510(k) · Cleared
ClearedBoehringer Mannheim Iga Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · CZP Iga, Antigen, Antiserum, Control
Cleared on Feb 9, 1996 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Feb 9, 1996
- Review
- 42 days
- Class
- Class II
- Product code
- CZP
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK955907 Boehringer Mannheim Iga AssayBoehringer Mannheim Corp. · 1996
- Descendant · cites it directly · 4 of its ownK040435 Roche Diagnostics Tina-Quant Iga Gen.2Roche Diagnostics Corp. · 2004 · Recalled
- Descendant · 2 generations on · 3 of its ownK103824 Human Iga Liquid Reagent Kit for Use on Spa PlusThe Binding Site · 2012
- Descendant · 3 generations on · 1 of its ownK191985 Optilite IgA KitThe Binding Site Group, Ltd. · 2019
- Descendant · 4 generations on · 0 of its ownK250159 Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserThe Binding Site Group, Ltd. · 2025 · Recalled
- Descendant · 3 generations on · 0 of its ownK192116 Human IgA liquid reagent kit for Use on SPAPlusThe Binding Site Group, Ltd. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K040435Roche Diagnostics Tina-Quant Iga Gen.2Roche Diagnostics Corp. · 2004 · cites it directly4descendants
- K103824Human Iga Liquid Reagent Kit for Use on Spa PlusThe Binding Site · 2012 · 2 generations on3descendants
- K191985Optilite IgA KitThe Binding Site Group, Ltd. · 2019 · 3 generations on1descendant
- K250159Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserThe Binding Site Group, Ltd. · 2025 · 4 generations on0descendants
- K192116Human IgA liquid reagent kit for Use on SPAPlusThe Binding Site Group, Ltd. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955907 | Boehringer Mannheim Iga Assay | Boehringer Mannheim Corp. | 1996 | — |
| +1 | K040435 | Roche Diagnostics Tina-Quant Iga Gen.2 | Roche Diagnostics Corp. | 2004 | 1 |
| +2 | K103824 | Human Iga Liquid Reagent Kit for Use on Spa Plus | The Binding Site | 2012 | — |
| +3 | K191985 | Optilite IgA Kit | The Binding Site Group, Ltd. | 2019 | — |
| +4 | K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | The Binding Site Group, Ltd. | 2025 | 1 |
| +3 | K192116 | Human IgA liquid reagent kit for Use on SPAPlus | The Binding Site Group, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 2 | 0 |
| 2025 | 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 CZP? 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 CZP device
- #1 K193525 Yumizen C1200 Immunoglobulin A, Yumizen C1200…score 0.2 · 3 generations · no Class I recall
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? (6)
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, K040435 (Roche Diagnostics Corp., 2004) has gone furthest, with 4 descendants of its own.
How does its category compare?
All CZP devicesCZP Iga, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CZP
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · CZP
Too few CZP 510(k)s in any year since 2007 to give a median.
Recalls per year · CZP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CZP
1in 2025
MAUDE reports naming product code CZP, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 1 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K955907 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955907: Boehringer Mannheim Iga Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955907
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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