Plan for Testing Fingerstick Bloods on Magellan Systems

Magellan Diagnostics190 enrolled

Overview

This study is to supplement our internal data that demonstrates the continued performance of capillary blood samples on Magellan's lead testing systems: LeadCare II, LeadCare Ultra (which have been cleared previously by FDA), and PediaStat, which is an upgraded LeadCare II instrument in development.

Study Type

OBSERVATIONAL

Enrollment

190

Conditions

Lead Poisoning

Interventions

Lead testingDEVICE

Fingerstick

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy subjects who consent to a capillary blood collection Exclusion Criteria: * Patients are not currently taking chelating agents, e.g., penicillamine, succimer

Locations (3)

Pediatric Associates, Inc.

Brockton, Massachusetts, United States

RECRUITING

Pediatrics Associates, Inc

Hanson, Massachusetts, United States

RECRUITING

Pediatrics Associates, Inc

West Bridgewater, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Lead poisoning

\>10ug/dL lead in whole blood is considered lead poisoning These measurements will be taken to compare the fingerstick data collected in the field with data received through reference method

Time frame: 1 day

Central Contacts

Catherine Lufkin

CONTACT

978-248-4963 Catherine.Lufkin@magellandx.com

Data from ClinicalTrials.gov

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