LZI Fentanyl II Enzyme Immunoassay

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K201938

Identifiers

510(k) Number: K201938 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 II Enzyme Immunoassay is an enzyme-linked immunoassay for the qualitative detection of fentanyl and its metabolites in biological samples. It employs a homogeneous assay format, utilizing a competition mechanism between the target analyte and enzyme-labeled fentanyl for antibody binding to determine the presence of fentanyl at specified cutoff levels.

This device is intended for in vitro diagnostic use in clinical toxicology settings, supplied as a ready-to-use liquid reagent. It is designed for single-use and requires calibration against norfentanyl at a cutoff of 5 ng/mL in human urine. The assay is authorized under FDA 510(k) and IVDR compliance, with no third-party certification. Storage and handling conditions are not specified in the provided data.

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: PDF LZI Fentanyl Enzyme Immunoassay - Lin-Zhi, Products - Fentanyl Enzyme Immunoassay - Lin-Zhi International, Inc., FEN2, Fentanyl II Enzyme Immunoassay - Roche Diagnostics USA, PDF C71555AA - beckmancoulter.com

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K201938	Class II	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Lin-Zhi International, Inc.

Sources (2)

FDA 510(k) K201938 24 fields · synced Oct 6, 2026
EUDAMED 1 fields · synced May 19, 2026