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510(k) Data Aggregation
(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 <50% below cutoff: Not explicitly stated as a numerical criterion, but implies minimizing errors for samples near cutoff and below. | False detection rate for PCP at levels less than 50% of cutoff: 0.6% | |
| Cosmetic Treatment Study | Absence of significant effects of various cosmetic treatments on the assay results. | Bleach: -28% mean change in concentration. Permanent: -36% mean change in concentration. Dyeing: -5% mean change in concentration. Relaxer: -9% mean change in concentration. Shampoo: -4% mean change in concentration. (Note: Permanent and Bleach showed more significant decreases, while "negligible" effect was reported for relaxer and shampoo, within GC/MS uncertainty). |
| Cross-Reactivity Study | No interference from a broad panel of compounds, with clear identification of structurally similar compounds that may cause a positive ELISA result. | Metaphit, 4-hydroxyphencyclidine, and phencyclidine morpholine may contribute to a PCP positive ELISA. None of the other 270 compounds demonstrated interference. |
| Environmental Contamination Study | Ability to distinguish between true analytically positive samples and those externally exposed to PCP. | Based on study results, the proposed testing procedures are able to distinguish between true analytically positive samples and those externally exposed to PCP. |
| Recovery Study | Acceptable effectiveness of the extraction method. | Mean recovery for acidic-methanol extraction: 102% (compared to 100% recovery base hydrolysis extraction). |
| Shipping Study | No adverse effect on donor hair samples when exposed to extreme temperatures and humidity during shipping. | Average mean % of change in result prior to shipping and after shipping was 0% for all locations combined. |
| Stability Study (Donor Samples) | Mean percent change over 2.5 year storage: less than 15%. | Mean change after 2.5 years: -8%. (Within acceptance criteria). |
2. Sample Sizes and Data Provenance
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Test Set Sample Size:
- Precision Study (Spiked Samples): Not explicitly stated, but implies multiple replicates for inter-assay and intra-assay evaluations.
- Precision Study (Individual Hair Specimens): 5 individual hair specimens (A, B, C, D, E), each tested with 3 replicates for intra-assay precision.
- Agreement Study: 352 donor hair samples (176 negative, 176 positive).
- Cross-Reactivity Study: Panel of 270 compounds, plus metaphit, 4-hydroxyphencyclidine, and phencyclidine morpholine. Specific number of samples tested with each is not detailed.
- Environmental Contamination Study: Not explicitly stated, but involved exposing drug-free hair to PCP and testing known positive samples.
- Recovery Study: Not explicitly stated, but involved comparing acidic-methanol extraction results to 100% recovery base hydrolysis extraction.
- Shipping Study: Not explicitly stated, but involved testing samples before and after simulated shipping conditions.
- Stability Study (Donor Samples): Not specified beyond indicating "donor sample PCP drug stability."
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Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the context of a 510(k) submission for a laboratory-developed test in the US, it is highly probable the studies were conducted in the US and were prospective for the purpose of demonstrating performance for the submission.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable in the traditional sense of human readers for image interpretation.
- Qualifications of Experts: Not applicable. The "ground truth" for this device is established primarily through instrumental analytical methods.
4. Adjudication Method
- Adjudication Method: Not applicable. The evaluation relies on quantitative measurements from instrumental methods rather than human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not done. This device is an in-vitro diagnostic assay for laboratory use, not typically evaluated with MRMC studies involving human readers and image interpretation.
6. Standalone Performance Study
- Standalone Performance: Yes, the entire performance testing section (Section 6.0) describes the standalone performance of the Omega Laboratories Hair Drug Screening Assay (PCP) algorithm (i.e., the ELISA protocol). The precision, agreement, cosmetic treatment, cross-reactivity, environmental contamination, recovery, shipping, and stability studies all evaluate the intrinsic performance of the assay without human-in-the-loop assistance in the analytical process itself. Human involvement is for sample preparation, running the assay, and interpreting the quantitative results of the microplate reader against a cutoff.
7. Type of Ground Truth Used
- Ground Truth Type:
- Instrumental Confirmation (GC/MS): For the Agreement Study, quantitative Gas Chromatography/Mass Spectrometry (GC/MS) was used as the gold standard for confirming PCP concentrations in hair samples. This is considered a highly reliable and specific analytical method.
- Spiked Samples: For the Precision Study, known concentrations of PCP were "spiked" into samples, providing a defined ground truth for evaluating analytical variability.
- Controlled Exposures: For the Environmental Contamination Study, controlled exposures of drug-free hair to PCP were used to create known conditions for analysis.
8. Sample Size for the Training Set
- Training Set Sample Size: The document does not explicitly mention a "training set" in the context of machine learning or AI development. Given that this is an enzyme immunoassay, it's a biochemical test rather than a machine learning algorithm that typically requires a training set. The various studies (precision, agreement, etc.) serve to validate the assay's performance characteristics. If "training set" refers to data used to initially develop or optimize the assay, that information is not provided.
9. How Ground Truth for Training Set was Established
- Ground Truth for Training Set: Not applicable in the context of a machine learning training set as described in the previous point. The ground truth for the assay's development and validation was established through similar instrumental methods (e.g., GC/MS) and the preparation of controlled, spiked samples to characterize its analytical performance.
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