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Rapid Tetrahydrocannabinol Urine Test; Catalog # OPI001000

FDA 510(k)

Class II (US FDA 510(k))

510(k) K053034

by Acro Biotech, LLC

Identifiers

510(k) Number
K053034 FDA 510(k)
FDA Product Code
LDJ FDA 510(k)
Models / Variants
Acro Biotech Llc Rapid Tetrahydrocannabinol Urine Test FDA 510(k)
Catalog# Opi001000 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)

This device is an enzyme immunoassay for the qualitative detection of tetrahydrocannabinol (THC) in human urine. It operates via a competitive immunochemical reaction to identify THC metabolites at a cutoff concentration of 50 ng/mL, providing a visual result through a lateral flow assay format.

The test is supplied as a single-use cassette containing a nitrocellulose membrane and a wicking pad with antibody-colloidal gold conjugate. It is intended for use in clinical toxicology settings and has received FDA 510K clearance under the Traditional pathway. No regulatory status beyond the stated clearance is implied.

Frequently asked questions

What is the Acro Biotech Rapid THC Urine Test used for?

This test is designed for the qualitative detection of tetrahydrocannabinol (THC) metabolites in human urine. It uses a competitive immunochemical reaction to identify THC at or above a cutoff concentration of 50 ng/mL, helping clinicians assess recent cannabis exposure in clinical toxicology settings. The visual result appears via a lateral flow assay format, making it suitable for point-of-care or laboratory use.

How is the Acro Biotech Rapid THC Urine Test supplied, and is it single-use?

The test is supplied as a single-use cassette containing a nitrocellulose membrane and a wicking pad with an antibody-colloidal gold conjugate. Each cassette is intended for one-time use only, ensuring sterility and preventing cross-contamination between samples. This format aligns with clinical toxicology workflows where individual, discrete testing is standard.

Is the test sterile, and what are the storage requirements?

The single-use cassette is designed to be sterile for one application only. Storage should follow the manufacturer’s instructions to maintain integrity, typically in a cool, dry place (e.g., 2–30°C) and protected from direct sunlight or moisture. Avoid freezing, as this may compromise the assay components. Check the packaging for expiration dates and ensure proper sealing before use.

Does this test require any special handling or regulatory approval beyond FDA clearance?

The test has received FDA 510K clearance under the Traditional pathway, confirming its substantial equivalence to a predicate device for clinical toxicology use. No additional regulatory approvals are implied beyond this clearance. However, adherence to local laboratory protocols and compliance with clinical toxicology guidelines (e.g., chain of custody for urine samples) is recommended for valid results.

Are there different models or sizes available for this test?

This device is supplied as a single, standardized cassette format (Catalog# OPI001000) with no variable sizing or model variations. The lateral flow assay design ensures consistency across all units, and the cutoff concentration (50 ng/mL) is fixed for all applications. Additional accessories (e.g., collection cups or diluents) may be available separately but are not part of the core test cassette.

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: Acro Biotech Llc Rapid Tetrahydrocannabinol Urine Test; Catalog ..., Acro Biotech Llc Rapid Tetrahydrocannabinol Urine Test; Catalog ..., Acro Biotech Llc Rapid Tetrahydrocannabinol Urine Test; Catalog ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Acro Biotech, LLC

Sources (1)

  • FDA 510(k) K053034 24 fields · synced Oct 1, 2026