# K933052: Abuscreen Online (R) for Amphetamines, Modified

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Sep 15, 1993 after 112 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.
25 later devices descend from it; 3 cite it directly.
0 of 26 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
- K992918: STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103I (2000), 14 descendants of its own
- K993208: STC Methamphetamine Intercept Micro-Plate Eia, Model 1104I (2000), 7 descendants of its own
- K103227: Oratect Oral Fluid Drug Screen Devices (2012), 6 descendants of its own
- K171403: OralTox Oral Fluid Drug Test (2018), 3 descendants of its own
- K062242: Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and Controls (2006), 3 descendants of its own

Source page: https://510kreport.com/device/K933052
Methodology: https://510kreport.com/methodology