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

• 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

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.

Predicate Devices

K101973

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on ELISA and GC/MS methods, with no mention of AI or ML.

Therapeutic

No.
Explanation: This device is an in vitro diagnostic test for detecting specific substances in human hair, not a device used for treating or managing a disease or condition.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states, "The Omega Laboratories Hair Drug Screening Assay for Methamphetamine (Meth) and 3,4 Methylenedioxymethamphetamine (MDMA) is an in vitro diagnostic test..." This directly identifies the device as a diagnostic test.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "test system using ELISA reagents and micro-plate reader," which are hardware components.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Explicitly stated in the Intended Use: The very first sentence of the "Intended Use / Indications for Use" section clearly states: "The Omega Laboratories Hair Drug Screening Assay for Methamphetamine (Meth) and 3,4 Methylenedioxymethamphetamine (MDMA) is an in vitro diagnostic test..."
• Analyzes human specimens: The device is intended for the detection of substances in "human head and body hair," which are human specimens.
• Provides information for diagnosis or treatment: While this specific test is a screening assay and requires confirmation, it provides information about the presence of drugs of abuse in a person's system, which is relevant to diagnosis (e.g., substance abuse) and potentially treatment decisions.
• Used in a laboratory setting: The device is intended for "single laboratory use only," which is typical for IVD tests.

The provided information strongly supports the classification of this device as an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

DKZ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human head and body hair

Indicated Patient Age Range

Not Found

Intended User / Care Setting

single laboratory use only

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Precision Studies (Intra-assay):

• Sample Size: 11 replicates for each concentration.
• Data Source: Negative head hair samples spiked to various concentrations of Methamphetamine or MDMA: zero drug, -75%, -50%, -25% below the cutoff, and +25%, +50%, +75% and+100% above the cutoff.
• Annotation Protocol: All samples were treated and analyzed in the same manner as donor hair samples and measured in one run.

Precision Studies (Inter-assay):

• Sample Size: 11 replicates for each concentration, analyzed over 20 non-consecutive days for Methamphetamine and 10 non-consecutive days for MDMA.
• Data Source: Negative head hair samples spiked to various concentrations of Methamphetamine and MDMA: zero drug, -75%, -50%, -25% below the cutoff, and +25%, +50%, +75% and+100% above the cutoff.
• Annotation Protocol: All samples were treated and analyzed in the same manner as donor hair samples.

Agreement Studies:

• Sample Size: 836 head hair samples (some positive for both MDMA and Methamphetamine), 138 donor body hair samples (69 Methamphetamine and 69 MDMA).
• Data Source: Donor specimens.
• Annotation Protocol: Qualitative results from the new assays were compared to those obtained from the predicate devices. ELISA results were compared to GC/MS confirmation.

Cross-reactivity Studies:

• Sample Size: Not explicitly stated as a single number, but involves testing various structurally similar compounds. Serial dilutions of each compound were prepared in negative hair matrix extract.
• Data Source: Structurally similar compounds and negative hair matrix extract.
• Annotation Protocol: The concentration of the structurally related compound that gave a similar absorbance to the 500 pg/mg S(+)methamphetamine Cutoff Control (CO) response was determined and the percent cross reactivity calculated. Percentage 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.

Interference Studies:

• Sample Size: Not explicitly stated as a single number, but involves testing various structurally related and unrelated compounds.
• Data Source: Negative hair extracts spiked with S(+)Methamphetamine or (±) MDMA at different concentrations (-50%, +125%, +150% of cutoff), then additionally spiked with 10000 ng/ml (400000 pg/mg) of interfering compounds.
• Annotation Protocol: The absorbances were compared to the 500 pg/mg S(+)Methamphetamine/MDMA Cutoff control (CO). Analysis was performed in triplicate.

Stability Studies:

• Sample Size: 100 samples (50 previously confirmed positive for Methamphetamine, 50 previously confirmed positive for MDMA).
• Data Source: Hair samples taken from the head. These samples were previously confirmed Positive using the Omega Confirmation Protocol.
• Annotation Protocol: Samples were packaged and stored in the Omega Collection Kit for an average of 4 years. They were then run a second time using the Omega Confirmation Protocol. Acceptable stability was defined as a mean variation in concentration of less than 15%.

Shipping Study:

• Sample Size: 200 head hair samples (49 previously confirmed positive for Methamphetamine, 48 previously confirmed positive for MDMA, 100 previously screened negative, 1 confirmed below cutoff for Methamphetamine, 2 confirmed below cutoff for MDMA).
• Data Source: Head hair samples with variety of hair color and curvature.
• Annotation Protocol: Hair samples were stored in a freezer at approx. -12°C for approx. 20 hours, then heated to approx. 43°C for approx. 7 hours. Each box was then shipped to different US locations, held for at least two days, and returned to Omega. Returned samples were screened and quantitatively tested using GC/MS.

Cosmetic Treatment Studies:

• Sample Size: Study 1 (Methamphetamine): 60 negative head hair specimens, 116 potentially positive head hair specimens. Study 2 (MDMA): 60 negative head hair specimens, 100 potentially positive head hair specimens.
• Data Source: Head hair specimens.
• Annotation Protocol: Each specimen was divided into 2 aliquots. One aliquot was analyzed by ELISA and GC/MS confirmation (Study 1) or ELISA (Study 2). The second aliquots were randomly assigned to various hair treatments (bleach, perm, dye, relaxer, shampoo) performed as suggested by manufacturers. Treated aliquots were then analyzed by ELISA and GC/MS confirmation (Study 1) or ELISA (Study 2).

Environmental Contamination Studies:

• Sample Size: Not explicitly stated as a single number, but involves "analytically negative samples" and "clinically positive samples."
• Data Source: Drug-free hair and known positive samples.
• Annotation Protocol: Drug-free hair was exposed to Meth-MDMA, washed with methanol three times, and then confirmation testing was performed on samples and washes. Known positive samples underwent confirmation testing to observe if methanol washes changed the final result.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

PRECISION:

• Study Type: Intra-assay and Inter-assay precision studies.
• Sample Size: Intra-assay: 11 replicates per concentration. Inter-assay: 11 replicates per concentration over 20 non-consecutive days (Methamphetamine) or 10 non-consecutive days (MDMA).
• Key results:
  • Intra-assay precision demonstrated acceptable results (%CV of 10% or less).
  • Inter-assay precision demonstrated acceptable results (%CV of 10% or less).
  • MDMA samples at 375 pg/mg were positive at the 500 pg/mg Methamphetamine cutoff level due to 166% cross-reactivity of MDMA.

AGREEMENT STUDIES:

• Study Type: Comparison of ELISA results with GC/MS confirmation results.
• Sample Size: 836 head hair samples and 138 body hair samples.
• Key results:
  • All performance studies demonstrated that the Omega assay is in 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.
  • Discordant results were found only in head hair samples and were consistent with the drug cutoff value of 500 pg/mg.

CROSSREACTIVITY:

• Study Type: Evaluation of specificity of the ELISA protocol and effect of interfering compounds with structurally similar compounds.
• Key results:
  • Identified percent cross-reactivity for various compounds relative to Methamphetamine (Tables 5a) and MDMA (Table 5b) 500 pg/mg cutoff controls.
  • PMMA showed 285.7% cross-reactivity for Methamphetamine ELISA and 250% for MDMA ELISA.
  • MDMA showed 166.7% cross-reactivity for Methamphetamine ELISA.
  • S(+) Methamphetamine showed 52.6% cross-reactivity for MDMA ELISA.
  • Extended testing confirmed some compounds previously thought not to cross-react did so at extremely high concentrations.

Effect of Interfering Compounds:

• Study Type: Evaluation of interference from structurally related and unrelated compounds on Methamphetamine ELISA and MDMA ELISA.
• Key results:
  • Only structurally cross-reactive compounds interfered in the assay, producing a positive response due to significant cross-reactivity, as shown in Table 6a and 6b.
  • No tested samples produced a negative result when expected to be positive.
  • d,l-desmethyl-Venlafaxine consistently produced a positive response in the -50% CO interference test at concentrations greater than 7500 ng/mL (30000 pg/mg) for MDMA ELISA, but did not cause negative results at higher concentrations (+125%, +150%).

CALIBRATOR AND CONTROL:

• Study Type: Validation and stability of in-house prepared calibrators and control solutions.
• Key results:
  • Study successfully demonstrated validation and stability of solutions and traceability to NIST standards.
  • Demonstrated one year stability of Meth-MDMA in methanol when refrigerated in amber bottle. Quantitative value within 10% of target value after one year for Methamphetamine.

