510(k) · Cleared
ClearedHevylite Human Igm Kappa and Lambda Kit for Use on Spaplus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site Group, Ltd. · PDE Immunoglobulin M Kappa Heavy And Light Chain Combined
Cleared on Aug 6, 2014 as substantially equivalent to K113823 (The Binding Site Group, Ltd., 2013) after a 140-day review. Its family tree reaches back 1 generation to 2013.
- Decided
- Aug 6, 2014
- Review
- 140 days
- Class
- Class II
- Product code
- PDE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K113823 (2013). No later device cites it as a predicate yet.
- Root · 1 generation backK113823 Hevylite Human Igm Kappa and Hevylite Igm Lambda KitThe Binding Site Group, Ltd. · 2013
- This deviceK140686 Hevylite Human Igm Kappa and Lambda Kit for Use on SpaplusThe Binding Site Group, Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K113823 | Hevylite Human Igm Kappa and Hevylite Igm Lambda Kit | The Binding Site Group, Ltd. | 2013 | — |
| 0 (this device) | K140686 | Hevylite Human Igm Kappa and Lambda Kit for Use on Spaplus | The Binding Site Group, Ltd. | 2014 | — |
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 PDE? 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? (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 |
|---|---|---|---|
| * | K113823 | Hevylite Human Igm Kappa and Hevylite Igm Lambda KitSummary page 5…read from the calibration curve. Substantial Equivalence Information: Predicate device: Hevylite Human IgM Kappa and IgM Lambda Kits for use on Siemens BN™II Systems (k113823) Comparison with Predicate: Similarities Item Device… | 2013 |
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?
- Its one ancestor has no recall.
How does its category compare?
All PDE devicesPDE Immunoglobulin M Kappa Heavy And Light Chain Combined: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PDE
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · PDE
Too few PDE 510(k)s in any year since 2007 to give a median.
Recalls per year · PDE
No recall names PDE since 2007.
Adverse event reports per year · PDE
No MAUDE report names PDE since 2007.
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 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 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 | — | 0 | — |
What is it indicated for?
Hevylite Human IgM Kappa kit for use on SPAPLUS is intended for the in-vitro quantification of IgM kappa (combined μ heavy and κ light chain) concentration in human serum on the Binding Site SPAPLUS. The test result is to be used with previously diagnosed Waldenstrӧm’s macroglobulinaemia in conjunction with other clinical findings. This assay has not been established for the diagnosis, monitoring and prognosis of Waldenstrӧm’s macroglobulinaemia.…
Read the full statement (140 words)
Hevylite Human IgM Kappa kit for use on SPAPLUS is intended for the in-vitro quantification of IgM kappa (combined μ heavy and κ light chain) concentration in human serum on the Binding Site SPAPLUS. The test result is to be used with previously diagnosed Waldenstrӧm’s macroglobulinaemia in conjunction with other clinical findings.
This assay has not been established for the diagnosis, monitoring and prognosis of Waldenstrӧm’s macroglobulinaemia.
Hevylite Human IgM Lambda kit for use on SPAPLUS is intended for the in-vitro quantification of IgM lambda (combined μ heavy and λ light chain) in human serum on the Binding Site SPAPLUS. The test result is to be used with previously diagnosed Waldenstrӧm’s macroglobulinaemia. The test result is to be used in conjunction with other clinical findings.
This assay has not been established for the diagnosis, monitoring and prognosis of Waldenstrӧm’s macroglobulinaemia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140686: Hevylite Human Igm Kappa and Lambda Kit for Use on Spaplus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140686
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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