# K070900: Freelite Human Kappa and Lambda Free Diagnostic Test Kits for Use on the Roche Cobas Integra 400/400 Plus Analyzer Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Nov 30, 2007 after 242 days
- Product code: DFH (Kappa, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5550
- Recalls of this device: 1 (0 Class I)
- 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
- K231290: Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit (2024), 0 descendants of its own

## Recalls of this device
- May 20, 2021 · Class II · Z-2030-2021: The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.

## Indications for use
For the quantitation of kappa free light chains in serum on the Roche COBAS INTEGRA 400 and 400plus. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom’s macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings. For the quantitation of lambda free light chains in serum on the Roche COBAS INTEGRA 400 and 400plus. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom’s macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K070900
Methodology: https://510kreport.com/methodology