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Freelite Human Kappa and Lambda Kits

by The Binding Site, Ltd. 510(k)

Active United States

510(k) K040009

Overview

Freelite Human Kappa and Lambda Kits are turbidimetric immunoassays designed to measure kappa and lambda free light chains in human serum. The assays use affinity-purified polyclonal antibodies coated onto latex particles for specific detection of kappa (κ) and lambda (λ) free light chains.

Each kit provides components required to perform 100 free kappa or 100 free lambda assays and is liquid stable. The device is cleared under FDA 510(k) K040009, classified as a Class II device with product code DFH, and is intended for use in immunology testing.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040009 Date11 Mar 2004ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DFH
Device Class
Class II
Regulation
21 CFR Part 866.5550
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Freelite Human Kappa and Lambda Kit used for?

    The Freelite Human Kappa and Lambda Kit is a turbidimetric immunoassay designed to measure kappa and lambda free light chains in human serum, aiding in the assessment of plasma cell disorders and kidney disease when used alongside other clinical findings.

  • How many tests can be performed with one Freelite Kappa or Lambda Kit?

    Each Freelite Kappa or Lambda Kit provides sufficient reagents to perform 100 free kappa or 100 free lambda assays, as the components are formulated and packaged for that specific test volume.

  • Is the Freelite Kappa and Lambda Kit supplied in a liquid-stable format?

    Yes, the Freelite Human Kappa and Lambda Kits are liquid stable, meaning the reagents are ready to use and do not require reconstitution, which helps reduce preparation time and potential errors in the laboratory workflow.