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Topiramate Assay, Ark Topiramate Calibrator And Ark Topiramate Control (5015-00…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K083799

by Ark Diagnostics Inc

Identifiers

510(k) Number
K083799 FDA 510(k)
FDA Product Code
NWM FDA 510(k)
Models / Variants
5015-0001-000 FDA 510(k)EUDAMED
5015-0002-00 FDA 510(k)EUDAMED
5015-0003-00 FDA 510(k)EUDAMED

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)

This device is an immunoassay system for the quantitative determination of topiramate in human serum or plasma. It includes a calibrator and control for use with automated clinical chemistry analyzers, designed to measure anti-seizure drug levels in clinical toxicology settings.

The Topiramate Assay, ARK Topiramate Calibrator, and ARK Topiramate Control are intended for use in clinical laboratories. Supplied as single-use reagents, they require no sterilization and are regulated under the In Vitro Diagnostic Device Directive (IVDD) and FDA 510(k) clearance (K083799). The calibrator (Model 5015-0001-000) and control (Model 5015-0003-00) accompany the assay (Model 5015-0002-00) for accurate measurement and monitoring.

Frequently asked questions

What clinical setting is this device primarily used for, and why is it important there?

This device is designed for use in clinical toxicology settings, particularly within clinical laboratories. It measures topiramate levels in human serum or plasma, which is critical for monitoring patients taking this anti-seizure medication. Accurate dosing helps prevent toxicity (e.g., drowsiness, cognitive impairment) or under-treatment (e.g., seizure recurrence), ensuring patient safety and therapeutic efficacy.

Are the calibrator, control, and assay single-use, and if so, why does that matter?

Yes, the ARK Topiramate Calibrator (Model 5015-0001-000), Control (Model 5015-0003-00), and Assay (Model 5015-0002-00) are all supplied as single-use reagents. This design eliminates cross-contamination risks, ensures consistent measurement accuracy, and reduces the need for sterilization—simplifying workflow and minimizing waste in laboratory environments.

How do I determine which model number corresponds to the assay itself versus the calibrator or control?

The assay is Model 5015-0002-00, while the calibrator is Model 5015-0001-000 and the control is Model 5015-0003-00. These components are packaged together for use with automated clinical chemistry analyzers, ensuring accurate quantification of topiramate levels in patient samples.

Does this device require any special handling or storage conditions?

While specific storage conditions aren’t detailed in the data, as single-use immunoassay reagents, they should be stored according to standard laboratory protocols for reagents—typically at 2–8°C (refrigerated) and protected from light. Always follow the included instructions for optimal performance, as improper storage could affect assay 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. Sources consulted: ARK Diagnostics, Inc., ARK™ Topiramate Calibrator - Sekisui Diagnostics, PDF 1600-0137-00_ARK Topiramate Calibrator_Rev06, Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control ..., Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ark Diagnostics Inc
FDA Applicant
Ark Diagnostics, Inc.

Sources (2)

  • FDA 510(k) K083799 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026