Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

K153693 · Immunalysis Corporation · LAF · Mar 18, 2016 · Clinical Toxicology

Device Facts

• Record ID: K153693
• Device Name: Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
• Applicant: Immunalysis Corporation
• Product Code: LAF · Clinical Toxicology
• Decision Date: Mar 18, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Intended Use

The Immunalysis Methamphetamine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with dual cutoffs of 500ng/mL and 1000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Methamphetamine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Methamphetamine. This in-vitro diagnostic device is for prescription use only. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/ Mass Spectrometry (GC-MS) or permitting laboratories to establish quality control procedures. The Immunalysis Methamphetamine Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC-MS or Liquid Chromatography / Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphetamine, Morphine, PCP and Oxazepam. The calibrators are designed for prescription use with immunoassays.

Device Story

The Immunalysis Methamphetamine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay used in clinical laboratories to detect methamphetamine in human urine. The device utilizes automated clinical chemistry analyzers to process urine samples. The assay reagents include monoclonal antibodies to methamphetamine, glucose-6-phosphate, NAD, and a methamphetamine derivative labeled with glucose-6-phosphate dehydrogenase. The principle of operation is based on competitive binding; the presence of methamphetamine in the sample competes with the enzyme-labeled drug for antibody binding sites, resulting in a measurable change in enzyme activity. The device provides qualitative and semi-quantitative results, which are used by clinicians to identify potential drug use and determine the need for confirmatory testing via GC-MS or LC/MS. The Immunalysis Multi-Drug Calibrators are used to calibrate the assay. The device aids in clinical decision-making by providing preliminary screening results, allowing for efficient laboratory workflows and timely patient assessment.

Clinical Evidence

Performance was evaluated using 80 clinical urine samples compared against LC-MS/MS. Qualitative and semi-quantitative modes were tested at 500ng/mL and 1000ng/mL cutoffs. Results showed high agreement (98-100%) with LC-MS/MS confirmation. Precision, specificity, and interference studies (including pH, specific gravity, and common drugs/endogenous compounds) were conducted on a Beckman Coulter AU 400e analyzer, confirming the assay is robust and unaffected by potential interferents.

Technological Characteristics

Homogeneous enzyme immunoassay; reagents include monoclonal antibody to Methamphetamine, G6P, NAD, and Methamphetamine-labeled G6PDH. Liquid, ready-to-use format. Energy source: spectrophotometric measurement at 340nm. Storage: 2–8°C. Compatible with automated clinical chemistry analyzers capable of precise temperature control, pipetting, and timing.

Indications for Use

Indicated for the qualitative and semi-quantitative analysis of Methamphetamine in human urine in laboratory settings using automated clinical chemistry analyzers. Intended for prescription use only. Provides preliminary analytical results requiring confirmation by GC-MS or LC/MS.

Regulatory Classification

Identification

A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

Special Controls

*Classification.* Class II (special controls). A methamphetamine 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).

Predicate Devices

• Microgenics, Inc. DRI® Methamphetamines Assay (k093114)
• Lin-Zhi International Multi-Analyte Urine Drugs of Abuse Calibrators (k051088)

Submission Summary (Full Text)

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

March 18, 2016

IMMUNALYSIS CORPORATION JOSEPH GINETE REGULATORY AFFAIRS SPECIALIST II 829 TOWNE CENTER DRIVE POMONA CA 91767

Re: K153693

Trade/Device Name: Immunalysis Methamphetamine Urine Enzyme Immunoassay. Immunalysis Multi-drug Calibrators Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: II Product Code: LAF, DKB Dated: December 21, 2015 Received: December 23, 2015

Dear Mr. Ginete:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [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 H. Lias -S

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)

#### Device Name

Immunalysis Methamphetamine Urine Enzyme Immunalysis Multi-Drug Calibrators

#### Indications for Use (Describe)

The Immunalysis Methamphetamine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 500ng/mL and 1000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Methamphetamine in human with automated clinical chemistry analyzers. This assay is calibrated against Methamphetamine. This in-vitro diagnostic device is for prescription use only.

The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/ Mass Spectrometry (GC-MS) or permitting laboratories to establish quality control procedures.

The Immunalysis Methamphetamine Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. GC-MS or Liquid Chromatography / Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Morphine, PCP and Oxazepan. The calibrators are designed for prescription use with immunoassays.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> X Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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 21 CFR 807.92(c).

