# K023281: Online Dat II Cocaine II

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Dec 6, 2002 after 66 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: 2 generations back to K933053 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983697: Modification to Abuscreen Online Cocaine Metabolite, Roche Diagnostic Systems, Inc. (1998) Summary page 2.

## Most influential descendants
- K062929: Quest Diagnostics Urine Cocaine Metabolite Eia (2006), 0 descendants of its own

## Indications for use
Cocaine II is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine on automated clinical chemistry analyzers at cutoff concentrations of 150 and 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

Source page: https://510kreport.com/device/K023281
Methodology: https://510kreport.com/methodology