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THC-Cannabinoids Direct Urine RIA Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K820903

by Immunalysis Corporation

Identifiers

510(k) Number
K820903 FDA 510(k)
FDA Product Code
LAT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3870 FDA 510(k)
Regulation Number
862.3870 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The THC-Cannabinoids Direct Urine RIA Kit is a radioimmunoassay (RIA) device designed for the qualitative detection of cannabinoids in human urine. Classified under the Radioimmunoassay nomenclature (FDA product code LAT), it falls under Device Class II and is regulated under FDA regulation number 862.3870. This kit leverages immunologic techniques to identify THC metabolites, aiding in clinical toxicology assessments.

This kit is supplied as a single-use diagnostic reagent for laboratory use, intended for automated clinical chemistry analyzers. It requires no sterilization beyond standard laboratory protocols and is not MRI-compatible. The device is authorized under FDA 510(k) clearance (K820903) and is distributed in a format compatible with clinical toxicology workflows. Storage conditions and shelf life are not specified in the regulatory data but must adhere to manufacturer guidelines for immunoassay reagents.

Frequently asked questions

What is the THC-Cannabinoids Direct Urine RIA Kit used for?

The THC-Cannabinoids Direct Urine RIA Kit is designed for the qualitative detection of cannabinoids, specifically THC metabolites, in human urine samples. It aids in clinical toxicology assessments by identifying the presence of these compounds, helping clinicians evaluate potential exposure or intoxication.

How is the THC-Cannabinoids Direct Urine RIA Kit supplied and intended for use?

This kit is supplied as a single-use diagnostic reagent intended exclusively for laboratory use. It is compatible with automated clinical chemistry analyzers, ensuring streamlined integration into clinical toxicology workflows. Each kit is meant for one-time use per test.

Is sterilization required for the THC-Cannabinoids Direct Urine RIA Kit?

No additional sterilization beyond standard laboratory protocols is required for this kit. Since it is designed for laboratory use and supplied as a reagent, adherence to general lab hygiene practices ensures proper handling and use.

Can the THC-Cannabinoids Direct Urine RIA Kit be reused?

The kit is explicitly designed for single-use only. Reusing it could compromise accuracy, reliability, and regulatory compliance, as it is intended to be used once per test in a controlled laboratory setting.

What storage conditions should be followed for the THC-Cannabinoids Direct Urine RIA Kit?

While specific storage conditions and shelf life details are not provided in the regulatory data, it is critical to follow the manufacturer’s guidelines for immunoassay reagents. Proper storage typically involves maintaining the kit in a cool, dry place, protected from light and extreme temperatures, to preserve its integrity and performance.

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: URINE THC CANNABINOIDS DIRECT RIA KIT (K833911) — FDA 510(k ..., THC-CANNABINOIDS DIRECT URINE RIA KIT - Innolitics, Ia Urine Thc Reagent Kit, 25ml, PDF Cannabinoids (THCA/CTHC) ELISA Kit (SE120020) - Technical Bulletin

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Immunalysis Corporation

Sources (1)

  • FDA 510(k) K820903 24 fields · synced Oct 1, 2026