# K031016: Freelite Human Kappa and Lambda Free Kits for Use on the Dad Behring Nephelometer II

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Jul 15, 2003 after 106 days
- Product code: DEH (Lambda, 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.
8 later devices descend from it; 6 cite it directly.
0 of 9 devices 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.

## Most influential descendants
- K182098: N Latex FLC kappa assay, N Latex FLC lambda assay (2018), 2 descendants of its own
- K171742: N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 (2017), 2 descendants of its own
- K201496: N Latex FLC kappa, N Latex FLC lambda (2021), 1 descendant of its own
- K193047: N Latex FLC kappa, N Latex FLC lambda (2021), 1 descendant of its own
- K231601: FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 (2024), 0 descendants of its own

## Indications for use
This kit is intended for the quantitation of kappa free light chains in serum and urine on the Dade Behring Nephelometer II (BNII). Measurement of the various amounts of the different types of 1light chains aids in the diagnosis and monitoring of nultiple myeloma, lymphocytic neoplasms, Waldenstrom’s macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic: Jupus erythemoatosus. This kit is intended for the quantitation of lambda free light chains in serum and urine on the Dade Behring Nephelometer II (BNII). Measurement of the various amounts of the different types of 1light chains aids in the diagnosis and monitoring of multiple nyeloma, lymphocytic neoplasms, Waldenstrom’s macroglobulinenia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythemoatosus.

Source page: https://510kreport.com/device/K031016
Methodology: https://510kreport.com/methodology