STABILITY:

• Study Type: Evaluation of stability of hair samples stored for an extended period.
• Sample Size: 100 samples (50 Methamphetamine, 50 MDMA).
• Key results:
  • Mean variance in Methamphetamine concentration was 4% and MDMA was 10%.
  • Mean variances were below the 15% acceptance criterion, demonstrating acceptable stability.

SHIPPING:

• Study Type: Evaluation of the effect of extreme temperatures and humidity during sample transport on hair samples.
• Sample Size: 200 head hair samples.
• Key results:
  • No adverse effect on hair samples when exposed to extreme temperatures and variations in humidity.
  • No samples had discordant screening results after being shipped and returned.

COSMETIC TREATMENT:

• Study Type: Evaluation of effects of various cosmetic treatments (bleaching, perms, dyes, relaxers, shampoos) on the ELISA protocol.
• Key results:
  • For negative samples, the percent difference between treated and untreated groups was negligible (less than 10% for most, 14% for relaxers, 21% for bleach in MDMA study).
  • One specimen changed overall positive/negative result in the Methamphetamine study due to relaxer treatment, but quantitative values were within standard uncertainty.
  • One specimen changed overall positive/negative result in the MDMA study due to bleach treatment.
  • For positive samples, permanent treatments had the greatest effect on Methamphetamine concentration (14% decrease), and bleach treatments had the greatest effect on MDMA concentration (17% decrease).
  • Mean changes for all treatments except perms were within the standard uncertainty range of the GC/MS confirmation assay.

ENVIRONMENTAL CONTAMINATION:

• Study Type: Investigation into distinguishing true analytical positive samples from externally exposed samples using a methanol wash procedure. (Head hair was used for this study.)
• Key results:
  • All analytically negative samples remained negative after exposure to Meth-MDMA and methanol wash.
  • All clinically positive samples remained positive after the wash steps.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not directly reported in standard sensitivity/specificity/PPV/NPV format for the overall assay.
The performance studies focus on:

• Precision (Coefficient of Variation): Intra-assay and Inter-assay %CV of 10% or less was acceptable.
• Agreement: Substantial agreement with predicate devices and GC/MS confirmation.
• Cross-reactivity: Percent cross-reactivity for various compounds.
• Interference: Qualitative results (POS/NEG) at different spike concentrations.
• Stability: Mean change in concentration (4% for Meth, 10% for MDMA) over time.
• Shipping: No discordant screening results after transport.
• Cosmetic Treatment: Mean change in drug concentration (e.g., -14% for Meth with permanent, -17% for MDMA with bleach).

Predicate Device(s)

K101973

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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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.

1

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 [phone] or [phone] 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 [phone] or [phone] 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. Corl
Chief Executive Officer
Omega Laboratories, Inc.
400 North Cleveland
Mogadore, OH 44260
Tel: [phone]
Fax: [phone]
Correspondent:
Name:	ROBERT J BARD, JD, CQE, RAC
Address:	Omega Laboratories
400 North Cleveland, Mogadore, OH 44260
Phone Number:	248-573-5040
E-mail	[e-mail]
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 the
addition of the body hair as an assay matri.;
Product 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.
Indication for 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

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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.

| Comparison
Element -
Similarities | Omega Laboratories Hair Drug Screening
Assay Methamphetamine_3, 4-
methylenedioxymethamphetamine
(Meth_MDMA) (Subject devices) | Omega Laboratories Hair Drug Screening
Assay Methamphetamine_3, 4-
methylenedioxymethamphetamine
(Meth_MDMA) (Predicate device K101973) |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Laboratory | Omega Laboratories, Inc. | Same. |
| Indication for/
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. | The Omega Laboratories Hair Drug
Screening Assay Methamphetamine and
3,4-Methylenedioxymethamphetamine
(MDMA) is a laboratory developed test
that is intended to be used for the
determination of the presence of
Methamphetamine and 3,4-
Methylenedioxymethamphetamine
(MDMA) in human hair from the crown of
the head. The Omega Laboratories Hair
Drug Screening Assay (Meth -MDMA)
utilizes International Diagnostics Systems
Corp One-Step Methamphetamine ELISA
for Hair Testing Kit for the qualitative
detection of Methamphetamine and
MDMA at or above 500 pg/mg of hair for
the purpose of identifying the use of
Methamphetamine and MDMA. D-
Methamphetamine is used as the standard
for the assay. 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 |

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

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| Comparison
Element -
Similarities | Omega Laboratories Hair Drug Screening
Assay Methamphetamine_3, 4-
methylenedioxymethamphetamine
(Meth_MDMA) (Subject devices) | Omega Laboratories Hair Drug Screening
Assay Methamphetamine_3, 4-
methylenedioxymethamphetamine
(Meth_MDMA) (Predicate device K101973) |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | 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. |
| Method of
Measurement | Microplate reader. Read at 450 nm | Same. |
| Matrix | Head and body hair | Head hair |
| Cutoff
concentration | 500 pg /mg hair for both Methamphetamine
and MDMA | Same |
| Assay Principal | ELISA | Same. |
| Extraction
Method | Utilized acid-methanol vs methanol alone to
facilitate extraction of drug from hair. | Same. |
| | Proprietary and patent pending method of
pulverizing hair vs cutting the hair into small
segments prior to acid-methanol extraction.
This improved extraction times without loss of
efficiency | |

				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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| Drug | Target
Concentration
pg/mg (%) | Number of
Replicates | Results

Negative | Results

Positive |

|-----------------|--------------------------------------|-------------------------|-----------------------|-----------------------|
| Methamphetamine | 0 | 11 | 11 | 0 |
| Methamphetamine | 125 (-75%) | 11 | 11 | 0 |
| Methamphetamine | 250 (-50%) | 11 | 11 | 0 |
| Methamphetamine | 375 (-25%) | 11 | 11 | 0 |
| Methamphetamine | 625 (+25%) | 11 | 0 | 11 |
| Methamphetamine | 750 (+50%) | 11 | 0 | 11 |
| Methamphetamine | 875 (+75%) | 11 | 0 | 11 |
| Methamphetamine | 1000 (+100%) | 11 | 0 | 11 |

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)

| Drug | Target
Concentration
pg/mg (%) | Number of
Replicates | Results

Negative | Results

Positive |

|------|--------------------------------------|-------------------------|-----------------------|-----------------------|
| MDMA | 0 | 11 | 11 | 0 |
| MDMA | 125 (-75%) | 11 | 11 | 0 |
| MDMA | 250 (-50%) | 11 | 11 | 0 |
| MDMA | 375 (-25%) | 11 | 11 | 0 |
| MDMA | 625 (+25%) | 11 | 0 | 11 |
| MDMA | 750 (+50%) | 11 | 0 | 11 |
| MDMA | 875 (+75%) | 11 | 0 | 11 |
| MDMA | 1000 (+100%) | 11 | 0 | 11 |

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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| Drug | Target
Concentration
pg/mg (%) | Number of
Replicates | Results

Negative | Results

Positive |

|-----------------|--------------------------------------|-------------------------|-----------------------|-----------------------|
| Methamphetamine | 0 | 220 | 220 | 0 |
| Methamphetamine | 125 (-75%) | 220 | 220 | 0 |
| Methamphetamine | 250 (-50%) | 220 | 220 | 0 |
| Methamphetamine | 375 (-25%) | 220 | 220 | 0 |
| Methamphetamine | 625 (+25%) | 220 | 0 | 220 |
| Methamphetamine | 750 (+50%) | 220 | 0 | 220 |
| Methamphetamine | 875 (+75%) | 220 | 0 | 220 |
| Methamphetamine | 1000 (+100%) | 220 | 0 | 220 |

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)

| Drug | Target
Concentration
pg/mg (%) | Number of
Replicates | Results

Negative | Results

Positive |

|------|--------------------------------------|-------------------------|-----------------------|-----------------------|
| MDMA | 0 | 110 | 110 | 0 |
| MDMA | 125 (-75%) | 110 | 110 | 0 |
| MDMA | 250 (-50%) | 110 | 110 | 0 |
| MDMA | 375 (-25%) | 110 | 14 | 96 |
| MDMA | 625 (+25%) | 110 | 0 | 110 |
| MDMA | 750 (+50%) | 110 | 0 | 110 |
| MDMA | 875 (+75%) | 110 | 0 | 110 |
| MDMA | 1000 (+100%) | 110 | 0 | 110 |

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.

