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Evaluation of the Plasma Cell Disorders Panel on the BD FACSLyric™ Flow Cytometer

NCT05032339 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 208

Last updated 2023-10-30

No results posted yet for this study

Summary

Multi-site, prospective performance study to determine equivalency between the investigational OneFlow PCD panel on the FACSLyric system versus the final clinical diagnosis.

Conditions

  • Plasma Cell Disorder

Interventions

DIAGNOSTIC_TEST

IUO Plasma Cell Disorders Panel

This Investigational Panel , comprised of 2 reagents , is intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of plasma cell populations. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, plasma cell disorders.

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Principal Investigators

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

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-04
Primary Completion
2023-10-25
Completion
2023-10-25
FDA Device
Yes

Countries

  • United States
  • Portugal
  • Spain
  • Switzerland
  • United Kingdom

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 NCT05032339 on ClinicalTrials.gov