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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) K173732

by The Binding Site Group Ltd

Identifiers

510(k) Number
K173732 FDA 510(k)
FDA Product Code
DFH 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 Optilite Freelite Mx Kappa Free Kit and Optilite Freelite Mx Lambda Free Kit are in vitro diagnostic devices designed for the qualitative detection of free kappa and free lambda light chains in human serum or plasma. These kits fall under the category of antigen and antiserum-based assays, utilised primarily in immunology for monitoring conditions associated with abnormal light chain production, such as multiple myeloma or monoclonal gammopathy of undetermined significance.

These kits are intended for single-use and are supplied as ready-to-use reagents for laboratory testing. They are classified as Class II devices under FDA regulations and comply with the In Vitro Diagnostic Regulation (IVDR). The kits require storage at controlled temperatures as specified in the accompanying instructions, ensuring stability and accuracy of results. Authorisations include FDA 510(k) clearance and IVDR compliance, with the Kappa and Lambda variants each carrying distinct registration numbers for traceability.

Frequently asked questions

What clinical conditions are these kits primarily used to monitor in patients?

These kits are designed for monitoring conditions linked to abnormal production of free light chains, such as multiple myeloma and monoclonal gammopathy of undetermined significance (MGUS). They detect free kappa and lambda light chains in human serum or plasma, helping clinicians assess and track these immunology-related disorders.

Are these kits intended for reuse, or are they single-use only?

The Optilite Freelite Mx Kappa Free Kit and Optilite Freelite Mx Lambda Free Kit are explicitly labeled for single-use only. This ensures accuracy and safety, as reuse could compromise test integrity or introduce contamination risks.

How should these kits be stored to maintain their stability and performance?

The kits require controlled temperature storage as outlined in the accompanying instructions. While the exact specifications aren’t detailed here, proper storage conditions are critical to preserve reagent stability and ensure reliable test results.

What regulatory pathways have these devices undergone, and how does that affect their use?

Both kits have undergone FDA 510(k) clearance and comply with the In Vitro Diagnostic Regulation (IVDR). This means they meet U.S. and EU standards for safety and performance, allowing authorized laboratories to use them for clinical testing under regulatory oversight.

Are there different models or sizes available for these kits, or is there only one variant?

There are two distinct variants of the kit: one for detecting free kappa light chains and another for free lambda light chains. Each variant is designed as a standalone assay, with no additional sizes or models listed in the provided data.

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.

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) K173732 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026