# K152389: Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: Dec 18, 2015 after 116 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Optilite Hevylite IgM Kappa Kit is intended for the quantitative in vitro measurement of IgM kappa (combined 1 heavy and « light chain) in serum using the Binding Site Optilite analyser. The test result is to be used with previously diagnosed Waldenstrom’s macroglobulinaemia. The test result should be used in conjunction with other laboratory and clinical findings. This assay has not been established for the diagnosis, monitoring and prognosis of Waldenstrém’s macroglobulinaemia. The Optilite Hevylite IgM Lambda Kit is intended for the quantitative in vitro measurement of IgM lambda (combined p heavy and A light chain) in serum using the Binding Site Optilite analyser. The test result is to be used with previously diagnosed Waldenstrom’s macroglobulinaemia. The test result should be used in conjunction with other laboratory and clinical findings. This assay has not been established for the diagnosis, monitoring and prognosis of Waldenstrom’s macroglobulinaemia.

Source page: https://510kreport.com/device/K152389
Methodology: https://510kreport.com/methodology