# K971640: Leadcare Blood Lead Testing System

- Pathway: 510(k) (Traditional)
- Applicant: Esa, Inc.
- Decided: Sep 9, 1997 after 130 days
- Product code: DOF (Lead, Atomic Absorption)
- Device class: 2
- Regulation: 21 CFR 862.3550
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K052549: Leadcare II Blood Lead Testing System (2005), 2 descendants of its own
- 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
- 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 
- May 23, 2017 · Class I · Z-2225-2017: Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
- May 19, 2005 · Not classified · Z-0914-05: Lead test results may be reported lower than the actual value

## Indications for use
The LEADCARE™ Blood Lead Testing System is an instrumented assay to be used in the quantitation of lead in human whole blood. The LEADCARE System is suitable for use in a physcian’s office laboratory environment (POL).

Source page: https://510kreport.com/device/K971640
Methodology: https://510kreport.com/methodology