Cleared Traditional

K181553 - Immunalysis Ethyl Alcohol Enzyme Assay

K181553 is an FDA 510(k) clearance for Immunalysis Ethyl Alcohol Enzyme Assay, manufactured by Immunalysis Corporation. The device is a Class 2 Toxicology device with product code DIC cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K181553 · Immunalysis Corporation · Toxicology device
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Oct 2018
Decision
140d
Days
Class 2
Risk

K181553 is an FDA 510(k) clearance for the Immunalysis Ethyl Alcohol Enzyme Assay. Classified as Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (product code DIC), Class II - Special Controls.

Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on October 31, 2018 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3040 - 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 Immunalysis Corporation devices

FDA 510(k) Submission Details - K181553

510(k) Number K181553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2018
Decision Date October 31, 2018
Days to Decision 140 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 87d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIC Device Classification - Class 2, Special Controls

Product Code DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3040
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.

Regulatory Peers - DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

All 29
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