# K001197: Cocaine Metabolite Intercept Micro-Plate Eia

- Pathway: 510(k) (Special)
- Applicant: OraSure Technologies, Inc.
- Decided: May 11, 2000 after 30 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
No predicates in its family tree.
12 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K103227: Oratect Oral Fluid Drug Screen Devices (2012), 6 descendants of its own
- K171403: OralTox Oral Fluid Drug Test (2018), 3 descendants of its own
- K050945: Oral Fluid Cocaine Metabolite Homogeneous Enzyme Immunoassays, Calibrators & Controls (2006), 2 descendants of its own
- K181305: OralTox Oral fluid Drug Test (2018), 1 descendant of its own
- K132688: Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, AU/NZ (2013), 1 descendant of its own

Source page: https://510kreport.com/device/K001197
Methodology: https://510kreport.com/methodology