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Leadcare Blood Lead Testing System

by Esa, Inc. 510(k)

Active United States

510(k) K971640

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK971640 Date9 Sep 1997ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

3 recalls · FDA

    • Terminated Z-0285-2019 FDA Class II initiated 8 Aug 2018

    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 as HIGH.

    • Terminated Z-2225-2017 FDA Class I initiated 23 May 2017

    Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems

    • Terminated Z-0914-05 FDA Unclassified (pre-2012) initiated 19 May 2005

    Lead test results may be reported lower than the actual value

Specification

510(k)

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

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