# K924446: Micro-Plate Opiates Assay

- Pathway: 510(k) (Traditional)
- Applicant: Solarcare Technologies Corp,Inc.
- Decided: Oct 15, 1992 after 44 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
No predicates in its family tree.
21 later devices descend from it; 1 cites 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K981341: STC Opiates Micro-Plate Eia (Orasure Application) (1998), 20 descendants of its own
- 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

Source page: https://510kreport.com/device/K924446
Methodology: https://510kreport.com/methodology