# K994380: Cedia Dau Amphassure Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: May 2, 2000 after 127 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 K883707 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883707: TDX Amphetamine/Methamphetamine II, Abbott Laboratories (1988) Summary page 1.

## Indications for use
The CEDIA® DAU AmphAssure Assay is a homogeneous enzyme immunoassay for the in vitro qualitative determination of amphetamines in human urine on automated clinical chemistry analyzers. This device is used as an accessory to immunoassay screening tests to reduce the number of false positive results needing confirmation testing. Measurements are used as an aid in the diagnosis and treatment of amphetamine use or overdose. The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. GCMS is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgement should be applied to any drug of abuse test result particularly when preliminary positive test results are used.

Source page: https://510kreport.com/device/K994380
Methodology: https://510kreport.com/methodology