# K934891: Amphetamines Eia Assay Modification

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Reagents, Inc.
- Decided: Jan 13, 1994 after 114 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K020395: Amphetamines Enzyme Immunoassay, Catalog #0040 (500 Tests Kit), Catalog #0041 (5000 Tests Kit) (2002), 3 descendants of its own
- K102210: Lzi Amphetamines 500 Homogenous Enzyme Immunoassay; Lzi Amphetamines 500 Calibrators; Lzi Amphetamines 500 Controls (2010), 2 descendants of its own
- K113661: Lzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine Calibrators, Lzi Methamphetamine Controls (2012), 1 descendant of its own
- K201442: Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers (2020), 0 descendants of its own

Source page: https://510kreport.com/device/K934891
Methodology: https://510kreport.com/methodology