# K013380: Acon Mop One Step Opiate Test Strip, Acon Mop Step Opiate Test Device

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Dec 18, 2001 after 67 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
Longest line of descent: 1 generation back to K000273 (2000). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000273: Screeners Opiates Test Drugscreen Dip Opiates Test, Drug Detection Devices, Ltd. (2000) Summary page 2.

## Most influential descendants
- K041685: Acon Multi-Clin Drug Screen Test Device (2004), 1 descendant of its own
- K122752: Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug Screen Dipcard (2013), 0 descendants of its own
- K080467: Bionexa Single and Multi-Strip Cassette/Dipstick Doa Screen Panels ( Amp, Bar, Bzo, Coc, Met, MTD, Mor, PCP, Tca, THC, (2008), 0 descendants of its own
- K041743: Acon Tri-Fect Drug Screen Test Device (2004), 0 descendants of its own

## Indications for use
The ACON MOP One Step Opiate Test Strip and ACON MOP One Step Opiate Test Device are rapid chromatographic immunoassays for the qualitative detection of Opiate in human urine at a cut-off concentration of 300 ng/mL. They are intended for healthcare professional use.

Source page: https://510kreport.com/device/K013380
Methodology: https://510kreport.com/methodology