# K101754: Thermo Scientific Cedia Opiate Oft Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Apr 8, 2011 after 290 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
Longest line of descent: 2 generations back to K924446 (1992). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981341: STC Opiates Micro-Plate Eia (Orasure Application), OraSure Technologies, Inc. (1998) Summary page 2.

## Most influential descendants
- K203564: SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay (2021), 1 descendant of its own
- K252520: SEFRIA™ Hydrocodone Oral Fluid (2025), 0 descendants of its own
- K133642: Rapidfret Oral Fluid Assay for Opiates; Rapidfret Oral Fluid Calibrators, Controls, Collector; Rapidfret Integrated Work (2014), 0 descendants of its own

## Indications for use
The CEDIA® Opiate OFT Assay is intended for use in the qualitative determination of opiate in human oral fluid at a cutoff concentration of 30 nglmL in neat oral fluid. The specimen must be collected exclusively with the Oral-EzeTM Saliva Collection System. The assay is calibrated against morphine and performed on the MG0240. This in vitro diagnostic device is intended for clinical laboratory use only. The CEDIA Opiate 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 (LG-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/K101754
Methodology: https://510kreport.com/methodology