# K013314: Opiates

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Mar 13, 2002 after 160 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 2.

## Indications for use
The Opiates assay is used for the qualitative analysis of opiates in human urine with a cutoff of 300 ng/mL or 2,000 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of opiates use or overdose. The Opiates assay is calibrated with morphine and will detect a variety of opiates and their metabolites. The Opiates assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K013314
Methodology: https://510kreport.com/methodology