# K052549: Leadcare II Blood Lead Testing System

- Pathway: 510(k) (Special)
- Applicant: Esa Biosciences, Inc.
- Decided: Oct 6, 2005 after 20 days
- Product code: DOF (Lead, Atomic Absorption)
- Device class: 2
- Regulation: 21 CFR 862.3550
- Recalls of this device: 13 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K971640 (1997). 1 ancestor in all.
2 later devices descend 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)
- K971640: Leadcare Blood Lead Testing System, Esa, Inc. (1997) Summary page 1.

## Most influential descendants
- K123563: Leadcare (R)  Ultra (TM) Blood Lead Testing System (2013), 1 descendant of its own
- K142705: LeadCare Plus Blood Lead Testing System (2015), 0 descendants of its own

## Recalls of this device
- Sep 4, 2026 · Class III · Z-0162-2027: In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the sys
- Mar 13, 2026 · Class II · Z-1893-2026: 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
- Mar 13, 2026 · Class II · Z-1895-2026: 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
- Feb 23, 2024 · Class II · Z-0584-2026: Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high
- Sep 19, 2023 · Class II · Z-0219-2024: During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found to not meet the minimum dimensional lip requirement and may have inadequate cap-
- May 25, 2022 · Class II · Z-1597-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- May 7, 2021 · Class I · Z-1952-2021: 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
- Aug 8, 2018 · Class II · Z-0285-2019: Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 g/dL). Results for patient testing with this lot will be displayed 
- Jan 9, 2018 · Class II · Z-1295-2018: The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are remov
- May 23, 2017 · Class I · Z-2226-2017: Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
- Jan 20, 2016 · Class II · Z-3035-2017: LeadCare II Test Kits controls out of range
- Sep 20, 2007 · Not classified · Z-0042-2008: Level 1 and Level 2 Control values were incorrectly assigned.
- Sep 20, 2007 · Not classified · Z-0043-2008: Level 1 and Level 2 Control values were incorrectly assigned.

## Indications for use
For In Vitro Diagnostic Use Only The LeadCare® II Blood Lead Testing System is an instrumented assay to be used in the quantitation of lead in human whole blood. The Leadcare® II System is suitable for use in a physician's office laboratory environment (POL).

Source page: https://510kreport.com/device/K052549
Methodology: https://510kreport.com/methodology