# K093114: Thermo Scientific Dri Amphetamines Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: May 12, 2010 after 223 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
Longest line of descent: 1 generation back to K943993 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943993: Cedia Dau Amphetamines Assay, Microgenics Corp. (1994) Summary page 1.

## Most influential descendants
- K153693: Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (2016), 0 descendants of its own

## Indications for use
The DRI® Amphetamines Assay is intended for the qualitative or semi-quantitative determination of amphetamine and methamphetamine in human urine. The assay has cutoff levels of 500 and 1000 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting amphetamine and methamphetamine in urine on automated clinical analyzers. The assay is calibrated with methamphetamine. This assay provides only a preliminary analytical test result. A more specific alternative 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/K093114
Methodology: https://510kreport.com/methodology