# K040350: Randox Amphetamine Class Assay

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: May 12, 2004 after 90 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.
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
evidence® Amphetamine Assay The evidence® Amphetamine assays have been designed for use only on the evidence® analyser for qualitative detection of the amphetamine class of compounds in urine using a cut off concentration of 1000ng/ml in accordance with SAMHSA recommendations. Qualitative results obtained can be utilized in the diagnosis and treatment of amphetamine use or overdose. This assay provides only a preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS. The evidence® Amphetamine assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions. evidence® Drugs of Abuse Calibrators. The evidence® Drugs of Abuse Calibrators are liquid Calibrators containing benzoylecgonine, amphetamine and methamphetamine. There are 9 levels of calibrator. They have been developed for use in calibration of the evidence® system. The evidence® Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K040350
Methodology: https://510kreport.com/methodology