# K231290: Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Jan 24, 2024 after 265 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
Longest line of descent: 1 generation back to K070900 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070900: Freelite Human Kappa and Lambda Free Diagnostic Test Kits for Use on the Roche Cobas Integra 400/400 Plus Analyzer Kit, The Binding Site, Ltd. (2007) Summary page 5.

## Indications for use
The Optilite Freelite Kappa Free Kit is intended for the quantitative in vitro measurement of Kappa free light chains in serum using the Binding Site Optilite analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström’s macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE), and aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS). Results of the free light chain measurements should always be interpreted in conjunction with other laboratory and clinical findings. The Optilite Freelite Lambda Free Kit is intended for the quantitative in vitro measurement of Lambda free light chains in serum using the Binding Site Optilite analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström’s macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE), and aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS). Results of the free light chain measurements should always be interpreted in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K231290
Methodology: https://510kreport.com/methodology