# LCM: Enzyme Immunoassay, Phencyclidine

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 88
- 510(k) review time 2021–2025: median 179 days (middle half 162–197)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2010: 1
- 2011: 2
- 2012: 1
- 2013: 2
- 2014: 1
- 2015: 1
- 2017: 1
- 2019: 1
- 2021: 1
- 2022: 1

## Most-cited predicates
- K011730: Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine Test Device (2001), cited by 6
- K000399: STC PCP Intercept Micro-Plate Eia, Model 11541 (2000), cited by 3
- K000462: Urine Phencyclidine (PCP) Screen Flex Reagent Cartridge, Catalog NO. DF 94A (2000), cited by 2
- K964355: Ontrak Testcup 5 (Modification) (1996), cited by 2
- K935320: Phencyclidine Eia Assay (1993), cited by 2
- K163220: Atellica CH Phencyclidine (Pcp) (2017), cited by 1
- K935650: Cedia (R) Dau PCP Assay (1994), cited by 1
- K111928: Psychemedics Phencyclidine Eia (2012), cited by 1
- K181135: Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay (2019), cited by 1
- K920935: Abuscreen Online for Phencyclidine (1992), cited by 1

Source page: https://510kreport.com/product-code/LCM
Data by year (CSV): https://510kreport.com/product-code/LCM.csv