# K002375: STC Cannabinoids Intercept Micro-Plate Eia, Model 1118I

- Pathway: 510(k) (Traditional)
- Applicant: OraSure Technologies, Inc.
- Decided: Jan 26, 2001 after 175 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 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
- 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
- K101744: Thermo Scientific Cedia Cannabinoids Oft Assay (2011), 1 descendant of its own

## Recalls of this device
- Sep 8, 2008 · Not classified · Z-0478-2009: Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.
- Sep 8, 2008 · Not classified · Z-0477-2009: Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.
- Sep 8, 2008 · Not classified · Z-0479-2009: Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.
- Sep 8, 2008 · Not classified · Z-0481-2009: Readings, high: intermittent high absorbance readings. For further information, please contact the firm at 610-882-1820.

Source page: https://510kreport.com/device/K002375
Methodology: https://510kreport.com/methodology