- A. Contact Information
- 1. Manufacturer: Immunalysis Corporation
- 2. Contact Name: Joseph Ginete
- 3. Contact Title: Regulatory Affairs Specialist II
- 4. Address: 829 Towne Center Drive Pomona, CA 91767
- 5. Phone: [phone]
- 6. Fax: [phone]
- 7. Email: jginete(@immunalysis.com
- 8. Summary prepared on: February 17, 2016
- B. Device Information
- 1. Trade Name: Immunalysis Methamphetamine Urine Enzvme Immunoassay Immunalysis Multi-Drug Calibrators
- 2. Common Name: Immunalysis Methamphetamine Urine Enzyme Immunoassay Immunalysis Multi-Drug Calibrators

## C. Regulatory Information

- 1. Device Classification: II
- 2. Regulation Number: 21 CFR 862.3100 Enzyme Immunoassay,

Methamphetamine

21 CFR 862.3200 Clinical Toxicology Calibrator

- 3. Panel: Toxicology(91)
- 4. Product Code: DKZ

DKB

- D. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3))
- 1. Predicate Device: DRI® Methamphetamines Assay LZI Multiple Analyte Drugs of Abuse Calibrators and Controls
- 2. Predicate Company: Microgenics, Inc. Lin-Zhi International, Inc.
- 3. Predicate K Number: K093114

K051088

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- E. Device Description
- 1. The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal antibodies to Methamphetamine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes Methamphetamine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative.
- 2. All of the Immunalysis Multi-Drug Calibrators are liquid and ready to use. Each contains a known concentration of a specific drug analyte as a mixture.

The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. The Level 1, 2, 3 and 4 calibrators are prepared by spiking known concentrations of drug analyte into the negative calibrator matrix. These five calibrators (negative, Level 1, 2, 3 and 4) are sold as individual bottles. The concentration of drug analyte in the corresponding calibrators is summarized as follows:

| Table 1 Immunalysis Multi-Drug Calibrators | | | | |
|--------------------------------------------|------------------------|-----------|-----------|-----------|
| Analyte | Multi-Drug Calibrators | | | |
| | Level 1 | Level 2 | Level 3 | Level 4 |
| Benzoylecgonine | 150ng/mL | 300ng/mL | 500ng/mL | 1000ng/mL |
| Methamphetamine | 500ng/mL | 1000ng/mL | 1500ng/mL | 2000ng/mL |
| Morphine | 100ng/mL | 300ng/mL | 500ng/mL | 1000ng/mL |
| PCP | 12.5ng/mL | 25ng/mL | 50ng/mL | 100ng/mL |
| Oxazepam | 100ng/mL | 200ng/mL | 500ng/mL | 1000ng/mL |

## F. Intended Use

- The Immunalysis Methamphetamine Urine Enzyme Immunoassay is a 1. homogeneous enzyme immunoassay with a dual cutoff of 500ng/mL and 1000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Methamphetamine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Methamphetamine. This in-vitro diagnostic device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures.

The Immunalysis Methamphetamine Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical

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consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

- 2. Immunalysis Multi-Drug Calibrators
The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphetamine, Morphine, PCP and Oxazepam. The calibrators are designed for prescription use with immunoassays.

- G. Comparison of the new device with the predicate device

| Item | Methamphetamine Assay K093114 | Immunalysis Methamphetamine Urine EIA |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the qualitative and semi-quantitative determination of the presence of Methamphetamine in human urine at a cutoff of 500ng/mL and 1000ng/mL | For the qualitative and semi-quantitative determination of the presence of Methamphetamine in human urine at a cutoff of 500ng/mL and 1000ng/mL |
| Type of Product | Analytical Reagents | Analytical Reagents |
| Measured Analytes | Methamphetamine and Amphetamine | Methamphetamine |
| Test Matrix | Urine | Urine |
| Cutoff Levels | 500ng/mL and 1000ng/mL of<br>Methamphetamine/Amphetamine | 500ng/mL and 1000ng/mL of<br>Methamphetamine |
| Test System | Homogeneous Enzyme Immunoassay | Homogeneous Enzyme Immunoassay |
| Materials | Liquid Ready-to-Use Two Reagent<br>Assay (R1 and R2) | Antibody/Substrate Reagents and Enzyme<br>Labeled Conjugate |
| Mass Spectroscopy<br>Confirmation | Required for preliminary positive<br>analytical results | Required for preliminary positive analytical<br>results |
| Antibody | Monoclonal antibodies to<br>Methamphetamine and/or<br>Amphetamine | Monoclonal antibody to Methamphetamine |
| Storage | 2 – 8°C until expiration date | 2 – 8°C until expiration date |

| Item | LZI Multiple Analyte K051088 | Immunalysis Multi-Drug Calibrator |
|-------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Analyte | benzoylecgonine, d-<br>methamphetamine, methadone,<br>morphine, oxazepam,<br>secobarbital, phencyclidine,<br>propoxyphene | benzoylecgonine, methamphetamine,<br>morphine, PCP, oxazepam |
| Matrix | Urine | Urine |
| Calibrator Levels | 5 Levels – See Table 2 Below | 5 Levels (Negative and Level 1, 2, 3 and 4) -<br>See Device Description Table 1 |
| Storage | 2 – 8°C until expiration date | 2 – 8°C until expiration date |

