510(k) · Cleared
ClearedQMS Lamotrigine Assay (Reagents), Calibrators & Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seradyn, Inc. · ORH Lamotrigine Assay
Cleared on Jan 12, 2007 as substantially equivalent to K051211 (Seradyn, Inc., 2005) after a 105-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Jan 12, 2007
- Review
- 105 days
- Class
- Class II
- Product code
- ORH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955562 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK955562 Innofluor Phenytoin Assay SystemOxis Intl., Inc. · 1996
- 1 generation backK051211 QMS Zonisamide Reagents, Calibrators and ControlsSeradyn, Inc. · 2005
- This deviceK062966 QMS Lamotrigine Assay (Reagents), Calibrators & ControlsSeradyn, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK101305 Ark Lamotrigine Assay, Calibrator & ControlArk Diagnostics, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K101305Ark Lamotrigine Assay, Calibrator & ControlArk Diagnostics, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955562 | Innofluor Phenytoin Assay System | Oxis Intl., Inc. | 1996 | — |
| −1 | K051211 | QMS Zonisamide Reagents, Calibrators and Controls | Seradyn, Inc. | 2005 | — |
| 0 (this device) | K062966 | QMS Lamotrigine Assay (Reagents), Calibrators & Controls | Seradyn, Inc. | 2007 | — |
| +1 | K101305 | Ark Lamotrigine Assay, Calibrator & Control | Ark Diagnostics, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 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 |
|---|---|---|---|
| * | K051211 | QMS Zonisamide Reagents, Calibrators and ControlsSummary page 1…otrigine Control set is intended for use in quality control of the QMS Lamotrigine assay. LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCY IS CLAIMED QMs® Zonisamide assay (K051211) DESCRIPTION OF DEVICE The QMS® Lamotrigine assay system is a homogeneous assay utilizing particle agglutination technology and… | 2005 |
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 |
|---|---|---|---|
| K101305 | Ark Lamotrigine Assay, Calibrator & Control | 2010 | 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 11 years and passes through 2 companies; a new generation was cleared every 9.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K101305 (Ark Diagnostics, Inc., 2010) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K051211.
How does its category compare?
All ORH devicesORH Lamotrigine Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 QMS® Lamotrigine assay is intended for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers.
Lamotnglne concentrations can be used as an aid in management of patients treated with lamotrigine.
The QMS® Lamotrigine Calibrator set is intended for use in calibration of the QMS Lamotrigine assay.
The QMS® Lamotrigine Control set is interded for use in quality control of the QMS 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/K062966 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062966: QMS Lamotrigine Assay (Reagents), Calibrators & Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062966
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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