8

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).

| ELISA
Methampheta
mine Test
Result | Negative
by GC/MS | Less than half of
the cutoff
concentration by
GC/MS | Near Cutoff
Negative
(Between 50%
below the cutoff
and the cutoff
concentration) | Near Cutoff
Positive
(Between the
cutoff and 50%
above the cutoff
concentration) | High Positive
(Greater than
50% above the
cutoff
concentration) |
|---------------------------------------------|----------------------|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Positive | 0 | 3 | 29 | 47 | 472 |
| Negative | 142 | 25 | 20 | 0 | 1 |

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

| ELISA
Methampheta
mine Test
Result | Negative
by GC/MS | Less than half of
the cutoff
concentration by
GC/MS | Near Cutoff
Negative
(Between 50%
below the cutoff
and the cutoff
concentration) | Near Cutoff
Positive
(Between the
cutoff and 50%
above the cutoff
concentration) | High Positive
(Greater than
50% above the
cutoff
concentration) |
|---------------------------------------------|----------------------|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Positive | 0 | 0 | 0 | 8 | 260 |
| Negative | 142 | 0 | 5 | 2 | 1 |

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) | Methamphetamine
GC/MS Drug Result
(pg/mg) |
|-----------------------------|--------------------------------|-------------------------|-------------------------------------------------|
| 500 | POS | 500 | Meth 159 |
| 500 | POS | 500 | Meth 184 |
| 500 | POS | 500 | Meth 248 |
| Screening Cutoff
(pg/mg) | ELISA Test Result
(POS/NEG) | GC/MS Cutoff (pg/mg) | Methamphetamine
GC/MS Drug Result
(pg/mg) |
| 500 | POS | 500 | Meth 269 |
| 500 | POS | 500 | Meth 292 |
| 500 | POS | 500 | Meth 296 |
| 500 | POS | 500 | Meth 337 |
| 500 | POS | 500 | Meth 359 |
| 500 | POS | 500 | Meth 367 |
| 500 | POS | 500 | Meth 369 |
| 500 | POS | 500 | Meth 372 |
| 500 | POS | 500 | Meth 373 |
| 500 | POS | 500 | Meth 380 |
| 500 | POS | 500 | Meth 380 |
| 500 | POS | 500 | Meth 390 |
| 500 | POS | 500 | Meth 392 |
| 500 | POS | 500 | Meth 394 |
| 500 | POS | 500 | Meth 397 |
| 500 | POS | 500 | Meth 400 |
| 500 | POS | 500 | Meth 407 |
| 500 | POS | 500 | Meth 413 |
| 500 | POS | 500 | Meth 426 |
| 500 | POS | 500 | Meth 430 |
| 500 | POS | 500 | Meth 440 |
| 500 | POS | 500 | Meth 442 |
| 500 | POS | 500 | Meth 448 |
| 500 | POS | 500 | Meth 470 |
| 500 | POS | 500 | Meth 472 |
| 500 | POS | 500 | Meth 478 |
| 500 | POS | 500 | Meth 480 |
| 500 | POS | 500 | Meth 480 |
| 500 | POS | 500 | Meth 499 |
| 500 | NEG | 500 | Meth 778 |
| Screening Cutoff
(pg/mg) | ELISA Test Result
(POS/NEG) | GC/MS Cutoff
(pg/mg) | MDMA GC/MS Drug
Result (pg/mg) |
| 500 | NEG | 500 | 557 |
| 500 | NEG | 500 | 563 |
| 500 | NEG | 500 | 778 |

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

9

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

10

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.

| Compound | Approximate Concentration of Compound
(pg/mg) Equivalent to 500 pg/mg
S(+)Methamphetamine Cutoff Control (n=3) | Percent Cross reactivity (%) |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------|
| para-Methoxy-N-methylamphetamine
(PMMA) | 175 | 285.7 |

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

11

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

| Compound | Approximate Concentration of Compound
(pg/mg) Equivalent to 500 pg/mg
S(+)Methamphetamine Cutoff Control (n=3) | Percent Cross reactivity (%) |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------|
| (+/-) 3,4-
Methylenedioxymethampheta-mine
((+/-) MDMA) | 300 | 166.7 |
| S (+) Methamphetamine | 500 | 100.0 |
| p-Hydroxymethamphetamine | 700 | 71.4 |
| (+/-)1,3-Benzodioxolyl-N-
methylbutanamine ((+/-) MBDB) | 1000 | 50.0 |
| (+/-)4-methylenedioxy-N-ethyl-
amphetamine ((+/-) MDEA) | 2500 | 20.0 |
| Mephentermine | 5500 | 9.1 |
| (+/-) 4-Hydroxyephedrine | 8500 | 5.9 |
| (+/-) 4-hydroxy-3-
methoxymethamphetamine ((+/-)
HMMA) | 17500 | 2.9 |
| 1R,2S (-) Ephedrine | 17500 | 2.9 |
| (-) Methamphetamine | 22500 | 2.2 |
| para-Methoxyamphetamine, or 4-
methoxyamphetamine (PMA) | 25000 | 2.0 |
| (+/-) 3,4-
Methylenedioxyamphetamine ((+/-)
MDA) | 40000 | 1.3 |
| Fenfluramine | 50000 | 1.0 |
| (+) Pseudoephedrine | 50000 | 1.0 |
| Methoxyphenamine | 70000 | 0.7 |
| (-) Amphetamine | 175000 | 0.3 |
| (+) Amphetamine | 300000 | 0.2 |
| (+/-)2,5-Dimethoxy-4-
bromoamphetamine | 2,000,000.0 | 0.03 |
| 1S,2R(+) Ephedrine | 900,000.0 | 0.06 |
| Phentermine | 600,000.0 | 0.08 |
| R(+) Methcathinone | 900,000.0 | 0.06 |
| R,R(-) Pseudoephedrine | 1,500,000.0 | 0.03 |
| Diphenhydramine | Not achieved at highest spike concentration.
400000 pg/mg | |
| Phenylpropanolamine | Not achieved at highest spike concentration.
400000 pg/mg | |
| Phendimetrazine | Not achieved at highest spike concentration.
400000 pg/mg | |
| Phentermine | Not achieved at highest spike concentration.
400000 pg/mg | |
| R (+) Cathinone | Not achieved at highest spike concentration.
400000 pg/mg | |

12

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

| Compound | Approximate Concentration of Compound
(pg/mg) Equivalent to 500 pg/mg
S(+)Methamphetamine Cutoff Control (n=3) | Percent Cross reactivity (%) |
|-------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------|
| Labetalol | Not achieved at highest spike concentration.
400000 pg/mg | |
| (-) Phenylephrine | Not achieved at highest spike concentration.
400000 pg/mg | |

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

| Compound | Approximate Concentration of
Compound (pg/mg) Equivalent to 500
pg/mg (+/-) MDMA Cutoff Control
(n=3) | Percent Cross-reactivity (%) |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------|
| para-Methoxy-N-methylamphetamine
(PMMA) | 200 | 250 |
| (+/-) 3,4-
Methylenedioxymethampheta-mine
((+/-) MDMA) | 500 | 100 |
| S (+) Methamphetamine | 950 | 52.6 |
| (+/-)1,3-Benzodioxolyl-N-
methylbutanamine ((+/-) MBDB) | 1500 | 33.3 |
| p-Hydroxymethamphetamine | 1500 | 33.3 |
| (+/-)4-methylenedioxy-N-ethyl-
amphetamine ((+/-) MDEA) | 3000 | 16.7 |
| Mephentermine | 7500 | 6.7 |
| (+/-) 4-Hydroxyephedrine | 10000 | 5 |
| 1R,2S (-) Ephedrine | 15000 | 3.3 |
| (-) Methamphetamine | 20000 | 2.5 |
| (+/-) 4-hydroxy-3-
methoxymethamphetamine ((+/-)
HMMA) | 25000 | 2 |
| para-Methoxyamphetamine, or 4-
methoxyamphetamine (PMA) | 35000 | 1.4 |
| (+/-) 3,4-
Methylenedioxyamphetamine ((+/-)
MDA) | 65000 | 0.8 |
| Fenfluramine | 85000 | 0.6 |
| (+) Pseudoephedrine | 90000 | 0.6 |
| Methoxyphenamine | 150000 | 0.3 |
| (-) Amphetamine | 250000 | 0.2 |
| (+/-)2,5-Dimethoxy-4-
bromoamphetamine | 2,000,000.0 | 0.03 |
| 1S,2R(+) Ephedrine | 900,000.0 | 0.06 |

