Identifiers
- 510(k) Number
- K781048 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 Direct RIA Kit is a radioimmunoassay (RIA) device designed for the quantitative detection of cannabinoids, specifically tetrahydrocannabinol (THC), in biological samples. It employs a competitive binding assay to measure THC concentrations, providing objective results for clinical toxicology assessments. Classified under the nomenclature for radioimmunoassay devices, it is intended for laboratory use in identifying THC presence and levels in urine or other relevant matrices. This kit falls under FDA regulation 862.3870, ensuring compliance with standards for diagnostic radiolabelled reagents.
The THC Direct RIA Kit is supplied as a single-use diagnostic tool, requiring laboratory processing with radiolabelled components (I-125). It is intended for use in clinical toxicology settings, where trained personnel perform assays to detect THC exposure. The device is classified as a Class II medical device under FDA regulations, with clearance granted through a 510(k) premarket notification process. Storage and handling must adhere to radiolabelled reagent safety protocols, and its use is governed by the applicable FDA authorization (K781048) for substantially equivalent devices in this category.
Frequently asked questions
What is the THC Direct RIA Kit used for?
The THC Direct RIA Kit is designed for the quantitative detection of tetrahydrocannabinol (THC) in biological samples, such as urine. It uses a competitive radioimmunoassay (RIA) to measure THC concentrations objectively, supporting clinical toxicology assessments where precise THC exposure levels are required.
How is the THC Direct RIA Kit supplied and intended for use?
The kit is supplied as a single-use diagnostic tool containing radiolabelled components (I-125). It is intended exclusively for laboratory use, where trained personnel perform the assay to detect and quantify THC in relevant biological matrices. The radiolabelled nature of the reagents necessitates adherence to strict safety protocols during handling and processing.
Is the THC Direct RIA Kit sterile and reusable?
The THC Direct RIA Kit is not designed for reuse and is intended for single-use only. While the kit itself is not explicitly described as sterile in the provided data, its use in clinical toxicology requires adherence to standard laboratory practices for radiolabelled reagents, including proper sterilization and contamination control during preparation and processing.
What regulatory pathway does the THC Direct RIA Kit follow?
The THC Direct RIA Kit is classified as a Class II medical device under FDA regulations and has received clearance through a 510(k) premarket notification process. It is substantially equivalent to predicate devices, as indicated by the decision code SESE (Substantially Equivalent, Special), and is governed by FDA regulation number 862.3870 for radioimmunoassay devices. The clearance number assigned is K781048.
How should the THC Direct RIA Kit be stored?
The THC Direct RIA Kit must be stored and handled according to radiolabelled reagent safety protocols due to the presence of I-125. This includes proper shielding, containment, and disposal procedures to minimize radiation exposure. Storage conditions should also comply with general laboratory guidelines for diagnostic reagents, ensuring stability and integrity until use.
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: THC DIRECT RIA KIT (K781048) — FDA 510 (k) | Innolitics, URINE THC DIRECT RIA KIT (I-125) (K913865) - Innolitics, Thc Direct Ria Kit 510 (k) FDA Premarket Notification K781048 ..., URINE THC DIRECT RIA KIT (I-125) 510 (k) K913865 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K781048 | Class II | Active |
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Manufacturer
- Manufacturer
- Immunalysis Corporation
Sources (1)
- FDA 510(k) K781048 24 fields · synced Oct 1, 2026