Cleared Traditional

ARK Lacosamide Assay

K201089 · ARK Diagnostics, Inc. · Toxicology

Aug 2021

Decision

469d

Days

Class 2

Risk

About This 510(k) Submission

K201089 is an FDA 510(k) clearance for the ARK Lacosamide Assay, a Immunoassay, Anti-seizure Drug (Class II — Special Controls, product code NWM), submitted by ARK Diagnostics, Inc. (Fremont, US). The FDA issued a Cleared decision on August 5, 2021, 469 days after receiving the submission on April 23, 2020. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number	K201089 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 23, 2020
Decision Date	August 05, 2021
Days to Decision	469 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF

Device Classification

Product Code	NWM — Immunoassay, Anti-seizure Drug
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.3350
Definition	To Aid In Management Of Patients Treated With Anti-seizure Drug.