# K972384: AQ One Step Cocaine Test

- Pathway: 510(k) (Traditional)
- Applicant: Bionike Laboratories, Inc.
- Decided: Aug 6, 1997 after 41 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Bionike One Step Cocaine Test is a rapid immunochromatographic competitive-assay used to screen humaii urine for the presence of benzoylecgonine at a cutoff concentration of 300ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS. The test is for use by health care professionals only.

Source page: https://510kreport.com/device/K972384
Methodology: https://510kreport.com/methodology