# K101745: Thermo Scientific Cedia Amphetamine Oft Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Apr 8, 2011 after 290 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- 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 K051579 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051579: Immunalysis Amphetamine Elisa for Oral Fluids, Immunalysis Corporation (2005) Summary page 2.

## Indications for use
The CEDIA® Amphetamine OFT Assay is intended for use in the qualitative determination of amphetamine in human oral fluid at a cutoff concentration of 150 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 d-amphetamine and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only. The CEDIA Amphetamine 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/K101745
Methodology: https://510kreport.com/methodology