# K000399: STC PCP Intercept Micro-Plate Eia, Model 11541

- Pathway: 510(k) (Traditional)
- Applicant: OraSure Technologies, Inc.
- Decided: May 15, 2000 after 98 days
- Product code: LCM (Enzyme Immunoassay, Phencyclidine)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 3 cite it directly.
0 of 13 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
- 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
- K101746: Thermo Scientific Cedia Phencyclidine (PCP) Oft Assay (2011), 3 descendants of its own
- K122703: Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and  Rapidease Oral Fluid Collector (2013), 2 descendants of its own
- K181135: Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay (2019), 1 descendant of its own

Source page: https://510kreport.com/device/K000399
Methodology: https://510kreport.com/methodology