# K021006: Startox Drug of Abuse Screening Test

- Pathway: 510(k) (Traditional)
- Applicant: Starplex Scientific, Inc.
- Decided: Jun 10, 2002 after 74 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 K002447 (2000). 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)
- K002447: Modification to Rapid Drug Screen 9-Panel, American Bio Medica Corp. (2000) Summary page 2.
- K012159: Rapid Drug Screen, American Bio Medica Corp. (2001)

## Indications for use
STARTOXTM Drugs of Abuse Screening Test is a one-step lateral flow immunoassay intended for the simultaneous detection of multiple drug analytes in urine. STARTOXTM is intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels: Compound — Abbreviation — Level Amphetamine (d-amphetamine sulfate) — AMP — 1000 ng/ml Opiates (morphine-3-P-D glucuronide) — OPIATES — 2000 ng/ml Phencyclidine (phencyclidine HCI) — PCP — 25 ng/ml Cocaine (benzoylecgonine) — COCAINE — 300 ng/ml Cannabinoids (1 l-nor-A9-THC-9-carboxylic-acid) — THC — 50 ng/ml STARTOXTM Drugs of Abuse Screening Test provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GUMS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained.

Source page: https://510kreport.com/device/K021006
Methodology: https://510kreport.com/methodology