# K012483: Ameditech Immutest Drug Screen Opiates

- Pathway: 510(k) (Traditional)
- Applicant: Ameditech, Inc.
- Decided: Nov 30, 2001 after 120 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Ameditech ImmuTest™ Drug Screen OPIATES is an In Vitro screen test for the qualitative detection of opiates or opiate metabolites in human urine at cut-off concentration of 2000 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use.

Source page: https://510kreport.com/device/K012483
Methodology: https://510kreport.com/methodology