510(k) · Cleared
ClearedImmuView S pneumoniae and L pneumophila Urinary Antigen Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ssi Diagnostica A/S · MJH Legionella, Spp., Elisa
Cleared on Mar 5, 2020 as substantially equivalent to K012521 (Binax, Inc., 2001) and 3 other predicates after a 307-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Mar 5, 2020
- Review
- 307 days
- Class
- Class II
- Product code
- MJH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K934965 (1994). 6 ancestors in all, the oldest K854852 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK934965 Binax Legionella Urinary Antigen EiaBinax, Inc. · 1994
- 2 generations backK982238 Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax…Binax, Inc. · 1998 · Recalled
- 1 generation backK070522 Modification to: Binax Now Legionella Urinary Antigen Test…Inverness Medical Professional Diagnostics · 2007
- This deviceK191184 ImmuView S pneumoniae and L pneumophila Urinary Antigen TestSsi Diagnostica A/S · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K934965 | Binax Legionella Urinary Antigen Eia | Binax, Inc. | 1994 | — |
| −2 | K982238 | Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg… | Binax, Inc. | 1998 | 1 |
| −1 | K070522 | Modification to: Binax Now Legionella Urinary Antigen Test, #852-000,852-012 | Inverness Medical Professional Diagnostics | 2007 | — |
| 0 (this device) | K191184 | ImmuView S pneumoniae and L pneumophila Urinary Antigen Test | Ssi Diagnostica A/S | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K012521 | Binax Now Streptococcus Pneumoniae TestSummary page 4…ogical reagents 21 CFR 866.3740 and 866.3300 Product Codes: GTZ and MJH Predicate Devices: BinaxNOW® Streptococcus pneumoniae (K012521) and BinaxNOW® Legionella (K982238) Panel: Microbiology Intended Use: The… | 2001 |
| * | K982238 | Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg Ionella…Summary page 4…00 Product Codes: GTZ and MJH Predicate Devices: BinaxNOW® Streptococcus pneumoniae (K012521) and BinaxNOW® Legionella (K982238) Panel: Microbiology Intended Use: The ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test is a… | 1998 |
| * | K991726 | Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test Kit),(12 Test Kit)…Summary page 5…mation: 1. Predicate device names(s): BinaxNOW® Streptococcus pneumoniae Card and BinaxNOW® Legionella pneumophila Card 2. Predicate 510(k) number(s): K991726 and K012521 and K982238 and K070522 Table 1 Comparison with predicate: Description ImmuView S.… | 1999 |
| * | K070522 | Modification to: Binax Now Legionella Urinary Antigen Test, #852-000,852-012Summary page 5…s(s): BinaxNOW® Streptococcus pneumoniae Card and BinaxNOW® Legionella pneumophila Card 2. Predicate 510(k) number(s): K991726 and K012521 and K982238 and K070522 Table 1 Comparison with predicate: Description ImmuView S. pneumoniae and BinaxNOW® St… | 2007 |
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 26 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- 2 of the 6 ancestors have a recall of any class.
How does its category compare?
All MJH devicesMJH Legionella, Spp., Elisa: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test is an in vitro, rapid, lateral flow test, also known as a lateral flow immunochromatographic assay, intended for the qualitative detection of Streptococcus pneumoniae and Legionella pneumophila antigens in urine specimens from patients with symptoms of pneumonia. The assay is intended to aid in diagnosis of S. pneumoniae and L. pneumophila serogroup 1 infections. The assay is further…
Read the full statement (114 words)
The ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test is an in vitro, rapid, lateral flow test, also known as a lateral flow immunochromatographic assay, intended for the qualitative detection of Streptococcus pneumoniae and Legionella pneumophila antigens in urine specimens from patients with symptoms of pneumonia. The assay is intended to aid in diagnosis of S. pneumoniae and L. pneumophila serogroup 1 infections. The assay is further intended to aid in the diagnosis of S. pneumoniae infections by detection of S. pneumoniae antigen in cerebrospinal fluid (CSF). Results from the ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test should be interpreted in conjunction with the patient’s clinical evaluation and other diagnostic methods.
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/K191184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191184: ImmuView S pneumoniae and L pneumophila Urinary Antigen Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191184
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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