13

| Compound | Approximate Concentration of Compound
(pg/mg) Equivalent to 500 pg/mg
S(+)Methamphetamine Cutoff Control (n=3) | Percent Cross reactivity (%) |
|-------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------|
| Phentermine | 600,000.0 | 0.08 |
| R(+) Methcathinone | 900,000.0 | 0.06 |
| R,R(-) Pseudoephedrine | 1,500,000.0 | 0.03 |
| 1S,2R (+) Ephedrine | Not achieved at highest spike concentration.
40000 pg/mg | |
| (+) Amphetamine | Not achieved at highest spike concentration.
400000 pg/mg | |
| Diphenhydramine | Not achieved at highest spike concentration.
400000 pg/mg | |
| Phenylpropanolamine | Not achieved at highest spike concentration.
400000 pg/mg | |
| R,R (-) Pseudoephedrine | Not achieved at highest spike concentration.
400000 pg/mg | |
| Phendimetrazine | Not achieved at highest spike concentration.
400000 pg/mg | |
| R ( +) Cathinone | Not achieved at highest spike concentration.
400000 pg/mg | |
| Labetalol | Not achieved at highest spike concentration.
400000 pg/mg | |
| (-) Phenylephrine | Not 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 (shaded
compounds are structurally
related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
|----------------------------------------------------------------------------------|------------------------------------|-----------------------|------------------------|------------------------|
| (-) 11-nor-9-carboxy-delta8-
Tetrahydrocannabinol | 10000 | NEG | POS | POS |
| (-) 11-nor-9-carboxy-delta9-
Tetrahydrocannabinol | 10000 | NEG | POS | POS |
| R (-) Amphetamine | 10000 | POS | POS | POS |
| (-) Cotinine | 10000 | NEG | POS | POS |
| (-) Cotinine-N-oxide | 10000 | NEG | POS | POS |
| (-) Isoproterenol | 10000 | NEG | POS | POS |
| (-) Methamphetamine | 10000 | POS | POS | POS |
| (-) Nicotine | 10000 | NEG | POS | POS |
| (-) Phenylephrine | 10000 | NEG | POS | POS |
| (-)-Alpha-methadol | 10000 | NEG | POS | POS |
| (+) Amphetamine | 10000 | POS | POS | POS |
| (+) Isoproterenol | 10000 | NEG | POS | POS |
| (+) Methamphetamine | 10000 | POS | POS | POS |
| (+) Pseudoephedrine | 10000 | POS | POS | POS |
| (+/-) 11-nor-9-carboxy-delta9-
Tetrahydrocannabinol | 10000 | NEG | POS | POS |
| (+/-) 2,5-Dimethoxy- 4-
bromoamphetamine | 10000 | POS | POS | POS |
| (+/-) Alphaprodine | 10000 | NEG | POS | POS |
| (+/-) Ketamine | 10000 | NEG | POS | POS |
| (+/-)1,3-Benzodioxolyl-N-
methylbutanamine ((+/-) MBDB) | 10000 | POS | POS | POS |
| Compound (shaded
compounds are structurally
related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| (+/-) 3,4-
Methylenedioxyamphetamine ((+/-)
MDA) | 10000 | POS | POS | POS |
| (+/-)4-methylenedioxy-N-ethyl-
amphetamine ((+/-) MDEA) | 10000 | POS | POS | POS |
| (+/-) 3,4-
Methylenedioxymethampheta-mine
((+/-) MDMA) | 10000 | POS | POS | POS |
| (+/-) Metanephrine | 10000 | NEG | POS | POS |
| (+/-) Metoprolol | 10000 | NEG | POS | POS |
| (+/-) Norcotinine | 10000 | NEG | POS | POS |
| (+/-) Propanolol | 10000 | NEG | POS | POS |
| (+/-) Trans-3'-Hydroxycotinine | 10000 | NEG | POS | POS |
| 11-Hydroxy-delta9-
Tetrahydrocannabinol | 10000 | NEG | POS | POS |
| 19-Nortestosterone (Nandrolone) | 10000 | NEG | POS | POS |
| 1R,2S (-) Ephedrine | 10000 | POS | POS | POS |
| 1S,2R (+) Ephedrine | 10000 | POS | POS | POS |
| 2-Oxo-3-hydroxy-LSD | 10000 | NEG | POS | POS |
| 3-Methoxynaltrexone | 10000 | NEG | POS | POS |
| 3-Trans-Hydroxy-norcotinine | 10000 | NEG | POS | POS |
| 4-Acetoamidophenol | 10000 | NEG | POS | POS |
| 4-Hydroxy-Phencyclidine | 10000 | NEG | POS | POS |
| 5,5-Diphenylhydantoin | 10000 | NEG | POS | POS |
| 6-Acetyl-codeine | 10000 | NEG | POS | POS |
| 6-MonoacetyImorphine | 10000 | NEG | POS | POS |
| 7-Aminoclonazepam | 10000 | NEG | POS | POS |
| 7-Aminonitrazepam | 10000 | NEG | POS | POS |
| Acebutolol | 10000 | NEG | POS | POS |
| Acetophenetidin | 10000 | NEG | POS | POS |
| Acetopromazine | 10000 | NEG | POS | POS |
| Acetylsalicyclic acid | 10000 | NEG | POS | POS |
| Alfentanil | 10000 | NEG | POS | POS |
| Alpha-Ergocryptine | 10000 | NEG | POS | POS |
| Alprazolam | 10000 | NEG | POS | POS |
| 7-Aminoflunitrazepam | 10000 | NEG | POS | POS |
| Aminorex | 10000 | NEG | POS | POS |
| Amitriptyline | 10000 | NEG | POS | POS |
| | | | | |
| Compound (shaded
compounds are structurally
related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Amobarbital | 10000 | NEG | POS | POS |
| Amoxicillin | 10000 | NEG | POS | POS |
| Anhydroecgonine | 10000 | NEG | POS | POS |
| Anileridine | 10000 | NEG | POS | POS |
| Apomorphine | 10000 | NEG | POS | POS |
| Atenolol | 10000 | NEG | POS | POS |
| Azaperone | 10000 | NEG | POS | POS |
| Benzoylecgonine | 10000 | NEG | POS | POS |
| Benzoylecgonine isopropyl ester | 10000 | NEG | POS | POS |
| Betamethasone | 10000 | NEG | POS | POS |
| Boldenone | 10000 | NEG | POS | POS |
| Bumetanide | 10000 | NEG | POS | POS |
| Bupivicaine | 10000 | NEG | POS | POS |
| Buprenorphine | 10000 | NEG | POS | POS |
| Buprenorphine-glucuronide
(2500ng/ml) | 10000 | NEG | POS | POS |
| Buspirone | 10000 | NEG | POS | POS |
| Butabarbital | 10000 | NEG | POS | POS |
| Butalbital | 10000 | NEG | POS | POS |
| Caffeine | 10000 | NEG | POS | POS |
| Cannabidiol | 10000 | NEG | POS | POS |
| Cannabinol | 10000 | NEG | POS | POS |
| Carbamazepine | 10000 | NEG | POS | POS |
| Carisoprodol | 10000 | NEG | POS | POS |
| Chlordiazepoxide | 10000 | NEG | POS | POS |
| Chlorpromazine | 10000 | NEG | POS | POS |
| Cimeterol | 10000 | NEG | POS | POS |
| Clenbuterol | 10000 | NEG | POS | POS |
| Clomipramine | 10000 | NEG | POS | POS |
| Clonazepam | 10000 | NEG | POS | POS |
| Clonidine | 10000 | NEG | POS | POS |
| Clozapine | 10000 | NEG | POS | POS |
| Cocaethylene | 10000 | NEG | POS | POS |
| Cocaine | 10000 | NEG | POS | POS |
| Codeine | 10000 | NEG | POS | POS |
| Corticosterone | 10000 | NEG | POS | POS |
| Cortisone | 10000 | NEG | POS | POS |
| Compound (shaded
compounds are structurally
related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Cotinine-N-beta-D-Glucuronide | 10000 | NEG | POS | POS |
| Cyclobenzaprine | 10000 | NEG | POS | POS |
| d,I-N-Desmethylvenlafaxine | 10000 | NEG | POS | POS |
| Delta8-Tetrahydrocannabinol | 10000 | NEG | POS | POS |
| Delta9-Tetrahydrocannabinol | 10000 | NEG | POS | POS |
| Deoxycorticosterone | 10000 | NEG | POS | POS |
| Desalkylflurazepam | 10000 | NEG | POS | POS |
| Desipramine | 10000 | NEG | POS | POS |
| Desmethyldoxepin (cis/trans) | 10000 | NEG | POS | POS |
| Despropionyl-fentanyl | 10000 | NEG | POS | POS |
| Dexamethasone | 10000 | NEG | POS | POS |
| Dextromethorphan | 10000 | NEG | POS | POS |
| Diazepam | 10000 | NEG | POS | POS |
| Dibucaine | 10000 | NEG | POS | POS |
| Dihydrocodeine | 10000 | NEG | POS | POS |
| Dihydroergotamine | 10000 | NEG | POS | POS |
| Dihydromorphine | 10000 | NEG | POS | POS |
| Diphenhydramine | 10000 | NEG | POS | POS |
| Diphenoxylate | 10000 | NEG | POS | POS |
| Diprenorphine | 10000 | NEG | POS | POS |
| Dothiepin (cis/trans) | 10000 | NEG | POS | POS |
| Doxepin | 10000 | NEG | POS | POS |
| Doxylamine | 10000 | NEG | POS | POS |
| Droperidol | 10000 | NEG | POS | POS |
| Ecgonine | 10000 | NEG | POS | POS |
| Ecgonine methyl ester | 10000 | NEG | POS | POS |
| Ethylidine Dimethyl Diphenyl
Pyrrolidine (Metabolite of Methadone)
(EDDP) | 10000 | NEG | POS | POS |
| Effexor (Venlafaxine) | 10000 | NEG | POS | POS |
| 2-Ethyl-5-methyl-3,3-
diphenylpyrroline (EMDP) | 10000 | NEG | POS | POS |
| Ergonovine | 10000 | NEG | POS | POS |
| Erythromycin | 10000 | NEG | POS | POS |
| Estazolam | 10000 | NEG | POS | POS |
| Ethacrynic acid | 10000 | NEG | POS | POS |
| Ethopropazine | 10000 | NEG | POS | POS |
| Ethylmorphine | 10000 | NEG | POS | POS |
| Compound (shaded
compounds are structurally
related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Fenfluramine | 10000 | POS | POS | POS |
| Fentanyl | 10000 | NEG | POS | POS |
| Flumethasone | 10000 | NEG | POS | POS |
| Flunitrazepam | 10000 | NEG | POS | POS |
| Fluphenazine | 10000 | NEG | POS | POS |
| Flurazepam | 10000 | NEG | POS | POS |
| Furosemide | 10000 | NEG | POS | POS |
| Gentamicin | 10000 | NEG | POS | POS |
| Gluthimide | 10000 | NEG | POS | POS |
| Haloperidol | 10000 | NEG | POS | POS |
| Heroin | 10000 | NEG | POS | POS |
| Hexobarbital | 10000 | NEG | POS | POS |
| (+/-) 4-hydroxy-3-
methoxymethamphetamine ((+/-)
HMMA) | 10000 | POS | POS | POS |
| Hydrochlorothiazide | 10000 | NEG | POS | POS |
| Hydrocodone | 10000 | NEG | POS | POS |
| Hydrocortisone | 10000 | NEG | POS | POS |
| Hydromorphone | 10000 | NEG | POS | POS |
| (+/-) 4-Hydroxyephedrine | 10000 | POS | POS | POS |
| Hydroxymethamphetamine | 10000 | POS | POS | POS |
| Ibogaine | 10000 | NEG | POS | POS |
| Ibuprofen | 10000 | NEG | POS | POS |
| Imipramine | 10000 | NEG | POS | POS |
| Ketoprofen | 10000 | NEG | POS | POS |
| Levo-Alpha Acetyl Methadol (LAAM) | 10000 | NEG | POS | POS |
| Labetalol | 10000 | NEG | POS | POS |
| Levorphanol | 10000 | NEG | POS | POS |
| L-Hyoscyamine | 10000 | NEG | POS | POS |
| Lidocaine | 10000 | NEG | POS | POS |
| Lorazepam | 10000 | NEG | POS | POS |
| Lysergic acid diethylamide (LSD/ ISO
Lysergic acid diethylamide -(ISO
LSD) | 10000 | NEG | POS | POS |
| Lysergic acid | 10000 | NEG | POS | POS |
| Lysergol | 10000 | NEG | POS | POS |
| Maprotiline | 10000 | NEG | POS | POS |
| Meperidine | 10000 | NEG | POS | POS |
| Compound (shaded
compounds are structurally
related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Mephentermine | 10000 | POS | POS | POS |
| Mepivacaine | 10000 | NEG | POS | POS |
| Metaphit | 10000 | NEG | POS | POS |
| Metaproterenol | 10000 | NEG | POS | POS |
| Metaraminol | 10000 | NEG | POS | POS |
| Methadone | 10000 | NEG | POS | POS |
| Methohexital | 10000 | NEG | POS | POS |
| Methoxyphenamine | 10000 | POS | POS | POS |
| Methylergonovine | 10000 | NEG | POS | POS |
| Methylphenidate | 10000 | NEG | POS | POS |
| m-Hydroxybenzoylecgonine | 10000 | NEG | POS | POS |
| Mianserin | 10000 | NEG | POS | POS |
| Midazolam | 10000 | NEG | POS | POS |
| Monensin | 10000 | NEG | POS | POS |
| Morphine | 10000 | NEG | POS | POS |
| Morphine-3-betaglucuronide | 10000 | NEG | POS | POS |
| Morphine-6-betaglucuronide | 10000 | NEG | POS | POS |
| Nadolol | 10000 | NEG | POS | POS |
| Nalmefene | 10000 | NEG | POS | POS |
| Nalorphine | 10000 | NEG | POS | POS |
| Naloxone-3-beta-D-glucuronide | 10000 | NEG | POS | POS |
| Naltrexone | 10000 | NEG | POS | POS |
| Naltriben | 10000 | NEG | POS | POS |
| Naproxen | 10000 | NEG | POS | POS |
| N-Desmethylclomipramine | 10000 | NEG | POS | POS |
| N-Desmethylflunitrazepam | 10000 | NEG | POS | POS |
| N-Desmethyltramadol | 10000 | NEG | POS | POS |
| N-Desmethyltrimipramine | 10000 | NEG | POS | POS |
| Neomycin | 10000 | NEG | POS | POS |
| Nitrazepam | 10000 | NEG | POS | POS |
| Norbenzoylecgonine | 10000 | NEG | POS | POS |
| Norbuprenorphine | 10000 | NEG | POS | POS |
| Norcocaethylene | 10000 | NEG | POS | POS |
| Norcocaine | 10000 | NEG | POS | POS |
| Norcodeine | 10000 | NEG | POS | POS |
| Nordiazepam | 10000 | NEG | POS | POS |

