# K020313: 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 Co.
- Decided: May 8, 2002 after 98 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: 2 generations back to K945610 (1995). 9 ancestors in all.
88 later devices descend from it; 4 cite it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011673: Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test Device, ACON Laboratories, Inc. (2001) Summary page 2.
- K011672: Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step Methamphetamine Test Device, ACON Laboratories, Inc. (2001) Summary page 2.
- K010841: Acon Coc One Step Cocaine Test Strip, Acon Coc One Step Cocaine Test Device, ACON Laboratories, Inc. (2001) Summary page 2.
- K011353: Acon Opi One Step Opiates Test Strip, Acon Opi One Step Opiates Test Device, ACON Laboratories, Inc. (2001) Summary page 2.
- K003557: Acon THC One Step Marijuana Test Strip (Urine);Acon THC One Step Marijuana Test Device (Urine), ACON Laboratories, Inc. (2001) Summary page 2.
- K011730: Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine Test Device, ACON Laboratories, Inc. (2001) Summary page 2.

## 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 cut-off concentrations for these drugs are as follows: Amphetamine at 1,000 ng/ml, Cocaine at 300 ng/ml, Methamphetamine at 1,000 ng/ml, Opiates at 2,000 ng/ml, Marijuana at 50 ng/ml and Phencyclidine at 25 ng/ml. They are intended for healthcare professionals including professionals at the point of care sites.

Source page: https://510kreport.com/device/K020313
Methodology: https://510kreport.com/methodology