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| Table 2 LZI Multiple Analyte DAU Calibrators and Controls | | | | |
|-----------------------------------------------------------|------------------------------|-----------|--------------|-----------|
| Analyte | Multiple Analyte Calibrators | | | |
| | Low | Cutoff | Intermediate | High |
| d-Methamphetamine | 250ng/mL | 500ng/mL | 750ng/mL | 1000ng/mL |
| Morphine | 1000ng/mL | 2000ng/mL | 4000ng/mL | 5000ng/mL |
| Phencyclidine | 12.5ng/mL | 25ng/mL | 50ng/mL | 100ng/mL |
| Benzoylecgonine | 75ng/mL | 150ng/mL | 300ng/mL | 1000ng/mL |
| Oxazepam | 100ng/mL | 200ng/mL | 500ng/mL | 1000ng/mL |
| Secobarbital | 100ng/mL | 200ng/mL | 500ng/mL | 1000ng/mL |
| Propoxyphene | 150ng/mL | 300ng/mL | 600ng/mL | 1000ng/mL |
| Methadone | 150ng/mL | 300ng/mL | 600ng/mL | 1000ng/mL |

- H. The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Methamphetamine Urine Enzyme Immunoassay to the predicate
- 1. Precision/ Cutoff Characterization/ Reproducibility Precision/Cutoff Characterization - Study was performed for 20 days, 2 runs per day in duplicate on drug free urine (N=80) spiked with methamphetamine to concentrations of ±25%, ±50%, ±75%, and ±100% of the cutoff. The spiked concentrations were confirmed by mass spectrometry (MS). The study verified that the cutoff serves as a boundary between a negative and positive interpretation of a qualitative result. The instruments used for this was Beckman Coulter AU 400e.

| a. The following is a summary table of the Qualitative Analysis for the |
|--------------------------------------------------------------------------|
| 500ng/mL cutoff test data results. |

| Table 3 - Qualitative Analysis (for 500ng/mL cutoff) | | | |
|------------------------------------------------------|-------------|---------------------|-------------------------|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 0 | -100% | 80 | 80 Negative |
| 125 | -75% | 80 | 80 Negative |
| 250 | -50% | 80 | 80 Negative |
| 375 | -25% | 80 | 80 Negative |
| 500 | Cutoff | 80 | 41 Negative/39 Positive |
| 625 | +25% | 80 | 80 Positive |
| 750 | +50% | 80 | 80 Positive |
| 875 | +75% | 80 | 80 Positive |
| 1000 | +100% | 80 | 80 Positive |

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| Table 4 - Qualitative Analysis (for 1000 ng/mL cutoff) | | | | |
|--------------------------------------------------------|-------------|---------------------|-------------------------|--|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result | |
| 0 | -100% | 80 | 80 Negative | |
| 250 | -75% | 80 | 80 Negative | |
| 500 | -50% | 80 | 80 Negative | |
| 750 | -25% | 80 | 80 Negative | |
| 1000 | Cutoff | 80 | 44 Negative/36 Positive | |
| 1250 | +25% | 80 | 80 Positive | |
| 1500 | +50% | 80 | 80 Positive | |
| 1750 | +75% | 80 | 80 Positive | |
| 2000 | +100% | 80 | 80 Positive | |

- b. The following is a summary table of the Qualitative Analysis for the 1000ng/mL cutoff test data results
- c. The following is a summary table of the Semi-Quantitative Analysis for the 500ng/mL cutoff test data results.

| Table 5 - Semi-Quantitative Analysis (for 500ng/mL cutoff) | | | |
|------------------------------------------------------------|-------------|---------------------|-------------------------|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 0 | -100% | 80 | 80 Negative |
| 125 | -75% | 80 | 80 Negative |
| 250 | -50% | 80 | 80 Negative |
| 375 | -25% | 80 | 80 Negative |
| 500 | Cutoff | 80 | 35 Negative/45 Positive |
| 625 | +25% | 80 | 80 Positive |
| 750 | +50% | 80 | 80 Positive |
| 875 | +75% | 80 | 80 Positive |
| 1000 | +100% | 80 | 80 Positive |

- d. The following is a summary table of the Semi-Quantitative Analysis for the 1000ng/mL cutoff test data results.

