# K962795: Cedia Dau Opiate 2K Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Oct 30, 1996 after 104 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
Longest line of descent: 1 generation back to K935346 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935346: Cedia (R) Dau Opiate Assay, Microgenics Corp. (1994) Summary page 1.

## Indications for use
The CEDIA DAU Opiate 2K Assay is a homogeneous enzyme immunoassay for the qualitative assay of opiates in human urine. Measurements are used in the diagnosis and treatment of opiate use or overdose.

Source page: https://510kreport.com/device/K962795
Methodology: https://510kreport.com/methodology