# K971596: Emit II Opiates 300/2000 Assay

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Jun 25, 1997 after 55 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 K902577 (1990). 1 ancestor in all.
2 later devices descend from it; 2 cite 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)
- K902577: Emit (R) II Opiate Assay, Syva Co. (1990) Summary page 1.

## Most influential descendants
- K013314: Opiates (2002), 0 descendants of its own
- K984232: Modification of Emit D.a.U. Opiates Assay (1999), 0 descendants of its own

## Indications for use
The Emite IT Opiates 300/2000 Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 2000 ng/mL cutoff. The assay is mtended for use.in the qualitative and semiquantitative analysis of opiates in human urine.

Source page: https://510kreport.com/device/K971596
Methodology: https://510kreport.com/methodology