510(k) · Cleared
ClearedArk Gabapentin Assay, Ark Gabepentin Califrator, and Ark Gabapentin Control MODEL5025-0001-00, 5025-0002-00, 5025-0003-0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ark Diagnostics, Inc. · OTF Gabapentin Assay
Cleared on Nov 23, 2010 as substantially equivalent to K083799 (Ark Diagnostics, Inc., 2009) after a 169-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Nov 23, 2010
- Review
- 169 days
- Class
- Class II
- Product code
- OTF
- 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 deviceK101574 Ark Gabapentin Assay, Ark Gabepentin Califrator, and Ark Gabapentin…Ark Diagnostics, Inc. · 2010
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) | 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 |
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 OTF? 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 1…(21 CFR 862.3200 DLJ, 21 CER 862.3280 LAS) 807.92 (a)(3): Identification of the legally marketed predicate device ARKTm Topiramate Assay K083799 (bundled) ARKTm Topiramate Calibrator ARKTm Topiramate Control ARK Diagnostics, Inc. - 5 10(k) Summary… | 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 13 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.
- 3 other devices also cite its predicate K083799.
How does its category compare?
All OTF devicesOTF Gabapentin Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OTF
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · OTF
Too few OTF 510(k)s in any year since 2007 to give a median.
Recalls per year · OTF
No recall names OTF since 2007.
Adverse event reports per year · OTF
No MAUDE report names OTF 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 | 1 | — | 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 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ARK™ Gabapentin Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of gabapentin in human serum or plasma on automated clinical chemistry analyzers.
Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin.
The ARK™ Gabapentin Calibrator is intended for use in calibration of the ARK Gabapentin Assay.
The ARK™ Gabapentin Control is intended for use in quality control of the ARK Gabapentin 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/K101574 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101574: Ark Gabapentin Assay, Ark Gabepentin Califrator, and Ark Gabapentin Control MODEL5025-0001-00, 5025-0002-00, 5025-0003-0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101574
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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