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Optilite Freelite Mx Kappa Free Kit; Optilite Freelite Mx Lambda Free Kit

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K250549

by The Binding Site Group Ltd

Identifiers

510(k) Number
K250549 FDA 510(k)
FDA Product Code
DFH FDA 510(k)
Models / Variants
Optilite® Freelite Mx Kappa Free Kit FDA 510(k)EUDAMED
Optilite® Freelite Mx Lambda Free Kit FDA 510(k)EUDAMED

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 Optilite Freelite Mx Kappa Free Kit and Optilite Freelite Mx Lambda Free Kit are in vitro diagnostic devices designed for the quantitative measurement of free light chains (FLC) in serum and urine. These assays fall under the category of antigen, antiserum, and control reagents, specifically tailored for immunology applications, including the detection and monitoring of conditions such as multiple myeloma and other plasma cell dyscrasias.

These kits are supplied as single-use components for use with the Optilite analyzer and are intended for laboratory settings. Each kit provides reagents for 100 tests, with no indication of sterility or MRI compatibility. Authorized under FDA 510(k) and IVDR, they are classified as Class II devices. Storage and handling instructions are not specified in the provided data.

Frequently asked questions

What clinical conditions are these kits primarily used to monitor or detect with the Optilite analyzer?

These kits are designed for the quantitative measurement of free light chains (FLC) in serum and urine, which is particularly useful in immunology applications. They are specifically tailored for detecting and monitoring conditions such as multiple myeloma and other plasma cell dyscrasias, where abnormal levels of free light chains can indicate disease activity or progression.

Are these kits single-use or reusable, and how many tests does each kit provide?

The Optilite Freelite Mx Kappa Free Kit and Optilite Freelite Mx Lambda Free Kit are supplied as single-use components for use with the Optilite analyzer. Each kit is intended for 100 tests, making them suitable for routine laboratory use without the need for reprocessing.

What regulatory pathways have these devices undergone, and what classification do they hold?

These devices are authorized under both the FDA’s 510(k) pathway and the In Vitro Diagnostic Regulation (IVDR) in the EU. They are classified as Class II devices, which indicates a moderate level of risk and requires compliance with additional regulatory controls to ensure safety and performance.

Are these kits compatible with any specific analyzer, and how should they be stored?

The kits are specifically designed for use with the Optilite analyzer. While storage and handling instructions are not detailed in the provided data, they are intended for laboratory use, so proper storage conditions (e.g., refrigeration, protection from light) should be followed as per standard in vitro diagnostic practices to maintain reagent integrity.

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: Freelite™ Assays for Serum Free Light Chains (sFLC) | Binding Site, Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free ..., Neurological Disorders | Binding Site - Thermo Fisher Scientific, Binding Site|Freelite kits available on Optilite

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
The Binding Site Group Ltd
FDA Applicant
The Binding Site Group , Ltd.

Sources (2)

  • FDA 510(k) K250549 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026