# K981341: STC Opiates Micro-Plate Eia (Orasure Application)

- Pathway: 510(k) (Traditional)
- Applicant: OraSure Technologies, Inc.
- Decided: May 22, 1998 after 39 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- 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 K924446 (1992). 1 ancestor in all.
20 later devices descend from it; 5 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924446: Micro-Plate Opiates Assay, Solarcare Technologies Corp,Inc. (1992) Summary page 1.

## Most influential descendants
- K103227: Oratect Oral Fluid Drug Screen Devices (2012), 6 descendants of its own
- K050988: Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls (2006), 6 descendants of its own
- K171403: OralTox Oral Fluid Drug Test (2018), 3 descendants of its own
- K101754: Thermo Scientific Cedia Opiate Oft Assay (2011), 3 descendants of its own
- K062242: Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and Controls (2006), 3 descendants of its own

## Indications for use
The STC Opiates Micro-Plate EIA is intended for use in the qualitative determination of opiates in oral fluid collected with the OraSure® Oral Collection Device. For In Vitro Diagnostic Use.

Source page: https://510kreport.com/device/K981341
Methodology: https://510kreport.com/methodology