510(k) · Cleared
ClearedQMS Zonisamide Reagents, Calibrators and Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seradyn, Inc. · NWM Immunoassay, Anti-Seizure Drug
Cleared on Nov 18, 2005 as substantially equivalent to K955562 (Oxis Intl., Inc., 1996) after a 191-day review. Its family tree reaches back 1 generation to 1996. 3 later devices descend from it.
- Decided
- Nov 18, 2005
- Review
- 191 days
- Class
- Class II
- Product code
- NWM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955562 (1996). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK955562 Innofluor Phenytoin Assay SystemOxis Intl., Inc. · 1996
- This deviceK051211 QMS Zonisamide Reagents, Calibrators and ControlsSeradyn, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK062966 QMS Lamotrigine Assay (Reagents), Calibrators & ControlsSeradyn, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK101305 Ark Lamotrigine Assay, Calibrator & ControlArk Diagnostics, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK091884 Ark Zonisamide Assay, Ark Zonisamide Calibrator, and Ark Zonisamide…Ark Diagnostics, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See all- K062966QMS Lamotrigine Assay (Reagents), Calibrators & ControlsSeradyn, Inc. · 2007 · cites it directly1descendant
- K101305Ark Lamotrigine Assay, Calibrator & ControlArk Diagnostics, Inc. · 2010 · 2 generations on0descendants
- K091884Ark Zonisamide Assay, Ark Zonisamide Calibrator, and Ark Zonisamide Contro, Models…Ark Diagnostics, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955562 | Innofluor Phenytoin Assay System | Oxis Intl., Inc. | 1996 | — |
| 0 (this device) | K051211 | QMS Zonisamide Reagents, Calibrators and Controls | Seradyn, Inc. | 2005 | — |
| +1 | K062966 | QMS Lamotrigine Assay (Reagents), Calibrators & Controls | Seradyn, Inc. | 2007 | — |
| +2 | K101305 | Ark Lamotrigine Assay, Calibrator & Control | Ark Diagnostics, Inc. | 2010 | — |
| +1 | K091884 | Ark Zonisamide Assay, Ark Zonisamide Calibrator, and Ark Zonisamide Contro… | Ark Diagnostics, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
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 |
|---|---|---|---|
| * | K955562 | Innofluor Phenytoin Assay SystemSummary page 1…Zonisamide Control set is intended for use in quality control of the QMS Zonisamide assay. LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCY IS CLAIMED Innofluor® Phenytoin (K955562) DESCRIPTION OF DEVICE The QMS@ Zonisamide assay system is a homogeneous assay utilizing particle agglutination technology and i… | 1996 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K062966 (Seradyn, Inc., 2007) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NWM devicesNWM Immunoassay, Anti-Seizure Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051211: QMS Zonisamide Reagents, Calibrators and Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051211
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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