510(k) · Cleared
ClearedArk Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark Levetiracetam Control, Models 5024-0001-00, 5024-0002-00
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 Nov 2, 2009 as substantially equivalent to K083799 (Ark Diagnostics, Inc., 2009) after a 146-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- Nov 2, 2009
- Review
- 146 days
- Class
- Class II
- Product code
- ORI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970510 (1997). 5 ancestors in all, the oldest K970509 (1997). 1 later device descends from it, 1 citing it directly.
- 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 deviceK091653 Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark…Ark Diagnostics, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK232522 ARK Levetiracetam II AssayArk Diagnostics, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K232522ARK Levetiracetam II AssayArk Diagnostics, Inc. · 2024 · cites it directly0descendants
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) | K091653 | Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark Levetiracetam… | Ark Diagnostics, Inc. | 2009 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 ORI? 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 ORI device
- #1 K232522 ARK Levetiracetam II Assayscore 7.8 · 4 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 |
|---|---|---|---|
| * | K083799 | Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models…Summary page 1…dantoin Test Sysfem; Class 11 (21 CFR 862.3200 DLJ, 21 CFR 862.3280 LAS) 807.92 (a)(3): Identification of the legally marketed predicate device ARK™ Topiramate Assay ! K083799 (bundled) ARK™ Topiramate Calibrator ' ARK™ Topiramate Control ARK Diagnostics, Inc. — 510(k) Summary page 1 of 11 ARK Levetirac… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232522 | ARK Levetiracetam II Assay | 2024 | 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 1.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K232522 (Ark Diagnostics, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K083799.
How does its category compare?
All ORI devicesORI Levetiracetam Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The ARK™ Levetiracetam 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.
The ARK™ Levetiracetam Calibrator is intended for use in calibration of the ARK Levetiracetam Assay.
The ARK™ Levetiracetam Control is intended for use in quality control of the ARK Levetiracetam Assay.
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/K091653 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091653: Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark Levetiracetam Control, Models 5024-0001-00, 5024-0002-00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091653
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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