| Table 6 - Semi-Quantitative Analysis (for 1000ng/mL cutoff) | | | |
|-------------------------------------------------------------|-------------|---------------------|-------------------------|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 0 | -100% | 80 | 80 Negative |
| 250 | -75% | 80 | 80 Negative |
| 500 | -50% | 80 | 80 Negative |
| 750 | -25% | 80 | 80 Negative |
| 1000 | Cutoff | 80 | 37 Negative/43 Positive |
| 1250 | +25% | 80 | 80 Positive |
| 1500 | +50% | 80 | 80 Positive |
| 1750 | +75% | 80 | 80 Positive |
| 2000 | +100% | 80 | 80 Positive |

- 2. Specificity and Cross-Reactivity Structurally similar compounds were spiked into drug free urine at levels that will yield a result that is equivalent to the cutoffs. The study verified assay performance relative to the ability of the device to exclusively determine certain drugs, in both the qualitative and semi-

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quantitative modes. The instrument used for this test was a Beckman Coulter AU 400e.

- a. The qualitative result summary table for the 500ng/mL cutoff is outlined below:

| Table 7 - Structurally Related Compounds (for 500 ng/mL cutoff) - Qualitative | | | |
|-------------------------------------------------------------------------------|------------------------------|----------|----------------------|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| (+) Methamphetamine | 500 | Positive | 100.00 |
| (-) Methamphetamine | 90,000 | Positive | 0.56 |
| (+) Amphetamine | 20,000 | Positive | 2.50 |
| (-) Amphetamine | 900,000 | Positive | 0.06 |
| Methylenedioxyamphetamine (MDA) | 18,000 | Positive | 2.78 |
| Methoxyamphetamine (PMA) | 15,000 | Positive | 3.33 |
| Methylenedioxymethamphetamine (MDMA) | 800 | Positive | 62.50 |
| MDEA | 3,000 | Positive | 16.67 |
| Fenfluramine | 7,000 | Positive | 7.14 |
| (+) Pseudoephedrine | 75,000 | Positive | 0.67 |
| (-) Pseudoephedrine | 300,000 | Positive | 0.17 |
| (-) Ephedrine | 65,000 | Positive | 0.77 |
| (+) Ephedrine | 1,000,000 | Negative | <0.05 |
| Phentermine | 500,000 | Positive | 0.10 |
| Tyramine | 850,000 | Positive | 0.06 |
| Phenylephrine | 800,000 | Positive | 0.06 |
| Diphenhydramine | 1,000,000 | Negative | <0.050 |
| Phenypropanolamine | 1,000,000 | Negative | <0.05 |

b. The qualitative result summary table for the 1000ng/mL cutoff is outlined below:

| Table 8 - Structurally Related Compounds (for 1000 ng/mL cutoff) - Qualitative | | | |
|--------------------------------------------------------------------------------|------------------------------|----------|----------------------|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| (+) Methamphetamine | 1,000 | Positive | 100.00 |
| (-) Methamphetamine | 200,000 | Positive | 0.44 |
| (+) Amphetamine | 60,000 | Positive | 2.50 |
| (-) Amphetamine | 1,000,000 | Negative | <0.10 |
| Methylenedioxyamphetamine (MDA) | 40,000 | Positive | 2.50 |
| Methoxyamphetamine (PMA) | 40,000 | Positive | 3.33 |
| Methylenedioxymethamphetamine (MDMA) | 1,000 | Positive | 71.43 |
| MDEA | 5,000 | Positive | 14.29 |
| Fenfluramine | 10,000 | Positive | 6.06 |
| (+) Pseudoephedrine | 200,000 | Positive | 0.67 |
| (-) Pseudoephedrine | 1,000,000 | Positive | 0.13 |
| (-) Ephedrine | 200,000 | Positive | 0.57 |
| (+) Ephedrine | 1,000,000 | Negative | <0.10 |

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| Table 8 - Structurally Related Compounds (for 1000 ng/mL cutoff) - Qualitative | | | |
|--------------------------------------------------------------------------------|------------------------------|----------|----------------------|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| Phentermine | 1,000,000 | Negative | <0.10 |
| Tyramine | 1,000,000 | Negative | <0.10 |
| Phenylephrine | 1,000,000 | Negative | <0.10 |
| Diphenhydramine | 1,000,000 | Negative | <0.10 |
| Phenypropanolamine | 1,000,000 | Negative | <0.10 |

c. The semi-quantitative result summary table for the 500ng/mL cutoff is outlined below:

