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K Number
K142855
Device Name
Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA)
Manufacturer
Omega Laboratories, Inc.
Date Cleared
2015-07-28

(301 days)

Product Code
DKZ
Regulation Number
862.3100
Type
Traditional
Panel
Toxicology
Reference & Predicate Devices
k101973
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Omega Laboratories Hair Drug Screening Assay for Methamphetamine (Meth) and 3,4 Methylenedioxymethamphetamine (MDMA) is an in vitro diagnostic test that is intended for the qualitative detection of Methamphetamine (calibrated with Methamphetamine) and MDMA (calibrated with MDMA) at or above 500 pg/mg in human head and body hair. 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 with deuterated internal standards is the preferred method. 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 Omega Laboratories Hair Drug Screening Assays for Methamphetamine_3,4-methylenedioxymethamphetamine (Meth_MDMA) is a test system using ELISA reagents and micro-plate reader for the qualitative detection of Methamphetamine and 3,4- Methylenedioxymethamphetamine (MDMA) in head and body hair samples at or above 500 pg/mg.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Omega Laboratories Hair Drug Screening Assay for Methamphetamine (Meth) and 3,4-Methylenedioxymethamphetamine (MDMA), based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria CategorySpecific CriteriaReported Device Performance
Precision (Intra-assay)Acceptable, typically %CV of 10% or less for spiked samples.Methamphetamine: All 11 replicates for 0, 125, 250, 375 pg/mg were negative; all 11 replicates for 625, 750, 875, 1000 pg/mg were positive. (Table 2a) MDMA: All 11 replicates for 0, 125, 250, 375 pg/mg were negative; all 11 replicates for 625, 750, 875, 1000 pg/mg were positive. (Table 2b)
Precision (Inter-assay)Acceptable, typically %CV of 10% or less for spiked samples.Methamphetamine: All 220 replicates for 0, 125, 250, 375 pg/mg were negative; all 220 replicates for 625, 750, 875, 1000 pg/mg were positive. (Table 3a) MDMA: All 110 replicates for 0, 125, 250 pg/mg were negative; 14 negative and 96 positive for 375 pg/mg; all 110 replicates for 625, 750, 875, 1000 pg/mg were positive. (Table 3b) Note on MDMA at 375 pg/mg: "due to the 166% cross-reactivity of MDMA."
Precision (Intra-assay, Individual Donor)Acceptable, typically %CV of 15% or less for individual donor replicates.Demonstrated as acceptable (specific %CV values for individual donor replicates not provided in tables).
Agreement with GC/MS (Qualitative)Substantial agreement with GC/MS confirmation for both head and body hair.Methamphetamine (n=739): 142 Negative by ELISA and GC/MS (negative); 472 Positive by ELISA and GC/MS (high positive). MDMA (n=418): 142 Negative by ELISA and GC/MS (negative); 260 Positive by ELISA and GC/MS (high positive). (Tables 4a, 4b)
Handling Discordant ResultsDiscordant results should be consistent with the 500 pg/mg cutoff.Discordant results were observed (e.g., ELISA Positive for Meth at GC/MS 159 pg/mg, 184 pg/mg, etc.; ELISA Negative for Meth at GC/MS 778 pg/mg; ELISA Negative for MDMA at GC/MS 557 pg/mg, 563 pg/mg, 778 pg/mg). The document states, "All Discordant results are consistent with drug cutoff value of 500 pg/mg." This implies potential sensitivity/specificity nuances around the cutoff, confirmed by the note that GC/MS confirmation is performed on all presumptive positive screening results.
Cross-reactivityAcceptable specificity with structurally similar compounds, and no interference from unrelated compounds.Numerous structurally similar compounds showed varying degrees of cross-reactivity (Tables 5a, 5b). Unrelated compounds at 10000 ng/ml (400000 pg/mg) generally showed no interference, with the exception of d,l-N-Desmethylvenlafaxine in the MDMA spike at -50% CO for concentrations greater than 7500 ng/mL.
Effect of Interfering CompoundsNo false negatives for expected positive results.No tested non-structurally cross-reactive samples produced a negative result when expected to be positive (Tables 6a, 6b). Structurally related compounds interfered as expected due to cross-reactivity.
Calibrator and Control Stability/TraceabilityValidation and stability of solutions, traceability to NIST standards.Study successfully demonstrated validation and stability of solutions and traceability to NIST standards. 1-year expiration for Calibrator Stock Solution validated.
Sample Stability (Storage)Mean variation in Meth or MDMA concentrations < 15% (due to 13.6% Uncertainty of Measurement of GC/MS).Methamphetamine: Mean change 4% (Range: -10% to +26%). MDMA: Mean change 10% (Range: -7% to +31%). Both well within 15%. (Table 8)
Sample Stability (Shipping)No adverse effect on hair samples when exposed to extreme temperatures and variations in humidity during transport. No discordant screening results.Extreme temperature (min -12.7°C, max 44.9°C) and humidity (min 4.4%RH, max 100.0%RH) conditions simulated. Of 200 samples, no discordant screening results were found after shipping. (Tables 9, 10).
Cosmetic Treatment EffectsEffects should be minimal or within the uncertainty range of the confirmation assay.Methamphetamine: Perms (-14%) and Bleaching (-11%) had the greatest average decrease in concentration in positive samples. Dyes (-8%), Relaxers (-8%), and Shampoos (-5%) showed less effect. One negative sample treated with relaxers changed result. MDMA: Bleach (-17%) had the greatest average decrease in concentration in positive samples. Perms (-13%), Relaxers (-12%), Dyes (-8%), and Shampoos (-5%) showed less effect. One negative sample treated with bleach changed result. (Table 11) Most mean changes were within the GC/MS uncertainty range (±12.6%).
Environmental Contamination MitigationMethanol wash procedure mitigates false positives and maintains true positives.Analytically negative samples remained negative after exposure to drugs and methanol wash. Clinically positive samples remained positive after wash steps.

Study Details

  1. Sample sizes used for the test set and the data provenance:

    • Agreement Studies:
      • Head Hair: 836 samples (some positive for both Meth and MDMA).
      • Body Hair: 138 samples (69 Methamphetamine, 69 MDMA).
      • Origin: Not explicitly stated, though a "Multi-Center Study" is mentioned elsewhere in the full document that this summary is part of, implying varied geographical input. The phrasing "donor specimens" suggests collected samples. The overall context for drug screening in the US would suggest US-based data.
      • Retrospective or Prospective: Not explicitly stated, but "Results obtained from donor specimens" and "previously determined to be negative/potentially positive" for cosmetic and stability studies suggest retrospective analysis of collected clinical samples.
    • Precision Studies (Spiked): 11 replicates per concentration level for intra-assay, 220 replicates (Meth) / 110 replicates (MDMA) per concentration level for inter-assay.
    • Stability Study (Storage): 100 head hair samples (50 previously confirmed positive for Meth, 50 for MDMA).
    • Shipping Study: 200 head hair samples (49 confirmed Meth positive, 48 confirmed MDMA positive, 100 negative, 3 near cutoff). Tested after shipping to various US locations (Portland, Maine, Anchorage, Alaska, Naples, Florida, Tempe, Arizona).
    • Cosmetic Treatment Studies:
      • Study 1 (Methamphetamine): 60 negative head hair, 116 potentially positive head hair.
      • Study 2 (MDMA): 60 negative head hair, 100 potentially positive head hair.
    • Cross-reactivity/Interference: Not specified, but likely laboratory-prepared spiked samples using various compounds.

  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

    • The primary ground truth for confirmation of positive/negative results is Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is an analytical chemical method, not an expert consensus process. The interpretation of GC/MS results is typically done by analytical chemists or toxicologists in a laboratory setting. No specific number or qualification of human experts are mentioned for establishing ground truth from GC/MS.

  3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

    • Not applicable as the primary ground truth is an analytical chemical method (GC/MS) rather than subjective expert interpretation requiring adjudication. For discordant results between the ELISA and GC/MS, the GC/MS result is considered the definitive confirmation.

  4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • No. This is an in vitro diagnostic test for drug screening, not an AI or imaging device involving human readers or interpretation of complex medical images.

  5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

    • Yes, the performance studies described (Precision, Agreement, Cross-reactivity, Interference, Stability, Shipping, Cosmetic Treatment, Environmental Contamination) represent the standalone performance of the ELISA assay (the "algorithm" in this context) compared to the definitive GC/MS method. The assay generates a qualitative "positive" or "negative" screen result.

  6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • The primary ground truth is Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical chemical method considered the gold standard for confirming drug presence and quantifying concentration in hair samples.

  7. The sample size for the training set:

    • The document implies that the device is a "Hair Drug Screening Assay" using ELISA reagents, which is a mature technology. It's likely that a "training set" in the context of machine learning or AI is not directly applicable here. ELISA assays are developed based on known chemical reactions and antibody-antigen binding principles rather than being "trained" on data in the modern AI sense. The development of an ELISA kit involves optimization and validation steps rather than a distinct training phase with a specific dataset size.

