# K011150: Dridau Opiate Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Jun 20, 2001 after 65 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 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
- K020368: Opiate Enzyme Immunoassay, Catalog # 0020 (500 Tests Kit); Catalog # 0021 (5000 Tests Kit) (2002), 6 descendants of its own
- K120761: Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators, Lzi Opiate 2000 Controls (2012), 2 descendants of its own
- K141803: Immunalysis Tramadol Urine Enzyme Immunoassay (2015), 1 descendant of its own
- K110298: Opiate Enzyme Immunoassay (2011), 1 descendant of its own
- K203527: Immunalysis Tapentadol Urine HEIA (2022), 0 descendants of its own

Source page: https://510kreport.com/device/K011150
Methodology: https://510kreport.com/methodology