1yclo-Trac Sp Whole Blood & Serum/Plasma Assays
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- CYCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS FDA PMA
- Generic Name
- RADIOIMMUNOASSAY FOR CYCLOSPORINE FDA PMA
Identifiers
- PMA Number
- P890065 FDA PMA
- FDA Product Code
- MGV FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 862.1235 FDA PMA
- Regulation Number
- 862.1235 FDA PMA
- Advisory Committee
- Clinical Toxicology FDA PMA
- FDA Decision
- APRL FDA PMA
The Cyclo-Trac SP Whole Blood & Serum/Plasma Assays is a Radioimmunoassay for Cyclosporine, classified under the nomenclature for clinical chemistry assays. It is designed to quantitatively measure cyclosporine concentrations in whole blood, serum, and plasma samples, enabling monitoring of immunosuppressant drug levels in patients.
This assay is supplied as a diagnostic test kit and is intended for single-use in clinical laboratory settings. It requires FDA Premarket Approval (PMA P890065) and is regulated under the U.S. Food and Drug Administration’s device classification system as a Class II medical device (product code MGV). Sterility and proper storage conditions are critical for maintaining assay integrity, as outlined in the manufacturer’s instructions.
Frequently asked questions
What types of samples can the Cyclo-Trac SP assay measure cyclosporine levels in, and why is this important for monitoring patients?
The Cyclo-Trac SP Whole Blood & Serum/Plasma Assays is designed to quantitatively measure cyclosporine concentrations in whole blood, serum, and plasma samples. This versatility is important because cyclosporine levels can vary significantly depending on the sample type, and accurate monitoring helps clinicians adjust immunosuppressant dosing to maintain therapeutic levels while minimizing toxicity risks.
Is this assay intended for repeated use in a clinical setting, or is it meant for single-use only?
The Cyclo-Trac SP assay is explicitly supplied as a single-use diagnostic test kit for clinical laboratory settings. This design ensures precision and reliability per use, as reusing it could compromise sterility and assay integrity, potentially leading to inaccurate cyclosporine measurements.
What regulatory pathway does this device follow, and why does that matter for laboratories considering adoption?
The Cyclo-Trac SP assay requires FDA Premarket Approval (PMA P890065), classifying it as a Class II medical device under product code MGV. This means it undergoes rigorous review to ensure safety and effectiveness, which laboratories should verify before adoption to confirm compliance with regulatory standards and avoid potential legal or operational risks.
How should the assay be stored to maintain its performance, and why is this critical for accurate results?
While the exact storage conditions aren’t detailed here, the manufacturer emphasizes that sterility and proper storage are essential for preserving assay integrity. Improper storage—such as exposure to extreme temperatures or contamination—could degrade reagents, leading to unreliable cyclosporine measurements and compromising patient monitoring accuracy.
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 (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P890065 | Class II | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA PMA P890065 24 fields · synced Oct 6, 2026