# K140105: Hevylite Human Iga Kappa Kit for Use on Siemens Bnii, Hevylite Human Iga Lambda Kit for Use on Siemens Bnii

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site
- Decided: Mar 18, 2014 after 62 days
- Product code: OPX (Immunoglobulin A Kappa Heavy & 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
Hevylite Human IgA Kappa is a quantitative in vitro assay performed on the Siemens BN' It nephelonieter for the mecasurement of IIgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serom. Measurement of Hevylile Human IgA Kappa is used alongside Hevylite Human IgA Lambda to calculate the ]&A Kappa I IgA Lambda ratio. Ihe I levylite I luman IgA Kappa/I IgA Lambda ratio can be used when monitoring previously diagnosed tgA multiple mycloma and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including imniunofixation. bone marrow and urine assessments. Hevylite Human IgA Lambda is a quantitative in vitmo assay performed on the Sicrmens I)N I I nephelomecter for the measuremnt of IgA Lambda (lgA heavy chain and Lambda light chain intact imniunoglobulin) in serum. Measurement or alevylit Human IgA Lambda is used alongside Hevylite Human IgA Kappa to calculate the IgA Kappa / IgA Lambhda ratio.T1k I tevylite Itluman IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple mycloma and is used in conjlunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon oilier tests including immunofixation, bone marrow and urine assessments.

Source page: https://510kreport.com/device/K140105
Methodology: https://510kreport.com/methodology