# K011730: Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine Test Device

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Aug 9, 2001 after 65 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 K961266 (1996). 1 ancestor in all.
95 later devices descend from it; 6 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961266: Accusign, Biosign PCP, Princeton BioMeditech Corp. (1996) Summary page 2.

## Most influential descendants
- K020313: Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug Multi-Line Screen Test Device (2002), 88 descendants of its own
- K031759: Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card (2003), 83 descendants of its own
- K061718: Innovacon Spectrum II Test Card (2006), 80 descendants of its own
- K122809: Advin Multi-Drug Screen Test Cassette, Dip Card and Cup (2013), 55 descendants of its own
- K140748: One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard (2014), 16 descendants of its own

## Indications for use
The ACON PCP One Step Phencyclidine Test Strip and ACON PCP One Step Phencyclidine Test Device are rapid chromatographic immunoassays for the qualitative detection of phencyclidine in human urine at a cut-off concentration of 25 ng/mL. They are intended for healthcare professionals including point of care sites.

Source page: https://510kreport.com/device/K011730
Methodology: https://510kreport.com/methodology