# K101059: Omega Laboratories Hair Drug Screening Assay for Phencyclidine

- Pathway: 510(k) (Traditional)
- Applicant: Omega Laboratories, Inc.
- Decided: Jul 12, 2010 after 88 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 K011275 (2002). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042726: Quest Diagnostics Haircheck-DT (PCP, Quest Diagnostics, Inc. (2005) Summary page 2.
- K011275: Psychemedics Ria Phencyclidine Assay, Psychemedics Corp. (2002) Summary page 2.

## Most influential descendants
- K131181: Omega Laboratories Hair Drug Screening Assay  Phencyclidine (2013), 0 descendants of its own

## Indications for use
The Omega Laboratories Hair Drug Screening Assay Phencyclidine (PCP) is a laboratory developed test that is intended to be used for the determination of the presence of PCP in human hair from the head. The Omega Laboratories Hair Drug Screening Assay (PCP) utilizes the International Diagnostic Systems Corp (IDS) One-Step 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 laboratory developed test is intended exclusively for in-house laboratory use only and is not intended for sale to anyone. Omega offers this laboratory developed test as a service to its clients.

Source page: https://510kreport.com/device/K101059
Methodology: https://510kreport.com/methodology