510(k) · Cleared
ClearedHevylite Human Igm Kappa and Hevylite Igm Lambda Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site Group, Ltd. · CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Cleared on Mar 27, 2013 after a 456-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Mar 27, 2013
- Review
- 456 days
- Class
- Class II
- Product code
- CFN
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK113823 Hevylite Human Igm Kappa and Hevylite Igm Lambda KitThe Binding Site Group, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK140686 Hevylite Human Igm Kappa and Lambda Kit for Use on SpaplusThe Binding Site Group, Ltd. · 2014
Most influential descendants
Showing 1 of 1 · See all- K140686Hevylite Human Igm Kappa and Lambda Kit for Use on SpaplusThe Binding Site Group, Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K113823 | Hevylite Human Igm Kappa and Hevylite Igm Lambda Kit | The Binding Site Group, Ltd. | 2013 | — |
| +1 | K140686 | Hevylite Human Igm Kappa and Lambda Kit for Use on Spaplus | The Binding Site Group, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140686 | Hevylite Human Igm Kappa and Lambda Kit for Use on Spaplus | 2014 | 0 |
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, K140686 (The Binding Site Group, Ltd., 2014) has gone furthest, with 0 descendants 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. 2013, 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?
Hevylite Human 1gM Kappa Kit for use on Siemens BNTMII is intended for the in vitro quantification of 1gM Kappa (combined heavy and K light chain) concentration in human serum on the Siemens Behring NephelometerTM 11(BNN TII1). The test result is to be used with previously diagnosed Waldenstoms Macrolobuiinaemiain conjunction with other clinical and laboratory findings. This assay has not been established for the diagnosis, monitoring and prognosis of…
Read the full statement (144 words)
Hevylite Human 1gM Kappa Kit for use on Siemens BNTMII is intended for the in vitro quantification of 1gM Kappa (combined heavy and K light chain) concentration in human serum on the Siemens Behring NephelometerTM 11(BNN TII1). The test result is to be used with previously diagnosed Waldenstoms Macrolobuiinaemiain conjunction with other clinical and laboratory findings.
This assay has not been established for the diagnosis, monitoring and prognosis of Waldenstroms macroglbulinaemia.
Hevylite Human IgM Lambda Kit for use on Siemens BNTMII is intended for the in vitro quantification of IgM Lambda (combined Ipheavy and Alight chain) concentration in human serum on the Siemens Behring Nephelometer TM 11 (BNTM 11). The test result is to be used with previously diagnosed Waldenstoms Macrolobulinaemnia in conjunction with other clinical and laboratory findings.
This assay has not been established for the diagnosis, monitoring and prognosis of Waldenstroms macroglbulinaemia.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K113823 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113823: Hevylite Human Igm Kappa and Hevylite Igm Lambda Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113823
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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