Resub Urine Cocaine Metabolite Direct RIA Kit [I-125]
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K871549 FDA 510(k)
- FDA Product Code
- KLN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3250 FDA 510(k)
- Regulation Number
- 862.3250 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a radioimmunoassay (RIA) system for measuring cocaine metabolites in urine, classified under the FDA product code KLN and device class II. It is designed to detect benzoylecgonine, the primary metabolite of cocaine, enabling quantitative analysis of cocaine exposure or overdose. The kit employs I-125 radiolabeling to facilitate precise immunoassay detection, aligning with the Clinical Toxicology specialty category. Its purpose is to support clinical decision-making in toxicology assessments.
The Resub Urine Cocaine Metabolite Direct RIA Kit [I-125] is supplied as a single-use diagnostic test intended for laboratory use only. It requires no sterilization beyond manufacturer-provided packaging and is regulated under FDA 510(k) clearance (K871549) as substantially equivalent to prior-generation devices. The kit includes all necessary reagents, controls, and instructions for performing the assay in compliance with FDA regulation 862.3250. Storage and handling must adhere to radioactive material safety protocols due to the I-125 isotope used in the assay.
Frequently asked questions
What is the Resub Urine Cocaine Metabolite Direct RIA Kit [I-125] used for?
This kit is designed for measuring benzoylecgonine, the primary metabolite of cocaine, in urine samples. It provides quantitative analysis to support clinical decision-making in toxicology assessments, such as evaluating cocaine exposure or overdose. The radioimmunoassay (RIA) method with I-125 labeling ensures high sensitivity and accuracy for detecting cocaine metabolites in laboratory settings.
How is the Resub Urine Cocaine Metabolite Direct RIA Kit [I-125] supplied and intended for use?
The kit is supplied as a single-use diagnostic test intended exclusively for laboratory use. It includes all necessary reagents, controls, and detailed instructions to perform the assay in compliance with FDA regulations. Since it is a single-use device, each kit must be used once and then discarded. No additional sterilization is required beyond the manufacturer-provided packaging.
Is the kit sterile and how should it be handled?
The kit is not intended to require sterilization beyond the manufacturer’s sealed packaging. However, due to the presence of the radioactive I-125 isotope, strict adherence to radioactive material safety protocols is mandatory during storage, handling, and disposal. Always follow local and institutional guidelines for radioactive substance management to ensure safety.
What regulatory approval does the Resub Urine Cocaine Metabolite Direct RIA Kit [I-125] hold?
The kit holds FDA 510(k) clearance under the reference number K871549, classified as substantially equivalent to prior-generation devices. This clearance falls under the Clinical Toxicology specialty category and is regulated under FDA product code KLN and regulation number 862.3250. The device is classified as Class II, indicating it poses moderate risk and requires special controls to ensure safety and effectiveness.
Are there different models or sizes available for this kit?
The Resub Urine Cocaine Metabolite Direct RIA Kit [I-125] is supplied as a single standardized kit without varying models or sizes. Each kit is designed to perform a single assay for benzoylecgonine detection in urine samples, adhering to the specified protocol and reagent quantities included in the package. No customization or additional configurations are available.
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: Resub. Urine Cocaine Meta. Direct Ria Kit [I-125], Resub. Urine Cocaine Meta. Direct Ria Kit [I-125], Urine Cocaine Metabolite Direct Ria Kit (I-125), Immunalysis Corporation FDA Filings - FDA.report, Immunalysis CTHC Urine Control Set
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K871549 | Class II | Active |
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Manufacturer
- Manufacturer
- Immunalysis Corporation
Sources (1)
- FDA 510(k) K871549 24 fields · synced Oct 5, 2026