# K210623: FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2

- Pathway: 510(k) (Traditional)
- Applicant: Sebia
- Decided: Nov 18, 2022 after 626 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 K031016 (2003). 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)
- K031016: Freelite Human Kappa and Lambda Free Kits for Use on the Dad Behring Nephelometer II, The Binding Site, Ltd. (2003) Summary page 7.

## Indications for use
The FLC Kappa kit is intended for the quantification of Kappa free light chains in human serum from adults with an Enzyme-Linked Immunosorbent Assay (ELISA) procedure. Measurement of free light chains aids in the diagnosis of multiple myeloma and AL amyloidosis. It must be used in conjunction with other laboratory and clinical findings. For In Vitro Diagnostic Use. The FLC Lambda kit is intended for the quantification of Lambda free light chains in human serum from adults with an Enzyme-Linked Immunosorbent Assay (ELISA) procedure. Measurement of free light chains aids in the diagnosis of multiple myeloma and AL amyloidosis. It must be used in conjunction with other laboratory and clinical findings. For In Vitro Diagnostic Use.

Source page: https://510kreport.com/device/K210623
Methodology: https://510kreport.com/methodology