Rapid Drug Screen 3-Panel Test for Cocaine, Marijuana (Thc) (Cannabinoids) and Opiates (3 Panel Test for Cto)
510(k) K993961
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK993961 | Date24 Jan 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LDJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3870
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is an enzyme immunoassay designed for the qualitative detection of cocaine (benzoylecgonine), THC (cannabinoids), and opiates in human urine. It functions as a rapid screening tool to identify the presence of these substances, aiding in clinical toxicology assessments.
The test is supplied as a single-use, non-sterile diagnostic kit, intended for use in clinical or forensic settings. It requires no special storage conditions beyond those specified in the instructions for use and is classified as a Class II medical device under FDA regulations. Authorized under FDA 510K clearance (K993961), it adheres to the regulatory standards outlined in 21 CFR 862.3870 for drug detection assays.
Other devices from American Bio Medica Corp.
Questions
AI-generated answers, 19 Sep 2026
What clinical settings is this test kit designed for and how does it function in those environments?
This RAPID DRUG SCREEN 3-PANEL TEST is specifically designed for clinical toxicology assessments and forensic applications, where rapid screening for drug presence in human urine is required. It functions as a qualitative enzyme immunoassay, providing a quick (rapid) indication of whether cocaine (benzoylecgonine), THC (cannabinoids), or opiates are present in a sample. Clinicians and forensic labs use it to identify potential substance use early, aiding in patient evaluation, workplace drug testing, or legal investigations.
Is this test kit reusable, or is it intended for single-use only? What does that mean for my workflow?
The RAPID DRUG SCREEN 3-PANEL TEST is explicitly labeled as a single-use, non-sterile diagnostic kit. This means each kit is designed for one test only and cannot be reused, even if components appear unused. For workflow efficiency, you’ll need to account for inventory management to ensure fresh kits are available for each test, while also adhering to the manufacturer’s instructions for use to avoid contamination or compromised results.
What storage requirements does this test kit have, and how should it be handled to maintain accuracy?
The kit does not require special storage conditions beyond what’s outlined in the instructions for use provided by American Bio Medica Corp. However, standard best practices for immunoassays—such as keeping it in a cool, dry place (typically 2–30°C) and protecting it from direct sunlight or extreme temperatures—should be followed. Avoid freezing or exposing it to moisture, as these factors could degrade performance. Always check the expiration date before use to ensure reliability.
How was this device’s regulatory pathway determined, and what does that mean for its use in clinical practice?
The RAPID DRUG SCREEN 3-PANEL TEST was cleared through the FDA’s 510(k) pathway under Traditional Review, with a Substantially Equivalent (SESE) determination by the Clinical Toxicology Advisory Committee. This means the device was compared to a legally marketed predicate and found to have the same intended use and technological characteristics. Clinically, this clearance confirms the test’s safety and effectiveness for its qualitative detection purpose in urine, but it does not imply confirmation of substance use—follow-up testing (e.g., GC/MS) is recommended for definitive results.