Advantage THC/Cocaine Test

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

510(k) Number

K003708 ↗

FDA Product Code

DIO

Device Class

Class II

Regulation

21 CFR Part 862.3250

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Advantage Thc Test

  Class II

  FDA 510(k) K001567 Active Cleared 19 Jun 2000

• Advantage Marijuana (Thc) and Cocaine Home Drug Test

  Class II

  FDA 510(k) K011962 Active Cleared 9 Aug 2001

• Cannula, Surgical

  Class I

  FDA 510(k) K903416 Active Cleared 23 Nov 1990

• Advantage Marijuana (Thc) Home Drug Test

  Class II

  FDA 510(k) K010921 Active Cleared 25 Jun 2001

• Advantage Hcg Test (Urine/Serum)

  Class II

  FDA 510(k) K994227 Active Cleared 3 Feb 2000

• Peace of Mind Home Drug Test

  Unclassified

  FDA 510(k) K013778 Active Cleared 7 Feb 2002

See all devices from Advantage Diagnostics Corp. →

• What types of biological specimens can the Advantage THC/Cocaine Test detect, and how is it used in clinical settings?

  The Advantage THC/Cocaine Test is designed for the qualitative detection of cocaine and its metabolites, as well as tetrahydrocannabinol (THC) in biological specimens. It functions as an enzyme immunoassay in vitro diagnostic device, primarily used for screening purposes in clinical toxicology assessments. This means it helps identify the presence of these substances in samples like urine, blood, or other relevant biological fluids to aid in diagnosing potential substance exposure or poisoning.

• Is the Advantage THC/Cocaine Test intended for single-use or repeated use, and what storage conditions are required?

  The Advantage THC/Cocaine Test is explicitly designed for single-use only in laboratory settings. It does not require special storage conditions beyond those specified by the manufacturer, meaning standard laboratory storage practices should suffice. This ensures consistency in test performance and reduces the risk of contamination or cross-reactivity.

• What regulatory pathway was followed for FDA clearance of the Advantage THC/Cocaine Test, and what classification does it hold?

  The Advantage THC/Cocaine Test received FDA 510(k) clearance under the classification of Class II, with the product code DIO. The clearance was granted through a traditional 510(k) review, meaning the device was determined to be substantially equivalent to a legally marketed predicate device. It is regulated under 21 CFR 862.3250, which pertains to enzyme immunoassays for cocaine and THC detection.

• How is the Advantage THC/Cocaine Test supplied, and what should clinicians or labs expect when ordering?

  The Advantage THC/Cocaine Test is supplied as a kit for qualitative analysis, meaning it includes all necessary components for performing the test in a laboratory environment. Clinicians or labs should expect a ready-to-use format, as no additional preparation or special handling is required beyond standard laboratory procedures. The kit is designed for ease of use in toxicology screening workflows.

• Can the Advantage THC/Cocaine Test be used in non-laboratory settings, such as point-of-care or home testing?

  No, the Advantage THC/Cocaine Test is intended exclusively for use in laboratory settings and is not approved for point-of-care or home testing. Its design as an enzyme immunoassay kit requires controlled conditions typically found in clinical or diagnostic laboratories, ensuring accurate and reliable results for clinical toxicology assessments.