510(k) · Cleared
ClearedTopiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models 5015-0001-000, 5015-0002-00, 5015-0003-00
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 Apr 16, 2009 as substantially equivalent to K070645 (Seradyn, Inc., 2007) and 2 other predicates after a 115-day review. Its family tree reaches back 2 generations to 1997. 5 later devices descend from it.
- Decided
- Apr 16, 2009
- Review
- 115 days
- Class
- Class II
- Product code
- NWM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K970510 (1997). 4 ancestors in all, the oldest K970509 (1997). 5 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK970510 Innoflour Topiramate Reagent SetOxis Intl., Inc. · 1997
- 1 generation backK070645 Seradyn QMS TopiramateSeradyn, Inc. · 2007
- This deviceK083799 Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate…Ark Diagnostics, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK091653 Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark…Ark Diagnostics, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK232522 ARK Levetiracetam II AssayArk Diagnostics, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK201089 ARK Lacosamide AssayArk Diagnostics, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK153596 ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite…Ark Diagnostics, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK101574 Ark Gabapentin Assay, Ark Gabepentin Califrator, and Ark Gabapentin…Ark Diagnostics, Inc. · 2010
Most influential descendants
Showing 5 of 5 · See all- K091653Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark Levetiracetam Control…Ark Diagnostics, Inc. · 2009 · cites it directly1descendant
- K232522ARK Levetiracetam II AssayArk Diagnostics, Inc. · 2024 · 2 generations on0descendants
- K201089ARK Lacosamide AssayArk Diagnostics, Inc. · 2021 · cites it directly0descendants
- K153596ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK…Ark Diagnostics, Inc. · 2016 · cites it directly0descendants
- K101574Ark Gabapentin Assay, Ark Gabepentin Califrator, and Ark Gabapentin Control…Ark Diagnostics, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970510 | Innoflour Topiramate Reagent Set | Oxis Intl., Inc. | 1997 | — |
| −1 | K070645 | Seradyn QMS Topiramate | Seradyn, Inc. | 2007 | — |
| 0 (this device) | K083799 | Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models… | Ark Diagnostics, Inc. | 2009 | — |
| +1 | K091653 | Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark Levetiracetam… | Ark Diagnostics, Inc. | 2009 | — |
| +2 | K232522 | ARK Levetiracetam II Assay | Ark Diagnostics, Inc. | 2024 | — |
| +1 | K201089 | ARK Lacosamide Assay | Ark Diagnostics, Inc. | 2021 | — |
| +1 | K153596 | ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator… | Ark Diagnostics, Inc. | 2016 | — |
| +1 | K101574 | Ark Gabapentin Assay, Ark Gabepentin Califrator, and Ark Gabapentin Control… | Ark Diagnostics, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K070645 | Seradyn QMS TopiramateSummary page 1…CFR 862.3200 DLJ, 21 CFR 862.3280 LAS) 807.92 (a)(3): Identification of the legally marketed predicate device Seradyn QMS® Topiramate Assay K070645 Seradyn QMS® Topiramate Calibrator K970509 INNOFLUOR Seradyn QMS® Topiramate Control… | 2007 |
| * | K970509 | Innoflour Calibrator Reagent SetSummary page 1…ion of the legally marketed predicate device Seradyn QMS® Topiramate Assay K070645 Seradyn QMS® Topiramate Calibrator K970509 INNOFLUOR Seradyn QMS® Topiramate Control K970517 INNOFLUOR ARK Diagnostics, Inc. - 5 10(k) Summary… | 1997 |
| * | K970517 | Innofluor Topiramate Control SetSummary page 1…K070645 Seradyn QMS® Topiramate Calibrator K970509 INNOFLUOR Seradyn QMS® Topiramate Control K970517 INNOFLUOR ARK Diagnostics, Inc. - 5 10(k) Summary, Rev. 4 page 2 of 10 807.92 (a)(… | 1997 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091653 | Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark Levetiracetam Control… | 2009 | 1 |
| K201089 | ARK Lacosamide Assay | 2021 | 0 |
| K153596 | ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK… | 2016 | 0 |
| K101574 | Ark Gabapentin Assay, Ark Gabepentin Califrator, and Ark Gabapentin Control… | 2010 | 0 |
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 12 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K091653 (Ark Diagnostics, Inc., 2009) 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. 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 ARKTM Topiramate Assay is a homogeneous enzyme immunoassay 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.
The ARKTM Topiramate Calibrator is intended for use in calibration of the ARK Topiramate Assay.
The ARKTM Topiramate Control is intended for use in quality control of the ARK Topiramate Assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083799 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083799: Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models 5015-0001-000, 5015-0002-00, 5015-0003-00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083799
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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