# K011353: Acon Opi One Step Opiates Test Strip, Acon Opi One Step Opiates Test Device

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Jul 30, 2001 after 88 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
91 later devices descend from it; 3 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020313: Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug Multi-Line Screen Test Device (2002), 88 descendants of its own
- K023946: Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug Multi-Line Screen Test Device (2003), 86 descendants of its own
- 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

Source page: https://510kreport.com/device/K011353
Methodology: https://510kreport.com/methodology