Cleared Traditional

K181159 - LZI Fentanyl Enzyme Immunoassay

K181159 is the FDA 510(k) clearance for LZI Fentanyl Enzyme Immunoassay by Lin-Zhi International, Inc.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K181159 · Lin-Zhi International, Inc. · Toxicology device
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Dec 2018
Decision
216d
Days
Class 2
Risk

K181159 is an FDA 510(k) clearance for the LZI Fentanyl Enzyme Immunoassay. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Lin-Zhi International, Inc. (Santa Clara, US). The FDA issued a Cleared decision on December 3, 2018 after a review of 216 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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 K181159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2018
Decision Date December 03, 2018
Days to Decision 216 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
129d slower than avg
Panel avg: 87d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 136
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K181159.
Psychemedics Microplate EIA for Fentanyl in Hair
K182103 · Psychemedics Corporation · Apr 2019
ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
K182123 · Advin Biotech, Inc. · Mar 2019
ARK Tramadol Assay
K182280 · ARK Diagnostics, Inc. · Dec 2018
ARK Fentanyl Assay
K180427 · ARK Diagnostics, Inc. · Jun 2018
Synermed Opiate Enzyme Immunoassay
K172416 · Infrared Laboratory Systems, LLC (Dba Synermed) · Apr 2018
DRI Hydrocodone Assay
K173195 · Microgenics Corporation · Feb 2018