(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
-
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."
-
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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JUL 1 2 2010
Premarket Notification - 510(k) Hair Drug Screening Assay (PCP) Summary of Safety and Effectiveness
SUMMARY OF SAFETY AND EFFECTIVENESS
April 12, 2010
Trade Name: Hair Drug Screening Assay (PCP)
Common Name: Hair Drug Screening Assay (PCP)
Applicant:
William R. Corl Vice President of Operations
400 North Cleveland Mogadore, OH 44260 Tel: 330-628-5748 Fax: 330-628-5803
Classification Name:
Classification Panel: Clinical Chemistry
All questions and/or comments concerning this document should be made to:
Robert J. Bard, Esq. Managing Director
HealthCare Technologies Consultants PO Box 506 South Lyon. MI 48178 Tel: 248-573-5040 Cell: 734-330-5990 email: rbard@reglaw.net
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1.0 ASSAY SUMMARY
The Assay is an enzyme immunoassay for the qualitative detection of phencyclidine in hair.
Phencyclidine (PCP), the hallucinogen commonly referred to as Angel Dust, can be detected in hair. Human head hair grows at approximately ½ inch per month, and has been measured using various biomarkers (1,2). Hair, due to its growth rate and stability, offers a much longer history of drug usage than any other matrix. Hair has been increasingly chosen as a workplace test specimen, since, in contrast to urine, the collection is observed, and the possibility of adulteration or substitution of the specimens is reduced. PCP itself is incorporated into the growing hair shaft. For the screening of PCP in hair, an enzyme linked immunosorbent assay (ELISA) procedure has been established; and for confirmatory analysis, gas chromatography with mass spectrometric detection is the preferred laboratory procedure.
| Classification or descriptor | Name or designation |
|---|---|
| Trade Name | Hair Drug Screening Assay for Phencyclidine (PCP) |
| Common Name | Hair Drug Screening Assay for Phencyclidine (PCP) |
| Classification Name | Enzyme immunoassay, phencyclidine |
| Classification Panel | 91 (Toxicology) |
| Product Code | LCM |
| Regulation Number | Unclassified, Enzyme Immunoassay, PCP |
1.1 Classification Information
PREDICATE DEVICES 2.0
- 2.1 Quest Diagnostics HairCheck-DT (PCP)
- 510(k) Number: K042726 2.1.1
- Psychemedics Corporation RIA Phencyclidine (PCP) Assay 2.2
- 510(k) Number: K011275 2.2.1
INTENDED USE AND INDICATIONS FOR USE 3.0
- The Omega Laboratories Hair Drug Screening Assay Phencyclidine 3.1 (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
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iudament 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) screening test provides only a preliminary qualitative test result. 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.
ASSAY DESCRIPTIONS 4.0
- 4.1 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.
- 4.2 The Omega Laboratories Hair Drug Screening Assay (PCP) screening test provides only a preliminary analytical test result. To confirm a screen positive result, a more specific alternate chemical method must be used.
- 4.3 Assay
- 4.3.1 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.
4.4 Specifications
- 4.4.1 Donor Sample Collection
- 4.4.1.1 Donor samples are collected using the Omega Collection Kit or a similar system that are equivalent to the Omega Collection Kit specifications. Hair samples stored in the Kit have a one vear shelf life.
- 4.4.2 IDS One-Step ELISA PCP (microplate format)
4.4.2.1 The IDS PCP utilizes an enzyme-linked immunosorbent assav technology (ELISA). ELISA utilizes highly sensitive and specific antibodies onto a solid-phase surface such as a microwell plate. The sample to be tested competes with an enzyme solution for the binding sites of the antibody. If the enzyme binds to the antibody, a
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Premarket Notification - 510(k) Hair Drug Screening Assay (PCP) Summary of Safety and Effectiveness
color change occurs after the addition of substrate. The darker the color, the lower the amount of analyte in the sample.
