# K040092: Ameditech Immu Test Drug Screen Panel

- Pathway: 510(k) (Special)
- Applicant: Ameditech, Inc.
- Decided: Mar 8, 2004 after 52 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K113046: Ameditech Immutest Milti-Drug Screen (2011), 1 descendant of its own
- K113501: Ameditech Checkcup Multi Drug Test (Flat/Round Cup) (2011), 0 descendants of its own
- K051966: First Check Multi Drug Cup 7 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Met), Ecstasy (2005), 0 descendants of its own

## Indications for use
The Ameditech ImmuTest Drug Screen Panel is a one-step panel immunoassay for the qualitative detection of amphetamine, cocaine metabolite (benzoylecgonine), methamphetamine, opiates, phencyclidine, and THC in human urine. The cutoff concentrations for this panel test are amphetamine at 11000 ng/ml, cocaine metabolite at 300 ng/ml, methamphetamine at 500 ng/ml, opiates at 2000 ng/ml, phencyclidine at 25 ng/ml, and THC at 50 ng/ml. This test kit is used to obtain a visual, qualitative results and is intended for professional use.

Source page: https://510kreport.com/device/K040092
Methodology: https://510kreport.com/methodology