# K082823: Hevylite Human Iga Kappa and Iga Lambda BN Kits

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: Mar 1, 2010 after 522 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.
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
This kit is intended for the in vitro quantification of IgA Kappa (combined ai heavy and K light chain) concentration in human serum on the Siemens Behring NephelometerTM II (BNTM II). The test result is to be used with previously diagnosed IgA multiple myelomna, in conjunction with other clinical and laboratory findings. This kit is intended for the in vitro quantification of IgA Lambda (combined a heavy and A light chain) concentration in human serum on the Siemens Behring Nephelometer TM II (BNTM~ II). The test result is, to be used with previously diagnosed IgA multiple myelomia, in conjunction with other clinical and laboratory findings.

Source page: https://510kreport.com/device/K082823
Methodology: https://510kreport.com/methodology