# K140686: Hevylite Human Igm Kappa and Lambda Kit for Use on Spaplus

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: Aug 6, 2014 after 140 days
- Product code: PDE (Immunoglobulin M Kappa Heavy And Light Chain Combined)
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K113823 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113823: Hevylite Human Igm Kappa and Hevylite Igm Lambda Kit, The Binding Site Group, Ltd. (2013) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K140686
Methodology: https://510kreport.com/methodology