# K201089: ARK Lacosamide Assay

- Pathway: 510(k) (Traditional)
- Applicant: Ark Diagnostics, Inc.
- Decided: Aug 5, 2021 after 469 days
- Product code: NWM (Immunoassay, Anti-Seizure Drug)
- 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 K970510 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083799: Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models 5015-0001-000, 5015-0002-00, 5015-0003-00, Ark Diagnostics, Inc. (2009) Summary page 5.

## Indications for use
The ARK Lacosamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of lacosamide in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of lacosamide to help ensure appropriate therapy.

Source page: https://510kreport.com/device/K201089
Methodology: https://510kreport.com/methodology