Materials 4.5
ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ
- Sample Collection Kit 4.5.1
- IDS One-Step ELISA PCP Kit 4.5.2
- Micro Plate Read 4.5.3
GC/MS for Confirmation Testing 4.5.4
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COMPARISON OF BASESENS SYSTEM AND ITS PREDICATES
.0
Comparison of Omega Laboratories PCP Assay vs Quest Diagnostic Hair Check-DT (PCP) Assay 5.1
| Hair Drug Screening Assay forPhencyclidine (PCP). (Subject devices) | Hair Drug Screening Assay forPhencyclidine (PCP). (Predicate device**K042726) | Psychemedics RIA PhencyclidineAssay (Predicate device. K011275). | |
|---|---|---|---|
| Omega Laboratories, Inc. | Quest Diagnostics, Inc. | Psychemedics Corp | |
| The Omega Laboratories Hair DrugScreening Assay Phencyclidine (PCP) is alaboratory developed test that is intended tobe used for the determination of thepresence of PCP in human hair. TheOmega Laboratories Hair Drug ScreeningAssay (PCP) utilizes the InternationalDiagnostic Systems Corp (IDS) One-Stepenzyme linked immunosorbent assay(ELISA) for PCP, for the qualitativedetection of PCP at or above 300 pg/mg ofhair for the purpose of identifying the use ofPCP. To confirm a screen positive result amore specific alternate chemical method,such as Gas Chromatography/MassSpectrometry (GC/MS) operating in theselected ion monitoring (SIM) mode is thepreferred method with deuterated internalstandards. Professional judgment should beapplied to any drug of abuse test result,particularly when presumptive positiveresults are obtained.This laboratory developed test is intendedexclusively for in-house laboratory use onlyand is not intended for sale to anyone.Omega offers this laboratory developed testas a service to its clients. | The Quest Diagnostics Hair Check-DT(PCP) is a test system that utilizes theIDS One-Step ELISA PCP Kit for thequalitative detection of Phencyclidine ator above 300 pg/mg in head hairsamples. This test system has not beenevaluated for use in specific userpopulations or with hair specimens otherthan the head. It is an in vitro diagnosticdevice intended exclusively for in-houseprofessional use only and is not intendedfor sale to anyone.The Quest Diagnostics Hair Check-DT(PCP) screening test provides only apreliminary analytical test result. A morespécific alternate chemical method mustbe used in order to obtain a confirmedresult. Gas Chromatograph - MassSpectrometry operating in the selectedion monitoring (SIM) mode is thepreferred method with deuterated internalstandards. Other chemical confirmationmethods are available. Clinicalconsideration and professional judgmentshould be applied to any drug of abusetest result, particularly when preliminarypositive results are obtained. (From FDAPublished Statement of Indications forUse) | The Psychemedics PCP Assay is aradioimmunoassay (RIA) for thepreliminary qualitative and semi-quantitative detection of phencyclidine(PCP) in hair using a 3 ng/110 mg haircutoff for the purpose of identifyingPCP use. For a quantitative analyticalresult or to confirm positive results viathe presence of PCP. a more specificalternate chemical method must beused in order to obtain a confirmedanalytical result. (From FDAPublished Statement of Indications forUse) |
Page 1 of 11
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| Product Code | Summary of Safety and Effectivene | |||
|---|---|---|---|---|
| LCM | LCM | LCL | ||
| Measurand | Phencyclidine (PCP) in hair | Phencyclidine (PCP) in hair | Phencyclidine (PCP) in hair | |
| Test system | International Diagnostics Systems CorpForensic Human Drugs of AbuseOne-Step ELISA for Hair Testing Kit – IDSpart# PCP-480-OM. | International Diagnostics Systems CorpForensic Human Drugs of AbuseOne-Step ELISA for Hair Testing Kit –IDS part# PCP-480-OM. | Polyclonal primary antibody;isotopically labeled PCP; doubleantibody precipitation | |
| Method ofMeasurement | Microplate reader. Read at 450 nm | Microplate reader. Read at 450 nm | ||
| Matrix | Head hair | Head hair | Hair/Head hair | |
| Cutoffconcentration | 300 pg PCP/mg hair | 300 pg PCP/mg hair | 3 ng PCP/10 mg hair | |
| Type of Test | ELISA | ELISA | Radioimmunoassay (RIA) | |
| ExtractionMethod | Utilized acid-methanol vs methanol alone tofacilitate extraction of PCP from hair.Proprietary and patent pending method ofPulverizing hair vs cutting the hair into smallsegments prior to acid-methanol extraction.This improved extraction times without lossof efficiency | Methanol | ProprietaryThe hair sample preparation for theassay is a 2-hour, pH = 9.5,enzymatic dilation of the hair. | |
| Confirmationmethods | GC/MS | GC/MS | GC/MS | |
| Producesradioactivewaste | No | No | Yes |
Page 2 of 11
:
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SUMMARY OF PERFORMANCE TESTING 6.0
- 6.1 Precision Study
- 6.1.1 The Screening Protocol was studied to evaluate its precision/reproducibility. The Precision Study was performed to evaluate the intra and inter-assay precision/reproducibility of the Protocol.
