Cleared Traditional

K201938 - LZI Fentanyl II Enzyme Immunoassay

K201938 is the FDA 510(k) clearance for LZI Fentanyl II Enzyme Immunoassay by Lin-Zhi International, Inc.. It is a Class 2 Chemistry device (product code DJG) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K201938 · Lin-Zhi International, Inc. · Chemistry device
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Aug 2020
Decision
25d
Days
Class 2
Risk

K201938 is an FDA 510(k) clearance for the LZI Fentanyl II 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 August 7, 2020 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3650 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lin-Zhi International, Inc. devices

Submission Details

510(k) Number K201938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2020
Decision Date August 07, 2020
Days to Decision 25 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 88d · This submission: 25d
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 Chemistry 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 K201938.
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K201223 · Lin-Zhi International, Inc. · Jun 2020
ARK Fentanyl II Assay
K200197 · ARK Diagnostics, Inc. · Feb 2020
CEDIA Heroin Metabolite (6-AM) assay
K192943 · Microgenics Corporation · Dec 2019