(88 days)
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.
The Omega Laboratories Hair Drug Screening Assay (PCP) is a test system that utilizes the International Diagnostic Systems Corp (IDS) One-Step ELISA PCP reagents and a micro-plate reader for the qualitative detection of Phencyclidine in hair samples at or above 300 pg/mg. It is an assay intended exclusively for in-house use by trained laboratory personnel only and is not intended for sale to anyone. The test consists of two parts; a pre-analytical proprietary and patent pending hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix), and the screening assay.
Acceptance Criteria and Device Performance for Omega Laboratories Hair Drug Screening Assay (PCP)
This document outlines the acceptance criteria and study results for the Omega Laboratories Hair Drug Screening Assay (PCP), an enzyme immunoassay for the qualitative detection of phencyclidine (PCP) in hair. The information is extracted from the provided Premarket Notification - 510(k) Summary of Safety and Effectiveness (K101009).
1. Table of Acceptance Criteria and Reported Device Performance
| Study | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision Study | ||
| Intra and Inter-Assay Precision (Spiked Samples) | %CV of 10% or less | Inter-Assay: %CV ranged from 2.9% to 6.2% across concentrations. Intra-Assay: %CV ranged from 4.4% to 17.0% for individual donor samples (though the document states acceptable if 15% or less, some individual values are higher like 15% and 17%). For GC/MS analysis of intra-assay precision, %CV ranged from 2.8% to 7.7%. |
| Agreement Study | False detection rate for samples >50% above cutoff: 0% | False detection rate for samples >50% above cutoff: 0% |
| False detection rate for samples |
N/A