OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE

K131181 · Omega Laboratories, Inc. · LCM · Jun 25, 2013 · TX

Device Facts

• Record ID: K131181
• Device Name: OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE
• Applicant: Omega Laboratories, Inc.
• Product Code: LCM · TX
• Decision Date: Jun 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

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.

Device Story

The Omega Laboratories Hair Drug Screening Assay is an in vitro diagnostic test for detecting phencyclidine (PCP) in human head and body hair. The process involves a proprietary, patent-pending acid-methanol extraction procedure to convert solid hair samples into a liquid matrix. The screening assay uses an Enzyme-Linked ImmunoSorbent Assay (ELISA) with polyclonal goat antibodies coated on micro-well plates. The sample competes with an enzyme-labeled drug conjugate for antibody binding sites; color intensity, measured by a plate reader at 450 nm, is inversely proportional to the drug concentration. The device is used exclusively in a single laboratory setting by trained personnel. Results are qualitative and provide a preliminary analytical finding; positive results require confirmation via a more specific method like GC/MS. The assay aids healthcare providers in identifying PCP use, though professional judgment is required for interpretation.

Clinical Evidence

No clinical trials were performed. Evidence consists of bench testing, including intra-assay and inter-assay precision studies (n=11 and n=220 replicates per concentration, respectively), and an agreement study comparing ELISA results to GC/MS confirmation on 393 head and body hair specimens. The agreement study showed high concordance with GC/MS. Cosmetic treatment studies (shampoo, perm, dye, bleach, relaxer) and environmental contamination assessments were conducted to evaluate assay robustness. Stability testing confirmed a 1-year shelf life for samples.

Technological Characteristics

ELISA-based immunoassay using polyclonal goat antibodies on micro-well plates. Extraction uses acid-methanol. Detection via microplate reader at 450 nm (background at 630 nm). Qualitative output. Single laboratory use. No electronic connectivity or software algorithms described beyond standard plate reader operation.

Indications for Use

Indicated for the qualitative detection of phencyclidine (PCP) in human head and body hair at or above a 300 pg/mg cutoff to identify PCP use. Intended for single laboratory use by trained personnel only.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k131181

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.