# K013004: Cocaine

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Mar 13, 2002 after 188 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
Longest line of descent: 1 generation back to K902579 (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)
- K902579: Emit (R) II Cocaine Metabolite Assay, Syva Co. (1990) Summary page 2.

## Indications for use
The Cocaine assay is used for the qualitative analysis of benzolecgonine (cocaine metabolite) in human urine with a cutoff of 300 ng/mL for use in clini¢al laboratories. Measurements obtained by this device arc used in the diagnosis and treatment of cocaine use or overdose. The Cocaine assay is calibrated with Benzoylccgonine and will detect cocaine and the major metabolites. The Cocaine assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirtned 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 resulr, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K013004
Methodology: https://510kreport.com/methodology