Cleared Special

K251634 - LZI Fentanyl III Enzyme Immunoassay

K251634 is an FDA 510(k) clearance for LZI Fentanyl III Enzyme Immunoassay, manufactured by Lin-Zhi International, Inc.. The device is a Class 2 Toxicology device with product code DJG cleared through the Special 510(k) pathway after a 20-day FDA review.

K251634 · Lin-Zhi International, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K251634

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.

DJG Device Classification - Class 2, Special Controls

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.
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
Dochek® Multi-Drug Urine Test Dipcard Rx
K240698 · Guangzhou Decheng Biotechnology Co., Ltd. · May 2024
Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard
K231904 · Co-Innovation Biotech Co., Ltd. · Mar 2024
K251634 · LZI Fentanyl III Enzyme Immunoassay
Download PDF FDA Summary Lin-Zhi International…