# K101746: Thermo Scientific Cedia Phencyclidine (PCP) Oft Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Apr 8, 2011 after 290 days
- Product code: LCM (Enzyme Immunoassay, Phencyclidine)
- Device class: U
- 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 K000399 (2000). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000399: STC PCP Intercept Micro-Plate Eia, Model 11541, OraSure Technologies, Inc. (2000) Summary page 2.

## Most influential descendants
- K122703: Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and  Rapidease Oral Fluid Collector (2013), 2 descendants of its own
- K181135: Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay (2019), 1 descendant of its own
- K203489: SEFRIA PCP Oral Fluid Enzyme Immunoassay (2021), 0 descendants of its own

## Indications for use
The CEDIA® Phencyclidine (POP) OFT Assay is intended for use in the qualitative determination of phencyclidine in human oral fluid at a cutoff concentration of 3 nglmL in neat oral fluid. The specimen must be collected exclusively with the Ora-Eze TM Saliva Collection System. The assay is calibrated against POP and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only. The CEDIA Phencyclidine (POP) 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/K101746
Methodology: https://510kreport.com/methodology