| PCP SpikedSample | negative | 75 pg/mg-75% | 150 pg/mg-50% | 225 pg/mg-25% | 375 pg/mg+25% | 450 pg/mg+50% | 525 pg/mg+75% | 600 pg/mg+100% |
|---|---|---|---|---|---|---|---|---|
| Mean Abs. (450nm) | 1.926 | 1.203 | 0.865 | 0.697 | 0.505 | 0.437 | 0.398 | 0.348 |
| S.D. | 0.05531 | 0.08171 | 0.03957 | 0.03382 | 0.02465 | 0.02637 | 0.02467 | 0.02157 |
| %CV | 2.9 | 3.8 | 4.6 | 4.9 | 4.9 | 6.0 | 6.2 | 6.2 |
Inter-Assay Precision using Spiked Samples (normalized data)
Intra-assay Precision of PCP using Individual Hair Specimens
| Accession # | A | B | C | D | E |
|---|---|---|---|---|---|
| 0.521 | 0.486 | 0.282 | 0.115 | 0.058 | |
| 0.534 | 0.492 | 0.342 | 0.113 | 0.073 | |
| 0.466 | 0.527 | 0.256 | 0.105 | 0.053 | |
| Mean | 0.507 | 0.502 | 0.293 | 0.111 | 0.061 |
| S.D. | 0.03609709 | 0.0221 | 0.0441 | 0.0053 | 0.0104 |
| %CV | 7.1 | 4.4 | 15.0 | 4.8 | 17.0 |
| 95% CI | 0.041 | 0.025 | 0.050 | 0.006 | 0.012 |
| 95% CI Lower | 0.466 | 0.477 | 0.243 | 0.105 | 0.050 |
| 95% CI Upper | 0.548 | 0.527 | 0.343 | 0.117 | 0.073 |
GC/MS Analysis of Intra-assay Precision of PCP using Individual Hair Specimens
| Accession # | A (pg/mg) | B (pg/mg) | C (pg/mg) | D (pg/mg) | E (pg/mg) |
|---|---|---|---|---|---|
| 379 | 568 | 1334 | 4749 | 7493 | |
| 406 | 542 | 1552 | 4134 | 6754 | |
| 411 | 571 | 1418 | 4702 | 7040 | |
| Mean | 399 | 560 | 1435 | 4528 | 7096 |
| S.D. | 17.2143 | 15.9478 | 109.952 | 342.31 | 372.632 |
| %CV | 4.3 | 2.8 | 7.7 | 7.6 | 5.3 |
| 95% CI | 19.5 | 18.0 | 124.4 | 387.4 | 421.7 |
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Premarket Notification - 510(k) Hair Drug Screening Assay (PCP) Summary of Safety and Effectiveness
| 95% CI Lower | 379 | 542 | 1310 | 4141 | 6674 |
|---|---|---|---|---|---|
| 95% CI Upper | 418 | 578 | 1559 | 4916 | 7517 |
- Evaluation of the precision of the Omega Laboratories, Inc. 6.1.2 ELISA PCP Screening Protocol demonstrated that the intra and inter-assay precision using spiked samples was acceptable (%CV of 10% or less).
