# K012585: Ameditech Immutest Drug Screen Methamphetamine

- Pathway: 510(k) (Traditional)
- Applicant: Ameditech, Inc.
- Decided: Nov 16, 2001 after 98 days
- Product code: LAF (Gas Chromatography, Methamphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3610
- 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 METHAMPHETAMINE is an In Vitro screen test for the qualitative detection of Methamphetamine in human urine at cut-off concentration of 500 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/K012585
Methodology: https://510kreport.com/methodology