  8. How the ground truth for the training set was established:

    • As noted above, a "training set" in the AI sense is not applicable. The assay itself is based on established principles of ELISA. The calibrators and controls used in the assay are traced to NIST standards (National Institute of Standards and Technology), ensuring their accuracy and reliability against a known, highly precise chemical standard.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 28, 2015

OMEGA LABORATORIES, INC. ROBERT BARD MANAGING DIRECTOR 400 N. CLEVELAND AVE. MOGADORE OH 44260

Re: K142855

Trade/Device Name: Omega Laboratories Hair Drug Screening Assav Methamphetamine (Meth) and 3, 4-Methylenedioxymethamphetamine (MDMA) Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: II Product Code: DKZ Dated: July 01, 2015 Received: July 13, 2015

Dear Robert 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142855

Device Name

Omega Laboratories Hair Drug Screening Assay for Methamphetamine (Meth) and 3,4-Methylenedioxymethamphetamine (MDMA)

Indications for Use (Describe)

The Omega Laboratories Hair Drug Screening Assay for Methamphetamine (Meth) and 3,4

Methylenedioxymethamphetamine (MDMA) is an in vitro diagnostic test that is intended for the qualitative detection of Methamphetamine (calibrated with Methamphetamine) and MDMA (calibrated with MDMA) at or above 500 pg/mg in human head and body hair. 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 with deuterated internal standards is the preferred method. 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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

510(k) Number:K142855
Date of Summary:July 27, 2015
Applicant:William R. CorlChief Executive OfficerOmega Laboratories, Inc.400 North ClevelandMogadore, OH 44260Tel: 330-628-5748Fax: 330-628-5803
Correspondent:Name:ROBERT J BARD, JD, CQE, RAC
Address:Omega Laboratories400 North Cleveland, Mogadore, OH 44260
Phone Number:248-573-5040
E-mailrbard@reglaw.net
Product Name:
Trade Name:Omega Laboratories Hair Drug Screening Assay Methamphetamine_3,4-methylenedioxymethamphetamine (Meth_MDMA)
Common Name:Hair Drug Screening Assay Methamphetamine
Regulation Number:CFR 862.3610 (ProCode DKZ)
Classification Name:Methamphetamine Test System
Classification Panel:91 (Toxicology)
Predicate Device:Omega Laboratories Hair Drug Screening Assay Methamphetamine_3,4-methylenedioxymethamphetamine (Meth_MDMA) K101973 with theaddition of the body hair as an assay matri.;
Product Description:The Omega Laboratories Hair Drug Screening Assays forMethamphetamine_3,4-methylenedioxymethamphetamine(Meth_MDMA) is a test system using ELISA reagents and micro-platereader for the qualitative detection of Methamphetamine and 3,4-Methylenedioxymethamphetamine (MDMA) in head and body hairsamples at or above 500 pg/mg.
Indication for Use:The Omega Laboratories Hair Drug Screening Assay forMethamphetamine (Meth) and 3,4-Methylenedioxymethamphetamine(MDMA) is an in vitro diagnostic test that is intended for the qualitativedetection of Methamphetamine (calibrated with Methamphetamine) andMDMA (calibrated with MDMA) at or above 500 pg/mg in human head

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and body hair. 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 with deuterated internal standards is the preferred method. 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.

All performance studies demonstrated that the Omega assay is in Comparison: substantial agreement with the predicate products.

Results obtained from donor specimens showed that the qualitative results from the new assays are substantially equivalent to those obtained from the predicate devices.

ComparisonElement -SimilaritiesOmega Laboratories Hair Drug ScreeningAssay Methamphetamine_3, 4-methylenedioxymethamphetamine(Meth_MDMA) (Subject devices)Omega Laboratories Hair Drug ScreeningAssay Methamphetamine_3, 4-methylenedioxymethamphetamine(Meth_MDMA) (Predicate device K101973)
LaboratoryOmega Laboratories, Inc.Same.
Indication for/Intended UseThe Omega Laboratories Hair Drug ScreeningAssay for Methamphetamine (Meth) and 3,4-Methylenedioxymethamphetamine (MDMA) isan in vitro diagnostic test that is intended forthe qualitative detection of Methamphetamine(calibrated with Methamphetamine) andMDMA (calibrated with MDMA) at or above500 pg/mg in human head and body hair. Toconfirm a screen positive result, a morespecific alternate chemical method, such asGas Chromatography/Mass Spectrometry(GC/MS) operating in the selected ionmonitoring (SIM) mode with deuterated internalstandards is the preferred method.Professional judgment should be applied toany drug of abuse test result, particularly whenpresumptive positive results are obtained.This test is intended exclusively for singlelaboratory use only and is not intended for saleto anyone.The Omega Laboratories Hair DrugScreening Assay Methamphetamine and3,4-Methylenedioxymethamphetamine(MDMA) is a laboratory developed testthat is intended to be used for thedetermination of the presence ofMethamphetamine and 3,4-Methylenedioxymethamphetamine(MDMA) in human hair from the crown ofthe head. The Omega Laboratories HairDrug Screening Assay (Meth -MDMA)utilizes International Diagnostics SystemsCorp One-Step Methamphetamine ELISAfor Hair Testing Kit for the qualitativedetection of Methamphetamine andMDMA at or above 500 pg/mg of hair forthe purpose of identifying the use ofMethamphetamine and MDMA. D-Methamphetamine is used as the standardfor the assay. To confirm a screen positiveresult a more specific alternate chemicalmethod, such as GasChromatography/Mass Spectrometry(GC/MS) operating in the selected ionmonitoring (SIM) mode is the preferredmethod with deuterated internalstandards. Professional judgment should

Table 1: Comparison of Omega Hair Drug Screening Assay for Meth and MDMA

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ComparisonElement -SimilaritiesOmega Laboratories Hair Drug ScreeningAssay Methamphetamine_3, 4-methylenedioxymethamphetamine(Meth_MDMA) (Subject devices)Omega Laboratories Hair Drug ScreeningAssay Methamphetamine_3, 4-methylenedioxymethamphetamine(Meth_MDMA) (Predicate device K101973)
be applied to any drug of abuse test result,particularly when presumptive positiveresults are obtained.
This laboratory developed test is intendedexclusively for in-house laboratory useonly and is not intended for sale toanyone. Omega offers this laboratorydeveloped test as a service to its clients.
Method ofMeasurementMicroplate reader. Read at 450 nmSame.
MatrixHead and body hairHead hair
Cutoffconcentration500 pg /mg hair for both Methamphetamineand MDMASame
Assay PrincipalELISASame.
ExtractionMethodUtilized acid-methanol vs methanol alone tofacilitate extraction of drug from hair.Same.
Proprietary and patent pending method ofpulverizing hair vs cutting the hair into smallsegments prior to acid-methanol extraction.This improved extraction times without loss ofefficiency
Table 1: Comparison of Omega Hair Drug Screening Assay for Meth and MDMA

Performance Studies

PRECISION:

Intra-assay precision studies were performed using 11 replicates of negative head hair samples spiked to the following concentrations of Methamphetamine or MDMA: zero drug, -75%, -50%, -25% below the cutoff, and +25%, +50%, +75% and+100% above the cutoff. All samples were treated and analyzed in the same manner as donor hair samples and measured in one run. The results of this study are summarized in the Tables 2a and 2b below.

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DrugTargetConcentrationpg/mg (%)Number ofReplicatesResults# NegativeResults# Positive
Methamphetamine011110
Methamphetamine125 (-75%)11110
Methamphetamine250 (-50%)11110
Methamphetamine375 (-25%)11110
Methamphetamine625 (+25%)11011
Methamphetamine750 (+50%)11011
Methamphetamine875 (+75%)11011
Methamphetamine1000 (+100%)11011

Table 2a: Intra-Assay Methamphetamine Precision Studies (CO=500 pg/mg head hair)

Table 2b: Intra-Assay MDMA Precision Studies (CO=500 pg/mg head hair)

DrugTargetConcentrationpg/mg (%)Number ofReplicatesResults# NegativeResults# Positive
MDMA011110
MDMA125 (-75%)11110
MDMA250 (-50%)11110
MDMA375 (-25%)11110
MDMA625 (+25%)11011
MDMA750 (+50%)11011
MDMA875 (+75%)11011
MDMA1000 (+100%)11011

Inter-assay precision studies were performed using negative head hair samples spiked to the following concentrations of Methamphetamine and MDMA: zero drug, -75%, -50%, -25% below the cutoff, and +25%, +50%, +75% and+100% above the cutoff. All samples were treated and analyzed in the same manner as donor hair samples. Eleven replicates of these were prepared and analyzed over 20 non-consecutive days for methamphetamine and 10 non-consecutive days for MDMA.

The results of this study are summarized in Tables 3a - 3b below. For the MDMA precision studies, 96 out of the 110 replicates of the -25% solution were positive. This is due to the 166% cross-reactivity of MDMA.

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DrugTargetConcentrationpg/mg (%)Number ofReplicatesResults# NegativeResults# Positive
Methamphetamine02202200
Methamphetamine125 (-75%)2202200
Methamphetamine250 (-50%)2202200
Methamphetamine375 (-25%)2202200
Methamphetamine625 (+25%)2200220
Methamphetamine750 (+50%)2200220
Methamphetamine875 (+75%)2200220
Methamphetamine1000 (+100%)2200220

Table 3a: Inter-Assay Methamphetamine Precision Studies (CO=500 pg/mg head hair)

Table 3b: Inter-Assay MDMA Precision Studies (CO=500 pg/mg head hair)

DrugTargetConcentrationpg/mg (%)Number ofReplicatesResults# NegativeResults# Positive
MDMA01101100
MDMA125 (-75%)1101100
MDMA250 (-50%)1101100
MDMA375 (-25%)1101496
MDMA625 (+25%)1100110
MDMA750 (+50%)1100110
MDMA875 (+75%)1100110
MDMA1000 (+100%)1100110

Conclusion

Evaluation of the precision of the Omega Laboratories, Inc. ELISA Methamphetamine 3, 4methylenedioxymethamphetamine (Meth MDMA) Screening Protocol using this study design 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. ELISA Meth MDMA Screening Protocol using this study design demonstrated that the intra-assay precision using individual donor sample replicates was acceptable (%CV of 15% or less).

