# K993961: Rapid Drug Screen 3-Panel Test for Cocaine, Marijuana (THC) (Cannabinoids) and Opiates (3 Panel Test for Cto)

- Pathway: 510(k) (Traditional)
- Applicant: American Bio Medica Corp.
- Decided: Jan 24, 2000 after 63 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K964900 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984525: Rapid Drug Screen 5-Panel with Methamphetamine Test, American Bio Medica Corp. (1999) Summary page 1.

## Indications for use
“Rapid Drug Screen” 3-Panel Test for Cocaine, THC and Opiates is a one-step, lateral flow immunoassay for the simultaneous detection in urine of three abused drugs at stated detectable limits. (Each assay occupies a separate channel). It is intended for use in the qualitative detection of Cocaine (Benzoyl ecgonine), 300 ng/ml, THC (Cannabinoids), 50 ng/ml) and Opiates, 300 ng/ml. “Rapid Drug Screen” is intended for professional use. It is not intended for over the counter sale to non-professionals. The assays are easy to perform, but should not be used without proper supervision. These immuno-assays are simplified qualitative screening methods that provide only a preliminary result for use in the need for additional or confirmatory testing, i.e., gas-chromatography/mass spectrometry (GC/MS). “Rapid Drug Screen” provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a more confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. “Rapid Drug Screen” is not intended for use as a Point of Care test.

Source page: https://510kreport.com/device/K993961
Methodology: https://510kreport.com/methodology