Freelite Human Kappa and Lambda Free Diagnostic Test Kits for Roche Cobas Integra 400/400 Plus Analyzer

• • Terminated Z-2030-2021 FDA Class II ·initiated 20 May 2021

  The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.

Full name

Freelite Human Kappa and Lambda Free Diagnostic Test Kits for Use on the Roche Cobas Integra 400/400 Plus Analyzer Kit

510(k) Number

K070900 ↗

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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• What clinical conditions are these test kits primarily used to evaluate in patients?

  The Freelite Human Kappa and Lambda Free Diagnostic Test Kits are designed to measure free light chains in human serum or plasma, which serve as critical biomarkers for diagnosing and monitoring conditions like multiple myeloma, monoclonal gammopathy of undetermined significance (MGUS), and other plasma cell dyscrasias. These assays help clinicians assess abnormalities in light chain production, aiding in the evaluation of these hematologic disorders.

• Are these test kits compatible with other analyzers besides the Roche Cobas Integra 400/400 Plus?

  No, these test kits are exclusively intended for use on the Roche Cobas Integra 400 and 400 Plus analyzers. The design and reagents are optimized for automated processing on these specific platforms, so compatibility with other systems is not supported or validated.

• How should the test kits be stored, and what precautions should be taken during handling?

  The Freelite test kits follow standard laboratory protocols for in vitro diagnostics, which typically require storage under refrigerated conditions (between 2°C and 8°C) to maintain stability and integrity. They should be protected from light, extreme temperatures, and contamination. Since they are single-use reagents, proper labeling and inventory management are essential to prevent cross-contamination or misuse.

• Are these kits reusable, or do they need to be sterilized between uses?

  The Freelite test kits are single-use reagents, meaning each kit is designed for one analysis only. No additional sterilization is required, as they are pre-packaged and intended for immediate use in the Roche Cobas Integra 400/400 Plus analyzer. This design minimizes the risk of contamination and ensures consistent, reliable results.

• What regulatory pathways have these test kits undergone, and what does that mean for their use?

  The Freelite test kits have been cleared through the FDA 510(k) pathway and comply with the EU In Vitro Diagnostic Regulation (IVDR), confirming their safety, performance, and regulatory compliance. This means they meet stringent standards for accuracy, reliability, and clinical utility in measuring free light chains, ensuring they can be confidently used in diagnostic settings for the intended conditions. The classification as Class II devices also reflects their moderate risk level.