Skip to content

LeadCare Ultra Blood Lead Testing System

by Magellan Diagnostics United States 510(k)

510(k) K123563 Product code DOF

Overview

The LeadCare Ultra Blood Lead Testing System is an in vitro diagnostic device designed to measure lead concentrations in whole blood. It employs electrochemical detection using anodic stripping voltammetry with a sensor that quantifies lead after the sample is mixed with a dilute hydrochloric acid reagent to lyse red blood cells.

The system is a benchtop, plug‑and‑play solution intended for external use in clinical toxicology laboratories. It is supplied as a complete system with reagents and test kits for capillary whole‑blood samples, provides results in approximately three minutes, and is classified as a Class II device cleared by the FDA under 510(k) decision K123563 (product code DOF).

Summary written by AI from registry data, 28 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK123563 Date20 Aug 2013ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

    • Terminated Z-1954-2021 FDA Class I initiated 7 May 2021

    Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.

    • Terminated Z-1925-2017 FDA Class I initiated 29 Nov 2014

    LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.

Specification

510(k) · synced 6 Oct 2026

Full name
Leadcare (R) Ultra (Tm) Blood Lead Testing System
510(k) Number
FDA Product Code
DOF
Device Class
Class II
Regulation
21 CFR Part 862.3550
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Other devices from Magellan Diagnostics, Inc.

See all devices from Magellan Diagnostics, Inc. →

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K123563 24 fields · synced 6 Oct 2026