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Buprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter Synchron Systems

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K081008

by Lin-Zhi International, Inc.

Identifiers

510(k) Number
K081008 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 in biological specimens. It functions as an analytical tool within the clinical toxicology field, enabling laboratories to identify the presence of buprenorphine metabolites in patient samples, aiding in the assessment of opioid exposure or overdose.

The assay is supplied as part of the Beckman Coulter Synchron Systems platform, including calibrators and controls for method validation. It is intended for in vitro diagnostic use in clinical laboratories, adhering to FDA 510K and IVDR regulatory frameworks. The device is non-sterile, single-use, and requires proper storage as specified in the accompanying documentation. No MRI safety information is provided, and its classification under OpenFDA is as a Class II device (device class=2).

Frequently asked questions

What clinical scenarios would this buprenorphine immunoassay be used for in a lab setting?

This buprenorphine enzyme immunoassay is designed for qualitative detection in clinical toxicology, helping laboratories identify the presence of buprenorphine metabolites in patient samples. It aids in assessing opioid exposure or overdose cases, particularly when evaluating patients suspected of ingesting buprenorphine or related compounds. The assay supports diagnostic workflows where rapid identification of opioid presence is critical, such as in emergency departments or forensic toxicology.

Is this assay compatible with any specific laboratory systems, and how is it supplied?

The buprenorphine enzyme immunoassay is specifically supplied as part of the Beckman Coulter Synchron Systems platform. It includes calibrators and controls for method validation, ensuring compatibility with this system for consistent, validated testing. The assay itself is non-sterile and single-use, meaning each test kit is intended for one-time use only. Storage instructions are detailed in the accompanying documentation.

What regulatory pathways does this device follow, and how does that affect its use in clinical labs?

This device follows FDA 510(k) clearance and adheres to the In Vitro Diagnostic Regulation (IVDR) framework, confirming its compliance with U.S. and EU regulatory standards. Clinically, this means it has undergone rigorous review by the FDA’s Clinical Toxicology Advisory Committee to ensure its safety, performance, and intended use for qualitative buprenorphine detection. Labs using it can rely on its regulatory approval for clinical toxicology applications, though they must follow manufacturer guidelines for proper handling and validation.

Are there any special handling or storage requirements for this assay beyond what’s stated in the documentation?

Beyond the manufacturer’s documented storage instructions, this assay is non-sterile and single-use, so it must be stored according to the provided guidelines to maintain integrity until use. Since it’s designed for in vitro diagnostic use, labs should ensure proper calibration and validation using the included calibrators and controls to achieve accurate results. No MRI safety information is provided, so it’s not intended for use in MRI environments. Always refer to the accompanying documentation for precise storage conditions, such as temperature and shelf life.

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) K081008 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026