Identifiers
- 510(k) Number
- K011813 FDA 510(k)
- FDA Product Code
- LDJ 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 ImmuTest Drug Screen THC is an enzyme immunoassay device designed for the qualitative detection of 11-nor-Δ9-THC-9-carboxylic acid (THC-COOH), the primary metabolite of tetrahydrocannabinol (THC), in human urine. It employs lateral flow immunoassay technology to provide rapid, visual results for clinical toxicology screening. This device aids in identifying potential THC exposure by exceeding a 50 ng/ml cutoff concentration, assisting healthcare professionals in clinical decision-making.
This single-use, in vitro diagnostic device is intended for professional use in clinical settings and is supplied as a ready-to-use cassette. It requires no additional processing beyond urine sample application and is not intended for reusable applications. The device is classified as Class II under FDA regulations and has received FDA 510(k) clearance (K011813). Storage and handling follow standard in vitro diagnostic protocols, with sterility maintained until first use.
Frequently asked questions
What is the ImmuTest Drug Screen THC used for?
The ImmuTest Drug Screen THC is designed for the qualitative detection of 11-nor-Δ9-THC-9-carboxylic acid (THC-COOH), the primary metabolite of tetrahydrocannabinol (THC), in human urine. It helps healthcare professionals identify potential THC exposure by exceeding a 50 ng/ml cutoff concentration, aiding in clinical decision-making for toxicology screening.
How is the ImmuTest Drug Screen THC supplied and prepared for use?
The device is supplied as a ready-to-use cassette, requiring no additional processing beyond applying a urine sample. It is intended for single-use only and is not designed for reusable applications. Simply add the urine sample to the cassette, and results are visually interpreted without further preparation.
Is the ImmuTest Drug Screen THC sterile and how should it be stored?
The ImmuTest Drug Screen THC maintains sterility until its first use, adhering to standard in vitro diagnostic protocols. Store the device according to manufacturer guidelines, typically in a cool, dry place away from direct sunlight, and ensure it remains in its sealed packaging until ready for use.
Can the ImmuTest Drug Screen THC be reused, and what are its regulatory details?
No, the ImmuTest Drug Screen THC is intended for single-use only. It has received FDA 510(k) clearance (K011813) and is classified as a Class II medical device under FDA regulations. The device is authorized for professional use in clinical settings and follows standard in vitro diagnostic handling procedures.
What technology does the ImmuTest Drug Screen THC use to provide results?
The ImmuTest Drug Screen THC employs lateral flow immunoassay technology, which allows for rapid and visual detection of THC metabolites in urine. This method provides quick results without the need for complex laboratory equipment, making it practical for point-of-care clinical toxicology screening.
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: AMEDITECH IMMUTEST DRUG SCREEN THC - Innolitics, fda.innolitics.com, PDF SPECIAL 510(k): Device Modification OIVD Review Memorandum (Decision ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011813 | Class II | Active |
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Manufacturer
- Manufacturer
- Ameditech Inc.
- FDA Applicant
- Ameditech, Inc.
Sources (1)
- FDA 510(k) K011813 24 fields · synced Oct 1, 2026