# K963918: Immulite Cocaine Metabolite

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Apr 8, 1997 after 190 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 K870740 (1987). 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)
- K870740: Coat-a-Count Cocaine Metabolite TKCN1 & TKCN5, Diagnostic Products Corp. (1987) Summary page 1.

## Indications for use
A reagent system designed for the semi-quantitative analysis of benzoylecgonine, and its parent compound, cocaine, in urine. It is intended strictly for in vitro diagnostic use in the context of a program involving an established confirmatory test for cocaine and its principal metabolites.

Source page: https://510kreport.com/device/K963918
Methodology: https://510kreport.com/methodology