TDX Cyclosporine and Metabolites Serum Assay

• • Terminated Z-0624-06 FDA Unclassified (pre-2012) ·initiated 23 Mar 2005

  Patient results reported using calibrators made from new primary material may be falsely decreased by 5-8% compared to results using calibrators made from the previous primary material. An Important Product Information Letter with technical information regarding the Whole Blood Calibrators and Controls, implementing new internal reference standards was issued.

Full name

Tdx Cyclosporine and Metabolites Serume Assay

Trade Name

Td Cyclosporine and Metabolites Serum Assay

Generic Name

Fluorescence polarization immunoassay for cyclosporine

PMA Number

P890025 ↗

FDA Product Code

MGU

Device Class

Class II

Regulation

21 CFR Part 862.1235

Advisory Committee

Clinical Toxicology

FDA Decision

APRL

• Architect 04J6230

  Class I

  GUDID on market

• Architect 08G9830

  Class I

  GUDID on market

• Architect 01G06-01

  Class I

  GUDID on market

• Architect 03M7401

  Class I

  GUDID on market

• Alinity 06P0107

  Not classified

  GUDID on market

• Alinity 06P0161

  Not classified

  GUDID on market

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• What clinical specialty does this assay support, and why is it important for that field?

  This assay supports Clinical Chemistry, specifically for managing immunosuppression therapy in organ transplant patients. It quantifies cyclosporine and its metabolites in serum, which is critical for ensuring proper drug dosing to prevent organ rejection while minimizing toxicity. Accurate measurement helps clinicians adjust treatment plans based on real-time patient data.

• How is the TDX Cyclosporine and Metabolites Serum Assay supplied, and what does that mean for its use in a lab?

  The assay is supplied as a reagent kit designed exclusively for use with the TDX analyzer system in clinical laboratories. This means it cannot be used independently—it requires the analyzer’s infrastructure, calibration, and maintenance protocols. The single-use nature of the kit also implies each test must be prepared fresh, reducing carryover risks but requiring careful inventory management.

• Is this device intended for reuse, and if not, what does that imply for cost and workflow?

  No, the device is intended for single-use only, as indicated by its classification as a reagent kit. This design eliminates cross-contamination risks but necessitates purchasing multiple kits for routine testing, which may impact budgeting and workflow efficiency. Labs must account for disposal costs and ensure timely reordering to avoid interruptions in immunosuppression monitoring.

• What storage conditions are required to maintain the assay’s stability, and why are these important?

  The assay requires controlled temperature storage to preserve stability, though exact conditions aren’t specified beyond this general requirement. Proper storage is critical because cyclosporine metabolites can degrade over time if exposed to improper temperatures, leading to inaccurate test results. Clinicians rely on these measurements to fine-tune patient therapy, so stability ensures consistent, reliable data for clinical decision-making.

• What does the FDA PMA approval (P890025) mean for healthcare providers using this assay?

  The FDA PMA approval (P890025) confirms that the assay meets stringent regulatory standards for in vitro diagnostic use in the United States, ensuring its safety, performance, and clinical validity. For healthcare providers, this approval signals that the assay has undergone rigorous validation for quantifying cyclosporine and its metabolites in serum, supporting evidence-based immunosuppression management in organ transplant patients. It also implies compliance with U.S. regulatory requirements for accuracy and reproducibility.