- Evaluation of the precision of the Omega Laboratories, Inc. 6.1.3 ELISA PCP Screening Protocol using this study design demonstrated that the intra-assay precision using individual donor sample replicates was acceptable (%CV of 15% or less).
6.2 Agreement Study
- The Agreement Study was performed by comparing ELISA 6.2.1 results against quantitative GC/MS confirmatory results on the same hair specimens. A total of 352 donor hair samples were tested in this study (Negative n=176 and Positive n=176).
| IDS ELISAPCP TestResult | Negative byGC/MS (lessthan 50 pg/mg) | Less than halfthe cutoffconcentrationby GC/MS | Near CutoffNegative(Between 50%below the cutoffand the cutoffconcentration) | Near CutoffPositive(Betweenthe cutoff and50% above thecutoffconcentration) | High Positive(Greater than50% above thecutoffconcentration) |
|---|---|---|---|---|---|
| Positive | 0 | 1 | 14 | 33 | 128 |
| Negative | 150 | 15 | 7 | 4 | 0 |
Summary of Agreement Study Results
Evaluation of the agreement of the Omega Laboratories, Inc. 6.2.2 ELISA PCP Screening Protocol vs quantitative GC/MS results demonstrated the false detection rate of samples containing PCP at levels higher than 50% above cutoff concentration is 0% and the false detection rate of PCP at levels less than 50% of the cutoff concentration is 0.6%.
- 6.3 Cosmetic Treatment Study
- The Cosmetic Treatment study documented the absence of 6.3.1 effects of various cosmetic treatments on the Omega Laboratories, Inc. ELISA PCP Screening Protocol.
| Hair Treatment Assignment | |
|---|---|
| BLEACH 1 | Salon Care Blue Flash Professional Powder Lightener |
| BLEACH 2 | Loreal Super Oreal Blanc® Professional PowderBleach |
| PERM 1 | Naturelle Natural Curls Alkiline Perm |
| PERM 2 | Natural Apple Self-Timing Perm |
| DYE 1 | Revlon® Colorsilk™ Black |
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Premarket Notification - 510(k) Hair Drug Screening Assay (PCP) Summary of Safety and Effectiveness
| DYE 2 | Garnier Herbashine Soft Mahogany Dark Brown |
|---|---|
| RELAXER 1 | Silk Elements™ No-Lye Sensitive Scalp RelaxerSystem |
| RELAXER 2 | Ultra Precise No-Lye Conditioning Relaxer |
| SHAMPOO 1 | After Burner drug removing shampoo |
| SHAMPOO 2 | Ultra Cleanse drug removing shampoo |
Summary of Effects for Positive GC/MS Confirmation Data
| Treatment | Mean change in concentration(pg/mg) |
|---|---|
| Bleach | -28% |
| Permanent | -36% |
| Dyeing | -5% |
| Relaxer | -9% |
| Shampoo | -4% |
- 6.3.2 Permanent treatments had the greatest effect on positive samples followed by bleaching resulting in an average decrease in PCP concentration of 36% and 28%, respectively. The mean effect of relaxer or shampoo treatments was negligible i.e. the mean change was within the standard uncertainty range of the GC/MS confirmation assay
6.4 Cross reativities
Cross Reactivity and Interference was studied were conducted to evaluate the specificity of the Omega Laboratories. Inc. ELISA PCP Screening Protocol and the possible effect of interfering compounds.
- The study demonstrated that the presence of the structurally 6.4.1 similar compounds metaphit, 4-hydroxyphencyclidine, and phencyclidine morpholine may contribute to a PCP positive ELISA result when utilizing this protocol. None of the other (270) compounds demonstrated interference with the ELISA PCP protocol. Since a GC/MS confirmation is performed on all presumptive positive screening results, these interfering compounds will not confirm as a positive PCP result report.
