# K020771: Acon One Step Drug Screen Test Card

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: May 15, 2002 after 68 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 9 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K112071: Wondfo Cocaine Urine Test Model W10-CU, W10-P, Wondfo Methamphetamine Urine Test Model W11-CU, W11-P (2011), 6 descendants of its own
- K102203: Chemtrue Single / Multi Drug Screen Cassette / Dip Card Tests (2011), 6 descendants of its own
- K121339: Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests (2012), 5 descendants of its own
- K142580: Chemtrue Multi-Panel DOA DIP Card Tests (2014), 4 descendants of its own
- K130665: Wondofo Multi-Drug Urine Test Cup / Panel (2013), 4 descendants of its own

## Indications for use
The ACON One Step Drug Screen Test Card and ACON One Step Drug Screen Test Card with Integrated Cup are rapid chromatographic immunoassay devices for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, and/or barbiturate in human urine. The test is calibrated against analytes with their respective cutoff concentrations listed in the following table. Test — Calibrator — Cut-off Amphetamine (AMP) — D-Amphetamine — 1,000 ng/mL Barbiturates (BAR) — Secobarbital — 300 ng/mL Benzodiazepines (BZO) — Oxazepam — 300 ng/mL Cocaine (COC) — Benzoylecgonine — 300 ng/mL Methamphetamine (mAMP) — D-Methamphetamine — 1,000 ng/mL Morphine (MOP 300 or OPI 300) — Morphine — 300 ng/mL Methadone (MTD) — Methadone — 300 ng/mL Opiates (OPI 2000) — Morphine — 2,000 ng/mL Phencyclidine (PCP) — Phencyclidine — 25 ng/mL Marijuana (THC) — 11-nor-A’-THC-9 COOH — 50 ng/mL The configurations of the ACON One Step Multi-Drug Screen Test Card and ACON One Step Multi-Drug Screen Test Card with Integrated Cup come with any combination of the above listed drug analytes. They are intended for the healthcare professionals including professionals at point-of-care sites.

Source page: https://510kreport.com/device/K020771
Methodology: https://510kreport.com/methodology