510(k) · Cleared
ClearedHuman Iga Liquid Reagent Kit for Use on Spa Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site · CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Cleared on Feb 27, 2012 as substantially equivalent to K040435 (Roche Diagnostics Corp., 2004) after a 424-day review. Its family tree reaches back 2 generations to 1996. 3 later devices descend from it.
- Decided
- Feb 27, 2012
- Review
- 424 days
- Class
- Class II
- Product code
- CFN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955907 (1996). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK955907 Boehringer Mannheim Iga AssayBoehringer Mannheim Corp. · 1996
- 1 generation backK040435 Roche Diagnostics Tina-Quant Iga Gen.2Roche Diagnostics Corp. · 2004 · Recalled
- This deviceK103824 Human Iga Liquid Reagent Kit for Use on Spa PlusThe Binding Site · 2012
- Descendant · cites it directly · 1 of its ownK191985 Optilite IgA KitThe Binding Site Group, Ltd. · 2019
- 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 ownK192116 Human IgA liquid reagent kit for Use on SPAPlusThe Binding Site Group, Ltd. · 2019
Most influential descendants
Showing 3 of 3 · See all- K191985Optilite IgA 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
- K192116Human IgA liquid reagent 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 |
|---|---|---|---|---|---|
| −2 | K955907 | Boehringer Mannheim Iga Assay | Boehringer Mannheim Corp. | 1996 | — |
| −1 | K040435 | Roche Diagnostics Tina-Quant Iga Gen.2 | Roche Diagnostics Corp. | 2004 | 1 |
| 0 (this device) | K103824 | Human Iga Liquid Reagent Kit for Use on Spa Plus | The Binding Site | 2012 | — |
| +1 | K191985 | Optilite IgA Kit | The Binding Site Group, Ltd. | 2019 | — |
| +2 | K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | The Binding Site Group, Ltd. | 2025 | 1 |
| +1 | 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 |
|---|---|---|
| 2019 | 2 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K040435 | Roche Diagnostics Tina-Quant Iga Gen.2Summary page 1…Predicate device We claim substantial equivalence to the Roche IgA Tina Quant Gen 2. on the Modular P( K040435) which measures low level IgA. Similarities and differences to the predicate device To… | 2004 |
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K191985 (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. 2012, 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 int vitro determination of human IgA in serum, lithium heparin or EDTA plasma using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103824: Human Iga Liquid Reagent Kit for Use on Spa Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103824
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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