MDMA samples at a level of 375 pg/mg were positive at the 500 pg/mg methamphetamine cutoff level due the significant cross-reactivity of MDMA. Quantitative GC/MS confirmation is performed on all presumptive positive screening results.

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AGREEMENT STUDIES:

A total of 836 head hair samples were tested of which some were positive for both MDMA and Methamphetamine. A total of 138 donor body hair samples were tested (69 Methamphetamine and 69 MDMA)."

The results are listed in Tables 4a-4d below.

Tables 4a - 4b summarize the combined Agreement Studies (head hair and body hair) with results for both Methamphetamine (Table 4a) and MDMA (Table 4b).

ELISAMethamphetamine TestResultNegativeby GC/MSLess than half ofthe cutoffconcentration byGC/MSNear CutoffNegative(Between 50%below the cutoffand the cutoffconcentration)Near CutoffPositive(Between thecutoff and 50%above the cutoffconcentration)High Positive(Greater than50% above thecutoffconcentration)
Positive032947472
Negative142252001

Table 4a: Combined Methamphetamine Summary of Agreement Studies Results (n=739) Head and Body Hair

Table 4b: Combined MDMA Summary of Agreement Studies Results (n=418) Head and Body Hair

ELISAMethamphetamine TestResultNegativeby GC/MSLess than half ofthe cutoffconcentration byGC/MSNear CutoffNegative(Between 50%below the cutoffand the cutoffconcentration)Near CutoffPositive(Between thecutoff and 50%above the cutoffconcentration)High Positive(Greater than50% above thecutoffconcentration)
Positive0008260
Negative1420521

Tables 4c – 4d summarize the discordant results for the combined Studies. Each drug (Meth and MDMA) is broken out to a separate table. All Discordant results are consistent with drug cutoff value of 500 pg/mg. Negative ELISA Discordant results are reported for assays that have GC/MS results of 500 pg/mg or greater. Similarly, Positive ELISA Discordant results are reported for assays that have GC/MS results that are less than 500 pg/mg. The discordant results were found in the head hair samples only.

Screening Cutoff(pg/mg)ELISA Test Result(POS/NEG)GC/MS Cutoff (pg/mg)MethamphetamineGC/MS Drug Result(pg/mg)
500POS500Meth 159
500POS500Meth 184
500POS500Meth 248
Screening Cutoff(pg/mg)ELISA Test Result(POS/NEG)GC/MS Cutoff (pg/mg)MethamphetamineGC/MS Drug Result(pg/mg)
500POS500Meth 269
500POS500Meth 292
500POS500Meth 296
500POS500Meth 337
500POS500Meth 359
500POS500Meth 367
500POS500Meth 369
500POS500Meth 372
500POS500Meth 373
500POS500Meth 380
500POS500Meth 380
500POS500Meth 390
500POS500Meth 392
500POS500Meth 394
500POS500Meth 397
500POS500Meth 400
500POS500Meth 407
500POS500Meth 413
500POS500Meth 426
500POS500Meth 430
500POS500Meth 440
500POS500Meth 442
500POS500Meth 448
500POS500Meth 470
500POS500Meth 472
500POS500Meth 478
500POS500Meth 480
500POS500Meth 480
500POS500Meth 499
500NEG500Meth 778
Screening Cutoff(pg/mg)ELISA Test Result(POS/NEG)GC/MS Cutoff(pg/mg)MDMA GC/MS DrugResult (pg/mg)
500NEG500557
500NEG500563
500NEG500778

Table 4c: Methamphetamine GC/MS Summary of Discordant Results

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Table 4c: Methamphetamine GC/MS Summary of Discordant Results

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Table 4d: MDMA GC/MS Summary of Discordant Results

Conclusion

Based on the data presented, the effectiveness of the entire process (including the ELISA plates, reagents, and equipment) utilized by the Omega Laboratories, Inc. ELISA Meth MDMA Screening Protocol has been demonstrated to meet the Acceptance Criteria for differentiating between specimens which are negative or positive for Methamphetamine and/or MDMA at a cut-off level of 500 pg/mg for head and body hair.

Because the Omega Meth MDMA hair assay reports historical use of drugs and is not intended to be used for application where the results are to be used for contemporaneous drug usetreatment of any disease or condition, there is no issue of safety. The results of the Agreement studies support the effectiveness of the assay for both head and body hair.

Note: All presumptive positive results from a Screening Assay must be confirmed using the recommended method of a GC/MS.

CROSSREACTIVITY:

The Cross-reactivity study was designed to evaluate the specificity of the Omega Laboratories, Inc. ELISA Screening Protocol and the possible effect of interfering compounds.

Cross reactivity with Structurally Similar Compounds:

The specificity of the Methamphetamine ELISA was determined by the generation of inhibition curves for each of compounds listed in Table 5a and 5b. Serial dilutions of each control compound were prepared in negative hair matrix extract. The concentration of the structurally related compound that gave a similar absorbance to the 500pg/mg S(+)methamphetamine Cutoff Control (CO) response was determined and the percent cross reactivity calculated. The percent cross reactivity was calculated by dividing the concentration of the Methamphetamine CO by the extrapolated concentration of the structurally similar compound and then multiplying by 100.

CompoundApproximate Concentration of Compound(pg/mg) Equivalent to 500 pg/mgS(+)Methamphetamine Cutoff Control (n=3)Percent Cross reactivity (%)
para-Methoxy-N-methylamphetamine(PMMA)175285.7

Table 5a. Cross-reactivity of Methambetamine ELISA with Structurally Similar Compounds (Methamphetamine spike) Head Hair

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Table 5a. Cross-reactivity of Methamphetamine ELISA with Structurally Similar Compounds (Methamphetamine
spike) Head Hair
CompoundApproximate Concentration of Compound(pg/mg) Equivalent to 500 pg/mgS(+)Methamphetamine Cutoff Control (n=3)Percent Cross reactivity (%)
(+/-) 3,4-Methylenedioxymethampheta-mine((+/-) MDMA)300166.7
S (+) Methamphetamine500100.0
p-Hydroxymethamphetamine70071.4
(+/-)1,3-Benzodioxolyl-N-methylbutanamine ((+/-) MBDB)100050.0
(+/-)4-methylenedioxy-N-ethyl-amphetamine ((+/-) MDEA)250020.0
Mephentermine55009.1
(+/-) 4-Hydroxyephedrine85005.9
(+/-) 4-hydroxy-3-methoxymethamphetamine ((+/-)HMMA)175002.9
1R,2S (-) Ephedrine175002.9
(-) Methamphetamine225002.2
para-Methoxyamphetamine, or 4-methoxyamphetamine (PMA)250002.0
(+/-) 3,4-Methylenedioxyamphetamine ((+/-)MDA)400001.3
Fenfluramine500001.0
(+) Pseudoephedrine500001.0
Methoxyphenamine700000.7
(-) Amphetamine1750000.3
(+) Amphetamine3000000.2
(+/-)2,5-Dimethoxy-4-bromoamphetamine2,000,000.00.03
1S,2R(+) Ephedrine900,000.00.06
Phentermine600,000.00.08
R(+) Methcathinone900,000.00.06
R,R(-) Pseudoephedrine1,500,000.00.03
DiphenhydramineNot achieved at highest spike concentration.400000 pg/mg
PhenylpropanolamineNot achieved at highest spike concentration.400000 pg/mg
PhendimetrazineNot achieved at highest spike concentration.400000 pg/mg
PhentermineNot achieved at highest spike concentration.400000 pg/mg
R (+) CathinoneNot achieved at highest spike concentration.400000 pg/mg

{12}------------------------------------------------

Table 5a. Cross-reactivity of Methamphetamine ELISA with Structurally Similar Compounds (Methamphetamine spike) Head Hair

CompoundApproximate Concentration of Compound(pg/mg) Equivalent to 500 pg/mgS(+)Methamphetamine Cutoff Control (n=3)Percent Cross reactivity (%)
LabetalolNot achieved at highest spike concentration.400000 pg/mg
(-) PhenylephrineNot achieved at highest spike concentration.400000 pg/mg

Table 5b. Cross-reactivity of Methamphetamine ELISA with Structurally Similar Compounds (MDMA spiked)

CompoundApproximate Concentration ofCompound (pg/mg) Equivalent to 500pg/mg (+/-) MDMA Cutoff Control(n=3)Percent Cross-reactivity (%)
para-Methoxy-N-methylamphetamine(PMMA)200250
(+/-) 3,4-Methylenedioxymethampheta-mine((+/-) MDMA)500100
S (+) Methamphetamine95052.6
(+/-)1,3-Benzodioxolyl-N-methylbutanamine ((+/-) MBDB)150033.3
p-Hydroxymethamphetamine150033.3
(+/-)4-methylenedioxy-N-ethyl-amphetamine ((+/-) MDEA)300016.7
Mephentermine75006.7
(+/-) 4-Hydroxyephedrine100005
1R,2S (-) Ephedrine150003.3
(-) Methamphetamine200002.5
(+/-) 4-hydroxy-3-methoxymethamphetamine ((+/-)HMMA)250002
para-Methoxyamphetamine, or 4-methoxyamphetamine (PMA)350001.4
(+/-) 3,4-Methylenedioxyamphetamine ((+/-)MDA)650000.8
Fenfluramine850000.6
(+) Pseudoephedrine900000.6
Methoxyphenamine1500000.3
(-) Amphetamine2500000.2
(+/-)2,5-Dimethoxy-4-bromoamphetamine2,000,000.00.03
1S,2R(+) Ephedrine900,000.00.06

