency between the investigational OneFlow Acute Leukemia Panel on the FACSLyric system versus the final clinical diagnosis.

Conditions

Interventions

DIAGNOSTIC_TEST

IUO Acute Leukemia Panel

This Investigational Panel , comprised of 6 reagents , is intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of immature hematopoietic cell populations. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, B-cell acute lymphoblastic leukemia or acute myeloid leukemia.

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Principal Investigators

  • Imelda Omana-Zapata, MD, PHD · Becton, Dickinson and Company

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2024-06-29
Completion
2024-07-18
FDA Device
Yes

Countries

  • United States
  • Brazil
  • Czechia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT05035615 on ClinicalTrials.gov