Monitect THC Drug Screen Test

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Branan Medical Corporartion Monitect Thc Drug Screen Test

510(k) Number

K002263 ↗

FDA Product Code

LDJ

Device Class

Class II

Regulation

21 CFR Part 862.3870

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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• What is the Monitect THC Drug Screen Test used for in clinical settings?

  The Monitect THC Drug Screen Test is designed as a rapid, point-of-care screening tool to qualitatively detect tetrahydrocannabinol (THC) and its metabolites in oral fluid specimens. It aids clinical toxicology assessments by helping identify recent cannabis use, which can be useful in medical or forensic evaluations where drug exposure may be relevant.

• Is the Monitect THC Drug Screen Test sterile, and how should it be handled?

  The Monitect THC Drug Screen Test is explicitly labeled as non-sterile, so it should not be considered sterile for surgical or invasive procedures. It is intended for professional use in clinical toxicology laboratories or drug testing facilities. While it requires no special storage conditions, it should be protected from extreme temperatures to maintain its integrity.

• How is the Monitect THC Drug Screen Test supplied, and what model variations are available?

  The test is supplied as single-use cassette tests, with at least one model variant listed as MC10. Since the device is classified as an enzyme immunoassay, it comes in a ready-to-use format for immediate testing without additional preparation. The exact range of available models or cassettes should be confirmed with the manufacturer.

• What regulatory pathway does the Monitect THC Drug Screen Test follow, and what does that mean for its use?

  The Monitect THC Drug Screen Test holds an FDA 510(k) clearance (K002263) under the Class II medical device classification, with the product code LDJ. This clearance indicates the device is deemed substantially equivalent to a predicate device and meets regulatory standards for drug screening assays. Its use is authorized for professional settings like clinical toxicology labs, adhering to FDA guidelines for enzyme immunoassays.

• Can the Monitect THC Drug Screen Test be reused, or is it intended for single-use only?

  The Monitect THC Drug Screen Test is explicitly labeled as single-use only, meaning each cassette (e.g., MC10) is designed for one test and should not be reused. This ensures accuracy and prevents cross-contamination, which is critical for reliable drug screening results.