# K140396: Freelite Human Lambda Free Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: Apr 16, 2014 after 57 days
- Product code: DEH (Lambda, 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.
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.

## Recalls of this device
- Oct 15, 2021 · Class II · Z-0274-2022: Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated

## Indications for use
The kit is intended for the quantitation of lambda free light chains in serum and urine on Binding Site SPAPLUS. Measurement of free light chains in serum aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstr6m's macroglobulinaemnia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythemnatosus (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, Waldenstrdm's macroglobulinaemnia, AL arnyloidosis and light chain deposition disease in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K140396
Methodology: https://510kreport.com/methodology