Freelite Human Lambda Free Kit for Roche cobas c Systems

• • Terminated Z-0274-2022 FDA Class II ·initiated 15 Oct 2021

  Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.

Full name

Freelite® Human Lambda Free Kit for use on the Roche cobas® c Systems

Generic Name

Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry

Model / Reference

LK018.CB

Primary DI / UDI-DI

05051700012102

510(k) Number

K040009 ↗

FDA Product Code

DEH

GMDN Term

Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry

Regulation Number

866.5550

Market of Registration

Germany

Commercial Distribution

In Commercial Distribution

EUDAMED SRN

UK-MF-000036707

Authorised representative

The Binding Site Ireland Limited IE-AR-000034426

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• What clinical conditions is this kit primarily used to monitor or diagnose, and how does it help in those cases?

  The Freelite Human Lambda Free Kit quantifies free lambda light chains in human serum or plasma, which are biomarkers linked to conditions like monoclonal gammopathy of undetermined significance (MGUS) and multiple myeloma. Elevated or abnormal levels of free lambda light chains can indicate these hematologic disorders, helping clinicians assess disease progression, monitor treatment response, or detect relapse. It supports diagnostic and management decisions by providing objective measurements of these proteins.

• Is this kit sterile, and if not, what precautions should be taken during use?

  The kit is explicitly labeled as non-sterile (sterility code: 0). Since it contains human-derived materials and is intended for professional use, standard aseptic techniques should be followed when handling components, especially if opening vials or preparing samples. Users should adhere to laboratory safety protocols, including wearing gloves and avoiding contamination of reagents, to ensure accurate results and prevent cross-contamination.

• How is this kit supplied, and what systems is it compatible with?

  The Freelite Human Lambda Free Kit is supplied as a non-sterile reagent kit designed exclusively for use on Roche cobas® c Systems. It includes all necessary components for near-patient or laboratory testing, but it is not a standalone device—it requires integration with the Roche cobas c platform to perform quantitative measurements of free lambda light chains. The kit’s compatibility is limited to these systems, as indicated by the manufacturer.

• Does this kit contain animal or human tissues, and what does that mean for testing or storage?

  Yes, the kit contains human-derived materials (human tissues marked as 1) and is also associated with animal tissues (marked as 1). This means the reagents may include components sourced from human or animal origins, which could influence storage requirements (e.g., refrigeration to maintain stability) and potential considerations for testing (e.g., risk of zoonotic agents or human pathogen transmission). Users should follow the manufacturer’s instructions for storage and handling to ensure reagent integrity and safety.

• What regulatory pathways does this device follow, and how does that affect its availability or use?

  The kit is cleared under FDA 510(k) and regulated under the In Vitro Diagnostic Device Directive (IVDD) and In Vitro Diagnostic Regulation (IVDR) in the EU. These pathways ensure compliance with safety, performance, and manufacturing standards. Availability depends on regional regulatory approvals, and clinicians or laboratories should verify local compliance before use. The Basic UDI (5051700LK018.CBXT) enables traceability, which may be relevant for procurement, inventory, or audit purposes.