Cleared Traditional

K192299 - LZI Cotinine II Enzyme Immunoassay (FDA 510(k) Clearance)

Class I Toxicology device.

K192299 · Lin-Zhi International, Inc. · Toxicology device
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Nov 2019
Decision
90d
Days
Class 1
Risk

K192299 is an FDA 510(k) clearance for the LZI Cotinine II Enzyme Immunoassay. Classified as Enzyme Immunoassay, Nicotine And Nicotine Metabolites (product code MKU), Class I - General Controls.

Submitted by Lin-Zhi International, Inc. (Santa Clara, US). The FDA issued a Cleared decision on November 21, 2019 after a review of 90 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 Lin-Zhi International, Inc. devices

Submission Details

510(k) Number K192299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2019
Decision Date November 21, 2019
Days to Decision 90 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
3d slower than avg
Panel avg: 87d · This submission: 90d
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.