510(k) · Cleared
ClearedModification to: Binax Now Legionella Urinary Antigen Test, #852-000,852-012
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inverness Medical Professional Diagnostics · MJH Legionella, Spp., Elisa
Cleared on Mar 15, 2007 as substantially equivalent to K982238 (Binax, Inc., 1998) after a 20-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Mar 15, 2007
- Review
- 20 days
- Class
- Class II
- Product code
- MJH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K934965 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK934965 Binax Legionella Urinary Antigen EiaBinax, Inc. · 1994
- 1 generation backK982238 Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax…Binax, Inc. · 1998 · Recalled
- This deviceK070522 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
Most influential descendants
Showing 1 of 1 · See all- K191184ImmuView S pneumoniae and L pneumophila Urinary Antigen TestSsi Diagnostica A/S · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934965 | Binax Legionella Urinary Antigen Eia | Binax, Inc. | 1994 | — |
| −1 | K982238 | Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg… | Binax, Inc. | 1998 | 1 |
| 0 (this device) | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K982238 | Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg Ionella…Summary page 1…CLASSIFICATION NAME Haemophilus spp. Serological reagents (per 21 CFR 866.3300) PREDICATE DEVICE Binax NOW® Legionella Urinary Antigen Test (unmodified) 510 (k) number K982238 DEVICE DESCRIPTION The Binax NOW® Legionella Urinary Antigen Test is an immunochromatographic membrane assay to detect Legionell… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191184 | ImmuView S pneumoniae and L pneumophila Urinary Antigen Test | 2020 | 0 |
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 13 years and passes through 2 companies; a new generation was cleared every 8.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K191184 (Ssi Diagnostica A/S, 2020) has gone furthest, with 0 descendants of its own.
- 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. 2007, 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 Binax NOW® Legionella Urinary Antigen Test is an in vitro rapid immunochromatographic assay for the qualitative detection of Legionella pneumophila serogroup 1 antigen (L. pneumophila serogroup 1 antigen) in urine specimens from patients with symptoms of pneumonia. It is intended to aid in the presumptive diagnosis of Legionella infection (Legionnaires' disease) caused by L. pneumophila serogroup 1 in conjunction with culture and other methods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070522 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070522: Modification to: Binax Now Legionella Urinary Antigen Test, #852-000,852-012.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070522
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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