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Analytical and Clinical Performance Testing Plan

NCT03595501 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 679

Last updated 2021-03-04

No results posted yet for this study

Summary

Clinical and analytical tests will be performed based on risk assessment and system specifications to verify that the performance of the investigational device is in accordance with its specifications.

Conditions

Interventions

DEVICE

Hematology Analyzer - OLO

Complete blood counts from OLO will be determined from analysis of whole blood samples

DEVICE

Hematology Analyzer - Predicate

Complete blood counts from Predicate will be determined from analysis of whole blood samples

Sponsors & Collaborators

  • Sight Diagnostics

    lead INDUSTRY

Principal Investigators

  • Dr. Eldad Hod, Dr · Colombia University

Eligibility

Min Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-20
Primary Completion
2019-03-06
Completion
2019-08-25
FDA Device
Yes

Countries

  • United States

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 NCT03595501 on ClinicalTrials.gov