510(k) · Cleared
ClearedSeradyn QMS Topiramate
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 May 17, 2007 as substantially equivalent to K970510 (Oxis Intl., Inc., 1997) after a 70-day review. Its family tree reaches back 1 generation to 1997. 6 later devices descend from it.
- Decided
- May 17, 2007
- Review
- 70 days
- Class
- Class II
- Product code
- NWM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970510 (1997). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK970510 Innoflour Topiramate Reagent SetOxis Intl., Inc. · 1997
- This deviceK070645 Seradyn QMS TopiramateSeradyn, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK083799 Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate…Ark Diagnostics, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK091653 Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark…Ark Diagnostics, Inc. · 2009
- Descendant · 3 generations on · 0 of its ownK232522 ARK Levetiracetam II AssayArk Diagnostics, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK201089 ARK Lacosamide AssayArk Diagnostics, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK153596 ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite…Ark Diagnostics, Inc. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K083799Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models…Ark Diagnostics, Inc. · 2009 · cites it directly5descendants
- K091653Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark Levetiracetam Control…Ark Diagnostics, Inc. · 2009 · 2 generations on1descendant
- K232522ARK Levetiracetam II AssayArk Diagnostics, Inc. · 2024 · 3 generations on0descendants
- K201089ARK Lacosamide AssayArk Diagnostics, Inc. · 2021 · 2 generations on0descendants
- K153596ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK…Ark Diagnostics, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970510 | Innoflour Topiramate Reagent Set | Oxis Intl., Inc. | 1997 | — |
| 0 (this device) | K070645 | Seradyn QMS Topiramate | Seradyn, Inc. | 2007 | — |
| +1 | K083799 | Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models… | Ark Diagnostics, Inc. | 2009 | — |
| +2 | K091653 | Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark Levetiracetam… | Ark Diagnostics, Inc. | 2009 | — |
| +3 | K232522 | ARK Levetiracetam II Assay | Ark Diagnostics, Inc. | 2024 | — |
| +2 | K201089 | ARK Lacosamide Assay | Ark Diagnostics, Inc. | 2021 | — |
| +2 | K153596 | ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator… | Ark Diagnostics, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K970510 | Innoflour Topiramate Reagent SetSummary page 1…opiramate to help ensure appropriate therapy. LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCY IS CLAIMED Seradyn Innofluor®~ Topiramate assay K97051 0 DESCRIPTION OF DEVICE The Seradyn QMS® Topiramate assay is a homogeneous particle-enhanced turbidimetric immunoassay. The assay… | 1997 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083799 | Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models… | 2009 | 5 |
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, K083799 (Ark Diagnostics, Inc., 2009) has gone furthest, with 5 descendants 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. 2007, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070645 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070645: Seradyn QMS Topiramate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070645
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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