{13}------------------------------------------------

CompoundApproximate Concentration of Compound(pg/mg) Equivalent to 500 pg/mgS(+)Methamphetamine Cutoff Control (n=3)Percent Cross reactivity (%)
Phentermine600,000.00.08
R(+) Methcathinone900,000.00.06
R,R(-) Pseudoephedrine1,500,000.00.03
1S,2R (+) EphedrineNot achieved at highest spike concentration.40000 pg/mg
(+) AmphetamineNot achieved at highest spike concentration.400000 pg/mg
DiphenhydramineNot achieved at highest spike concentration.400000 pg/mg
PhenylpropanolamineNot achieved at highest spike concentration.400000 pg/mg
R,R (-) PseudoephedrineNot achieved at highest spike concentration.400000 pg/mg
PhendimetrazineNot achieved at highest spike concentration.400000 pg/mg
R ( +) CathinoneNot achieved at highest spike concentration.400000 pg/mg
LabetalolNot achieved at highest spike concentration.400000 pg/mg
(-) PhenylephrineNot achieved at highest spike concentration.400000 pg/mg

Table 5a. Cross-reactivity of Methamphetamine ELISA with Structurally Similar Compounds (Methamphetamine spike) Head Hair

In the original Cross-reactivity study, several structurally similar compounds, including R (-) Amphetamine, (-) Methamphetamine, (+) Amphetamine, (+) Pseudoephedrine, (+/-) 2, 5-Dimethoxy-4-Bromoamphetamine, (+/-) MBDB, (+/-) MDA, (+/-) MDEA, 1R, 2S (-) Ephedrine, 1S, 2R (+) Ephedrine, Fenfluramine, (+/-) HMMA, (+/-) 4-Hydroxyephedrine, Mephentermine, Methoxyphenamine. Phentermine. PMA. R (+) Methcathinone, and R. R (-)-Pseudoephedrine. we observed positive test results at -50% of the cut off drug concentration. However, some of these compounds (e.g., (+/-) 2. 5-Dimethoxy-4-Bromoamphetamine . 1S. 2R (+) Ephedrine. Phentermine, R (+) Methcathinone , and R, R (-)-Pseudoephedrine ) did not cross react with the assay in it cross reactivity study as a result additional testing was conducted. To better under the observed cross-reactivity of the above identified compounds, the concentration ranges were extended to generate new CR data that could not be seen in the original reported data. The additional test results have been incorporated into the Tables 2a and 2b.

Meth/MDMA cross-reactivity extended testing included (+/-) 2,5-Dimethoxy-4bromoamphetamine, 1S,2R (+) Ephedrine, Phentermine, R(+) Methcathinone, R,R (-) Pseudoephedrine. The highest concentration tested was 200000 pg/mg. With the extremely high concentrations, some cross-reactivity was now observable.

The interference tests were also rerun at -50% of cutoffs. There was qood correlation with the previous dataset. The calculated equivalents based on the CR curve resulted in a calculated equivalent concentration close to the assay cutoff.

{14}------------------------------------------------

Effect of Interfering Compounds:

A variety of structurally related and unrelated compounds were tested for interference at 10000ng/ml (400000pg/mg) in the Methamphetamine ELISA. Neqative hair extracts were spiked with S(+)Methamphetamine at -50% (250pg/mg), +125% (625pg/mg) and +150% (750pg/mg) of the S(+)Methamphetamine Cutoff Concentration (500pg/mg). These were then additionally spiked with 10000ng/ml (40000pg/mg) of the structurally related and unrelated compounds unless otherwise noted. The absorbances were compared to the 500 pg/mg S(+)Methamphetamine Cutoff control (CO). Only compounds that were structurally crossreactive (Table 6a) interfered in the assay. These structurally related compounds produced a positive response due to significant cross-reactivity. Compounds tested that were not structurally cross-reactive did not interfere with the assay at any of the tested concentrations (Table 6b). No tested samples produced a negative result when expected to be positive. The analysis was performed in triplicate.

Compound (shadedcompounds are structurallyrelated)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
(-) 11-nor-9-carboxy-delta8-Tetrahydrocannabinol10000NEGPOSPOS
(-) 11-nor-9-carboxy-delta9-Tetrahydrocannabinol10000NEGPOSPOS
R (-) Amphetamine10000POSPOSPOS
(-) Cotinine10000NEGPOSPOS
(-) Cotinine-N-oxide10000NEGPOSPOS
(-) Isoproterenol10000NEGPOSPOS
(-) Methamphetamine10000POSPOSPOS
(-) Nicotine10000NEGPOSPOS
(-) Phenylephrine10000NEGPOSPOS
(-)-Alpha-methadol10000NEGPOSPOS
(+) Amphetamine10000POSPOSPOS
(+) Isoproterenol10000NEGPOSPOS
(+) Methamphetamine10000POSPOSPOS
(+) Pseudoephedrine10000POSPOSPOS
(+/-) 11-nor-9-carboxy-delta9-Tetrahydrocannabinol10000NEGPOSPOS
(+/-) 2,5-Dimethoxy- 4-bromoamphetamine10000POSPOSPOS
(+/-) Alphaprodine10000NEGPOSPOS
(+/-) Ketamine10000NEGPOSPOS
(+/-)1,3-Benzodioxolyl-N-methylbutanamine ((+/-) MBDB)10000POSPOSPOS
Compound (shadedcompounds are structurallyrelated)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
(+/-) 3,4-Methylenedioxyamphetamine ((+/-)MDA)10000POSPOSPOS
(+/-)4-methylenedioxy-N-ethyl-amphetamine ((+/-) MDEA)10000POSPOSPOS
(+/-) 3,4-Methylenedioxymethampheta-mine((+/-) MDMA)10000POSPOSPOS
(+/-) Metanephrine10000NEGPOSPOS
(+/-) Metoprolol10000NEGPOSPOS
(+/-) Norcotinine10000NEGPOSPOS
(+/-) Propanolol10000NEGPOSPOS
(+/-) Trans-3'-Hydroxycotinine10000NEGPOSPOS
11-Hydroxy-delta9-Tetrahydrocannabinol10000NEGPOSPOS
19-Nortestosterone (Nandrolone)10000NEGPOSPOS
1R,2S (-) Ephedrine10000POSPOSPOS
1S,2R (+) Ephedrine10000POSPOSPOS
2-Oxo-3-hydroxy-LSD10000NEGPOSPOS
3-Methoxynaltrexone10000NEGPOSPOS
3-Trans-Hydroxy-norcotinine10000NEGPOSPOS
4-Acetoamidophenol10000NEGPOSPOS
4-Hydroxy-Phencyclidine10000NEGPOSPOS
5,5-Diphenylhydantoin10000NEGPOSPOS
6-Acetyl-codeine10000NEGPOSPOS
6-MonoacetyImorphine10000NEGPOSPOS
7-Aminoclonazepam10000NEGPOSPOS
7-Aminonitrazepam10000NEGPOSPOS
Acebutolol10000NEGPOSPOS
Acetophenetidin10000NEGPOSPOS
Acetopromazine10000NEGPOSPOS
Acetylsalicyclic acid10000NEGPOSPOS
Alfentanil10000NEGPOSPOS
Alpha-Ergocryptine10000NEGPOSPOS
Alprazolam10000NEGPOSPOS
7-Aminoflunitrazepam10000NEGPOSPOS
Aminorex10000NEGPOSPOS
Amitriptyline10000NEGPOSPOS
Compound (shadedcompounds are structurallyrelated)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
Amobarbital10000NEGPOSPOS
Amoxicillin10000NEGPOSPOS
Anhydroecgonine10000NEGPOSPOS
Anileridine10000NEGPOSPOS
Apomorphine10000NEGPOSPOS
Atenolol10000NEGPOSPOS
Azaperone10000NEGPOSPOS
Benzoylecgonine10000NEGPOSPOS
Benzoylecgonine isopropyl ester10000NEGPOSPOS
Betamethasone10000NEGPOSPOS
Boldenone10000NEGPOSPOS
Bumetanide10000NEGPOSPOS
Bupivicaine10000NEGPOSPOS
Buprenorphine10000NEGPOSPOS
Buprenorphine-glucuronide(2500ng/ml)10000NEGPOSPOS
Buspirone10000NEGPOSPOS
Butabarbital10000NEGPOSPOS
Butalbital10000NEGPOSPOS
Caffeine10000NEGPOSPOS
Cannabidiol10000NEGPOSPOS
Cannabinol10000NEGPOSPOS
Carbamazepine10000NEGPOSPOS
Carisoprodol10000NEGPOSPOS
Chlordiazepoxide10000NEGPOSPOS
Chlorpromazine10000NEGPOSPOS
Cimeterol10000NEGPOSPOS
Clenbuterol10000NEGPOSPOS
Clomipramine10000NEGPOSPOS
Clonazepam10000NEGPOSPOS
Clonidine10000NEGPOSPOS
Clozapine10000NEGPOSPOS
Cocaethylene10000NEGPOSPOS
Cocaine10000NEGPOSPOS
Codeine10000NEGPOSPOS
Corticosterone10000NEGPOSPOS
Cortisone10000NEGPOSPOS
Compound (shadedcompounds are structurallyrelated)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
Cotinine-N-beta-D-Glucuronide10000NEGPOSPOS
Cyclobenzaprine10000NEGPOSPOS
d,I-N-Desmethylvenlafaxine10000NEGPOSPOS
Delta8-Tetrahydrocannabinol10000NEGPOSPOS
Delta9-Tetrahydrocannabinol10000NEGPOSPOS
Deoxycorticosterone10000NEGPOSPOS
Desalkylflurazepam10000NEGPOSPOS
Desipramine10000NEGPOSPOS
Desmethyldoxepin (cis/trans)10000NEGPOSPOS
Despropionyl-fentanyl10000NEGPOSPOS
Dexamethasone10000NEGPOSPOS
Dextromethorphan10000NEGPOSPOS
Diazepam10000NEGPOSPOS
Dibucaine10000NEGPOSPOS
Dihydrocodeine10000NEGPOSPOS
Dihydroergotamine10000NEGPOSPOS
Dihydromorphine10000NEGPOSPOS
Diphenhydramine10000NEGPOSPOS
Diphenoxylate10000NEGPOSPOS
Diprenorphine10000NEGPOSPOS
Dothiepin (cis/trans)10000NEGPOSPOS
Doxepin10000NEGPOSPOS
Doxylamine10000NEGPOSPOS
Droperidol10000NEGPOSPOS
Ecgonine10000NEGPOSPOS
Ecgonine methyl ester10000NEGPOSPOS
Ethylidine Dimethyl DiphenylPyrrolidine (Metabolite of Methadone)(EDDP)10000NEGPOSPOS
Effexor (Venlafaxine)10000NEGPOSPOS
2-Ethyl-5-methyl-3,3-diphenylpyrroline (EMDP)10000NEGPOSPOS
Ergonovine10000NEGPOSPOS
Erythromycin10000NEGPOSPOS
Estazolam10000NEGPOSPOS
Ethacrynic acid10000NEGPOSPOS
Ethopropazine10000NEGPOSPOS
Ethylmorphine10000NEGPOSPOS
Compound (shadedcompounds are structurallyrelated)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
Fenfluramine10000POSPOSPOS
Fentanyl10000NEGPOSPOS
Flumethasone10000NEGPOSPOS
Flunitrazepam10000NEGPOSPOS
Fluphenazine10000NEGPOSPOS
Flurazepam10000NEGPOSPOS
Furosemide10000NEGPOSPOS
Gentamicin10000NEGPOSPOS
Gluthimide10000NEGPOSPOS
Haloperidol10000NEGPOSPOS
Heroin10000NEGPOSPOS
Hexobarbital10000NEGPOSPOS
(+/-) 4-hydroxy-3-methoxymethamphetamine ((+/-)HMMA)10000POSPOSPOS
Hydrochlorothiazide10000NEGPOSPOS
Hydrocodone10000NEGPOSPOS
Hydrocortisone10000NEGPOSPOS
Hydromorphone10000NEGPOSPOS
(+/-) 4-Hydroxyephedrine10000POSPOSPOS
Hydroxymethamphetamine10000POSPOSPOS
Ibogaine10000NEGPOSPOS
Ibuprofen10000NEGPOSPOS
Imipramine10000NEGPOSPOS
Ketoprofen10000NEGPOSPOS
Levo-Alpha Acetyl Methadol (LAAM)10000NEGPOSPOS
Labetalol10000NEGPOSPOS
Levorphanol10000NEGPOSPOS
L-Hyoscyamine10000NEGPOSPOS
Lidocaine10000NEGPOSPOS
Lorazepam10000NEGPOSPOS
Lysergic acid diethylamide (LSD/ ISOLysergic acid diethylamide -(ISOLSD)10000NEGPOSPOS
Lysergic acid10000NEGPOSPOS
Lysergol10000NEGPOSPOS
Maprotiline10000NEGPOSPOS
Meperidine10000NEGPOSPOS
Compound (shadedcompounds are structurallyrelated)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
Mephentermine10000POSPOSPOS
Mepivacaine10000NEGPOSPOS
Metaphit10000NEGPOSPOS
Metaproterenol10000NEGPOSPOS
Metaraminol10000NEGPOSPOS
Methadone10000NEGPOSPOS
Methohexital10000NEGPOSPOS
Methoxyphenamine10000POSPOSPOS
Methylergonovine10000NEGPOSPOS
Methylphenidate10000NEGPOSPOS
m-Hydroxybenzoylecgonine10000NEGPOSPOS
Mianserin10000NEGPOSPOS
Midazolam10000NEGPOSPOS
Monensin10000NEGPOSPOS
Morphine10000NEGPOSPOS
Morphine-3-betaglucuronide10000NEGPOSPOS
Morphine-6-betaglucuronide10000NEGPOSPOS
Nadolol10000NEGPOSPOS
Nalmefene10000NEGPOSPOS
Nalorphine10000NEGPOSPOS
Naloxone-3-beta-D-glucuronide10000NEGPOSPOS
Naltrexone10000NEGPOSPOS
Naltriben10000NEGPOSPOS
Naproxen10000NEGPOSPOS
N-Desmethylclomipramine10000NEGPOSPOS
N-Desmethylflunitrazepam10000NEGPOSPOS
N-Desmethyltramadol10000NEGPOSPOS
N-Desmethyltrimipramine10000NEGPOSPOS
Neomycin10000NEGPOSPOS
Nitrazepam10000NEGPOSPOS
Norbenzoylecgonine10000NEGPOSPOS
Norbuprenorphine10000NEGPOSPOS
Norcocaethylene10000NEGPOSPOS
Norcocaine10000NEGPOSPOS
Norcodeine10000NEGPOSPOS
Nordiazepam10000NEGPOSPOS

