ONLINE TDM Phenytoin - Free Phenytoin Application
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230161 FDA 510(k)
- FDA Product Code
- MOJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3350 FDA 510(k)
- Regulation Number
- 862.3350 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ONLINE TDM Phenytoin - Free Phenytoin Application is a fluorescence polarization immunoassay (FPIA) for the quantitative determination of free phenytoin in human serum and plasma. Classified as a Class II device under FDA regulation 862.3350, it measures unbound phenytoin levels to support therapeutic drug monitoring (TDM) in clinical toxicology settings. The assay is designed for use on Roche Diagnostics’ cobas c systems, providing precise measurement of free phenytoin concentrations.
This in vitro diagnostic device is supplied as a reagent kit for laboratory use and is intended for single-use per manufacturer specifications. It requires no special storage conditions beyond refrigeration and is compatible with standard clinical laboratory workflows. The device holds FDA 510(k) clearance (K230161) under the Traditional review pathway, with registration numbers 3006198300, 3003795116, 9610126, and 9610529. No MRI safety or reusable components are indicated in the specifications.
Frequently asked questions
What is the ONLINE TDM Phenytoin - Free Phenytoin Application used for?
This device is a fluorescence polarization immunoassay (FPIA) specifically for measuring unbound (free) phenytoin levels in human serum and plasma. It supports therapeutic drug monitoring (TDM) in clinical toxicology settings, helping clinicians assess phenytoin concentrations that are pharmacologically active and not protein-bound.
On which systems can the ONLINE TDM Phenytoin - Free Phenytoin Application be used?
The assay is designed exclusively for Roche Diagnostics’ cobas c systems, ensuring compatibility with laboratory workflows that rely on this platform for immunoassay-based measurements.
How is the ONLINE TDM Phenytoin - Free Phenytoin Application supplied, and is it single-use?
The device is supplied as a reagent kit intended for laboratory use. According to manufacturer specifications, it is designed for single-use per application, ensuring accuracy and sterility for each test.
What storage conditions are required for the ONLINE TDM Phenytoin - Free Phenytoin Application?
No special storage conditions are required beyond standard refrigeration. This allows for convenient integration into typical clinical laboratory environments without additional infrastructure.
Does the ONLINE TDM Phenytoin - Free Phenytoin Application have reusable components?
No, the device and its components are not intended for reuse. The single-use design aligns with best practices for maintaining sterility and preventing cross-contamination in diagnostic testing.
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. Sources consulted: PHNY2, Phenytoin - Roche Diagnostics USA, ONLINE TDM Phenytoin - Free Phenytoin application (K230161) — FDA 510 ..., PHNY2, Phenytoin - Roche Diagnostics USA, Free Online Games on CrazyGames | Play Now!
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230161 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics
Sources (1)
- FDA 510(k) K230161 24 fields · synced Oct 1, 2026