# K051579: Immunalysis Amphetamine Elisa for Oral Fluids

- Pathway: 510(k) (Traditional)
- Applicant: Immunalysis Corporation
- Decided: Oct 21, 2005 after 129 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K101745: Thermo Scientific Cedia Amphetamine Oft Assay (2011), 0 descendants of its own

## Indications for use
The Immunalysis Amphetamine ELISA test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of Amphetamine in oral fluid samples collected with the Quantisal™ oral fluid collection device using a cutoff of 50 ng/mL of d-Amphetamine. This in-vitro diagnostic device is intended for clinical laboratory use only. The Immunalysis Amphetamine ELISA Kit for Oral Fluids 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 (GS-MS) is the preferred confirmatory method. Clinical 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/K051579
Methodology: https://510kreport.com/methodology