# K051211: QMS Zonisamide Reagents, Calibrators and Controls

- Pathway: 510(k) (Traditional)
- Applicant: Seradyn, Inc.
- Decided: Nov 18, 2005 after 191 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 K955562 (1996). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955562: Innofluor Phenytoin Assay System, Oxis Intl., Inc. (1996) Summary page 1.

## Most influential descendants
- K062966: QMS Lamotrigine Assay (Reagents), Calibrators & Controls (2007), 1 descendant of its own
- K101305: Ark Lamotrigine Assay, Calibrator & Control (2010), 0 descendants of its own
- K091884: Ark Zonisamide Assay, Ark Zonisamide Calibrator, and Ark Zonisamide Contro, Models 5022-0001-00, 5022-0002-00, 5022-0003 (2009), 0 descendants of its own

## Indications for use
The QMS ® Zonisamide assay is intended for the quantitative determination of zonisamide in human serum or plasma on automated clinical chemistry analyzers. Zonisamide concentrations can be used as an aid in management of patients treated with zonisamide. The QMS® Zonisamide Calibrator set is intended for use in calibration of the QMS Zonisamide assay. The QMS® Zonisamide Control set is intended for use in quality control of the QMS Zonisamide assay.

Source page: https://510kreport.com/device/K051211
Methodology: https://510kreport.com/methodology