510(k) · Cleared
ClearedWellcogen Bacterial Antigen Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wellcome Diagnostics · GTJ Antisera, All Groups, N. Meningitidis
Cleared on Feb 4, 1986 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Feb 4, 1986
- Review
- 61 days
- Class
- Class II
- Product code
- GTJ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK854852 Wellcogen Bacterial Antigen KitWellcome Diagnostics · 1986
- Descendant · cites it directly · 1 of its ownK012521 Binax Now Streptococcus Pneumoniae TestBinax, Inc. · 2001 · Recalled
- Descendant · cites it directly · 1 of its ownK991726 Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test…Binax, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK191184 ImmuView S pneumoniae and L pneumophila Urinary Antigen TestSsi Diagnostica A/S · 2020
Most influential descendants
Showing 3 of 3 · See all- K012521Binax Now Streptococcus Pneumoniae TestBinax, Inc. · 2001 · cites it directly1descendant
- K991726Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test Kit),(12 Test Kit)…Binax, Inc. · 1999 · cites it directly1descendant
- K191184ImmuView S pneumoniae and L pneumophila Urinary Antigen TestSsi Diagnostica A/S · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K854852 | Wellcogen Bacterial Antigen Kit | Wellcome Diagnostics | 1986 | — |
| +1 | K012521 | Binax Now Streptococcus Pneumoniae Test | Binax, Inc. | 2001 | 1 |
| +1 | K991726 | Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test Kit),(12… | Binax, Inc. | 1999 | — |
| +2 | 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 |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GTJ? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012521 (Binax, Inc., 2001) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GTJ devicesGTJ Antisera, All Groups, N. Meningitidis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GTJ
FDA has decided no GTJ device since 2007.
Median 510(k) review, days · GTJ
Too few GTJ 510(k)s in any year since 2007 to give a median.
Recalls per year · GTJ
4in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GTJ
1in 2008
MAUDE reports naming product code GTJ, 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 | 0 | — | 4 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K854852 · printed Nov 4, 2026
Cite this page
510(k) Report. “K854852: Wellcogen Bacterial Antigen Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K854852
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026