# K142705: LeadCare Plus Blood Lead Testing System

- Pathway: 510(k) (Traditional)
- Applicant: Magellan Diagnostics
- Decided: Jul 7, 2015 after 288 days
- Product code: DOF (Lead, Atomic Absorption)
- Device class: 2
- Regulation: 21 CFR 862.3550
- Recalls of this device: 4 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K971640 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
4 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123563: Leadcare (R)  Ultra (TM) Blood Lead Testing System, Magellan Diagnostics (2013) Summary page 6.

## Recalls of this device
- Mar 13, 2026 · Class II · Z-1894-2026: Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positi
- May 7, 2021 · Class I · Z-1953-2021: 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
- Jan 9, 2018 · Class II · Z-1296-2018: The incorrect placement of AA batteries into certain LeadCare Plus Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are rem
- Nov 29, 2014 · Class I · Z-1926-2017: 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® Plus™ Blood Lead Testing System is intended for the quantitative measurement of lead in a whole blood sample. The LeadCare Plus Blood Lead Testing System is intended for in vitro (external) use only. The test kit components are for use with both the LeadCare Plus and LeadCare Ultra® Blood Lead Testing Systems. This test system is for prescription use only. This system is not intended for point of care use.

Source page: https://510kreport.com/device/K142705
Methodology: https://510kreport.com/methodology