Cleared Traditional

ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0

K101574 · ARK Diagnostics, Inc. · Toxicology
Nov 2010
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K101574 is an FDA 510(k) clearance for the ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0, a Gabapentin Assay (Class II — Special Controls, product code OTF), submitted by ARK Diagnostics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 23, 2010, 169 days after receiving the submission on June 7, 2010. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number K101574 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 2010
Decision Date November 23, 2010
Days to Decision 169 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code OTF — Gabapentin Assay
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3350
Definition Test For The Quantitative Determination Of Gabapentin In Human Serum Or Plasma. Gabapentin Concentrations Can Be Used As An Aid In Management Of Patients Treated With Gabapentin.