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    K Number
    K131181
    Device Name
    OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE
    Manufacturer
    OMEGA LABORATORIES, INC.
    Date Cleared
    2013-06-25

    (61 days)

    Product Code
    LCM
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    k101059
    Why did this record match?
    Reference Devices :

    K101059

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Omega Laboratories Hair Drug Screening Assay Phencyclidine 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 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.

    Device Description

    The Assay is an enzyme immunoassay for the qualitative detection of phencyclidine in head and body hair (hair). Phencyclidine (PCP), the hallucinogen commonly referred to as Angel Dust, can be detected in hair.

    The assay consists of two parts; a pre-analytical proprietary and patent pending hair treatment procedure (to remove PCP from the solid hair matrix to a measurable liquid matrix), and the screening assay. The screening assay is an Enzyme-Linked ImmunoSorbent Assay (ELISA).

    After the extraction treatment, the test sample is added to a well of the coated micro strip plate and enzyme conjugate is added, followed by incubation. During this phase the enzyme-labeled drug conjugate competes with drug in the sample for a limited number of binding sites on the antibody-coated micro wells. The two bind in proportion to their concentrations. A wash solution is applied to remove any unbound materials. Enzyme substrate solution containing a chromagen is added. The reaction is stopped with an acid and the absorbance is read using a plate reader at 450 nm. A background reading is also taken at 630 nm. Color intensity is inversely proportional to the amount of drug present in the sample. For the screening of PCP in hair, an enzyme linked immunosorbent assay (ELISA) procedure has been established.

    AI/ML Overview

    Acceptance Criteria and Device Performance for Omega Laboratories Hair Drug Screening Assay Phencyclidine (K131181)

    The Omega Laboratories Hair Drug Screening Assay Phencyclidine (PCP) is an in vitro diagnostic test for the qualitative detection of PCP in human head and body hair at or above 300 pg/mg.

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document does not explicitly state pre-defined acceptance criteria (e.g., target true positive rate, true negative rate, or specific ranges for precision values) against which the study results are directly measured. However, the studies demonstrate the precision, agreement with a reference method, and robustness of the assay. The performance is reported in terms of observed precision and agreement rates.

    Performance MetricAcceptance Criteria (Implicit/Demonstrated)Reported Device Performance
    Intra-assay Precision (Individual Samples)Consistent detection of PCP in positive samples.100% positive agreement for 3 replicates of 5 different positive PCP samples (399-7096 pg/mg).
    Intra-assay Precision (Spiked Samples at Cutoff)Consistent detection across negative, below cutoff, and above cutoff concentrations.Negative samples (0, 75, 150, 225 pg/mg): 100% negative results (11/11 replicates each).
    Positive samples (375, 450, 525, 600 pg/mg): 100% positive results (11/11 replicates each).
    Inter-assay Precision (Spiked Samples at Cutoff)Consistent detection across negative, below cutoff, and above cutoff concentrations over multiple runs.Negative samples (0, 75, 150, 225 pg/mg): 100% negative results (220/220 replicates each).
    Positive samples (375, 450, 525, 600 pg/mg): 100% positive results (220/220 replicates each).
    Agreement with GC/MS (Combined Head & Body Hair)High agreement with GC/MS as the confirmatory method, especially around the cutoff.Total samples (n=393):
    • ELISA Positive / GC/MS Positive (>300 pg/mg): 38 + 162 = 200 samples
    • **ELISA Negative / GC/MS Negative (
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