# K023946: Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug Multi-Line Screen Test Device

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Feb 5, 2003 after 70 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: 2 generations back to K991079 (1999). 8 ancestors in all.
86 later devices descend from it; 2 cite it directly.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012824: Acon Bar One Step Barbiturates Test Strip, Acon Bar One Step Barbiturates Test Device, ACON Laboratories, Inc. (2001)
- K012300: Acon Bzo One Step Benzodiazepines Test Strip; Acon Bzo One Step Benzodiazepines Test Device, ACON Laboratories, Inc. (2001)
- K022589: Acon Mdma One Step Ecstasy Test Strip & Acon Mdma One Step Ecstasy Test Device, ACON Laboratories, Inc. (2002)
- K011353: Acon Opi One Step Opiates Test Strip, Acon Opi One Step Opiates Test Device, ACON Laboratories, Inc. (2001)
- K021526: Acon Tca One Step Tricyclic Antidepressant Test Strip and Device, ACON Laboratories, Inc. (2002)
- (no number) ACON MTD One Step Methadone Test Strip: named in the summary without a submission number

## Most influential descendants
- K031759: Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card (2003), 83 descendants of its own
- K061718: Innovacon Spectrum II Test Card (2006), 80 descendants of its own
- K122809: Advin Multi-Drug Screen Test Cassette, Dip Card and Cup (2013), 55 descendants of its own
- K140748: One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard (2014), 16 descendants of its own
- K182701: Wondfo T-Cup Multi-Drug Urine Test Cup (2018), 13 descendants of its own

## Indications for use
The ACON@One Step Multi-Drug Multi-Line Screen Test Card and Test Device are rapid chromatographic immunoassays for the qualitative and simultaneous detection of two to six drugs in a variety of combinations in human urine. The designated Cutoff concentrations for these drugs are as follows: Analyte — Abbreviation — Calibrator — Cutoff Conc. Barbiturates — BAR — Secobarbital — 300 ng/mL Benzodiazepines — BZO — Oxazepam — 300 ng/mL Methadone — MTD — Methadone — 300 ng/mL MDMA (Ecstasy) — MDMA — MDMA — 500 ng/mL Opiates — MOP or OP1 — Morphine — 300 ng/mL Tricyclic Antidepressants — TCA — Nortriptyline — 1,000 ng/mL These tests are intended for healthcare professionals including professionals at the point of care sites.

Source page: https://510kreport.com/device/K023946
Methodology: https://510kreport.com/methodology