# K151759: Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: Nov 6, 2015 after 130 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 Binding Site SPAPLUS for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgA Kappa is used alongside Hevylite Human IgA Lambda to calculate the IgA Kappa / IgA Lambda ratio. The Hevylite Human IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients 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 IgA Lambda is a quantitative in vitro assay performed on The Binding Site SPAPLUS for the measurement of [gA Lambda (IgA heavy chain and Lambda light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgA Lambda is used alongside Hevylite Human IgA Kappa to calculate the IgA Kappa / IgA Lambda ratio. The Hevylite Human IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients 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/K151759
Methodology: https://510kreport.com/methodology