# K992918: STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103I

- Pathway: 510(k) (Traditional)
- Applicant: OraSure Technologies, Inc.
- Decided: Apr 3, 2000 after 217 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 K933052 (1993). 1 ancestor in all.
14 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933052: Abuscreen Online (R) for Amphetamines, Modified, Roche Diagnostic Systems, Inc. (1993) Summary page 1.

## Most influential descendants
- 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
- K033743: Cozart Eia Amphetamines Oral Fluid Microplate Kit (2004), 2 descendants of its own
- K181305: OralTox Oral fluid Drug Test (2018), 1 descendant of its own
- K132688: Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, AU/NZ (2013), 1 descendant of its own

## Indications for use
The STC Amphetamine-Specific Intercept™ MICRO-PLATE EIA is intended for use in the qualitative determination of amphetamine in oral fluid collected with the Intercept™ Drugs of Abuse (DOA) Oral Specimen Collection Device. For In Vitro Diagnostic Use.

Source page: https://510kreport.com/device/K992918
Methodology: https://510kreport.com/methodology