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 (shaded
compounds are structurally
related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
|---------------------------------------------------------------------------------------------------|------------------------------------|-----------------------|------------------------|------------------------|
| Norfentanyl | 10000 | NEG | POS | POS |
| Nor- Levo-Alpha Acetyl Methadol
(Nor-LAAM) | 10000 | NEG | POS | POS |
| Nor- Lysergic acid diethylamide (Nor-
LSD/Nor-ISO Lysergic acid
diethylamide -(Nor-ISO LSD) | 10000 | NEG | POS | POS |
| Normeperidine | 10000 | NEG | POS | POS |
| Normeperidinic acid | 10000 | NEG | POS | POS |
| Normorphine | 10000 | NEG | POS | POS |
| Noroxycodone | 10000 | NEG | POS | POS |
| Noroxymorphone | 10000 | NEG | POS | POS |
| Norpropoxyphene | 10000 | NEG | POS | POS |
| Nortriptyline | 10000 | NEG | POS | POS |
| Noscapine | 10000 | NEG | POS | POS |
| O-Desmethyltramadol | 10000 | NEG | POS | POS |
| Oxazepam | 10000 | NEG | POS | POS |
| Oxprenolol | 10000 | NEG | POS | POS |
| Oxycodone | 10000 | NEG | POS | POS |
| Oxymorphone | 10000 | NEG | POS | POS |
| p-Acetamidophenyl-beta-D-
glucuronide | 10000 | NEG | POS | POS |
| Papaverine | 10000 | NEG | POS | POS |
| Pemoline | 10000 | NEG | POS | POS |
| Penicillin G | 10000 | NEG | POS | POS |
| Pentazocine | 10000 | NEG | POS | POS |
| Pentobarbital | 10000 | NEG | POS | POS |
| Perphenazine | 10000 | NEG | POS | POS |
| Phendimetrazine | 10000 | NEG | POS | POS |
| Phenelzine | 10000 | NEG | POS | POS |
| Phenobarbital | 10000 | NEG | POS | POS |
| Phenothiazine | 10000 | NEG | POS | POS |
| Phentermine | 10000 | POS | POS | POS |
| Phenylbutazone | 10000 | NEG | POS | POS |
| Phenylethyamine | 10000 | NEG | POS | POS |
| Phenylpropanolamine | 10000 | NEG | POS | POS |
| para-Methoxyamphetamine, or 4-
methoxyamphetamine (PMA) | 10000 | POS | POS | POS |
| | | | | |
| Compound (shaded
compounds are structurally
related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| para-Methoxy-N-methylamphetamine
(PMMA) | 10000 | POS | POS | POS |
| Prednisolone | 10000 | NEG | POS | POS |
| Prilocaine | 10000 | NEG | POS | POS |
| Prochlorperazine | 10000 | NEG | POS | POS |
| Progesterone | 10000 | NEG | POS | POS |
| Promazine | 10000 | NEG | POS | POS |
| Promethazine | 10000 | NEG | POS | POS |
| Propiomazine | 10000 | NEG | POS | POS |
| Propionylpromazine | 10000 | NEG | POS | POS |
| Propoxyphene | 10000 | NEG | POS | POS |
| Protriptyline | 10000 | NEG | POS | POS |
| Quinidine | 10000 | NEG | POS | POS |
| R (+) Methcathinone | 10000 | POS | POS | POS |
| R (-) Epinephrine | 10000 | NEG | POS | POS |
| R (+) Cathinone | 10000 | NEG | POS | POS |
| Salbutamol | 10000 | NEG | POS | POS |
| Secobarbital | 10000 | NEG | POS | POS |
| Sertraline | 10000 | NEG | POS | POS |
| Stanazalol | 10000 | NEG | POS | POS |
| Streptomycin | 10000 | NEG | POS | POS |
| Sulfadimethoxine | 10000 | NEG | POS | POS |
| Sulfamethazine | 10000 | NEG | POS | POS |
| Sulfathiazole | 10000 | NEG | POS | POS |
| Temazepam | 10000 | NEG | POS | POS |
| Terbutaline | 10000 | NEG | POS | POS |
| Tetracycline | 10000 | NEG | POS | POS |
| Thebaine | 10000 | NEG | POS | POS |
| Theophylline | 10000 | NEG | POS | POS |
| Thioridazine | 10000 | NEG | POS | POS |
| Tramadol | 10000 | NEG | POS | POS |
| Triamcinolone | 10000 | NEG | POS | POS |
| Triazolam | 10000 | NEG | POS | POS |
| Trifluoperazine | 10000 | NEG | POS | POS |
| Trifluopromazine | 10000 | NEG | POS | POS |
| Trimeprazine | 10000 | NEG | POS | POS |
| Trimipramine | 10000 | NEG | POS | POS |
| Compound (shaded
compounds are structurally
related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Tylosin | 10000 | NEG | POS | POS |
| Tyramine | 10000 | NEG | POS | POS |
| Yohimbic acid | 10000 | NEG | POS | POS |
| Yohimbine | 10000 | NEG | POS | POS |
| Zolpidem | 10000 | NEG | POS | POS |
| Zopiclone | 10000 | NEG | POS | POS |
| Phencyclidine | 10000 | NEG | POS | POS |
| R,R (-)-Pseudoephedrine | 10000 | POS | POS | POS |
| Phencyclidine Morpholine | 10000 | NEG | POS | POS |

