Cleared Traditional

K101305 - ARK LAMOTRIGINE ASSAY

K101305 is an FDA 510(k) clearance for ARK LAMOTRIGINE ASSAY, manufactured by ARK Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code ORH cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K101305 · ARK Diagnostics, Inc. · Toxicology device
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Oct 2010
Decision
172d
Days
Class 2
Risk

K101305 is an FDA 510(k) clearance for the ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL. Classified as Lamotrigine Assay (product code ORH), Class II - Special Controls.

Submitted by ARK Diagnostics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on October 29, 2010 after a review of 172 days - an extended review cycle.

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 - K101305

510(k) Number K101305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2010
Decision Date October 29, 2010
Days to Decision 172 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 87d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ORH Device Classification - Class 2, Special Controls

Product Code ORH Lamotrigine Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3350
Definition For The Quantitative Determination Of Lamotrigine In Human Serum Or Plasma On Automated Clinical Chemistry Analyzers.
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.