# K062966: QMS Lamotrigine Assay (Reagents), Calibrators & Controls

- Pathway: 510(k) (Traditional)
- Applicant: Seradyn, Inc.
- Decided: Jan 12, 2007 after 105 days
- Product code: ORH (Lamotrigine Assay)
- Device class: 2
- Regulation: 21 CFR 862.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K955562 (1996). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051211: QMS Zonisamide Reagents, Calibrators and Controls, Seradyn, Inc. (2005) Summary page 1.

## Most influential descendants
- K101305: Ark Lamotrigine Assay, Calibrator & Control (2010), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K062966
Methodology: https://510kreport.com/methodology