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Buprenorphine Enzyme Immunoassay with Norbuprenorphine Calibrators and Controls

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K090844

by Lin-Zhi International, Inc.

Identifiers

510(k) Number
K090844 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)

This device is an enzyme immunoassay designed for the qualitative detection of buprenorphine and its metabolite, norbuprenorphine, in biological specimens. It employs immunoassay technology to identify the presence of these substances, aiding in clinical toxicology assessments for drug monitoring or overdose investigations.

The assay is supplied as a single-use, in vitro diagnostic reagent kit, intended for use in clinical laboratories. It requires no special storage conditions beyond refrigeration and is classified as a Class II device under FDA regulations. The device is authorized for use in the United States via FDA 510(k) clearance and complies with the In Vitro Diagnostic Regulation (IVDR) in the European Union. Multiple registration numbers and FEI numbers are associated with its distribution and regulatory compliance.

Frequently asked questions

What clinical scenarios is this buprenorphine immunoassay primarily used for?

This enzyme immunoassay is designed for qualitative detection of buprenorphine and its metabolite, norbuprenorphine, in biological specimens. It is most commonly used in clinical toxicology settings to aid in drug monitoring or to investigate suspected overdose cases involving buprenorphine. The assay helps clinicians assess the presence of these substances, supporting decisions in patient care or forensic evaluations.

Is this device single-use, and if so, how should it be stored before use?

Yes, this device is supplied as a single-use, in vitro diagnostic reagent kit. It requires no special storage conditions beyond refrigeration (typically between 2°C and 8°C) to maintain its integrity until use. Always follow the manufacturer’s instructions for storage duration and handling to ensure accuracy and reliability of results.

What regulatory pathways does this device follow in the U.S. and Europe?

In the United States, this device is authorized via FDA 510(k) clearance under the Traditional pathway, classified as a Class II device. It is also compliant with the In Vitro Diagnostic Regulation (IVDR) in the European Union. The device’s regulatory compliance is supported by multiple FEI numbers and registration numbers, ensuring adherence to both U.S. and EU regulatory requirements.

How does this assay differ from other opiate detection tests, and what does it specifically measure?

This assay specifically targets buprenorphine and its metabolite, norbuprenorphine, using enzyme immunoassay technology. Unlike broader opiate tests that may detect multiple substances, this test is tailored for buprenorphine, a semi-synthetic opioid used in medication-assisted treatment for opioid dependence. It helps distinguish buprenorphine presence from other opioids or drugs, aiding precise clinical toxicology assessments.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Lin-Zhi International, Inc.

Sources (2)

  • FDA 510(k) K090844 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026