# K902577: Emit (R) II Opiate Assay

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Jul 27, 1990 after 46 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.
3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K971596: Emit II Opiates 300/2000 Assay (1997), 2 descendants of its own
- K013314: Opiates (2002), 0 descendants of its own
- K984232: Modification of Emit D.a.U. Opiates Assay (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K902577
Methodology: https://510kreport.com/methodology