# K013096: Phencyclidine

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Mar 13, 2002 after 177 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 K904765 (1990). 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)
- K904765: Emit (R) II Phencyclidine Assay, Syva Co. (1990) Summary page 2.

## Indications for use
The Phencyclidine assay is used for the qualitative analysis of phencyclidine in human urine with a cutoff of 25 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of phencyclidine use or overdose. The Phencyclidine assay is calibrated with phencyclidine and will detect phencyclidine and its metabolites and analogs. The Phencyclidine assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. 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/K013096
Methodology: https://510kreport.com/methodology