# K113823: Hevylite Human Igm Kappa and Hevylite Igm Lambda Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: Mar 27, 2013 after 456 days
- Product code: CFN (Method, Nephelometric, Immunoglobulins (G, A, M))
- 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K140686: Hevylite Human Igm Kappa and Lambda Kit for Use on Spaplus (2014), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K113823
Methodology: https://510kreport.com/methodology