# K132555: Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site
- Decided: Dec 20, 2013 after 128 days
- Product code: PCN (Immunoglobulin G 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.
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
- K172613: Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit (2018), 0 descendants of its own

## Indications for use
Hevylite Human IgG Kappa is a quantitative in vitro assay performed on the Siemens BN II nephelometer for the measurement of IgG Kappa (IgG heavy chain and Kappa light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgG Kappa is used alongside Hevylite Human IgG Lambda to calculate the IgG Kappa / IgG Lambda ratio. The Hevylite Human IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments. Hevylite Human IgG Lambda is a quantitative in vitro assay performed on the Siemens BN II nephelometer for the measurement of IgG Lambda (IgG heavy chain and Lambda light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgG Lambda is used alongside Hevylite Human IgG Kappa to calculate the IgG Kappa / IgG Lambda ratio. The Hevylite Human IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.

Source page: https://510kreport.com/device/K132555
Methodology: https://510kreport.com/methodology