OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE
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 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K131181 · Jun 25, 2013 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE | Omega Laboratories, Inc. | Retrospective donor hair samples; Clinical laboratory records | Retrospective donor hair samples were used to conduct agreement studies against GC/MS, cosmetic treatment effect studies, shipping stability studies, and long-term storage stability studies. | Retrospective clinical samples; Agreement study; Stability study; Hair drug testing |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Agreement Study (Head and Body Hair); Retrospective comparison of ELISA screening results against GC/MS confirmatory results | Donor hair samples (head and body); Sample Size: 393; Number of Sites: 1 | GC/MS confirmatory method | Qualitative detection of PCP at or above 300 pg/mg |
| Shipping Study; Retrospective analysis of donor hair samples subjected to environmental stress (temperature/humidity) during shipping; Follow-up/Duration: At least two days of shipping | 137 head hair samples (30 positive, 100 negative, 7 near-cutoff); Sample Size: 137; Number of Sites: 4 | Not applicable for this study | Stability of PCP concentration in hair matrix after shipping |
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.
