510(k) · Cleared
ClearedARK Lacosamide Assay
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 Aug 5, 2021 as substantially equivalent to K083799 (Ark Diagnostics, Inc., 2009) after a 469-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Aug 5, 2021
- Review
- 469 days
- Class
- Class II
- Product code
- NWM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970510 (1997). 5 ancestors in all, the oldest K970509 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK970510 Innoflour Topiramate Reagent SetOxis Intl., Inc. · 1997
- 2 generations backK070645 Seradyn QMS TopiramateSeradyn, Inc. · 2007
- 1 generation backK083799 Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate…Ark Diagnostics, Inc. · 2009
- This deviceK201089 ARK Lacosamide AssayArk Diagnostics, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970510 | Innoflour Topiramate Reagent Set | Oxis Intl., Inc. | 1997 | — |
| −2 | K070645 | Seradyn QMS Topiramate | Seradyn, Inc. | 2007 | — |
| −1 | K083799 | Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models… | Ark Diagnostics, Inc. | 2009 | — |
| 0 (this device) | K201089 | ARK Lacosamide Assay | Ark Diagnostics, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K083799 | Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models…Summary page 5…807.92 (a)(3): Identification of the legally marketed predicate device Predicate Device Name: ARK™ Topiramate Assay Predicate 510(k) Number: K083799 807.92 (a)(4): Device Description The ARK Lacosamide Assay is a homogeneous enzyme immunoassay based on competition between dr… | 2009 |
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 24 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K083799.
How does its category compare?
All NWM devicesNWM Immunoassay, Anti-Seizure Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Lacosamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of lacosamide in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of lacosamide to help ensure appropriate therapy.
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/K201089 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201089: ARK Lacosamide Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201089
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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