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 are
structurally related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
|----------------------------------------------------------------------------------------------------|------------------------------------|-----------------------|------------------------|------------------------|
| (-) 11-nor-9-carboxy-delta8-
Tetrahydrocannabinol | 1000 | NEG | POS | POS |
| (-) 11-nor-9-carboxy-delta9-
Tetrahydrocannabinol | 1000 | NEG | POS | POS |
| R (-) Amphetamine | 10000 | POS | POS | POS |
| (-) Cotinine | 10000 | NEG | POS | POS |
| Compound (shaded compounds are
structurally related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| (-) Cotinine-N-oxide | 10000 | NEG | POS | POS |
| (-) Isoproterenol | 10000 | NEG | POS | POS |
| (-) Methamphetamine | 10000 | POS | POS | POS |
| (-) Nicotine | 10000 | NEG | POS | POS |
| (-) Phenylephrine | 10000 | NEG | POS | POS |
| (-)-Alpha-methadol | 10000 | NEG | POS | POS |
| (+) Amphetamine | 10000 | POS | POS | POS |
| (+) Isoproterenol | 10000 | NEG | POS | POS |
| (+) Methamphetamine | 10000 | POS | POS | POS |
| (+) Pseudoephedrine | 10000 | POS | POS | POS |
| (+/-) 11-nor-9-carboxy-delta9-
Tetrahydrocannabinol | 1000 | NEG | POS | POS |
| (+/-) 2,5-Dimethoxy- 4-bromoamphetamine | 10000 | POS | POS | POS |
| (+/-) Alphaprodine | 10000 | NEG | POS | POS |
| (+/-) Ketamine | 10000 | NEG | POS | POS |
| (+/-)1,3-Benzodioxolyl-N-methylbutanamine
(MBDB) | 10000 | POS | POS | POS |
| (+/-) 3,4-Methylenedioxyamphetamine ((+/-)
MDA) | 10000 | POS | POS | POS |
| (+/-)4-methylenedioxy-N-ethyl-amphetamine
((+/-) MDEA) | 10000 | POS | POS | POS |
| (+/-) 3,4-Methylenedioxymethampheta-mine
((+/-)MDMA) | 10000 | POS | POS | POS |
| (+/-) Metanephrine | 10000 | NEG | POS | POS |
| (+/-) Metoprolol | 10000 | NEG | POS | POS |
| (+/-) Norcotinine | 10000 | NEG | POS | POS |
| (+/-) Propanolol | 10000 | NEG | POS | POS |
| Compound (shaded compounds are
structurally related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| (+/-) Trans-3'-Hydroxycotinine | 10000 | NEG | POS | POS |
| 11-Hydroxy-delta9-Tetrahydrocannabinol | 1000 | NEG | POS | POS |
| 19-Nortestosterone (Nandrolone) | 10000 | NEG | POS | POS |
| 1R,2S (-) Ephedrine | 10000 | POS | POS | POS |
| 1S,2R (+) Ephedrine | 10000 | POS | POS | POS |
| 2-Oxo-3-hydroxy-LSD | 1000 | NEG | POS | POS |
| 3-Methoxynaltrexone | 10000 | NEG | POS | POS |
| 3-Trans-Hydroxy-norcotinine | 10000 | NEG | POS | POS |
| 4-Acetoamidophenol | 10000 | NEG | POS | POS |
| 4-Hydroxy-Phencyclidine | 10000 | NEG | POS | POS |
| 5,5-Diphenylhydantoin | 10000 | NEG | POS | POS |
| 6-Acetyl-codeine | 10000 | NEG | POS | POS |
| 6-MonoacetyImorphine | 1000 | NEG | POS | POS |
| 7-Aminoclonazepam | 1000 | NEG | POS | POS |
| 7-Aminonitrazepam | 1000 | NEG | POS | POS |
| Acebutolol | 10000 | NEG | POS | POS |
| Acetophenetidin | 10000 | NEG | POS | POS |
| Acetopromazine | 10000 | NEG | POS | POS |
| AcetyIsalicyclic acid | 10000 | NEG | POS | POS |
| Alfentanil | 10000 | NEG | POS | POS |
| Alpha-Ergocryptine | 10000 | NEG | POS | POS |
| Alprazolam | 10000 | NEG | bos | POS |
| 7-Aminoflunitrazepam | 1000 | NEG | POS | POS |
| Aminorex | 10000 | NEG | POS | POS |
| Compound (shaded compounds are
structurally related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Amitriptyline | 10000 | NEG | POS | POS |
| Amobarbital | 10000 | NEG | POS | POS |
| Amoxicillin | 10000 | NEG | POS | POS |
| Anhydroecgonine | 10000 | NEG | POS | POS |
| Anileridine | 10000 | NEG | POS | POS |
| Apomorphine | 10000 | NEG | POS | POS |
| Atenolol | 10000 | NEG | POS | POS |
| Azaperone | 10000 | NEG | POS | POS |
| Benzoylecgonine | 10000 | NEG | POS | POS |
| Benzoylecgonine isopropyl ester | 10000 | NEG | POS | POS |
| Betamethasone | 10000 | NEG | POS | POS |
| Boldenone | 10000 | NEG | POS | POS |
| Bumetanide | 10000 | NEG | POS | POS |
| Bupivicaine | 10000 | NEG | POS | POS |
| Buprenorphine | 1000 | NEG | POS | POS |
| Buprenorphine-glucuronide | 2500 | NEG | POS | POS |
| Buspirone | 10000 | NEG | POS | POS |
| Butabarbital | 10000 | NEG | POS | POS |
| Butalbital | 10000 | NEG | POS | POS |
| Caffeine | 10000 | NEG | POS | POS |
| Cannabidiol | 10000 | NEG | POS | POS |
| Cannabinol | 10000 | NEG | POS | POS |
| Carbamazepine | 10000 | NEG | POS | POS |
| Carisoprodol | 10000 | NEG | POS | POS |
| Compound (shaded compounds are
structurally related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Chlordiazepoxide | 10000 | NEG | POS | POS |
| Chlorpromazine | 10000 | NEG | POS | POS |
| Cimeterol | 10000 | NEG | POS | POS |
| Clenbuterol | 10000 | NEG | POS | POS |
| Clomipramine | 10000 | NEG | POS | POS |
| Clonazepam | 10000 | NEG | POS | POS |
| Clonidine | 10000 | NEG | POS | POS |
| Clozapine | 10000 | NEG | POS | POS |
| Cocaethylene | 10000 | NEG | POS | POS |
| Cocaine | 10000 | NEG | POS | POS |
| Codeine | 10000 | NEG | POS | POS |
| Corticosterone | 10000 | NEG | POS | POS |
| Cortisone | 10000 | NEG | POS | POS |
| Cotinine-N-beta-D-Glucuronide | 10000 | NEG | POS | POS |
| Cyclobenzaprine | 10000 | NEG | POS | POS |
| d,l-N-Desmethylvenlafaxine | 10000 | POS | POS | POS |
| d,l-N-Desmethylvenlafaxine | 7500 | NEG | Not Tested | Not Tested |
| Delta8-Tetrahydrocannabinol | 10000 | NEG | POS | POS |
| Delta9-Tetrahydrocannabinol | 10000 | NEG | POS | POS |
| Deoxycorticosterone | 10000 | NEG | POS | POS |
| Desalkylflurazepam | 10000 | NEG | POS | POS |
| Desipramine | 10000 | NEG | POS | POS |
| Desmethyldoxepin (cis/trans) | 10000 | NEG | POS | POS |
| Despropionyl-fentanyl | 1000 | NEG | POS | POS |
| Compound (shaded compounds are
structurally related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Dexamethasone | 10000 | NEG | POS | POS |
| Dextromethorphan | 10000 | NEG | POS | POS |
| Diazepam | 10000 | NEG | POS | POS |
| Dibucaine | 10000 | NEG | POS | POS |
| Dihydrocodeine | 10000 | NEG | POS | POS |
| Dihydroergotamine | 10000 | NEG | POS | POS |
| Dihydromorphine | 10000 | NEG | POS | POS |
| Diphenhydramine | 10000 | NEG | POS | POS |
| Diphenoxylate | 10000 | NEG | POS | POS |
| Diprenorphine | 10000 | NEG | POS | POS |
| Dothiepin (cis/trans) | 10000 | NEG | POS | POS |
| Doxepin | 10000 | NEG | POS | POS |
| Doxylamine | 10000 | NEG | POS | POS |
| Droperidol | 10000 | NEG | POS | POS |
| Ecgonine | 10000 | NEG | POS | POS |
| Ecgonine methyl ester | 10000 | NEG | POS | POS |
| Ethylidine Dimethyl Diphenyl Pyrrolidine
(Metabolite of Methadone) (EDDP) | 10000 | NEG | POS | POS |
| Effexor (Venlafaxine) | 10000 | NEG | POS | POS |
| 2-Ethyl-5-methyl-3,3-diphenylpyrroline
(EMDP) | 10000 | NEG | POS | POS |
| Ergonovine | 10000 | NEG | POS | POS |
| Erythromycin | 10000 | NEG | POS | POS |
| Estazolam | 10000 | NEG | POS | POS |
| Ethacrynic acid | 10000 | NEG | POS | POS |
| Compound (shaded compounds are
structurally related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Ethopropazine | 10000 | NEG | POS | POS |
| Ethylmorphine | 10000 | NEG | POS | POS |
| Fenfluramine | 10000 | POS | POS | POS |
| Fentanyl | 1000 | NEG | POS | POS |
| Flumethasone | 10000 | NEG | POS | POS |
| Flunitrazepam | 10000 | NEG | POS | POS |
| Fluphenazine | 10000 | NEG | POS | POS |
