# K201496: N Latex FLC kappa, N Latex FLC lambda

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics Products GmbH
- Decided: Oct 29, 2021 after 511 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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

## 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 FLC 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. Results of FLC measurements should always be interpreted in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K201496
Methodology: https://510kreport.com/methodology