# K083799: Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models 5015-0001-000, 5015-0002-00, 5015-0003-00

- Pathway: 510(k) (Traditional)
- Applicant: Ark Diagnostics, Inc.
- Decided: Apr 16, 2009 after 115 days
- Product code: NWM (Immunoassay, Anti-Seizure Drug)
- Device class: 2
- Regulation: 21 CFR 862.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970510 (1997). 4 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070645: Seradyn QMS Topiramate, Seradyn, Inc. (2007) Summary page 1.
- K970509: Innoflour Calibrator Reagent Set, Oxis Intl., Inc. (1997) Summary page 1.
- K970517: Innofluor Topiramate Control Set, Oxis Intl., Inc. (1997) Summary page 1.

## Most influential descendants
- K091653: Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark Levetiracetam Control, Models 5024-0001-00, 5024-0002-00 (2009), 1 descendant of its own
- K232522: ARK Levetiracetam II Assay (2024), 0 descendants of its own
- K201089: ARK Lacosamide Assay (2021), 0 descendants of its own
- K153596: ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control (2016), 0 descendants of its own
- K101574: Ark Gabapentin Assay, Ark Gabepentin Califrator, and Ark Gabapentin Control MODEL5025-0001-00, 5025-0002-00, 5025-0003-0 (2010), 0 descendants of its own

## Indications for use
The ARKTM Topiramate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of topiramate in human serum or plasma on automated clinical chemistry analyzers. The results obtained are used in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy. The ARKTM Topiramate Calibrator is intended for use in calibration of the ARK Topiramate Assay. The ARKTM Topiramate Control is intended for use in quality control of the ARK Topiramate Assay.

Source page: https://510kreport.com/device/K083799
Methodology: https://510kreport.com/methodology