# K091884: Ark Zonisamide Assay, Ark Zonisamide Calibrator, and Ark Zonisamide Contro, Models 5022-0001-00, 5022-0002-00, 5022-0003

- Pathway: 510(k) (Traditional)
- Applicant: Ark Diagnostics, Inc.
- Decided: Dec 9, 2009 after 168 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 K955562 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051211: QMS Zonisamide Reagents, Calibrators and Controls, Seradyn, Inc. (2005) Summary page 1.

## Indications for use
The ARK™ Zonisamide Assay is a homogeneous enzyme immunoassay 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 ARK™ Zonisamide Calibrator is intended for use in calibration of the ARK Zonisamide Assay. The ARK™ Zonisamide Control is intended for use in quality control of the ARK Zonisamide Assay.

Source page: https://510kreport.com/device/K091884
Methodology: https://510kreport.com/methodology