Cleared Special

K251634 - LZI Fentanyl III Enzyme Immunoassay (FDA 510(k) Clearance)

Class II Toxicology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K251634 · Lin-Zhi International, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
20d
Days
Class 2
Risk

K251634 is an FDA 510(k) clearance for the LZI Fentanyl III 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 June 18, 2025 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - the FDA toxicology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Lin-Zhi International, Inc. devices

Submission Details

510(k) Number K251634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2025
Decision Date June 18, 2025
Days to Decision 20 days
Submission Type Special
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
67d faster than avg
Panel avg: 87d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 214
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K251634.
Labcorp Fentanyl Urine Visual Test
K252684 · Medtox Diagnostics, Inc. · Jan 2026
Evidence MultiSTAT DOA Urine MultiPlex
K250741 · Randox Laboratories Limited · Jan 2026
LZI Buprenorphine II Enzyme Immunoassay
K253082 · Lin-Zhi International, Inc. · Jan 2026
SEFRIA™ Hydrocodone Oral Fluid
K252520 · Immunalysis Corporation · Sep 2025
Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative
K251972 · Healgen Scientific, LLC · Aug 2025
BioSieve™ Fentanyl FIA Test Kit
K240124 · Vivachek Biotech (Hangzhou) Co., Ltd. · Jun 2024