# K960187: Cocaine Metabolite Eia Test

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Reagents, Inc.
- Decided: Apr 2, 1996 after 77 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K020763: Cocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit), #0031 (5000 Tests Kit) (2002), 4 descendants of its own
- K181499: DRI Cocaine Metabolite Assay (2018), 1 descendant of its own
- K113139: Lzi Cocaine Metabolite Homogeneous Enzyme Immunoassay,Calibrators,Controls (2011), 1 descendant of its own
- K213211: Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System (2022), 0 descendants of its own
- K211973: DRI Cocaine Metabolite Assay (2021), 0 descendants of its own

## Recalls of this device
- Jul 23, 2013 · Class II · Z-2267-2013: Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected decreasing change in the reaction rate, indicating a faster than expected reagent degradation.

Source page: https://510kreport.com/device/K960187
Methodology: https://510kreport.com/methodology