Table 6a. Interferences of Structurally Related and Unrelated Compounds on Methamphetamine ELISA (Methamphetamine spike)

{15}------------------------------------------------

{16}------------------------------------------------

{17}------------------------------------------------

{18}------------------------------------------------

{19}------------------------------------------------

{20}------------------------------------------------

Table 6a. Interferences of Structurally Related and Unrelated Compounds on
Methamphetamine ELISA (Methamphetamine spike)
Compound (shadedcompounds are structurallyrelated)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
Norfentanyl10000NEGPOSPOS
Nor- Levo-Alpha Acetyl Methadol(Nor-LAAM)10000NEGPOSPOS
Nor- Lysergic acid diethylamide (Nor-LSD/Nor-ISO Lysergic aciddiethylamide -(Nor-ISO LSD)10000NEGPOSPOS
Normeperidine10000NEGPOSPOS
Normeperidinic acid10000NEGPOSPOS
Normorphine10000NEGPOSPOS
Noroxycodone10000NEGPOSPOS
Noroxymorphone10000NEGPOSPOS
Norpropoxyphene10000NEGPOSPOS
Nortriptyline10000NEGPOSPOS
Noscapine10000NEGPOSPOS
O-Desmethyltramadol10000NEGPOSPOS
Oxazepam10000NEGPOSPOS
Oxprenolol10000NEGPOSPOS
Oxycodone10000NEGPOSPOS
Oxymorphone10000NEGPOSPOS
p-Acetamidophenyl-beta-D-glucuronide10000NEGPOSPOS
Papaverine10000NEGPOSPOS
Pemoline10000NEGPOSPOS
Penicillin G10000NEGPOSPOS
Pentazocine10000NEGPOSPOS
Pentobarbital10000NEGPOSPOS
Perphenazine10000NEGPOSPOS
Phendimetrazine10000NEGPOSPOS
Phenelzine10000NEGPOSPOS
Phenobarbital10000NEGPOSPOS
Phenothiazine10000NEGPOSPOS
Phentermine10000POSPOSPOS
Phenylbutazone10000NEGPOSPOS
Phenylethyamine10000NEGPOSPOS
Phenylpropanolamine10000NEGPOSPOS
para-Methoxyamphetamine, or 4-methoxyamphetamine (PMA)10000POSPOSPOS
Compound (shadedcompounds are structurallyrelated)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
para-Methoxy-N-methylamphetamine(PMMA)10000POSPOSPOS
Prednisolone10000NEGPOSPOS
Prilocaine10000NEGPOSPOS
Prochlorperazine10000NEGPOSPOS
Progesterone10000NEGPOSPOS
Promazine10000NEGPOSPOS
Promethazine10000NEGPOSPOS
Propiomazine10000NEGPOSPOS
Propionylpromazine10000NEGPOSPOS
Propoxyphene10000NEGPOSPOS
Protriptyline10000NEGPOSPOS
Quinidine10000NEGPOSPOS
R (+) Methcathinone10000POSPOSPOS
R (-) Epinephrine10000NEGPOSPOS
R (+) Cathinone10000NEGPOSPOS
Salbutamol10000NEGPOSPOS
Secobarbital10000NEGPOSPOS
Sertraline10000NEGPOSPOS
Stanazalol10000NEGPOSPOS
Streptomycin10000NEGPOSPOS
Sulfadimethoxine10000NEGPOSPOS
Sulfamethazine10000NEGPOSPOS
Sulfathiazole10000NEGPOSPOS
Temazepam10000NEGPOSPOS
Terbutaline10000NEGPOSPOS
Tetracycline10000NEGPOSPOS
Thebaine10000NEGPOSPOS
Theophylline10000NEGPOSPOS
Thioridazine10000NEGPOSPOS
Tramadol10000NEGPOSPOS
Triamcinolone10000NEGPOSPOS
Triazolam10000NEGPOSPOS
Trifluoperazine10000NEGPOSPOS
Trifluopromazine10000NEGPOSPOS
Trimeprazine10000NEGPOSPOS
Trimipramine10000NEGPOSPOS
Compound (shadedcompounds are structurallyrelated)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
Tylosin10000NEGPOSPOS
Tyramine10000NEGPOSPOS
Yohimbic acid10000NEGPOSPOS
Yohimbine10000NEGPOSPOS
Zolpidem10000NEGPOSPOS
Zopiclone10000NEGPOSPOS
Phencyclidine10000NEGPOSPOS
R,R (-)-Pseudoephedrine10000POSPOSPOS
Phencyclidine Morpholine10000NEGPOSPOS

