510(k) · Cleared
Recalled · Class I · 2026Leadcare II Blood Lead Testing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Esa Biosciences, Inc. · DOF Lead, Atomic Absorption
Cleared on Oct 6, 2005 as substantially equivalent to K971640 (Esa, Inc., 1997) after a 20-day review. Its family tree reaches back 1 generation to 1997. 4 of the 4 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 13 times, including 2 Class I recalls.
- Decided
- Oct 6, 2005
- Review
- 20 days
- Class
- Class II
- Product code
- DOF
- Recalls
- 13 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971640 (1997). 2 later devices descend from it, 1 citing it directly. 4 of the 4 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK971640 Leadcare Blood Lead Testing SystemEsa, Inc. · 1997 · Recalled (Class I)
- This deviceK052549 Leadcare II Blood Lead Testing SystemEsa Biosciences, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK123563 Leadcare (R) Ultra (TM) Blood Lead Testing SystemMagellan Diagnostics · 2013 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK142705 LeadCare Plus Blood Lead Testing SystemMagellan Diagnostics · 2015 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971640 | Leadcare Blood Lead Testing System | Esa, Inc. | 1997 | Class I |
| 0 (this device) | K052549 | Leadcare II Blood Lead Testing System | Esa Biosciences, Inc. | 2005 | — |
| +1 | K123563 | Leadcare (R) Ultra (TM) Blood Lead Testing System | Magellan Diagnostics | 2013 | Class I |
| +2 | K142705 | LeadCare Plus Blood Lead Testing System | Magellan Diagnostics | 2015 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 1 |
| 2015 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K971640 | Leadcare Blood Lead Testing SystemSummary page 1…Substantial Equivalence to ESA Bioscience Inc. (formerly ESA Umed Saee Inc.) LeadCare® Blood Lead Testing System. (K971640) (800) 235 2436 Fax (785) 832 0406 wwwcypresssystemscorm 4. Device Description… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123563 | Leadcare (R) Ultra (TM) Blood Lead Testing System Class I | 2013 | 1 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2026 | Class III | Z-0162-2027 | Labeling Change Control | 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 system will display an error message and… |
| Mar 13, 2026 | Class II | Z-1893-2026 | Device Design | 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 positive lead results may cause delayed… |
| Mar 13, 2026 | Class II | Z-1895-2026 | Device Design | 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 positive lead results may cause delayed… |
| Feb 23, 2024 | Class II | Z-0584-2026 | Labeling mix-ups | 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 or erroneous low results. |
| Sep 19, 2023 | Class II | Z-0219-2024 | Nonconforming Material/Component | 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-to-tube seals. Manufacturing with… |
| May 25, 2022 | Class II | Z-1597-2022 | Environmental control | 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 | Nonconforming Material/Component | 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 samples. |
| Aug 8, 2018 | Class II | Z-0285-2019 | Process control | 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. |
| Jan 9, 2018 | Class II | Z-1295-2018 | Device Design | 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 removed while hot. |
| May 23, 2017 | Class I | Z-2226-2017 | Device Design | 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 | Device Design | LeadCare II Test Kits controls out of range |
| Sep 20, 2007 | Not classified | Z-0042-2008 | Process design | Level 1 and Level 2 Control values were incorrectly assigned. |
| Sep 20, 2007 | Not classified | Z-0043-2008 | Process design | Level 1 and Level 2 Control values were incorrectly assigned. |
The 5 latest of 13 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K971640Leadcare Blood Lead Testing SystemEsa, Inc. · 1997 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K123563Leadcare (R) Ultra (TM) Blood Lead Testing SystemMagellan Diagnostics · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K142705LeadCare Plus Blood Lead Testing SystemMagellan Diagnostics · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Its one ancestor has a recall, Class I.
- Of its descendants, K123563 (Magellan Diagnostics, 2013) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DOF devicesDOF Lead, Atomic Absorption: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DOF
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · DOF
Too few DOF 510(k)s in any year since 2007 to give a median.
Recalls per year · DOF
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DOF
55in 2025
MAUDE reports naming product code DOF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 39 |
| 2018 | 0 | — | 1 | 40 |
| 2019 | 0 | — | 0 | 63 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 98 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 1 | 0 |
| 2024 | 0 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 55 |
| 2026 | 0 | — | 4 | — |
What is it indicated for?
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052549: Leadcare II Blood Lead Testing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052549
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026