510(k) · Cleared
Recalled · Class II · 2018Human Igm Liquid Reagent Kit for Use on the Spaplus Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site, Ltd. · CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Cleared on Feb 10, 2009 after a 196-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 10, 2009
- Review
- 196 days
- Class
- Class II
- Product code
- CFN
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK082129 Human Igm Liquid Reagent Kit for Use on the Spaplus AnalyzerThe Binding Site, Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK191635 Optilite IgM KitThe Binding Site Group, Ltd. · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK250159 Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserThe Binding Site Group, Ltd. · 2025 · Recalled
- Descendant · cites it directly · 0 of its ownK191465 Human IgM Kit for use on SPAPlusThe Binding Site Group, Ltd. · 2019 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K191635Optilite IgM KitThe Binding Site Group, Ltd. · 2019 · cites it directly1descendant
- K250159Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserThe Binding Site Group, Ltd. · 2025 · 2 generations on0descendants
- K191465Human IgM Kit for use on SPAPlusThe Binding Site Group, Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082129 | Human Igm Liquid Reagent Kit for Use on the Spaplus Analyzer | The Binding Site, Ltd. | 2009 | — |
| +1 | K191635 | Optilite IgM Kit | The Binding Site Group, Ltd. | 2019 | 1 |
| +2 | K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | The Binding Site Group, Ltd. | 2025 | 1 |
| +1 | K191465 | Human IgM Kit for use on SPAPlus | The Binding Site Group, Ltd. | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CFN? 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 CFN device
- #1 K233663 N Antisera to Human Immunoglobulins (IgG, IgA…score 8.3 · 7 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 6, 2018 | Class II | Z-0604-2019 | Under Investigation by firm | Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges. |
| Jul 25, 2018 | Class II | Z-0477-2019 | Under Investigation by firm | After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control results may be out of range one day after running the assay calibration curve.… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K191635 (The Binding Site Group, Ltd., 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CFN devicesCFN Method, Nephelometric, Immunoglobulins (G, A, M): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · CFN
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CFN
28in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CFN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFN
1in 2024
MAUDE reports naming product code CFN, 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 | 7 | 69 | 0 | 0 |
| 2009 | 4 | 160 | 0 | 0 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 4 | 431 | 0 | 0 |
| 2014 | 2 | — | 5 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 2 | 2 |
| 2019 | 6 | 28 | 0 | 8 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 1 |
| 2023 | 2 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This kit is intended for the quantitative in vitro determination of human IgM in human serum, heparinised or EDTA plasma, using the Binding Site SPApLusTM turbidimetric analyser. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K082129 · printed Nov 3, 2026
Cite this page
510(k) Report. “K082129: Human Igm Liquid Reagent Kit for Use on the Spaplus Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K082129
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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