| Table 9 - Structurally Related Compounds (for 500 ng/mL cutoff) – Semi-Quantitative | | | |
|-------------------------------------------------------------------------------------|------------------------------|----------|----------------------|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| (+) Methamphetamine | 500 | Positive | 100.00 |
| (-) Methamphetamine | 90,000 | Positive | 0.56 |
| (+) Amphetamine | 20,000 | Positive | 2.50 |
| (-) Amphetamine | 900,000 | Positive | 0.06 |
| Methylenedioxyamphetamine (MDA) | 18,000 | Positive | 2.78 |
| Methoxyamphetamine (PMA) | 15,000 | Positive | 3.33 |
| Methylenedioxymethamphetamine<br>(MDMA) | 800 | Positive | 62.50 |
| MDEA | 3,000 | Positive | 16.67 |
| Fenfluramine | 7,000 | Positive | 7.14 |
| (+) Pseudoephedrine | 75,000 | Positive | 0.67 |
| (-) Pseudoephedrine | 300,000 | Positive | 0.17 |
| (-) Ephedrine | 65,000 | Positive | 0.77 |
| (+) Ephedrine | 1,000,000 | Negative | <0.05 |
| Phentermine | 500,000 | Positive | 0.10 |
| Tyramine | 850,000 | Positive | 0.06 |
| Phenylephrine | 800,000 | Positive | 0.06 |
| Diphenhydramine | 1,000,000 | Negative | <0.050 |
| Phenypropanolamine | 1,000,000 | Negative | <0.05 |

- d. The semi-quantitative result summary table for the 1000ng/mL cutoff is outlined below:

| Table 10 - Structurally Related Compounds (for 1000 ng/mL cutoff) - Qualitative | | | |
|---------------------------------------------------------------------------------|------------------------------|----------|----------------------|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| (+) Methamphetamine | 1,000 | Positive | 100.00 |
| (-) Methamphetamine | 200,000 | Positive | 0.44 |
| (+) Amphetamine | 60,000 | Negative | 2.50 |
| (-) Amphetamine | 1,000,000 | Positive | <0.10 |
| Methylenedioxyamphetamine (MDA) | 40,000 | Positive | 2.50 |
| Methoxyamphetamine (PMA) | 40,000 | Positive | 3.33 |
| Methylenedioxymethamphetamine (MDMA) | 1,000 | Positive | 71.43 |
| MDEA | 5,000 | Positive | 14.29 |

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| Table 10 - Structurally Related Compounds (for 1000 ng/mL cutoff) - Qualitative | | | |
|---------------------------------------------------------------------------------|------------------------------|----------|----------------------|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| Fenfluramine | 10,000 | Positive | 6.06 |
| (+) Pseudoephedrine | 200,000 | Positive | 0.67 |
| (-) Pseudoephedrine | 1,000,000 | Positive | 0.13 |
| (-) Ephedrine | 200,000 | Positive | 0.57 |
| (+) Ephedrine | 1,000,000 | Negative | <0.10 |
| Phentermine | 1,000,000 | Negative | <0.10 |
| Tyramine | 1,000,000 | Negative | <0.10 |
| Phenylephrine | 1,000,000 | Negative | <0.10 |
| Diphenhydramine | 1,000,000 | Negative | <0.10 |
| Phenypropanolamine | 1,000,000 | Negative | <0.10 |

- 3. Interference Structurally unrelated compounds were evaluated in qualitative and semi-quantitatyive modes by spiking the potential interferent into drug free urine containing methamphetamine at ±25% of the cutoff. All potential interferents analyzed verified that assay performance is unaffected by externally ingested compounds. The instrument used for this test was a Beckman Coulter AU 400e.
a. The following is a summary table of the structurally unrelated compounds for the 500ng/mL cutoff :

