# K984525: Rapid Drug Screen 5-Panel with Methamphetamine Test

- Pathway: 510(k) (Traditional)
- Applicant: American Bio Medica Corp.
- Decided: Feb 26, 1999 after 67 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964900 (1997). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964900: Rapid Drug Screen, American Bio Medica Corp. (1997) Summary page 1.

## Most influential descendants
- K993961: Rapid Drug Screen 3-Panel Test for Cocaine, Marijuana (THC) (Cannabinoids) and Opiates (3 Panel Test for Cto) (2000), 0 descendants of its own
- K993796: Rapid Drug Screen 5-Panel Drug Screening Test for Cocaine, Marijuana, Opiates, Amphetamine and Methamphetamine (1999), 0 descendants of its own

## Indications for use
“Rapid Drug Screen” with methamphetamine is a one-step, lateral flow immunoassay for the simulatenous detection in urine of five abused drugs at stated detectable limits. (Each assay occupies a seperate channel). It is intended for use in the qualitative detection of d-Amphetamine (750 ng/ml), Benzoy! ecgonine (225 ng/ml), Cannabinoids (50 ng/ml), Methamphetamines (1000 ng/ml) and Opiates (225 ng/ml). “Rapid Drug Screen” is intended for use by professional laboratories. The assays are easy to perform, but should not be used without proper supervision. These immuno-assay is a simplified qualatative screening method that provides only a preliminary result for use in the need for aditional 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 judgement showld be applied to any drug of abuse test result, partlculary when preliminary positive-results are used.

Source page: https://510kreport.com/device/K984525
Methodology: https://510kreport.com/methodology