510(k) · Cleared
Recalled · 2006Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg Ionella Urinary Antigen Control Kit Model 8522
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Binax, Inc. · MJH Legionella, Spp., Elisa
Cleared on Aug 21, 1998 as substantially equivalent to K934965 (Binax, Inc., 1994) after a 57-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it. It has been recalled once.
- Decided
- Aug 21, 1998
- Review
- 57 days
- Class
- Class II
- Product code
- MJH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934965 (1994). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK934965 Binax Legionella Urinary Antigen EiaBinax, Inc. · 1994
- This deviceK982238 Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax…Binax, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK070522 Modification to: Binax Now Legionella Urinary Antigen Test…Inverness Medical Professional Diagnostics · 2007
- Descendant · cites it directly · 0 of its ownK191184 ImmuView S pneumoniae and L pneumophila Urinary Antigen TestSsi Diagnostica A/S · 2020
- Descendant · cites it directly · 0 of its ownK113190 Tru LegionellaMeridian Bioscience, Inc. · 2012
Most influential descendants
Showing 3 of 3 · See all- K070522Modification to: Binax Now Legionella Urinary Antigen Test, #852-000,852-012Inverness Medical Professional Diagnostics · 2007 · cites it directly1descendant
- K191184ImmuView S pneumoniae and L pneumophila Urinary Antigen TestSsi Diagnostica A/S · 2020 · cites it directly0descendants
- K113190Tru LegionellaMeridian Bioscience, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934965 | Binax Legionella Urinary Antigen Eia | Binax, Inc. | 1994 | — |
| 0 (this device) | K982238 | Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg… | Binax, Inc. | 1998 | — |
| +1 | K070522 | Modification to: Binax Now Legionella Urinary Antigen Test, #852-000,852-012 | Inverness Medical Professional Diagnostics | 2007 | — |
| +1 | K191184 | ImmuView S pneumoniae and L pneumophila Urinary Antigen Test | Ssi Diagnostica A/S | 2020 | — |
| +1 | K113190 | Tru Legionella | Meridian Bioscience, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
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 |
|---|---|---|---|
| * | K934965 | Binax Legionella Urinary Antigen EiaSummary page 1…gionella ICT Classification Name: Haemophilus spp. serological reagents (per - 21 CFR 8660.3300) Predicate Device: Binax Legionella Urinary Antigen EIA, 510 (k) number K934965/S1 Device Description: The Binax NOW™ Legionella Urinary Antigen Test is an immunochromatographic membrane assay to detect Legio… | 1994 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 29, 2006 | Not classified | Z-0222-2007 | Other | Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S. pneumonia test pouches |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K070522 (Inverness Medical Professional Diagnostics, 2007) has gone furthest, with 1 descendant of its own.
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?
The Binax NOW™ Legionella Urinary Antigen Test is a rapid immunochromatographic assay for the qualitative detection of Legionella pneumophila serogroup 1 antigen (L. pneumophila serogroup 1 antigen) in human urine as an adjunct to culture for the presumptive diagnosis of Legionnaires’ Disease. It is intended for in vitro diagnostic use.
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/K982238 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982238: Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg Ionella Urinary Antigen Control Kit Model 8522.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982238
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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