510(k) · Cleared
ClearedArk Lamotrigine Assay, Calibrator & Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ark Diagnostics, Inc. · ORH Lamotrigine Assay
Cleared on Oct 29, 2010 as substantially equivalent to K062966 (Seradyn, Inc., 2007) after a 172-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Oct 29, 2010
- Review
- 172 days
- Class
- Class II
- Product code
- ORH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K955562 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK955562 Innofluor Phenytoin Assay SystemOxis Intl., Inc. · 1996
- 2 generations backK051211 QMS Zonisamide Reagents, Calibrators and ControlsSeradyn, Inc. · 2005
- 1 generation backK062966 QMS Lamotrigine Assay (Reagents), Calibrators & ControlsSeradyn, Inc. · 2007
- This deviceK101305 Ark Lamotrigine Assay, Calibrator & ControlArk Diagnostics, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955562 | Innofluor Phenytoin Assay System | Oxis Intl., Inc. | 1996 | — |
| −2 | K051211 | QMS Zonisamide Reagents, Calibrators and Controls | Seradyn, Inc. | 2005 | — |
| −1 | K062966 | QMS Lamotrigine Assay (Reagents), Calibrators & Controls | Seradyn, Inc. | 2007 | — |
| 0 (this device) | K101305 | Ark Lamotrigine Assay, Calibrator & Control | Ark Diagnostics, Inc. | 2010 | — |
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 ORH? 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 |
|---|---|---|---|
| * | K062966 | QMS Lamotrigine Assay (Reagents), Calibrators & ControlsSummary page 2…(21 CFR 862.3200 DLJ, 21 CFR 862.3280 LAS) 807.92 (a)(3): Identification of the legally marketed predicate device QMIS9 Lamotrigine, calibrators and controls (K062966) ARK Diagnostics, Inc. - 5 10(k) Summary page 2 of 15 ARK Lamotrigine Assay === Page 3 ==… | 2007 |
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 14 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All ORH devicesORH Lamotrigine Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · ORH
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · ORH
Too few ORH 510(k)s in any year since 2007 to give a median.
Recalls per year · ORH
No recall names ORH since 2007.
Adverse event reports per year · ORH
No MAUDE report names ORH since 2007.
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 | 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 ARKTm Lamotrigine Assay is a homogeneous enzyme immunoassay intended for the
quantitative determination of lamotrigine in human serum or plasma on automated clinical
chemistry analyzers.
Lamotrigine concentrations can be used as an aid in management of patients treated with
lamotrigine.
The ARKTM Lamotrigine Calibrator is intended for use in calibration of the ARK Lamotrigine
Assay.
The ARKTmi Lamotrigine Control is intended for use in quality control of the ARK Lamotrigine
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/K101305 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101305: Ark Lamotrigine Assay, Calibrator & Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101305
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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