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LZI Fentanyl III Enzyme Immunoassay

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251634

by Lin-Zhi International, Inc.

Identifiers

510(k) Number
K251634 FDA 510(k)
FDA Product Code
DJG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3650 FDA 510(k)
Regulation Number
862.3650 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The LZI Fentanyl III Enzyme Immunoassay is an enzyme immunoassay device intended for the qualitative determination of fentanyl in human urine at a cutoff value of 1 ng/mL when calibrated against fentanyl. It is designed for prescription use with automated clinical chemistry analyzers.

The device is supplied for in vitro diagnostic use in clinical laboratory settings. It is regulated under FDA 510(k) clearance (K251634) as a Class II device with product code DJG and regulation number 862.3650, and is indicated for use in clinical toxicology.

Frequently asked questions

What is the LZI Fentanyl III Enzyme Immunoassay used for?

The LZI Fentanyl III Enzyme Immunoassay is intended for the qualitative determination of fentanyl in human urine at a cutoff value of 1 ng/mL when calibrated against fentanyl, aiding in clinical toxicology testing.

How is the LZI Fentanyl III Enzyme Immunoassay supplied and used?

The device is supplied for in vitro diagnostic use in clinical laboratory settings and is designed for prescription use with automated clinical chemistry analyzers.

What regulatory pathway was used for the LZI Fentanyl III Enzyme Immunoassay?

The device received FDA 510(k) clearance (K251634) as a Class II device under product code DJG and regulation number 862.3650, indicating it is substantially equivalent to a legally marketed predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Products - Fentanyl III Enzyme Immunoassay - Lin-Zhi International, Inc., PDF LZI.PI.BCI.USA.FEN III.Q.AU5800.Rev.0.07302025 - lin-zhi.com, PDF C71555AA - beckmancoulter.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Lin-Zhi International, Inc.

Sources (1)

  • FDA 510(k) K251634 24 fields · synced Oct 6, 2026