510(k) · Cleared
ClearedARK Levetiracetam II Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ark Diagnostics, Inc. · ORI Levetiracetam Assay
Cleared on Feb 27, 2024 as substantially equivalent to K091653 (Ark Diagnostics, Inc., 2009) after a 193-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Feb 27, 2024
- Review
- 193 days
- Class
- Class II
- Product code
- ORI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K970510 (1997). 6 ancestors in all, the oldest K970509 (1997). No later device cites it as a predicate yet.
- Root · 4 generations backK970510 Innoflour Topiramate Reagent SetOxis Intl., Inc. · 1997
- 3 generations backK070645 Seradyn QMS TopiramateSeradyn, Inc. · 2007
- 2 generations backK083799 Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate…Ark Diagnostics, Inc. · 2009
- 1 generation backK091653 Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark…Ark Diagnostics, Inc. · 2009
- This deviceK232522 ARK Levetiracetam II AssayArk Diagnostics, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K970510 | Innoflour Topiramate Reagent Set | Oxis Intl., Inc. | 1997 | — |
| −3 | K070645 | Seradyn QMS Topiramate | Seradyn, Inc. | 2007 | — |
| −2 | 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 | — |
| 0 (this device) | K232522 | ARK Levetiracetam II Assay | Ark Diagnostics, Inc. | 2024 | — |
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 ORI? 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 |
|---|---|---|---|
| * | K091653 | Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark Levetiracetam Control…Summary page 4…807.92 (a)(3): Identification of the legally marketed predicate device Predicate Device Name: ARK Levetiracetam Assay Predicate Device 510(k) Number: K091653 ARK Diagnostics, Inc. – 510(k) Summary, Rev. 0 Page 05-2 of 05-11 ARK Levetiracetam II Assay === Page 5… | 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 27 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All ORI devicesORI Levetiracetam Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · ORI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · ORI
Too few ORI 510(k)s in any year since 2007 to give a median.
Recalls per year · ORI
No recall names ORI since 2007.
Adverse event reports per year · ORI
No MAUDE report names ORI since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 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 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ARK Levetiracetam II Assay: The ARK Levetiracetam II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of levetiracetam in human serum or plasma on automated clinical chemistry analyzers. Levetiracetam concentrations can be used as an aid in management of patients treated with levetiracetam.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232522: ARK Levetiracetam II Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232522
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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