# K253358: Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories, Inc.
- Decided: Dec 19, 2025 after 80 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 K211648 (2022). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211648: Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Laboratories, Inc. (2022) Summary page 8.

## Indications for use
The Diazyme Human Kappa (κ) Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Kappa Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis and monitoring of multiple myeloma and aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS) in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only. The Diazyme Human Lambda (λ) Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis and monitoring of multiple myeloma and aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS) in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.

Source page: https://510kreport.com/device/K253358
Methodology: https://510kreport.com/methodology