# K190879: N Latex FLC kappa, N Latex FLC lambda

- Pathway: 510(k) (Special)
- Applicant: Siemens Healthcare Diagnostics Products GmbH
- Decided: May 3, 2019 after 29 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: 2 generations back to K031016 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171742: N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2, Siemens Healthcare Diagnostics Products GmbH (2017) Summary page 5.
- K182098: N Latex FLC kappa assay, N Latex FLC lambda assay, Siemens Healthcare Diagnostics Products GmbH (2018) Summary page 5.

## 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. 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/K190879
Methodology: https://510kreport.com/methodology