BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx

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

510(k) Number

K180878 ↗

FDA Product Code

DJC

Device Class

Class II

Regulation

21 CFR Part 862.3610

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use

  Class II

  FDA 510(k) K180879 Active Cleared 14 Dec 2018

• What substances can the Bio-Venture Rapid Test Cassettes detect, and how are they used in clinical settings?

  The Bio-Venture Rapid Test Cassettes are designed to qualitatively detect amphetamine, cocaine, methamphetamine, morphine, marijuana (THC), and oxazepam in urine samples. They utilize immunochromatographic technology for rapid, point-of-care testing, which is particularly useful in clinical toxicology for screening patients for substance use. These cassettes are available for both over-the-counter (OTC) and prescription (Rx) use, making them versatile for different settings like emergency rooms, clinics, or even at-home testing under medical supervision.

• Are these test cassettes single-use, and if so, how should they be stored?

  Yes, the Bio-Venture Rapid Test Cassettes are single-use devices, meaning each cassette is intended for one test only. They do not require special storage conditions beyond protecting them from extreme temperatures and moisture. Simply keeping them in a dry, cool environment away from direct sunlight will ensure their integrity until use.

• What regulatory pathway was followed for FDA clearance, and what does this mean for buyers or clinicians?

  The Bio-Venture Rapid Test Cassettes received FDA 510(k) clearance under the traditional review pathway, with a decision date of December 17, 2018. This clearance indicates that the devices are classified as Class II under FDA regulations (862.3610) and were deemed substantially equivalent to predicate devices already on the market. For buyers and clinicians, this means the cassettes meet established safety and performance standards, ensuring reliability for clinical toxicology assessments.

• How are the cassettes packaged, and what should be considered when ordering?

  Each Bio-Venture Rapid Test Cassette is packaged individually, ensuring sterility and ease of use. When ordering, buyers should confirm the specific substances they need to test for, as there are separate cassettes for amphetamine, cocaine, methamphetamine, morphine, marijuana (THC), and oxazepam—both for OTC and Rx use. Additionally, since they are single-use, ordering should account for the expected volume of tests to avoid shortages.

• Can these cassettes be used for both prescription and over-the-counter purposes, and how does that affect their application?

  Yes, the Bio-Venture Rapid Test Cassettes are available in versions for both over-the-counter (OTC) and prescription (Rx) use, allowing flexibility depending on the testing environment or patient population. For OTC use, they may be accessible in settings like pharmacies or for at-home testing under guidance, while Rx versions are typically used in clinical or medical settings where a prescription is required. This dual availability ensures broader applicability for substance use screening across different scenarios.