# K153394: Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Nov 18, 2016 after 360 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 K023009 (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)
- K023009: Freelite Human Kappa and Human Lambda Free Kits for Use on the Hitachi 911/912 Analyzer, The Binding Site, Ltd. (2003) Summary page 7.
- K023131: Freelite Human Lambda Free Kit, The Binding Site, Ltd. (2003) Summary page 9.
- K040009: Freelite Human Kappa and Lambda Kits, The Binding Site, Ltd. (2004) Summary page 9.

## Indications for use
The Diazyme Human Kappa 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 Hitachi 917 analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis of multiple myeloma in conjunction with other laboratory findings. For in-vitro diagnostic use only. Diazyme Human Kappa/Lambda FLC Calibrator (DZ169A-CAL) is intended for use in establishing the calibration curve for the Diazyme Human Kappa/Lambda Free Light Chain Assay. For in-vitro diagnostic use only. Diazyme Human Kappa/Lambda FLC Control (DZ169A-CON) is intended for use in monitoring the quality control of results obtained with the Diazyme Human Kappa/Lambda Free Light Chain Assay. For in-vitro diagnostic use only. The Diazyme Human Lambda 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 Hitachi 917 analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis of multiple myeloma in conjunction with other laboratory findings. For in-vitro diagnostic use only. Diazyme Human Kappa/Lambda FLC Calibrator (DZ169A-CAL) is intended for use in establishing the calibration curve for the Diazyme Human Kappa/Lambda Free Light Chain Assay. For in-vitro diagnostic use only. Diazyme Human Kappa/Lambda FLC Control (DZ169A-CON) is intended for use in monitoring the quality control of results obtained with the Diazyme Human Kappa/Lambda Free Light Chain Assay. For in-vitro diagnostic use only.

Source page: https://510kreport.com/device/K153394
Methodology: https://510kreport.com/methodology