Cleared Traditional

K083799 - TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00

K083799 is an FDA 510(k) clearance for TOPIRAMATE ASSAY, manufactured by ARK Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code NWM cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K083799 · ARK Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
115d
Days
Class 2
Risk

K083799 is an FDA 510(k) clearance for the TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODEL.... Classified as Immunoassay, Anti-seizure Drug (product code NWM), Class II - Special Controls.

Submitted by ARK Diagnostics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 16, 2009 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3350 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all ARK Diagnostics, Inc. devices

FDA 510(k) Submission Details - K083799

510(k) Number K083799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2008
Decision Date April 16, 2009
Days to Decision 115 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 87d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NWM Device Classification - Class 2, Special Controls

Product Code NWM Immunoassay, Anti-seizure Drug
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3350
Definition To Aid In Management Of Patients Treated With Anti-seizure Drug.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - NWM Immunoassay, Anti-seizure Drug

Devices cleared under the same product code (NWM) and FDA review panel - the closest regulatory comparables to K083799.
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K091884 · ARK Diagnostics, Inc. · Dec 2009
SERADYN QMS TOPIRAMATE
K070645 · Seradyn, Inc. · May 2007
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K051211 · Seradyn, Inc. · Nov 2005