# K171742: N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics Products GmbH
- Decided: Nov 17, 2017 after 158 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
N Latex FLC kappa and lambda assays: 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 of multiple myeloma (MM) and amyloidosis (AL). N FLC Supplementary Reagent: Supplementary reagent for the immunonephelometric determination of free light chains (FLC), type kappa and type lambda on BN Systems. A mixture of both supplementary reagents is used to suppress interference by rheumatoid factors and human anti-mouse antibodies (HAMA). N FLC Standard SL: Establishment of reference curves for the determination of free light chains (FLC), type kappa and type lambda on the BN Systems. N FLC Controls SL1 and SL2: The N FLC Controls SL1 and SL2 are for use as assayed accuracy controls and precision controls in the determination of free light chains (FLC), type kappa and type lambda by immunonephelometry with the BN Systems.

Source page: https://510kreport.com/device/K171742
Methodology: https://510kreport.com/methodology