Sandimmune Radioimmunoassay Kit

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Sandimmune(R) Radioimmunoassay Kit

Generic Name

CYCLOSPORINE RADIOIMMUNOASSAY

PMA Number

P850086 ↗

FDA Product Code

LTB

Device Class

Class II

Regulation

21 CFR Part 862.1235

Advisory Committee

Clinical Chemistry

FDA Decision

APPR Approved

PMA Supplement

S001 (Normal 180 Day Track)

• What clinical setting or specialty is this device primarily intended for use in, and why?

  This device is primarily intended for use in clinical chemistry laboratories, particularly within specialties like transplant medicine, nephrology, or immunology where cyclosporine therapy is monitored. The advisory committee classification under Clinical Chemistry and the device’s role in quantifying cyclosporine levels in blood, plasma, or serum align with settings where precise drug monitoring is critical to adjust dosing, manage toxicity, and ensure therapeutic efficacy in patients (e.g., organ transplant recipients).

• Is this kit designed for single-use or repeated use, and what does that mean for my lab’s workflow?

  The kit is explicitly designed for single-use only, meaning each kit is intended for one assay procedure. This design ensures sterility and accuracy, as reuse could compromise integrity or introduce contamination. Your lab will need to account for this in workflow planning—ordering kits in advance to avoid interruptions and disposing of used components per radiation safety protocols (since radioimmunoassay involves radioactive materials).

• How does the use of monoclonal antibodies in this kit differ from older versions, and what does that imply for test accuracy?

  This kit replaces the prior polyclonal antibody method with monoclonal antibodies for both specific and non-specific binding, as noted in the FDA approval for a change in assay components (PMA supplement S001). Monoclonal antibodies offer higher specificity and reproducibility, which can reduce variability in results and improve the precision of cyclosporine concentration measurements. This change likely enhances the kit’s reliability for clinical decision-making compared to earlier versions.

• What safety measures should my lab implement when handling this kit, given its classification as a radioimmunoassay?

  Since this kit employs radioimmunoassay technology, your lab must adhere to standard radiation safety protocols for handling, storage, and disposal of radioactive materials. This includes using lead shielding, minimizing exposure time, and following local/regional regulations for radioactive waste management. The manufacturer’s documentation will outline specific handling instructions, and your lab’s radiation safety officer should oversee its use to ensure compliance with occupational and environmental protection standards.

• Are there specific storage conditions or shelf life details I should confirm before using this kit?

  The exact storage conditions and shelf life are detailed in the accompanying documentation provided by the manufacturer, as the data does not specify these parameters directly. Typically, radioimmunoassay kits require refrigeration (e.g., 2–8°C) and protection from light, but you should verify the exact requirements in the kit’s insert or with Sandoz’s technical support. Expiry dates are critical—using expired components could compromise assay accuracy or safety.