# K182098: N Latex FLC kappa assay, N Latex FLC lambda assay

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics Products GmbH
- Decided: Nov 1, 2018 after 90 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.
2 later devices descend from it; 2 cite it directly.
0 of 4 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 5.

## Most influential descendants
- K212379: N Latex FLC kappa, N Latex FLC lambda (2022), 0 descendants of its own
- K190879: N Latex FLC kappa, N Latex FLC lambda (2019), 0 descendants of its own

## Indications for use
In-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTA-plasma by means of particle-enhanced immunonephelometry using the BN Systems. FLC measurements are used as an aid in the diagnosis and monitoring of multiple myeloma (MM) and as an aid in the diagnosis of amyloidosis (AL) in conjunction with other laboratory and clinical findings. The response category assignment of Complete Response for the monitoring of MM is reliant upon the combination of clinical history and other tests including protein electrophoresis, immunofixation and bone marrow, imaging and urine assessments.

Source page: https://510kreport.com/device/K182098
Methodology: https://510kreport.com/methodology