{21}------------------------------------------------

{22}------------------------------------------------

Table 6a. Interferences of Structurally Related and Unrelated Compounds on Methamphetamine ELISA (Methamphetamine spike)

A variety of structurally related and unrelated compounds were tested for interference at 10000ng/ml (400000pg/mg) unless otherwise noted in the Methamphetamine ELISA. Negative hair extracts were spiked with (±) MDMA at -50% (250pg/mg), +125% (625pg/mg) and +150% (750pg/mg) of the (±)MDMA Cutoff Concentration (500pg/mg). These were then additionally spiked with 10000g/ml (400000pg/mg) of the structurally related and unrelated compounds unless otherwise noted. The absorbances were compared to the 500 pg/mg (±)MDMA Cutoff control (CO). Compounds that were structurally similar to (±) MDMA (Table 6b) interfered in the assay. These structurally related compounds produced a positive response due to significant cross-reactivity. The remaining compounds which were tested did not interfere with the assay at any of the tested concentrations (Table 6b) except for d.J-desmethyl-Venlafaxine which consistently produced a positive response in the -50% CO interference test at concentrations greater than 7500nq/mL(30000pg/mg). The presence of d.I-desmethyl-Venlafaxine at 10000 ng/mL (40000 pg/mg) did not produce a negative result in the +125% and +150% interference experiments. No tested samples produced a negative result when expected to be positive. The analysis was performed in triplicate.

Compound (shaded compounds arestructurally related)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
(-) 11-nor-9-carboxy-delta8-Tetrahydrocannabinol1000NEGPOSPOS
(-) 11-nor-9-carboxy-delta9-Tetrahydrocannabinol1000NEGPOSPOS
R (-) Amphetamine10000POSPOSPOS
(-) Cotinine10000NEGPOSPOS
Compound (shaded compounds arestructurally related)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
(-) Cotinine-N-oxide10000NEGPOSPOS
(-) Isoproterenol10000NEGPOSPOS
(-) Methamphetamine10000POSPOSPOS
(-) Nicotine10000NEGPOSPOS
(-) Phenylephrine10000NEGPOSPOS
(-)-Alpha-methadol10000NEGPOSPOS
(+) Amphetamine10000POSPOSPOS
(+) Isoproterenol10000NEGPOSPOS
(+) Methamphetamine10000POSPOSPOS
(+) Pseudoephedrine10000POSPOSPOS
(+/-) 11-nor-9-carboxy-delta9-Tetrahydrocannabinol1000NEGPOSPOS
(+/-) 2,5-Dimethoxy- 4-bromoamphetamine10000POSPOSPOS
(+/-) Alphaprodine10000NEGPOSPOS
(+/-) Ketamine10000NEGPOSPOS
(+/-)1,3-Benzodioxolyl-N-methylbutanamine(MBDB)10000POSPOSPOS
(+/-) 3,4-Methylenedioxyamphetamine ((+/-)MDA)10000POSPOSPOS
(+/-)4-methylenedioxy-N-ethyl-amphetamine((+/-) MDEA)10000POSPOSPOS
(+/-) 3,4-Methylenedioxymethampheta-mine((+/-)MDMA)10000POSPOSPOS
(+/-) Metanephrine10000NEGPOSPOS
(+/-) Metoprolol10000NEGPOSPOS
(+/-) Norcotinine10000NEGPOSPOS
(+/-) Propanolol10000NEGPOSPOS
Compound (shaded compounds arestructurally related)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
(+/-) Trans-3'-Hydroxycotinine10000NEGPOSPOS
11-Hydroxy-delta9-Tetrahydrocannabinol1000NEGPOSPOS
19-Nortestosterone (Nandrolone)10000NEGPOSPOS
1R,2S (-) Ephedrine10000POSPOSPOS
1S,2R (+) Ephedrine10000POSPOSPOS
2-Oxo-3-hydroxy-LSD1000NEGPOSPOS
3-Methoxynaltrexone10000NEGPOSPOS
3-Trans-Hydroxy-norcotinine10000NEGPOSPOS
4-Acetoamidophenol10000NEGPOSPOS
4-Hydroxy-Phencyclidine10000NEGPOSPOS
5,5-Diphenylhydantoin10000NEGPOSPOS
6-Acetyl-codeine10000NEGPOSPOS
6-MonoacetyImorphine1000NEGPOSPOS
7-Aminoclonazepam1000NEGPOSPOS
7-Aminonitrazepam1000NEGPOSPOS
Acebutolol10000NEGPOSPOS
Acetophenetidin10000NEGPOSPOS
Acetopromazine10000NEGPOSPOS
AcetyIsalicyclic acid10000NEGPOSPOS
Alfentanil10000NEGPOSPOS
Alpha-Ergocryptine10000NEGPOSPOS
Alprazolam10000NEGbosPOS
7-Aminoflunitrazepam1000NEGPOSPOS
Aminorex10000NEGPOSPOS
Compound (shaded compounds arestructurally related)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
Amitriptyline10000NEGPOSPOS
Amobarbital10000NEGPOSPOS
Amoxicillin10000NEGPOSPOS
Anhydroecgonine10000NEGPOSPOS
Anileridine10000NEGPOSPOS
Apomorphine10000NEGPOSPOS
Atenolol10000NEGPOSPOS
Azaperone10000NEGPOSPOS
Benzoylecgonine10000NEGPOSPOS
Benzoylecgonine isopropyl ester10000NEGPOSPOS
Betamethasone10000NEGPOSPOS
Boldenone10000NEGPOSPOS
Bumetanide10000NEGPOSPOS
Bupivicaine10000NEGPOSPOS
Buprenorphine1000NEGPOSPOS
Buprenorphine-glucuronide2500NEGPOSPOS
Buspirone10000NEGPOSPOS
Butabarbital10000NEGPOSPOS
Butalbital10000NEGPOSPOS
Caffeine10000NEGPOSPOS
Cannabidiol10000NEGPOSPOS
Cannabinol10000NEGPOSPOS
Carbamazepine10000NEGPOSPOS
Carisoprodol10000NEGPOSPOS
Compound (shaded compounds arestructurally related)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
Chlordiazepoxide10000NEGPOSPOS
Chlorpromazine10000NEGPOSPOS
Cimeterol10000NEGPOSPOS
Clenbuterol10000NEGPOSPOS
Clomipramine10000NEGPOSPOS
Clonazepam10000NEGPOSPOS
Clonidine10000NEGPOSPOS
Clozapine10000NEGPOSPOS
Cocaethylene10000NEGPOSPOS
Cocaine10000NEGPOSPOS
Codeine10000NEGPOSPOS
Corticosterone10000NEGPOSPOS
Cortisone10000NEGPOSPOS
Cotinine-N-beta-D-Glucuronide10000NEGPOSPOS
Cyclobenzaprine10000NEGPOSPOS
d,l-N-Desmethylvenlafaxine10000POSPOSPOS
d,l-N-Desmethylvenlafaxine7500NEGNot TestedNot Tested
Delta8-Tetrahydrocannabinol10000NEGPOSPOS
Delta9-Tetrahydrocannabinol10000NEGPOSPOS
Deoxycorticosterone10000NEGPOSPOS
Desalkylflurazepam10000NEGPOSPOS
Desipramine10000NEGPOSPOS
Desmethyldoxepin (cis/trans)10000NEGPOSPOS
Despropionyl-fentanyl1000NEGPOSPOS
Compound (shaded compounds arestructurally related)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
Dexamethasone10000NEGPOSPOS
Dextromethorphan10000NEGPOSPOS
Diazepam10000NEGPOSPOS
Dibucaine10000NEGPOSPOS
Dihydrocodeine10000NEGPOSPOS
Dihydroergotamine10000NEGPOSPOS
Dihydromorphine10000NEGPOSPOS
Diphenhydramine10000NEGPOSPOS
Diphenoxylate10000NEGPOSPOS
Diprenorphine10000NEGPOSPOS
Dothiepin (cis/trans)10000NEGPOSPOS
Doxepin10000NEGPOSPOS
Doxylamine10000NEGPOSPOS
Droperidol10000NEGPOSPOS
Ecgonine10000NEGPOSPOS
Ecgonine methyl ester10000NEGPOSPOS
Ethylidine Dimethyl Diphenyl Pyrrolidine(Metabolite of Methadone) (EDDP)10000NEGPOSPOS
Effexor (Venlafaxine)10000NEGPOSPOS
2-Ethyl-5-methyl-3,3-diphenylpyrroline(EMDP)10000NEGPOSPOS
Ergonovine10000NEGPOSPOS
Erythromycin10000NEGPOSPOS
Estazolam10000NEGPOSPOS
Ethacrynic acid10000NEGPOSPOS
Compound (shaded compounds arestructurally related)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
Ethopropazine10000NEGPOSPOS
Ethylmorphine10000NEGPOSPOS
Fenfluramine10000POSPOSPOS
Fentanyl1000NEGPOSPOS
Flumethasone10000NEGPOSPOS
Flunitrazepam10000NEGPOSPOS
Fluphenazine10000NEGPOSPOS
Flurazepam10000NEGPOSPOS
Furosemide10000NEGPOSPOS
Gentamicin10000NEGPOSPOS
Gluthimide10000NEGPOSPOS
Haloperidol10000NEGPOSPOS
Heroin10000NEGPOSPOS
Hexobarbital10000NEGPOSPOS
(+/-) 4-hydroxy-3-methoxymethamphetamine((+/-) HMMA)10000POSPOSPOS
Hydrochlorothiazide10000NEGPOSPOS
Hydrocodone10000NEGPOSPOS
Hydrocortisone10000NEGPOSPOS
Hydromorphone10000NEGPOSPOS
(+/-) 4-Hydroxyephedrine10000POSPOSPOS
Hydroxymethamphetamine10000POSPOSPOS
lbogaine10000NEGPOSPOS
Ibuprofen10000NEGPOSPOS
Compound (shaded compounds arestructurally related)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
Imipramine10000NEGPOSPOS
Ketoprofen10000NEGPOSPOS
Levo-Alpha Acetyl Methadol (LAAM)10000NEGPOSPOS
Labetalol10000NEGPOSPOS
Levorphanol10000NEGPOSPOS
L-Hyoscyamine10000NEGPOSPOS
Lidocaine10000NEGPOSPOS
Lorazepam10000NEGPOSPOS
Lysergic acid diethylamide (LSD/ ISOLysergic acid diethylamide -(ISO LSD)10000NEGPOSPOS
Lysergic acid10000NEGPOSPOS
Lysergol10000NEGPOSPOS
Maprotiline10000NEGPOSPOS
Meperidine10000NEGPOSPOS
Mephentermine10000POSPOSPOS
Mepivacaine10000NEGPOSPOS
Metaphit10000NEGPOSPOS
Metaproterenol10000NEGPOSPOS
Metaraminol10000NEGPOSPOS
Methadone10000NEGPOSPOS
Methohexital10000NEGPOSPOS
Methoxyphenamine10000POSPOSPOS
Methylergonovine10000NEGPOSPOS
Methylphenidate10000NEGPOSPOS
Compound (shaded compounds arestructurally related)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
m-Hydroxybenzoylecgonine10000NEGPOSPOS
Mianserin10000NEGPOSPOS
Midazolam10000NEGPOSPOS
Monensin10000NEGPOSPOS
Morphine(1000ng/ml)10000NEGPOSPOS
Morphine-3-betaglucuronide10000NEGPOSPOS
Morphine-6-betaglucuronide1000NEGPOSPOS
Nadolol10000NEGPOSPOS
Nalmefene10000NEGPOSPOS
Nalorphine10000NEGPOSPOS
Naloxone-3-beta-D-glucuronide10000NEGPOSPOS
Naltrexone10000NEGPOSPOS
Naltriben10000NEGPOSPOS
Naproxen10000NEGPOSPOS
N-Desmethylclomipramine10000NEGPOSPOS
N-Desmethylflunitrazepam1000NEGPOSPOS
N-Desmethyltramadol10000NEGPOSPOS
N-Desmethyltrimipramine10000NEGPOSPOS
Neomycin10000NEGPOSPOS
Nitrazepam10000NEGPOSPOS
Norbenzoylecgonine10000NEGPOSPOS
Norbuprenorphine(1000ng/ml)10000NEGPOSPOS
Norcocaethylene10000NEGPOSPOS
Compound (shaded compounds arestructurally related)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
Norcocaine10000NEGPOSPOS
Norcodeine10000NEGPOSPOS
Nordiazepam10000NEGPOSPOS
Norfentanyl(1000ng/ml)10000NEGPOSPOS
Nor- Levo-Alpha Acetyl Methadol (Nor-LAAM)1000NEGPOSPOS
Nor- Lysergic acid diethylamide (Nor-LSD/Nor-ISO Lysergic acid diethylamide -(Nor-ISO LSD)1000NEGPOSPOS
Normeperidine1000NEGPOSPOS
Normeperidinic acid10000NEGPOSPOS
Normorphine10000NEGPOSPOS
Noroxycodone10000NEGPOSPOS
Noroxymorphone1000NEGPOSPOS
Norpropoxyphene10000NEGPOSPOS
Nortriptyline10000NEGPOSPOS
Noscapine10000NEGPOSPOS
O-Desmethyltramadol10000NEGPOSPOS
Oxazepam10000NEGPOSPOS
Oxprenolol10000NEGPOSPOS
Oxycodone10000NEGPOSPOS
Oxymorphone10000NEGPOSPOS
p-Acetamidophenyl-beta-D-glucuronide10000NEGPOSPOS
Papaverine10000NEGPOSPOS
Pemoline10000NEGPOSPOS
Compound (shaded compounds arestructurally related)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
Penicillin G10000NEGPOSPOS
Pentazocine10000NEGPOSPOS
Pentobarbital10000NEGPOSPOS
Perphenazine10000NEGPOSPOS
Phendimetrazine10000NEGPOSPOS
Phenelzine10000NEGPOSPOS
Phenobarbital10000NEGPOSPOS
Phenothiazine10000NEGPOSPOS
Phentermine10000POSPOSPOS
Phenylbutazone10000NEGPOSPOS
Phenylethyamine10000NEGPOSPOS
Phenylpropanolamine10000NEGPOSPOS
para-Methoxyamphetamine, or 4-methoxyamphetamine (PMA)10000POSPOSPOS
para-Methoxy-N-methylamphetamine (PMMA)10000POSPOSPOS
Prednisolone10000NEGPOSPOS
Prilocaine10000NEGPOSPOS
Prochlorperazine10000NEGPOSPOS
Progesterone10000NEGPOSPOS
Promazine10000NEGPOSPOS
Promethazine10000NEGPOSPOS
Propiomazine10000NEGPOSPOS
Propionylpromazine10000NEGPOSPOS
Propoxyphene10000NEGPOSPOS
Compound (shaded compounds arestructurally related)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
Protriptyline10000NEGPOSPOS
Quinidine10000NEGPOSPOS
R (+) Methcathinone10000POSPOSPOS
R (-) Epinephrine10000NEGPOSPOS
R (+) Cathinone10000NEGPOSPOS
Salbutamol10000NEGPOSPOS
Secobarbital10000NEGPOSPOS
Sertraline10000NEGPOSPOS
Stanazalol10000NEGPOSPOS
Streptomycin10000NEGPOSPOS
Sulfadimethoxine10000NEGPOSPOS
Sulfamethazine10000NEGPOSPOS
Sulfathiazole10000NEGPOSPOS
Temazepam10000NEGPOSPOS
Terbutaline10000NEGPOSPOS
Tetracycline10000NEGPOSPOS
Thebaine10000NEGPOSPOS
Theophylline10000NEGPOSPOS
Thioridazine10000NEGPOSPOS
Tramadol10000NEGPOSPOS
Triamcinolone10000NEGPOSPOS
Triazolam10000NEGPOSPOS
Trifluoperazine10000NEGPOSPOS
Trifluopromazine10000NEGPOSPOS
Compound (shaded compounds arestructurally related)Concentration ofcompound ng/ml-50% CO(250pg/mg)+125% CO(625pg/mg)+150% CO(750pg/mg)
Trimeprazine10000NEGPOSPOS
Trimipramine10000NEGPOSPOS
Tylosin10000NEGPOSPOS
Tyramine10000NEGPOSPOS
Yohimbic acid10000NEGPOSPOS
Yohimbine10000NEGPOSPOS
Zolpidem10000NEGPOSPOS
Zopiclone10000NEGPOSPOS
Phencyclidine10000NEGPOSPOS
R,R (-)-Pseudoephedrine10000POSPOSPOS
Phencyclidine Morpholine10000NEGPOSPOS

