Cleared Traditional

K021688 - NICALERT

K021688 is an FDA 510(k) clearance for NICALERT, manufactured by Nymox Pharmaceutical Corporation. The device is a Class 1 Toxicology device with product code MRS cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K021688 · Nymox Pharmaceutical Corporation · Toxicology device
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Oct 2002
Decision
149d
Days
Class 1
Risk

K021688 is an FDA 510(k) clearance for the NICALERT. Classified as Test System, Nicotine, Cotinine, Metabolites (product code MRS), Class I - General Controls.

Submitted by Nymox Pharmaceutical Corporation (Maywood, US). The FDA issued a Cleared decision on October 18, 2002 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3220 - 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 Nymox Pharmaceutical Corporation devices

FDA 510(k) Submission Details - K021688

510(k) Number K021688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2002
Decision Date October 18, 2002
Days to Decision 149 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 87d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

MRS Device Classification - Class 1, General Controls

Product Code MRS Test System, Nicotine, Cotinine, Metabolites
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3220
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.