# K002010: STC Methadone Intercept Micro-Plate Eia, Model 11421

- Pathway: 510(k) (Traditional)
- Applicant: OraSure Technologies, Inc.
- Decided: Nov 29, 2000 after 149 days
- Product code: DJR (Enzyme Immunoassay, Methadone)
- Device class: 2
- Regulation: 21 CFR 862.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K051058: Methadone Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls (2006), 6 descendants of its own
- K062242: Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and Controls (2006), 3 descendants of its own
- K131652: Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, Controls (2014), 2 descendants of its own
- K063024: Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral Fluid Calibrators and Controls (2006), 1 descendant of its own
- K203647: SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay (2021), 0 descendants of its own

Source page: https://510kreport.com/device/K002010
Methodology: https://510kreport.com/methodology