Table 6b: Interferences of Structurally Related and Unrelated Compounds on Methamphetamine/MDMA ELISA (MDMA spike)

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CALIBRATOR AND CONTROL:

The Omega Laboratories, Inc. ELISA Meth-MDMA Screening Protocols utilize in-house prepared calibrators and control solutions. The study successfully demonstrated the validation and stability of these solutions and the traceability to NIST standards.

The data demonstrating the stability of Meth-MDMA in methanol for a period of one year when stored refrigerated in an amber bottle was provide as part of K101973. The quantitative values of 512 pg/mg for methamphetamine, after a one year period is within 10% of the target value of 500 pg/mg. The study validated the one 1 year expiration date for the Calibrator Stock Solution.

STABILITY:

Hair samples were taken from the head were packaged (stored) in the Omega Collection Kit (The Hair Collection Kit consists of a poly transport bag, a small piece of foil, a small specimen pouch (envelope). The Collection Kit, containing the hair sample was previously confirmed Positive then stored for an average of 4 years.

A variety of ethnic origin, hair color and curvature were tested.

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Table 7: Stability Test Samples
---------------------------------
Description of samplesQuantity
Total samples were used in the stability study100
Previously confirmed Positive for Methamphetamine samples(1 under cutoff of 500pg/mg)50
previously confirmed Positive for MDMA samples(2 under cutoff of 500pg/mg)50

Samples Testing

The samples were originally confirmed Positive for Methamphetamine or MDMA using the Omega Confirmation Protocol.

The samples were run a second time using the Omega Confirmation Protocol.

The stability of the samples when stored for an extended period of time will be deemed acceptable if the mean variation in the Methamphetamine or MDMA concentrations is less than 15%. A variance of 15% was chosen since the Uncertainty of Measurement associated with the Omega Laboratories, Inc. GC/MS Confirmation Test process is 13.6% at a 95% confidence level (see the attached Uncertainty Budget completed in accordance with ISO17025 Laboratory Accreditation).

Methamphetamine and MDMA data from this study are shown in the table below.

