Cleared Traditional

QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS (K062966) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K062966 · Seradyn, Inc. · Chemistry device
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Jan 2007
Decision
105d
Days
Class 2
Risk

K062966 is an FDA 510(k) clearance for the QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS. Classified as Lamotrigine Assay (product code ORH), Class II - Special Controls.

Submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 12, 2007 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3350 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Seradyn, Inc. devices

Submission Details

510(k) Number K062966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2006
Decision Date January 12, 2007
Days to Decision 105 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 88d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Chemistry devices follow this clearance model.