# K980746: Cedia Dau Eddp Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: May 26, 1998 after 89 days
- Product code: DJR (Enzyme Immunoassay, Methadone)
- Device class: 2
- Regulation: 21 CFR 862.3620
- 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 K931780 (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)
- K931780: Methadone Metabolite Eia Assay, Diagnostic Reagents, Inc. (1993) Summary page 1.

## Most influential descendants
- K081378: Dri Methadone Metabolite (100/300) Assay, Calibrators and Controls (2009), 1 descendant of its own
- K092048: One Step Eddp (Methadone Metabolite) Test Strip (2010), 0 descendants of its own

## Indications for use
The CEDIA® DAU EDDP Assay is a homogeneous enzyme immunoassay for the in vitro qualitative and semiquantitative determination of EDDP in human urine on automated clinical chemistry analyzers. Measurements are used as an aid in the diagnosis and treatment of methadone use or overdose.

Source page: https://510kreport.com/device/K980746
Methodology: https://510kreport.com/methodology