Cleared Traditional

K974534 - MICRO-PLATE COTININE EIA (FDA 510(k) Clearance)

Class I Toxicology device.

K974534 · OraSure Technologies, Inc. · Toxicology device
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May 1998
Decision
167d
Days
Class 1
Risk

K974534 is an FDA 510(k) clearance for the MICRO-PLATE COTININE EIA. Classified as Enzyme Immunoassay, Nicotine And Nicotine Metabolites (product code MKU), Class I - General Controls.

Submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on May 18, 1998 after a review of 167 days - an extended review cycle.

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 OraSure Technologies, Inc. devices

Submission Details

510(k) Number K974534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1997
Decision Date May 18, 1998
Days to Decision 167 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
80d slower than avg
Panel avg: 87d · This submission: 167d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MKU Enzyme Immunoassay, Nicotine And Nicotine 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.