# K001178: Cedia Dau 6-Acetylmorphine Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Jun 9, 2000 after 59 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.
60 later devices descend from it; 4 cite it directly.
0 of 61 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
- K040316: Cedia Buprenorphine Assay (2004), 52 descendants of its own
- K150606: Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive (2015), 25 descendants of its own
- K161216: Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators (2017), 23 descendants of its own
- K180427: ARK Fentanyl Assay (2018), 19 descendants of its own
- K042988: Rapid One Step Buprenorphine Test Card (2005), 18 descendants of its own

Source page: https://510kreport.com/device/K001178
Methodology: https://510kreport.com/methodology