# K101744: Thermo Scientific Cedia Cannabinoids Oft Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Apr 8, 2011 after 290 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- 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 K002375 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002375: STC Cannabinoids Intercept Micro-Plate Eia, Model 1118I, OraSure Technologies, Inc. (2001) Summary page 2.

## Most influential descendants
- K132096: Rapidfret Oral Fluid Assay for THC, THC Calibrator Set, THC Control Set, Collector (2013), 0 descendants of its own

## Indications for use
The CEDIA® Cannabinoids OFT Assay is intended for use in the qualitative determination of Cannabinoids in human oral fluid at a cutoff concentration of 3 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze TM Saliva Collection System. The assay is calibrated against I-A9 THC and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only. The CEDIA THO OFT Calibrators are intended for use in the calibration of I-A9 THC when used with the CEDIA Cannabinoids OFT Assay. This in vitro diagnostic device is intended for clinical laboratory use only. The CEDIA Cannabinoids OFT Assay provides only a preliminary analytical test result. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K101744
Methodology: https://510kreport.com/methodology