| Table 11 - Structurally Unrelated Compounds (for 500ng/mL cutoff) | | | | | | |
|-------------------------------------------------------------------|------------------------------|------------------------|-------------------|------------------------|-------------------|--|
| Compound | Concentration Tested (ng/mL) | -25% Cutoff (375ng/mL) | | +25% Cutoff (625ng/mL) | | |
| | | Qualitative | Semi-Quantitative | Qualitative | Semi-Quantitative | |
| 4-Bromo-2,5,Dimethoxyphenethylamine | 100,000 | Negative | Negative | Positive | Positive | |
| 6-Acetylmorphine | 100,000 | Negative | Negative | Positive | Positive | |
| 7-Aminoclonazepam | 100,000 | Negative | Negative | Positive | Positive | |
| Acetaminophen | 500,000 | Negative | Negative | Positive | Positive | |
| Acetylsalicylic Acid | 500,000 | Negative | Negative | Positive | Positive | |
| Alprazolam | 100,000 | Negative | Negative | Positive | Positive | |
| Amitriptyline | 100,000 | Negative | Negative | Positive | Positive | |
| Amobarbital | 100,000 | Negative | Negative | Positive | Positive | |
| Benzoylecgonine | 500,000 | Negative | Negative | Positive | Positive | |
| Benzylpiperazine | 100,000 | Negative | Negative | Positive | Positive | |
| Bromazepam | 100,000 | Negative | Negative | Positive | Positive | |
| Buprenorphine | 100,000 | Negative | Negative | Positive | Positive | |
| Bupropion | 100,000 | Negative | Negative | Positive | Positive | |
| Butabarbital | 100,000 | Negative | Negative | Positive | Positive | |
| Caffeine | 500,000 | Negative | Negative | Positive | Positive | |
| Carbamazepine | 100,000 | Negative | Negative | Positive | Positive | |
| Chlordiazepoxide | 100,000 | Negative | Negative | Positive | Positive | |
| Chlorpromazine | 100,000 | Negative | Negative | Positive | Positive | |
| cis-Tramadol | 100,000 | Negative | Negative | Positive | Positive | |
| Table 11 - Structurally Unrelated Compounds (for 500ng/mL cutoff) | | | | | | |
| | | -25% Cutoff | | +25% Cutoff | | |
| | Concentration | (375ng/mL) | | (625ng/mL) | | |
| Compound | Tested | | Semi- | | Semi- | |
| | (ng/mL) | Qualitative | Quantitative | Qualitative | Quantitative | |
| Clobazam | 100,000 | Negative | Negative | Positive | Positive | |
| Clomipramine | 100,000 | Negative | Negative | Positive | Positive | |
| Clonazepam | 100,000 | Negative | Negative | Positive | Positive | |
| Cocaine | 100,000 | Negative | Negative | Positive | Positive | |
| Codeine | 100,000 | Negative | Negative | Positive | Positive | |
| Cyclobenzaprine | 100,000 | Negative | Negative | Positive | Positive | |
| N-Demethyltapentadol | 100,000 | Negative | Negative | Positive | Positive | |
| Delta-9-THC | 100,000 | Negative | Negative | Positive | Positive | |
| Desipramine | 100,000 | Negative | Negative | Positive | Positive | |
| Dextromethorphan | 100,000 | Negative | Negative | Positive | Positive | |
| Diazepam | 100,000 | Negative | Negative | Positive | Positive | |
| Dihydrocodeine | 100,000 | Negative | Negative | Positive | Positive | |
| Doxepin | 100,000 | Negative | Negative | Positive | Positive | |
| EDDP | 100,000 | Negative | Negative | Positive | Positive | |
| Ethyl ß-D-glucuronide | 100,000 | Negative | Negative | Positive | Positive | |
| Ethylmorphine | 100,000 | Negative | Negative | Positive | Positive | |
| Fentanyl | 100,000 | Negative | Negative | Positive | Positive | |
| Flunitrazepam | 100,000 | Negative | Negative | Positive | Positive | |
| Fluoxetine | 100,000 | Negative | Negative | Positive | Positive | |
| Flurazepam | 100,000 | Negative | Negative | Positive | Positive | |
| Heroin | 100,000 | Negative | Negative | Positive | Positive | |
| Hexobarbital | 100,000 | Negative | Negative | Positive | Positive | |
| Hydrocodone | 100,000 | Negative | Negative | Positive | Positive | |
| Hydromorphone | 100,000 | Negative | Negative | Positive | Positive | |
