510(k) · Cleared
ClearedArk Zonisamide Assay, Ark Zonisamide Calibrator, and Ark Zonisamide Contro, Models 5022-0001-00, 5022-0002-00, 5022-0003
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ark Diagnostics, Inc. · NWM Immunoassay, Anti-Seizure Drug
Cleared on Dec 9, 2009 as substantially equivalent to K051211 (Seradyn, Inc., 2005) after a 168-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Dec 9, 2009
- Review
- 168 days
- Class
- Class II
- Product code
- NWM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955562 (1996). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955562 | Innofluor Phenytoin Assay System | Oxis Intl., Inc. | 1996 | — |
| −1 | K051211 | QMS Zonisamide Reagents, Calibrators and Controls | Seradyn, Inc. | 2005 | — |
| 0 (this device) | K091884 | Ark Zonisamide Assay, Ark Zonisamide Calibrator, and Ark Zonisamide Contro… | Ark Diagnostics, Inc. | 2009 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NWM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NWM device
- #1 K201089 ARK Lacosamide Assayscore 2.4 · 3 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051211 | QMS Zonisamide Reagents, Calibrators and ControlsSummary page 1…in Test System; Class 11 (21 CFR 862.3200 DLJ, 21 CFR 862.3280 LAS) 807.92 (a)(3): Identification of the legally marketed predicate device K051211I QMS® Zonisamide Assay, QMS®~Zonisamide Calibrator Set, QMS® Zonisamide Control Set ARK Diagnostics, Inc. -5 10(k) Summary… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 9.8 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K051211.
How does its category compare?
All NWM devicesNWM Immunoassay, Anti-Seizure Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NWM
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · NWM
Too few NWM 510(k)s in any year since 2007 to give a median.
Recalls per year · NWM
No recall names NWM since 2007.
Adverse event reports per year · NWM
1in 2024
MAUDE reports naming product code NWM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K091884 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091884: Ark Zonisamide Assay, Ark Zonisamide Calibrator, and Ark Zonisamide Contro, Models 5022-0001-00, 5022-0002-00, 5022-0003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091884
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026