6.5 Environmental Contamination
- 6.5.1 Two studies were conducted. The first study involved exposing drug-free hair to PCP, washing the hair with methanol three times, performing confirmation testing on the samples and the washes, and observing the final test result. The second study involved performing confirmation testing on known positive samples and observing whether the methanol washes change the final result.
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- The studies examined the following potential exposure modes. 6.5.2 Dry Contact, Dry Contact plus Liquid, Dry Contact ply Saline (NaCI) Solution and Smoke.
- Based on the study results, the proposed testing procedures 6.5.3 are able to distinguish between true analytically positive samples and those that have been externally exposed to PCP.
- Calibrator and Control રે છે. ક
- The in-house calibrator and control solutions are prepared 6.6.1 solely for use within Omega and only at its laboratories in Mogadore, OH.
- The study demonstrated the stability of PCP in methanol for a 6.6.2 period of one year when stored refrigerated in an amber bottle is also attached. This validates the one 1 year expiration date for the PCP Calibrator Stock Solution
- 6.7 Recovery Study
- The Extraction Recovery Study evaluated the effectiveness of 6.7.1 the extraction method utilized by the Omega Laboratories, Inc. ELISA PCP Screening Protocol.
- The GC/MS results of the acidic-methanol extraction were 6.7.2 compared to the results of the 100% recovery base hydrolysis extraction to determine the relative recovery of PCP using the acidic-methanol incubation. The mean recovery for the acidicmethanol extraction was 102%.
6.8 Shipping Study
- The Shipping Study was conducted to determine whether 6.8.1 there is any adverse effect on donor hair samples when exposed to extreme temperatures and variations in humidity that might occur during sample shipments.
- The average mean % of change in result prior to shipping and 6.8.2 after shipping was 0% for all locations combined. The study demonstrated that because a hair sample is a solid matrix, it is not susceptible to the same temperature constraints as a urine sample.
- 6.9 Stability Study
- The Stability Study was conducted to determine whether there 6.9.1 are any adverse effects on the level of PCP contained in a hair sample when it is placed in storage for an extended period of time.
| Measured value | Value or range |
|---|---|
| Range in concentration pg/mg hair (Before) | 110 - 4999 |
| Range in concentration pg/mg hair (After) | 115 - 5102 |
| Mean Change | -8% |
Table 16: Stability values
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Premarket Notification – 510(k) Hair Drug Screening Assay (PCP) Summary of Safety and Effectiveness
| % Max and Min Decrease | -32% and -2% |
|---|---|
| % Max and Min Increase | 9% and 2% |
| Number that increased in concentration | 8 |
| Number that decreased in concentration | 12 |
Based on the 8 % mean percent change over the 2.5 year storage, donor sample PCP drug stability is maintained at value well within the Acceptance Criteria of less 15% and is consider acceptable for use in the Protocol. Shelf life for the hair samples has been set at 1 year after collection.
Conclusion:
The Omega Laboratory Hair Drug Screening Assay for Phencyclidine (PCP) does not raise any new safety and efficacy concerns when compared to the cleared Quest Diagnostics HairCheck-DT (PCP).
Based on the design and performance test results, the Omega assay is substantially equivalent to the Quest Diagnostic HairCheck-DT (PCP).
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Image /page/11/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Omega Laboratories, Inc. c/o Mr. Robert J Bard JD Managing Director PO Box 506 South Lyon, Michigan 48178
JUL 1 2 2010
K101059 Re:
Trade Name: Omega Laboratories Hair Drug Screening Assay for Phencyclidine Regulation Number: Unclassified Regulatory Class: Class II Product Codes: LCM Dated: April 11, 2010
Received: April 15, 2010
Dear Mr. Bard:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
K101059 510(k):
Device Name: Omega Laboratories Hair Drug Screening Assay Phencyclidine (PCP)
Indication for Use:
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.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) <10/059
N/A