510(k) · Cleared
Recalled · Class II · 2025Bartels Legionella Urinary Antigen Elisa Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intracel Corp. · MJH Legionella, Spp., Elisa
Cleared on Dec 21, 1999 after a 265-day review. The FDA summary names its predicate without a number. It has been recalled 2 times.
- Decided
- Dec 21, 1999
- Review
- 265 days
- Class
- Class II
- Product code
- MJH
- Recalls
- 2
- Predicates
- 0
The FDA summary names its predicate without a number.
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.
Planning a device in MJH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MJH device
- #1 K191184 ImmuView S pneumoniae and L pneumophila…score -0.4 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | — | Binax Legionella Urinary Antigen EIA Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 22, 2025 | Class II | Z-2292-2025 | Under Investigation by firm | Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter. |
| Oct 11, 2021 | Class II | Z-0382-2022 | Material/Component Contamination | Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MJH devicesMJH Legionella, Spp., Elisa: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MJH
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · MJH
Too few MJH 510(k)s in any year since 2007 to give a median.
Recalls per year · MJH
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJH
1in 2025
MAUDE reports naming product code MJH, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Bartels Legionella Urinary Antigen ELISA Test is intended as an adjunct to culture for the presumptive diagnosis of past or current Legionnaires' Disease by qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991074 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991074: Bartels Legionella Urinary Antigen Elisa Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991074
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026