# K050024: One Step Multiple Drugs of Abuse Assays

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Nov 17, 2005 after 316 days
- Product code: DIS (Enzyme Immunoassay, Barbiturate)
- Device class: 2
- Regulation: 21 CFR 862.3150
- 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 K020771 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020771: Acon One Step Drug Screen Test Card, ACON Laboratories, Inc. (2002) Summary page 2.

## Indications for use
One Step Multiple Drugs of Abuse Assays is used for the qualitative determination of the following drugs of abuse in urine: Product Name — Cutoff Amphetamine (amphetamine) — 1000ng/ml Barbiturate (secobarbital) — 300ng/ml Benzodiazipines (oxazepam) — 300ng/ml Cocaine (benzoylecgonine) — 300ng/ml Methamphetamine (methamphetamine) — 10OOng/ml Morphine (morphine) — 300ng/ml Opiate (morphine) — 2000ng/ml Methadone (methadone) — 300ng/ml Methylenedioxymethamphetamine (methylenedioxymethamphetamine) — 500ng/ml Phencyclidine (phencyclidine) — 25ng/ml Tricyclic antidepressant drugs (nortriptyline) — 10OOng/ml Cannabinoids (tetrahydrocannabinol-COOH) — 50ng/ml The configurations of the One Step Multiple Drugs of Abuse Assays are available in any combination of the above tests. These devices are intended to be used by healthcare professionals only. For in vitro diagnostic use. Measurements obtained by this device are used in the diagnosis and treatment of use or overdose of the drugs listed above. This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.

Source page: https://510kreport.com/device/K050024
Methodology: https://510kreport.com/methodology