# K043305: Online Dat Phencyclidine Plus

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jan 10, 2005 after 41 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: 2 generations back to K920935 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983704: Modification to Abuscreen Online for Phencyclidine, Roche Diagnostic Systems, Inc. (1999) Summary page 1.

## Indications for use
The Phencyclidine Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of phencyclidine and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 25 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Phencyclidine Plus 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 (GS/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/K043305
Methodology: https://510kreport.com/methodology