# K040274: Acon Opi One Step Opiate Test Strip and Acon Opi One Step Opiate Test Device

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: May 3, 2004 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) FDA-cleared Opiate Test Device with 2,000 ng/mL Opiate cutoff: named in the summary without a submission number

## Most influential descendants
- K050594: Nano-Check Dat 5 Multi Drug Screening Test for Cannabinoids, Opiates, Cocaine, Methamphetamine & Phencyclidine (2005), 0 descendants of its own

## Indications for use
The ACON OPI II One Step Opiate Test Strip or the ACON OPI II One Step Opiate Test Device is a lateral flow chromatographic immunoassay for the qualitative detection of opiates in human urine at a cut-off concentration of 2,000 ng/mL. It is a prescription assay intended for use by healthcare professionals including those at the point of care sites. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K040274
Methodology: https://510kreport.com/methodology