| 11-hydroxy-delta-9-THC | 100,000 | Negative | Negative | Positive | Positive | |
| Ibuprofen | 100,000 | Negative | Negative | Positive | Positive | |
| Imipramine | 100,000 | Negative | Negative | Positive | Positive | |
| Ketamine | 100,000 | Negative | Negative | Positive | Positive | |
| Levorphanol Tartrate | 100,000 | Negative | Negative | Positive | Positive | |
| Lidocaine | 100,000 | Negative | Negative | Positive | Positive | |
| Lorazepam | 100,000 | Negative | Negative | Positive | Positive | |
| LSD | 100,000 | Negative | Negative | Positive | Positive | |
| Maprotiline | 100,000 | Negative | Negative | Positive | Positive | |
| Meperidine | 100,000 | Negative | Negative | Positive | Positive | |
| Meprobamate | 100,000 | Negative | Negative | Positive | Positive | |
| Methadone | 100,000 | Negative | Negative | Positive | Positive | |
| Methaquolone | 100,000 | Negative | Negative | Positive | Positive | |
| Methylphenidate | 100,000 | Negative | Negative | Positive | Positive | |
| Morphine | 100,000 | Negative | Negative | Positive | Positive | |
| Morphine-3ß-glucuronide | 100,000 | Negative | Negative | Positive | Positive | |
| Morphine-6ß-glucuronide | 100,000 | Negative | Negative | Positive | Positive | |
| Nalorphine | 100,000 | Negative | Negative | Positive | Positive | |
| Table 11 - Structurally Unrelated Compounds (for 500ng/mL cutoff) | | | | | | |
| | | -25% Cutoff | | +25% Cutoff | | |
| Compound | Concentration | (375ng/mL) | | (625ng/mL) | | |
| | Tested | Qualitative | Semi- | Qualitative | Semi- | |
| | (ng/mL) | | Quantitative | | Quantitative | |
| Naloxone | 100,000 | Negative | Negative | Positive | Positive | |
| Naltrexone | 100,000 | Negative | Negative | Positive | Positive | |
| Nitrazepam | 100,000 | Negative | Negative | Positive | Positive | |
| Norbuprenorphine | 100,000 | Negative | Negative | Positive | Positive | |
| Norcodeine | 100,000 | Negative | Negative | Positive | Positive | |
| Nordiazepam | 100,000 | Negative | Negative | Positive | Positive | |
| Normorphine | 100,000 | Negative | Negative | Positive | Positive | |
| Norpropoxyphene | 100,000 | Negative | Negative | Positive | Positive | |
| Nortriptyline | 100,000 | Negative | Negative | Positive | Positive | |
| Oxazepam | 100,000 | Negative | Negative | Positive | Positive | |
| Oxycodone | 100,000 | Negative | Negative | Positive | Positive | |
| Oxymorphone | 100,000 | Negative | Negative | Positive | Positive | |
| PCP | 100,000 | Negative | Negative | Positive | Positive | |
| Pentazocine | 100,000 | Negative | Negative | Positive | Positive | |
| Pentobarbital | 100,000 | Negative | Negative | Positive | Positive | |
| Phenobarbital | 100,000 | Negative | Negative | Positive | Positive | |
| Phentermine | 100,000 | Negative | Negative | Positive | Positive | |
| Phenytoin | 100,000 | Negative | Negative | Positive | Positive | |
| Prazepam | 100,000 | Negative | Negative | Positive | Positive | |
| Propranolol | 100,000 | Negative | Negative | Positive | Positive | |
| Protriptyline | 100,000 | Negative | Negative | Positive | Positive | |
| Ranitidine | 100,000 | Negative | Negative | Positive | Positive | |
| Ritalinic Acid | 100,000 | Negative | Negative | Positive | Positive | |
| Secobarbital | 100,000 | Negative | Negative | Positive | Positive | |
| Sufentanil Citrate | 100,000 | Negative | Negative | Positive | Positive | |
| Temazepam | 100,000 | Negative | Negative | Positive | Positive | |
| 11-nor-9 carboxy THC | 100,000 | Negative | Negative | Positive | Positive | |
| Thioridazine | 100,000 | Negative | Negative | Positive | Positive | |
| Triazolam | 100,000 | Negative | Negative | Positive | Positive | |
| Trifluoromethylphenyl-<br>piperazine | 100,000 | Negative | Negative | Positive | Positive | |
| Trimipramine | 100,000 | Negative | Negative | Positive | Positive | |
| Venlafaxine | 100,000 | Negative | Negative | Positive | Positive | |

