# K971841: Bionike AQ One Step Cannabinoids (THC) Test

- Pathway: 510(k) (Traditional)
- Applicant: Bionike Laboratories, Inc.
- Decided: Jun 25, 1997 after 37 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- 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 AQ™ One Step Cannabinoids Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of Cannabinoids and its metabolites at a cutoff concentration of 50ng/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/K971841
Methodology: https://510kreport.com/methodology