# K983697: Modification to Abuscreen Online Cocaine Metabolite

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Dec 11, 1998 after 51 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 K933053 (1993). 1 ancestor in all.
2 later devices descend 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)
- K933053: Abuscreen Online (R) for Cocaine Metabolite, Modif, Roche Diagnostic Systems, Inc. (1993) Summary page 2.

## Most influential descendants
- K023281: Online Dat II Cocaine II (2002), 1 descendant of its own
- K062929: Quest Diagnostics Urine Cocaine Metabolite Eia (2006), 0 descendants of its own

## Indications for use
Abuscreen ONLINE Cocaine Metabolite is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzoylecgonine, the primary metabolite of cocaine in human urine on automated clinical chemistry analyzers at a cutoff concentrations of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of cocaine use or abuse.

Source page: https://510kreport.com/device/K983697
Methodology: https://510kreport.com/methodology