510(k) · Cleared
ClearedTru Legionella
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Bioscience, Inc. · MJH Legionella, Spp., Elisa
Cleared on Feb 24, 2012 as substantially equivalent to K982238 (Binax, Inc., 1998) after a 116-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Feb 24, 2012
- Review
- 116 days
- Class
- Class II
- Product code
- MJH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K934965 (1994). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K982238 | Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg Ionella…Summary page 1…ation: Haemnophilus spp serological reagents MJH, CFR Section 866.3300 Predicate device: K982238: Binax NOW Legionella Reference comparator: Binax NOW Legionella Description af the Device The TRU Legionella… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 13.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K982238.
How does its category compare?
All MJH devicesMJH Legionella, Spp., Elisa: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
The TRU Legionella assay is an in vitro, rapid, lateral-flow immunoassay for the qualitative detection of
Legionella pneumophila serogroup I antigens in human urine specimens. It is designed to test specimens
from patients with symptoms of pneumonia. Test results are to be used as an aid in diagnosis of
Legionella pneumophila serogroup I infection. A negative result does not preclude infection with
Legionellapneumophild serogroup 1. Test results are to be used in conjunction with information obtained
from the patient's clinical evaluation and other diagnostic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113190 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113190: Tru Legionella.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113190
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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