Seradyn QMS Topiramate
by Seradyn, Inc. 510(k)
Active
510(k) K070645
Overview
The Seradyn QMS Topiramate is a homogeneous particle-enhanced turbidimetric immunoassay designed for the quantitative measurement of topiramate in human serum or plasma. Classified as an immunoassay for anti-seizure drugs, it employs a competitive binding mechanism between drug-coated microparticles and topiramate in the sample for antibody sites. This assay provides objective, automated detection of topiramate levels, supporting clinical decision-making in toxicology and pharmacotherapy monitoring. The device operates on automated clinical chemistry analyzers, ensuring precision and reproducibility in laboratory settings.
This assay is supplied as a reusable reagent for use on designated analyzers, requiring no additional sterility measures beyond standard laboratory protocols. It is regulated under 21 CFR 862.3350 and holds FDA 510(k) clearance (K070645) as a substantially equivalent device, classified as Class II. Storage and handling follow manufacturer guidelines for immunoassay reagents, with compatibility confirmed for automated systems in clinical toxicology workflows. No MRI safety or single-use specifications are applicable to this device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK070645 | Date17 May 2007 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- NWM
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3350
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Seradyn, Inc.
Questions
What clinical scenarios is the Seradyn QMS Topiramate assay primarily used for in a lab setting?
The Seradyn QMS Topiramate assay is designed for quantitative measurement of topiramate in human serum or plasma, supporting clinical toxicology and pharmacotherapy monitoring. This means it helps clinicians assess drug levels in patients taking topiramate for seizure management, ensuring proper dosing and identifying potential toxicity or non-compliance.
Is the Seradyn QMS Topiramate assay single-use or reusable, and what does that mean for my lab’s workflow?
The assay is supplied as a reusable reagent for use on designated automated clinical chemistry analyzers. This means it can be used repeatedly within the same analyzer system, reducing waste and streamlining workflows—though it requires adherence to standard laboratory protocols for handling and storage, as with any immunoassay reagent.
How does the assay’s competitive binding mechanism work, and why does it matter for accuracy?
The assay uses a competitive binding mechanism where drug-coated microparticles compete with topiramate in the patient sample for antibody sites. This design ensures precise quantification by directly correlating the amount of topiramate present to the turbidity detected, providing objective, automated results that minimize human error and improve reproducibility in clinical decision-making.
What storage and handling requirements should my lab follow for the Seradyn QMS Topiramate reagent?
The reagent follows standard immunoassay storage guidelines, as outlined by the manufacturer. Since it’s reusable and designed for automated systems, it should be stored according to the manufacturer’s instructions (typically at controlled temperatures to preserve stability) and handled in a clean, controlled lab environment. No additional sterility measures beyond routine lab protocols are required, as it’s not a single-use or sterile consumable.
Which automated analyzers is the Seradyn QMS Topiramate assay compatible with, and how does that affect my lab’s equipment needs?
The assay is explicitly designed for use on automated clinical chemistry analyzers, though the exact compatible models are specified in the manufacturer’s instructions. This compatibility ensures seamless integration into existing toxicology workflows, reducing manual intervention and leveraging the analyzer’s precision for consistent, high-volume testing. Always verify compatibility with your lab’s specific equipment before use.