# K013247: Cannabinoids

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Mar 13, 2002 after 166 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
Longest line of descent: 1 generation back to K904571 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904571: Emit (R) II Cannabinoid 50 NG Assay, Syva Co. (1990) Summary page 2.

## Indications for use
The Cannabinoids assay is used for the qualitative analysis of cannabinoids in human urine with a cutoff of 50 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoids use or overdose. The Cannabinoids assay is calibrated with 11-nor-A°-THC-9-COOH and will detect a variety of —A’-THC metabolites. The Cannabinoids 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/K013247
Methodology: https://510kreport.com/methodology