# K123563: Leadcare (R)  Ultra (TM) Blood Lead Testing System

- Pathway: 510(k) (Traditional)
- Applicant: Magellan Diagnostics
- Decided: Aug 20, 2013 after 274 days
- Product code: DOF (Lead, Atomic Absorption)
- Device class: 2
- Regulation: 21 CFR 862.3550
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K971640 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052549: Leadcare II Blood Lead Testing System, Esa Biosciences, Inc. (2005) Summary page 1.

## Most influential descendants
- K142705: LeadCare Plus Blood Lead Testing System (2015), 0 descendants of its own

## Recalls of this device
- May 7, 2021 · Class I · Z-1954-2021: 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 sampl
- Nov 29, 2014 · Class I · Z-1925-2017: 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 lav

## Indications for use
The LeadCare® UltraTM Blood Lead Testing System is designed to quantitatively measure the amount of lead in a whole blood sample. The LeadCare® UltraTM Blood Lead Testing System is intended for in vitro (external) use only. The test kit components are designed for use only with the LeadCare® Ultrarm Blood Lead Testing System. This test system is for prescription use only. This system is not intended for point of care use.

Source page: https://510kreport.com/device/K123563
Methodology: https://510kreport.com/methodology