Cleared Traditional

K972481 - AUTO-LYTE COTININE EIA

K972481 is an FDA 510(k) clearance for AUTO-LYTE COTININE EIA, manufactured by OraSure Technologies, Inc.. The device is a Class 1 Toxicology device with product code MKU cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K972481 · OraSure Technologies, Inc. · Toxicology device
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Oct 1997
Decision
111d
Days
Class 1
Risk

K972481 is an FDA 510(k) clearance for the AUTO-LYTE 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 October 21, 1997 after a review of 111 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 OraSure Technologies, Inc. devices

FDA 510(k) Submission Details - K972481

510(k) Number K972481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1997
Decision Date October 21, 1997
Days to Decision 111 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 87d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

MKU Device Classification - Class 1, General Controls

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.