# K000273: Screeners Opiates Test Drugscreen Dip Opiates Test

- Pathway: 510(k) (Traditional)
- Applicant: Drug Detection Devices, Ltd.
- Decided: Apr 7, 2000 after 70 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.
5 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013380: Acon Mop One Step Opiate Test Strip, Acon Mop Step Opiate Test Device (2001), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K000273
Methodology: https://510kreport.com/methodology