510(k) · Cleared
ClearedARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ark Diagnostics, Inc. · POX Enzyme Immunoassay, Oxcarbazepine Metabolite
Cleared on Aug 9, 2016 as substantially equivalent to K010814 (Syva Co., Dade Behring, Inc., 2001) and 1 other predicate after a 237-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Aug 9, 2016
- Review
- 237 days
- Class
- Class II
- Product code
- POX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K970510 (1997). 6 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 deviceK153596 ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite…Ark Diagnostics, Inc. · 2016
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) | K153596 | ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator… | Ark Diagnostics, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2001 | 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 POX? 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? (2)
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 |
|---|---|---|---|
| * | K010814 | Emit 2000 Carbamazepine Assay, Model OSR4F229Summary page 4…CFR 862.3200 DLJ; 21 CFR 862.3280 LAS 807.92 (a)(3): Identification of the legally marketed predicate device Emit® 2000 Carbamazepine Assay K010814 ARK™ Topiramate Calibrator K083799 ARK™ Topiramate Control K0837… | 2001 |
| * | K083799 | Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models…Summary page 4…ion of the legally marketed predicate device Emit® 2000 Carbamazepine Assay K010814 ARK™ Topiramate Calibrator K083799 ARK™ Topiramate Control K083799 ARK Diagnostics, Inc. – 510(k) Summary Rev 08… | 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 19 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All POX devicesPOX Enzyme Immunoassay, Oxcarbazepine Metabolite: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · POX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · POX
Too few POX 510(k)s in any year since 2007 to give a median.
Recalls per year · POX
No recall names POX since 2007.
Adverse event reports per year · POX
No MAUDE report names POX 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 | 0 | — | 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 | 1 | — | 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 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ARK™ Oxcarbazepine Metabolite Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of Oxcarbazepine Metabolite in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of Oxcarbazepine Metabolite to help ensure appropriate therapy.
The ARK™ Oxcarbazepine Metabolite Calibrator is intended for use in calibration of the ARK Oxcarbazepine Metabolite Assay.
The ARK™ Oxcarbazepine Metabolite Control is an assayed quality control material intended for use in quality control of the ARK Oxcarbazepine Metabolite 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/K153596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153596: ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153596
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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