| Flurazepam | 10000 | NEG | POS | POS |
| Furosemide | 10000 | NEG | POS | POS |
| Gentamicin | 10000 | NEG | POS | POS |
| Gluthimide | 10000 | NEG | POS | POS |
| Haloperidol | 10000 | NEG | POS | POS |
| Heroin | 10000 | NEG | POS | POS |
| Hexobarbital | 10000 | NEG | POS | POS |
| (+/-) 4-hydroxy-3-methoxymethamphetamine
((+/-) HMMA) | 10000 | POS | POS | POS |
| Hydrochlorothiazide | 10000 | NEG | POS | POS |
| Hydrocodone | 10000 | NEG | POS | POS |
| Hydrocortisone | 10000 | NEG | POS | POS |
| Hydromorphone | 10000 | NEG | POS | POS |
| (+/-) 4-Hydroxyephedrine | 10000 | POS | POS | POS |
| Hydroxymethamphetamine | 10000 | POS | POS | POS |
| lbogaine | 10000 | NEG | POS | POS |
| Ibuprofen | 10000 | NEG | POS | POS |
| Compound (shaded compounds are
structurally related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Imipramine | 10000 | NEG | POS | POS |
| Ketoprofen | 10000 | NEG | POS | POS |
| Levo-Alpha Acetyl Methadol (LAAM) | 10000 | NEG | POS | POS |
| Labetalol | 10000 | NEG | POS | POS |
| Levorphanol | 10000 | NEG | POS | POS |
| L-Hyoscyamine | 10000 | NEG | POS | POS |
| Lidocaine | 10000 | NEG | POS | POS |
| Lorazepam | 10000 | NEG | POS | POS |
| Lysergic acid diethylamide (LSD/ ISO
Lysergic acid diethylamide -(ISO LSD) | 10000 | NEG | POS | POS |
| Lysergic acid | 10000 | NEG | POS | POS |
| Lysergol | 10000 | NEG | POS | POS |
| Maprotiline | 10000 | NEG | POS | POS |
| Meperidine | 10000 | NEG | POS | POS |
| Mephentermine | 10000 | POS | POS | POS |
| Mepivacaine | 10000 | NEG | POS | POS |
| Metaphit | 10000 | NEG | POS | POS |
| Metaproterenol | 10000 | NEG | POS | POS |
| Metaraminol | 10000 | NEG | POS | POS |
| Methadone | 10000 | NEG | POS | POS |
| Methohexital | 10000 | NEG | POS | POS |
| Methoxyphenamine | 10000 | POS | POS | POS |
| Methylergonovine | 10000 | NEG | POS | POS |
| Methylphenidate | 10000 | NEG | POS | POS |
| Compound (shaded compounds are
structurally related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| m-Hydroxybenzoylecgonine | 10000 | NEG | POS | POS |
| Mianserin | 10000 | NEG | POS | POS |
| Midazolam | 10000 | NEG | POS | POS |
| Monensin | 10000 | NEG | POS | POS |
| Morphine
(1000ng/ml) | 10000 | NEG | POS | POS |
| Morphine-3-betaglucuronide | 10000 | NEG | POS | POS |
| Morphine-6-betaglucuronide | 1000 | NEG | POS | POS |
| Nadolol | 10000 | NEG | POS | POS |
| Nalmefene | 10000 | NEG | POS | POS |
| Nalorphine | 10000 | NEG | POS | POS |
| Naloxone-3-beta-D-glucuronide | 10000 | NEG | POS | POS |
| Naltrexone | 10000 | NEG | POS | POS |
| Naltriben | 10000 | NEG | POS | POS |
| Naproxen | 10000 | NEG | POS | POS |
| N-Desmethylclomipramine | 10000 | NEG | POS | POS |
| N-Desmethylflunitrazepam | 1000 | NEG | POS | POS |
| N-Desmethyltramadol | 10000 | NEG | POS | POS |
| N-Desmethyltrimipramine | 10000 | NEG | POS | POS |
| Neomycin | 10000 | NEG | POS | POS |
| Nitrazepam | 10000 | NEG | POS | POS |
| Norbenzoylecgonine | 10000 | NEG | POS | POS |
| Norbuprenorphine
(1000ng/ml) | 10000 | NEG | POS | POS |
| Norcocaethylene | 10000 | NEG | POS | POS |
| Compound (shaded compounds are
structurally related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Norcocaine | 10000 | NEG | POS | POS |
| Norcodeine | 10000 | NEG | POS | POS |
| Nordiazepam | 10000 | NEG | POS | POS |
| Norfentanyl
(1000ng/ml) | 10000 | NEG | POS | POS |
| Nor- Levo-Alpha Acetyl Methadol (Nor-LAAM) | 1000 | NEG | POS | POS |
| Nor- Lysergic acid diethylamide (Nor-
LSD/Nor-ISO Lysergic acid diethylamide -
(Nor-ISO LSD) | 1000 | NEG | POS | POS |
| Normeperidine | 1000 | NEG | POS | POS |
| Normeperidinic acid | 10000 | NEG | POS | POS |
| Normorphine | 10000 | NEG | POS | POS |
| Noroxycodone | 10000 | NEG | POS | POS |
| Noroxymorphone | 1000 | NEG | POS | POS |
| Norpropoxyphene | 10000 | NEG | POS | POS |
| Nortriptyline | 10000 | NEG | POS | POS |
| Noscapine | 10000 | NEG | POS | POS |
| O-Desmethyltramadol | 10000 | NEG | POS | POS |
| Oxazepam | 10000 | NEG | POS | POS |
| Oxprenolol | 10000 | NEG | POS | POS |
| Oxycodone | 10000 | NEG | POS | POS |
| Oxymorphone | 10000 | NEG | POS | POS |
| p-Acetamidophenyl-beta-D-glucuronide | 10000 | NEG | POS | POS |
| Papaverine | 10000 | NEG | POS | POS |
| Pemoline | 10000 | NEG | POS | POS |
| Compound (shaded compounds are
structurally related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Penicillin G | 10000 | NEG | POS | POS |
| Pentazocine | 10000 | NEG | POS | POS |
| Pentobarbital | 10000 | NEG | POS | POS |
| Perphenazine | 10000 | NEG | POS | POS |
| Phendimetrazine | 10000 | NEG | POS | POS |
| Phenelzine | 10000 | NEG | POS | POS |
| Phenobarbital | 10000 | NEG | POS | POS |
| Phenothiazine | 10000 | NEG | POS | POS |
| Phentermine | 10000 | POS | POS | POS |
| Phenylbutazone | 10000 | NEG | POS | POS |
| Phenylethyamine | 10000 | NEG | POS | POS |
| Phenylpropanolamine | 10000 | NEG | POS | POS |
| para-Methoxyamphetamine, or 4-
methoxyamphetamine (PMA) | 10000 | POS | POS | POS |
| para-Methoxy-N-methylamphetamine (PMMA) | 10000 | POS | POS | POS |
| Prednisolone | 10000 | NEG | POS | POS |
| Prilocaine | 10000 | NEG | POS | POS |
| Prochlorperazine | 10000 | NEG | POS | POS |
| Progesterone | 10000 | NEG | POS | POS |
| Promazine | 10000 | NEG | POS | POS |
| Promethazine | 10000 | NEG | POS | POS |
| Propiomazine | 10000 | NEG | POS | POS |
| Propionylpromazine | 10000 | NEG | POS | POS |
| Propoxyphene | 10000 | NEG | POS | POS |
| Compound (shaded compounds are
structurally related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Protriptyline | 10000 | NEG | POS | POS |
| Quinidine | 10000 | NEG | POS | POS |
| R (+) Methcathinone | 10000 | POS | POS | POS |
| R (-) Epinephrine | 10000 | NEG | POS | POS |
| R (+) Cathinone | 10000 | NEG | POS | POS |
| Salbutamol | 10000 | NEG | POS | POS |
| Secobarbital | 10000 | NEG | POS | POS |
| Sertraline | 10000 | NEG | POS | POS |
| Stanazalol | 10000 | NEG | POS | POS |
| Streptomycin | 10000 | NEG | POS | POS |
| Sulfadimethoxine | 10000 | NEG | POS | POS |
| Sulfamethazine | 10000 | NEG | POS | POS |
| Sulfathiazole | 10000 | NEG | POS | POS |
| Temazepam | 10000 | NEG | POS | POS |
| Terbutaline | 10000 | NEG | POS | POS |
| Tetracycline | 10000 | NEG | POS | POS |
| Thebaine | 10000 | NEG | POS | POS |
| Theophylline | 10000 | NEG | POS | POS |
| Thioridazine | 10000 | NEG | POS | POS |
| Tramadol | 10000 | NEG | POS | POS |
| Triamcinolone | 10000 | NEG | POS | POS |
| Triazolam | 10000 | NEG | POS | POS |
| Trifluoperazine | 10000 | NEG | POS | POS |
| Trifluopromazine | 10000 | NEG | POS | POS |
| Compound (shaded compounds are
structurally related) | Concentration of
compound ng/ml | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Trimeprazine | 10000 | NEG | POS | POS |
| Trimipramine | 10000 | NEG | POS | POS |
| Tylosin | 10000 | NEG | POS | POS |
| Tyramine | 10000 | NEG | POS | POS |
| Yohimbic acid | 10000 | NEG | POS | POS |
| Yohimbine | 10000 | NEG | POS | POS |
| Zolpidem | 10000 | NEG | POS | POS |
| Zopiclone | 10000 | NEG | POS | POS |
| Phencyclidine | 10000 | NEG | POS | POS |
| R,R (-)-Pseudoephedrine | 10000 | POS | POS | POS |
| Phencyclidine Morpholine | 10000 | NEG | POS | POS |

