# K053359: Rapidtox

- Pathway: 510(k) (Special)
- Applicant: American Bio Medica Corp.
- Decided: May 25, 2006 after 174 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K073078: Rapid Tox Cup (2008), 0 descendants of its own

## Indications for use
The RapidTox TM is a one-step, lateral flow immunoassay for the simultaneous detection of up to ten abused drug analytes in urine (each analyte is represented by a line in the test window of the cassette). Rapid Tox is intended for use in the qualitative detection of the following drugs of abuse in human urine at the following levels: Compound — Test Abbreviation — Level (ng/ml) Amphetamine (d-amphetamine sulfate) — AMP — 1000 Barbiturates (secobarbital) — BAR — 300 Benzodiazepine (oxazepam) — BZO — 300 Cocaine (benzoylecgonine) — COC — 300 MDMA ((+/-)3,4-methylenedioxy-methamphetamine) (Ecstasy) — MDMA — 1000 Methadone — MTD — 300 Methamphetamine ((+/-)methamphetamine HCI) — MET — 1000 Opiates (morphine-3-b-D-glucuronide) — OPt — 300 2000 Oxycodone — OXY — IOO Phencyclidine (phencyclidine HC1) — PCP — 25* Propoxyphene/Norpropoxyphene — PPX — 300 THC/Cannabinoids (I 1-nor-A9-THC-9-carboxylic-acid) — THC — 50' Tricyclic Antidepressants (nortriptyline) — TCA — 1000 Rapid Tox provides only a preliminary analytic test result. More specific alternative chemical methods must be used to obtain a 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 results are used. The Test is recommended for professional use. It is not intended for over-the-counter sales to nonprofessionals.

Source page: https://510kreport.com/device/K053359
Methodology: https://510kreport.com/methodology