# K984232: Modification of Emit D.a.U. Opiates Assay

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Jan 22, 1999 after 58 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: 2 generations back to K902577 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971596: Emit II Opiates 300/2000 Assay, Behring Diagnostics, Inc. (1997) Summary page 1.

## Indications for use
Emit® d.a.u.™ Opiates Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 2000 ng/mL cutoff. The assay is intended for use in the qualitative or semiquantitative analysis of opiates in human urine. The assay is used to screen for potential drugs of abuse.

Source page: https://510kreport.com/device/K984232
Methodology: https://510kreport.com/methodology