# K131181: Omega Laboratories Hair Drug Screening Assay  Phencyclidine

- Pathway: 510(k) (Traditional)
- Applicant: Omega Laboratories, Inc.
- Decided: Jun 25, 2013 after 61 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 K011275 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101059: Omega Laboratories Hair Drug Screening Assay for Phencyclidine, Omega Laboratories, Inc. (2010) Summary page 2.

## Indications for use
The Omega Laboratories Hair Drug Screening Assay Phencyclidine (PCP) is an in vitro diagnostic test that is intended to be used for the determination of the presence of PCP in human hair from the head and body. The Omega Laboratories Hair Drug Screening Assay (PCP) utilizes an enzyme linked immunosorbent assay (ELISA) for PCP, for the qualitative detection of PCP at or above 300 pg/mg of hair for the purpose of identifying the use of PCP. To confirm a screen positive result, a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode is the preferred method with deuterated internal standards. Professional judgment should be applied to any drug of abuse test result, particularly when presumptive positive results are obtained. This test is intended exclusively for single laboratory use only and is not intended for sale to anyone.

Source page: https://510kreport.com/device/K131181
Methodology: https://510kreport.com/methodology