# K020254: Phencyclidine Enzyme Immunoassay, Catalog Numbers 0010 & 0011

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: May 10, 2002 after 106 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 K935320 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935320: Phencyclidine Eia Assay, Diagnostic Reagents, Inc. (1993) Summary page 1.

## Most influential descendants
- K033866: Camp Multiple Analyte Enzyme Immunoassay, Cat.# 0510, 0511 (500 & 5000 Test Kits) (2004), 0 descendants of its own

## Indications for use
The Phencyclidine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 25 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of phencyclidine (PCP) in human urine. The Phencyclidine Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K020254
Methodology: https://510kreport.com/methodology