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

23

24

25

26

27

28

29

30

31

32

33

34

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.

35

Table 7: Stability Test Samples
---------------------------------

Description of samples	Quantity
Total samples were used in the stability study	100
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 Parameter	Value 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 Change	4%
% Max and Min Decrease	-10% and -1%
% Max and Min Increase	26% and 1%
Number that increased in concentration	31
Number that decreased in concentration	29
MDMA Stability Study Data Summary Ranges
Range in concentration pg/mg hair (3.5 Years Prior)(pg/mg)	167 - 12,107

36

Test Parameter	Value or Range
Range in concentration pg/mg hair (After)(pg/mg)	183 - 15,852
Mean Change	10%
% Max and Min Decrease	-7% and 0%
% Max and Min Increase	31% and 0%
Number that increased in concentration	41
Number that decreased in concentration	7
Number that had no change in concentration	2

	Table 8: Stability Study Data Summary Ranges
--	----------------------------------------------

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").

37

Description of Samples	No.
Previously confirmed Methamphetamine Positive samples	49
Previously confirmed MDMA Positive samples	48
Previously screened Negative For Methamphetamine and MDMA samples	100
Samples that confirmed below the 500 pg/mg cutoff level For
Methamphetamine	1
Samples that confirmed below the 500 pg/mg cutoff level For MDMA	2
Total Samples used in the shipping study	200

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.

| DataLogger
ID | Shipped to Location Then Returned to
Omega Laboratories | Min Temp
(°C) | Max Temp
(°C) | Min Humidity
(%RH) | Max Humidity
(%RH) |
|------------------|------------------------------------------------------------|------------------|------------------|-----------------------|-----------------------|
| 7310005629 | 1. Portland, Maine | -12.7 | 44.5 | 10.8 | 100.0 |
| 7310005644 | 2. Anchorage, Alaska | -12.7 | 44.9 | 8.1 | 96.1 |
| 7310005628 | 3. Naples, Florida | -10.8 | 43.3 | 4.4 | 100.0 |
| 7310005627 | 4. Tempe Arizona | -12.2 | 42.9 | 8.9 | 73.5 |

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.

39

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).

| Treatment | Mean change in Meth
concentration (pg/mg) | Mean change in MDMA
concentration (pg/mg) |
|-----------|----------------------------------------------|----------------------------------------------|
| Permanent | -14% | -17% |

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

40

| Treatment | Mean change in Meth
concentration (pg/mg) | Mean change in MDMA
concentration (pg/mg) |
|-----------|----------------------------------------------|----------------------------------------------|
| Bleach | -11% | -13% |
| Dyeing | -8% | -12% |
| Relaxer | -8% | -8% |
| Shampoo | 5% | -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.