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Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay

FDA 510(k)

Class II (US FDA 510(k))

510(k) K181438

by Diazyme Laboratories, Inc.

Identifiers

510(k) Number
K181438 FDA 510(k)
FDA Product Code
DFH FDA 510(k)
Models / Variants
Diazyme Human Kappa Free Light Chain Assay FDA 510(k)
Diazyme Human Lambda Free Light Chain Assay FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5550 FDA 510(k)
Regulation Number
866.5550 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Diazyme Human Kappa Free Light Chain Assay and Diazyme Human Lambda Free Light Chain Assay are in vitro diagnostic devices used for the quantitative measurement of human kappa and lambda free light chains in serum. These assays are designed to aid in the assessment of immune system disorders and hematologic conditions by measuring free light chain levels, which can be elevated in conditions such as multiple myeloma and other plasma cell dyscrasias.

The assays are supplied in a liquid stable format requiring no reagent preparation, which reduces sample handling and saves time. They are intended for use in clinical laboratory settings and have been cleared by the FDA under 510(k) submission K181438. The device is classified as a Class II medical device under regulation number 866.5550 and is authorized for marketing in the United States.

Frequently asked questions

What is the Diazyme Human Kappa Free Light Chain Assay used for?

The Diazyme Human Kappa Free Light Chain Assay is used for the quantitative measurement of human kappa free light chains in serum to aid in the assessment of immune system disorders and hematologic conditions, such as multiple myeloma and other plasma cell dyscrasias, by measuring elevated free light chain levels.

How is the Diazyme Human Lambda Free Light Chain Assay supplied and prepared for use?

The Diazyme Human Lambda Free Light Chain Assay is supplied in a liquid stable format that requires no reagent preparation, which reduces sample handling and saves time in clinical laboratory settings.

Is the Diazyme Human Kappa Free Light Chain Assay intended for single-use or reuse?

The Diazyme Human Kappa Free Light Chain Assay is intended for single-use in clinical laboratory settings, as it is an in vitro diagnostic reagent designed for one-time application per test to ensure accurate quantitative measurement of kappa free light chains in serum.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Human Kappa Free Light Chain Assay - Diazyme Laboratories, PDF HUMAN KAPPA (Ƙ) AND LAMBDA (λ FREE LIGHT CHAIN ASSAYS - diazyme.com, Free Light Chain Assay White Paper | Cancer Biomarkers

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Diazyme Laboratories, Inc.

Sources (1)

  • FDA 510(k) K181438 24 fields · synced Sep 22, 2026