# K101305: Ark Lamotrigine Assay, Calibrator & Control

- Pathway: 510(k) (Traditional)
- Applicant: Ark Diagnostics, Inc.
- Decided: Oct 29, 2010 after 172 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: 3 generations back to K955562 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062966: QMS Lamotrigine Assay (Reagents), Calibrators & Controls, Seradyn, Inc. (2007) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K101305
Methodology: https://510kreport.com/methodology