# K120056: Human Kappa and Lambda Free Kitfor Use on the Spa Plus Analyser

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: Apr 1, 2013 after 448 days
- Product code: DFH (Kappa, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5550
- 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. The FDA summary names no predicate by number.

## Indications for use
This kit is intended for the quantitation of kappa free light chains in serum and urine on Binding Site SPAPLUS. Measurement of free light chains in serum aids inthe diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrdm's macroglobulinaemnia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. Measurement of free light chains in urine aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrbm's macroglobulinaemnia, AL amyloidosis and light chain deposition disease in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K120056
Methodology: https://510kreport.com/methodology