# K212379: N Latex FLC kappa, N Latex FLC lambda

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics Products GmbH
- Decided: Mar 2, 2022 after 212 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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.
- K193047: N Latex FLC kappa, N Latex FLC lambda, Siemens Healthcare Diagnostics Products GmbH (2021) Summary page 5.
- K201496: N Latex FLC kappa, N Latex FLC lambda, Siemens Healthcare Diagnostics Products GmbH (2021). Cleared while this submission was under review Summary page 5.

## Indications for use
N Latex FLC kappa and lambda are in-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTA-plasma. N Latex FL.C kappa and lambda assays are used: » as an aid in the diagnosis and monitoring of multiple myeloma (MM) on the BN Systems and Atellica® CH Analyzer. » as an aid in the diagnosis of immunoglobulin light-chain amyloidosis (AL) on the BN Systems and Atellica® CH Analyzer. * as an aid in the monitoring of immunoglobulin light-chain amyloidosis (AL) on the BN Systems. » as an aid in the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS) on the BN Systems and Atellica® CH Analyzer. Results of FLC measurements should always be interpreted in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K212379
Methodology: https://510kreport.com/methodology