# K080431: Rapidsense Drugs of Abuse Phencyclidine (PCP) 25 Device with Models 900-0054

- Pathway: 510(k) (Traditional)
- Applicant: Quantrx Biomedical Corporation
- Decided: Jan 8, 2009 after 324 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 K961266 (1996). 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)
- K011730: Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine Test Device, ACON Laboratories, Inc. (2001) Summary page 2.

## Indications for use
The RapidSense TM Drugs of Abuse Phencyclidine (PCP) 25 Device is a lateral flow competitive immunoassay intended for the qualitative detection for phencyclidine in human urine at a cut-off concentration of 25 ng/mL. The assay is intended for use in professional laboratories by healthcare professionals. For in vitro diagnostic use. This assay provides only'a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method. Tests for PCP cannot distinguish between abused drugs and certain prescribed medications. Certain foods or medications may interfere with tests for, PCP and cause false positive results.

Source page: https://510kreport.com/device/K080431
Methodology: https://510kreport.com/methodology