Test ParameterValue or Range
Meth Stability Study Data Summary Ranges
Range in concentration pg/mg hair (4 Years Prior)(pg/mg)271 - 30,262
Range in concentration pg/mg hair (After)(pg/mg)342- 34,002
Mean Change4%
% Max and Min Decrease-10% and -1%
% Max and Min Increase26% and 1%
Number that increased in concentration31
Number that decreased in concentration29
MDMA Stability Study Data Summary Ranges
Range in concentration pg/mg hair (3.5 Years Prior)(pg/mg)167 - 12,107

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Test ParameterValue or Range
Range in concentration pg/mg hair (After)(pg/mg)183 - 15,852
Mean Change10%
% Max and Min Decrease-7% and 0%
% Max and Min Increase31% and 0%
Number that increased in concentration41
Number that decreased in concentration7
Number that had no change in concentration2
Table 8: Stability Study Data Summary Ranges
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Conclusion

This Stability Study demonstrated that the mean variance in the concentration of Methamphetamine of 4% or MDMA of 10% in hair samples when stored for an extended period of time was acceptable at less than 15%.

SHIPPING:

200 head hair samples were used in the shipping study: 49 samples previously confirmed Positive for Methamphetamine, 48 -samples previously confirmed positive for MDMA, 100 previously screened negative samples that were just under the cutoff. Each box contained a variety of hair color and curvature. Four separate shipping boxes each containing 25 previously screened neqative samples, a minimum of 12 previously confirmed positive samples or close to cutoff were stored in a freezer at approximately -12°C for approximately 20 hours then heated to approximately 43°C for a period of approximately seven hours. This represented exposure to extreme temperature. The minimum and maximum temperature and humidity ranges are in Table 9 below. Each box was then shipped to a different location in the United States of America. (Portland, Maine, Anchorage, Alaska, Naples, Florida and Tempe, Arizona). The shipments were held at their respective locations for a period of at least two days then returned to Omega. The returned samples were then confirmed using GC/MS. The comparison of the results prior to shipping and after shipping is summarized below.

All hair samples were taken from the crown of the head and packaged (stored) in the Omega preferred Collection Kit (The Hair Collection Kit consists of a poly transport bag, a small piece of foil, a small specimen pouch/envelope). Collection Kits containing the hair samples were packed in a shipping box (Corrugated box 2.5"X13.5"X11.5").

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Description of SamplesNo.
Previously confirmed Methamphetamine Positive samples49
Previously confirmed MDMA Positive samples48
Previously screened Negative For Methamphetamine and MDMA samples100
Samples that confirmed below the 500 pg/mg cutoff level ForMethamphetamine1
Samples that confirmed below the 500 pg/mg cutoff level For MDMA2
Total Samples used in the shipping study200

Table 9: Shipping Test Samples

Sample shipping

Each Shipping box contained a "DataLogger" to record humidity and temperature. The DataLogger takes readings every five minutes.

The DataLogger specifications and the raw data generated are attached.

Each box contained hair samples exhibiting a variety color and curvature.

Four separate shipping boxes each containing 25 previously screened negative samples, a minimum of 12 previously confirmed positive samples or close to cutoff were stored in a freezer at approximately -12° C for approximately 20 hours then heated to approximately 43° C for a period of approximately seven hours. This represented exposure to extreme temperature.

Shipping study transport time totaled at least 5 days.

Each box was then shipped to a different location in the United States (Portland, Maine, Anchorage, Alaska, Naples, Florida and Tempe, Arizona). The shipments were held at their respective locations for at least two days and then returned to Omega.

The returned samples were then screened and quantitatively tested using GC/MS.

The minimum and maximum shipping temperature and humidity ranges are shown in Table 10 below.

DataLoggerIDShipped to Location Then Returned toOmega LaboratoriesMin Temp(°C)Max Temp(°C)Min Humidity(%RH)Max Humidity(%RH)
73100056291. Portland, Maine-12.744.510.8100.0
73100056442. Anchorage, Alaska-12.744.98.196.1
73100056283. Naples, Florida-10.843.34.4100.0
73100056274. Tempe Arizona-12.242.98.973.5

Table 10 Shipping Temperatures and Humidity Ranges

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Conclusion

This Shipping Study demonstrated that there is no adverse effect on hair samples when exposed to extreme temperatures and variations in humidity that might occur during sample transport. Of the 200 samples screened and confirmed then shipped and returned then screened and confirmed a second time, no samples had discordant screening results.

COSMETIC TREATMENT:

The study was designed to evaluate and document the effects of various cosmetic treatments on the Omega Laboratories, Inc. ELISA Meth MDMA Screening Protocol

Two Cosmetic Treatment Studies were conducted.

  • I Study 1 was specific to Methamphetamine and reported MDMA when present.
  • . Study 2 was specific to MDMA and reported Methamphetamine when present.

Cosmetic Treatment. Studies 1 and 2

BLEACH #1 - Salon Care Blue Flash Professional Powder Lightener

BLEACH #2 - Loreal Super Oreal Blanc® Professional Powder Bleach

PERM #1 - Naturelle Natural Curls Alkiline Perm

PERM #2 - Natural Apple Self-Timing Perm

DYE #1 - Revlon® Colorsilk™ Black

DYE #2 - Garnier Herbashine Soft Mahogany Dark Brown

RELAXER #1 - Silk Elements™ No-Lye Sensitive Scalp Relaxer System

RELAXER #2 - Ultra Precise No-Lye Conditioning Relaxer

SHAMPOO #1 - After Burner drug removing shampoo

SHAMPOO #2 - Ultra Cleanse drug removing shampoo

Study 1

Sixty (60) head hair specimens previously determined to be negative for Meth MDMA by the screening assay were obtained and the ethnic origin, hair color and curvature were documented.

One hundred and sixteen (116) hair specimens potentially positive for Meth_MDMA by the screening assay were obtained and the ethnic origin, hair color and curvature were documented.

Each specimen was divided into 2 aliquots. One aliquot was analyzed by the ELISA protocol and the GC/MS confirmation method.

The second aliguots were randomly assigned to the hair treatments listed in above and the treatments were performed suggested by the manufacturers.

Treated aliquots were analyzed by the ELISA protocol and the GC/MS confirmation method.

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All samples in this study were analyzed by the ELISA protocol and the GC/MS confirmation method before and after cosmetic treatments were applied.

Study 2

Sixty head hair specimens previously determined to be negative for MDMA were obtained and the ethnic origin, hair color and curvature were documented.

One hundred hair specimens potentially positive for MDMA were obtained and the ethnic origin, hair color and curvature were documented.

Each specimen was divided into 2 aliquots. One aliquot was analyzed by the ELISA protocol

The second aliquots were randomly assigned to the hair treatments listed.

Treated aliquots were analyzed by the ELISA protocol

Cosmetic Treatment Study 1 (Methamphetamine)

This effect was negligible for negative samples. The percent difference between the mean normalized absorbance values of the treated and untreated groups was less than 10% for bleaching, perms, dyes, and shampoos. The % change for the hair specimens treated with relaxers was greater at a mean of 14%. However, this only changed the overall positive/negative result for one specimen and the quantitative values before and after treatment was within the standard uncertainty ranqe of the GC/MS confirmation assay as determined in accordance with ISO17025 Accreditation (±12.6% at a 95% confidence interval, equivalent to a range of 437- 563 pg/mg, see attached Uncertainty Budget).

Permanent treatments had the greatest effect on positive samples followed by bleaching resulting in an average decrease in methamphetamine/MDMA concentration of 14% and 11%, respectively. The mean effect of dyes, relaxers, and shampoos was 8%, 8%, and 5% respectively.

Cosmetic Treatment Study 2 (MDMA)

This effect was negligible for negative samples. The percent difference between the mean normalized absorbance values of the treated and untreated groups was 15% or less for permanent, relaxers, dyes, and shampoos. The % change for the hair specimens treated with bleach was greater at a mean of 21%. The overall positive/negative result changed for only one specimen which was due to bleach treatment.

Bleach treatments had the greatest effect on positive resulting in an average decrease in MDMA concentration of 17%. The mean effect of permanents, relaxers, dyes, and shampoos was 13%. 12%, 8%, and 5%, respectively.

The mean change for all treatments except perms, was within the standard uncertainty range of the GC/MS confirmation assay as determined in accordance with ISO17025 Accreditation (±12.6% at a 95% confidence interval).

TreatmentMean change in Methconcentration (pg/mg)Mean change in MDMAconcentration (pg/mg)
Permanent-14%-17%

Table 11: Summary of Effects for Positive GC/MS Confirmation Data

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TreatmentMean change in Methconcentration (pg/mg)Mean change in MDMAconcentration (pg/mg)
Bleach-11%-13%
Dyeing-8%-12%
Relaxer-8%-8%
Shampoo5%-5%

ENVIRONMENTAL CONTAMINATION:

Two studies were performed to investigate whether confirmatory testing procedures are able to distinguish between true analytically positive samples and those that have been externally exposed to Meth -MDMA. The focus of the studies was to demonstrate that a methanol wash procedure mitigates the risk of false positive results while maintaining true analytical positive results.

The first study involved exposing drug-free hair to Meth - MDMA, 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. Head hair was used for this study.

Evaluating potential environmental contamination and the effectiveness of a methanol wash using this study design, all analytically negative samples tested remained negative after being subjected to Meth - MDMA by the exposure modes described followed by a single methanol wash.

Additionally, all clinically positive samples tested remain positive after the wash steps were performed.

SUMMARY CONCLUSION:

The comparison of results of the proposed assay with the confirmatory GC/MS testing of head and body hair samples showed the results to be substantially equivalent

The candidate Omega Hair Drug Screening Assay for Meth-MDMA (head and body hair) is substantially equivalent to the predicate Omega Hair Drug Screening Assay for Meth - MDMA (K101973 for head hair) based on the design and performance studies discussed in this summary. Supporting Performance Testing presented for review in this document, includes agreement, precision, specificity, interference (including cosmetic effects), removal of environmental contamination, stability and shipping tests.

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).