# K070645: Seradyn QMS Topiramate

- Pathway: 510(k) (Traditional)
- Applicant: Seradyn, Inc.
- Decided: May 17, 2007 after 70 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: 1 generation back to K970510 (1997). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970510: Innoflour Topiramate Reagent Set, Oxis Intl., Inc. (1997) Summary page 1.

## Most influential descendants
- K083799: Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models 5015-0001-000, 5015-0002-00, 5015-0003-00 (2009), 5 descendants of its own
- 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

## Indications for use
The Seradyn QMS® Topiramate assay is 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.

Source page: https://510kreport.com/device/K070645
Methodology: https://510kreport.com/methodology