# K101753: Thermo Scientific Cedia Methamphetamine Oft Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Apr 8, 2011 after 290 days
- Product code: LAF (Gas Chromatography, Methamphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3610
- 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 K933052 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993208: STC Methamphetamine Intercept Micro-Plate Eia, Model 1104I, OraSure Technologies, Inc. (2000) Summary page 2.

## Most influential descendants
- K133047: Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral Fluid Controls, Rapidease Oral Flu (2014), 0 descendants of its own

## Indications for use
The CEDIA® Methamphetamine OFT Assay is intended for use in the qualitative detection of methamphetamine at a cutoff concentration of 120.0 ng/mL in neat oral fluid. The specimen must be collected exclusively with the OraI-EzeTh Saliva Collection System. The assay is calibrated against d-methamphetamine and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only. The CEDIA Methamphetamine OFT Calibrators are intended for use in the calibration of d-Methamphetamine when used with the CEDIA Methamphetamine OFT Assay for human oral fluid samples collected with the Oral-Ezem Saliva Collection System. This in vitro diagnostic device is intended for clinical laboratory use only. The CEDIA Methamphetamine 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-MSIMS) 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/K101753
Methodology: https://510kreport.com/methodology