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b. The following is a summary table of the structurally unrelated compounds for the 1,000ng/mL cutoff:

| Table 12 - Structurally Non-Similar Compounds (for 1,000ng/mL cutoff) | | | | | |
|-----------------------------------------------------------------------|------------------------------------|---------------------------|-----------------------|----------------------------|-----------------------|
| Compound | Concentration<br>Tested<br>(ng/mL) | -25% Cutoff<br>(750ng/mL) | | +25% Cutoff<br>(1250ng/mL) | |
| | | Qualitative | Semi-Quantitative | Qualitative | Semi-Quantitative |
| 4-Bromo-<br>2,5,Dimethoxyphenethylamine | 100,000 | Negative | Negative | Positive | Positive |
| 6-Acetylmorphine | 100,000 | Negative | Negative | Positive | Positive |
| 7-Aminoclonazepam | 100,000 | Negative | Negative | Positive | Positive |
| Acetaminophen | 500,000 | Negative | Negative | Positive | Positive |
| Acetylsalicyclic Acid | 500,000 | Negative | Negative | Positive | Positive |
| Alprazolam | 100,000 | Negative | Negative | Positive | Positive |
| Amitriptyline | 100,000 | Negative | Negative | Positive | Positive |
| Amobarbital | 100,000 | Negative | Negative | Positive | Positive |
| Benzoylecgonine | 500,000 | Negative | Negative | Positive | Positive |
| Benzylpiperazine | 100,000 | Negative | Negative | Positive | Positive |
| Bromazepam | 100,000 | Negative | Negative | Positive | Positive |
| Buprenorphine | 100,000 | Negative | Negative | Positive | Positive |
| Bupropion | 100,000 | Negative | Negative | Positive | Positive |
| Butabarbital | 100,000 | Negative | Negative | Positive | Positive |
| Caffeine | 500,000 | Negative | Negative | Positive | Positive |
| Carbamazepine | 100,000 | Negative | Negative | Positive | Positive |
| Chlordiazepoxide | 100,000 | Negative | Negative | Positive | Positive |
| Chlorpromazine | 100,000 | Negative | Negative | Positive | Positive |
| cis-Tramadol | 100,000 | Negative | Negative | Positive | Positive |
| Clobazam | 100,000 | Negative | Negative | Positive | Positive |
| Clomipramine | 100,000 | Negative | Negative | Positive | Positive |
| Clonazepam | 100,000 | Negative | Negative | Positive | Positive |
| Cocaine | 100,000 | Negative | Negative | Positive | Positive |
| Codeine | 100,000 | Negative | Negative | Positive | Positive |
| Cyclobenzaprine | 100,000 | Negative | Negative | Positive | Positive |
| N-Demethyltapentadol | 100,000 | Negative | Negative | Positive | Positive |
| Delta-9-THC | 100,000 | Negative | Negative | Positive | Positive |
| Desipramine | 100,000 | Negative | Negative | Positive | Positive |
| Dextromethorphan | 100,000 | Negative | Negative | Positive | Positive |
| Diazepam | 100,000 | Negative | Negative | Positive | Positive |
| Dihydrocodeine | 100,000 | Negative | Negative | Positive | Positive |
| Doxepin | 100,000 | Negative | Negative | Positive | Positive |
| EDDP | 100,000 | Negative | Negative | Positive | Positive |
| Ethyl β-D-glucuronide | 100,000 | Negative | Negative | Positive | Positive |
| Ethylmorphine | 100,000 | Negative | Negative | Positive | Positive |
| Fentanyl | 100,000 | Negative | Negative | Positive | Positive |
| Flunitrazepam | 100,000 | Negative | Negative | Positive | Positive |
| Fluoxetine | 100,000 | Negative | Negative | Positive | Positive |
| Compound | Concentration<br>Tested<br>(ng/mL) | -25% Cutoff<br>(750ng/mL) | | +25% Cutoff<br>(1250ng/mL) | |
| | | Qualitative | Semi-<br>Quantitative | Qualitative | Semi-<br>Quantitative |
| Flurazepam | 100,000 | Negative | Negative | Positive | Positive |
| Heroin | 100,000 | Negative | Negative | Positive | Positive |
| Hexobarbital | 100,000 | Negative | Negative | Positive | Positive |
| Hydrocodone | 100,000 | Negative | Negative | Positive | Positive |
| Hydromorphone | 100,000 | Negative | Negative | Positive | Positive |
| 11-hydroxy-delta-9-THC | 100,000 | Negative | Negative | Positive | Positive |
| Ibuprofen | 100,000 | Negative | Negative | Positive | Positive |
| Imipramine | 100,000 | Negative | Negative | Positive | Positive |
| Ketamine | 100,000 | Negative | Negative | Positive | Positive |
| Levorphanol Tartrate | 100,000 | Negative | Negative | Positive | Positive |
| Lidocaine | 100,000 | Negative | Negative | Positive | Positive |
| Lorazepam | 100,000 | Negative | Negative | Positive | Positive |
| LSD | 100,000 | Negative | Negative | Positive | Positive |
| Maprotiline | 100,000 | Negative | Negative | Positive | Positive |
| Meperidine | 100,000 | Negative | Negative | Positive | Positive |
| Meprobamate | 100,000 | Negative | Negative | Positive | Positive |
| Methadone | 100,000 | Negative | Negative | Positive | Positive |
| Methaquolone | 100,000 | Negative | Negative | Positive | Positive |
| Methylphenidate | 100,000 | Negative | Negative | Positive | Positive |
| Morphine | 100,000 | Negative | Negative | Positive | Positive |
| Morphine-3 β-glucuronide | 100,000 | Negative | Negative | Positive | Positive |
| Morphine-6 β-glucuronide | 100,000 | Negative | Negative | Positive | Positive |
| Nalorphi…