Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set

K143500 · Immunalysis Corporation · DKZ · Feb 6, 2015 · Clinical Toxicology

Device Facts

• Record ID: K143500
• Device Name: Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set
• Applicant: Immunalysis Corporation
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Feb 6, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The Immunalysis Amphetamine Urine Enzyme Immunoassay Kit is a homogeneous enzyme immunoassay with dual cutoffs of 500 ng/mL and 1000 ng/mL. The assay is intended for use in laboratories for the qualitative and semiquantitative analysis of Amphetamine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Amphetamine. This in-vitro 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 Amphetamine 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. Gas Chromatography/Mass Spectrometry (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.

Device Story

The Immunalysis Amphetamine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay used in clinical laboratories to detect amphetamine in human urine. The device utilizes an antibody/substrate reagent containing monoclonal antibodies to amphetamine, G6P, and NAD, and an enzyme conjugate reagent containing amphetamine derivative labeled with G6PDH. When used on automated clinical chemistry analyzers, the assay provides qualitative or semi-quantitative results. The semi-quantitative mode assists laboratories in determining appropriate specimen dilutions for confirmatory testing. Results are preliminary; positive findings require confirmation via GC-MS or LC/MS. The device aids healthcare providers in drug abuse screening, where clinical judgment is required to interpret results. Benefits include rapid, automated screening for amphetamine presence in urine samples.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (n=80 per cutoff). Method comparison performed against LC/MS using clinical urine samples (n=80 for 500 ng/mL cutoff; n=81 for 1000 ng/mL cutoff). Qualitative agreement for 500 ng/mL cutoff was 100% for both positives and negatives. Qualitative agreement for 1000 ng/mL cutoff was 98% for positives and 100% for negatives. Interference testing conducted per CLSI EP7-A2; no interference observed for tested endogenous substances, pH, or specific gravity ranges.

Technological Characteristics

Homogeneous enzyme immunoassay. Reagents: mouse monoclonal antibodies to Amphetamine, G6PDH-labeled Amphetamine, G6P, NAD, Tris buffer, Sodium Azide preservative. Liquid, ready-to-use form. Sensing principle: spectrophotometric measurement of G6PDH activity at 340 nm. Storage: 2–8°C. Compatible with automated clinical chemistry analyzers (e.g., Beckman Coulter AU400e).

Indications for Use

Indicated for the qualitative and semi-quantitative analysis of Amphetamine in human urine for prescription use in laboratory settings using automated clinical chemistry analyzers.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• VITROS® Chemistry Products AMPH Reagent, VITROS® Chemistry Products Calibrator Kit 26, VITROS® Chemistry Products FS Calibrator 1, VITROS® Chemistry Products DAT Performance Verifiers I, II, III, IV and V (K062077)

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

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

February 6, 2015

Re: K143500

Trade/Device Name: Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: DKZ, DLJ, LAS Dated: December 9, 2014 Received: December 10, 2014

Dear Mr. Joseph 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 (QS) regulation (21 CFR Part 820); and if applicable, the

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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,

Katherine Serrano -S

For : 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) k143500

#### Device Name

Immunalysis Amphetamine Urine Enzyne Immunalysis Amphetamine Urine Calibrators, Immunalysis Amphetamine Urine Control Set

#### Indications for Use (Describe)

The Immunalysis Amphetamine Urine Enzyme Immunoassay Kit is a homogeneous enzyme immunoassay with dual cutoffs of 500 ng/mL and 1000 ng/mL. The assay is intended for use in laboratories for the qualitative and semiquantitative analysis of Amphetamine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Amphetamine. This in-vitro 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 Amphetamine 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. Gas Chromatography/Mass Spectrometry (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.

Immunalysis Amphetamine Urine Controls: The Immunalysis Amphetamine Urine Control materials in Immunalysis Amphetamine Urine Enzyme Immunoassay.

Immunalysis Amphetamine Urine Calibrators: The Immunalysis Amphetamine Urine Calibrators in the Immunalysis Amphetamine Urine Enzyme Immunoassay. for the qualitative and semi-quantitative determination of Amphetamine in urine on automated clinical chemistry analyzers.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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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 |
| 4. | Address: | 829 Towne Center Drive Pomona, CA 91767 |
| 5. | Phone: | [phone] |
| 6. | Fax: | [phone] |
| 7. | Email: | [e-mail] |
| 8. | Summary prepared on: | January 27, 2015 |
| B. | Device Information | |
| 1. | Trade Name: | Immunalysis Amphetamine Urine Enzyme Immunoassay<br>Immunalysis Amphetamine Urine Controls<br>Immunalysis Amphetamine Urine Calibrators |
| 2. | Common Name: | Immunalysis Amphetamine Urine Enzyme Immunoassay<br>Immunalysis Amphetamine Urine Controls<br>Immunalysis Amphetamine Urine Calibrators |
| 3. | Device Classification: | II |
| 4. | Regulation Number: | CFR 862.3100 Enzyme Immunoassay, Amphetamine<br>CFR 862.3200 Calibrators, Drug Specific<br>CFR 862.3280 Drug Specific Control Materials |
| 5. | Panel: | Toxicology(91) |
| 6. | Product Code: | DKZ<br>DLJ<br>LAS |

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## IMMUNALYSIS

C. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3))

| 1. Predicate Device: | VITROS® Chemistry Products AMPH Reagent<br>VITROS® Chemistry Products Calibrator Kit 26<br>VITROS® Chemistry Products FS Calibrator 1<br>VITROS® Chemistry Products DAT Performance<br>Verifiers I, II, III, IV and V |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Predicate Company: | Ortho-Clinical Diagnostics, Inc |
| 3. Predicate K Number: | K062077 |

### D. Device Description

The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal antibodies to Amphetamine, glucose-6phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes amphetamine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. Calibrators and controls are sold separately. Reagents are liquid, ready to use

The amphetamine calibrator and controls consist of dual cutoff calibrators at 500ng/mL and 1000ng/mL, a control set containing a LOW control at 375ng/mL and a HIGH control at 625ng/mL for the 500ng/mL cutoff and a LOW control at 750ng/mL and HIGH control at 1250ng/mL for the 1000ng/mL cutoff, and a calibrator set containing a negative calibrator, a Level 1 calibrator at 500ng/mL, a Level 2 calibrator at 1000ng/mL, a Level 3 calibrator at 1500ng/mL, and a Level 4 calibrator at 2000ng/mL.

- E. Intended Use
The Immunalysis Amphetamine 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 Amphetamine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Amphetamine. This in-vitro 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 Amphetamine 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 consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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Immunalysis Amphetamine Urine Controls: The Immunalysis Amphetamine Urine Controls are used as control materials in Imunalysis Amphetamine Urine Enzyme Immunoassay.

Immunalysis Amphetamine Urine Calibrators: The Immunalysis Amphetamine Urine Calibrators are used as calibrators in the Immunalysis Amphetamine Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of Amphetamine in urine on automated clinical chemistry analyzers

| Item | Amphetamine Assay K062077 | Immunalysis Amphetamine Urine EIA |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the qualitative and semi-<br>quantitative determination of the<br>presence of amphetamine in human<br>urine at a cutoff of 500ng/mL and<br>1000ng/mL | For the qualitative and semi-quantitative<br>determination of the presence of<br>amphetamine in human urine at a cutoff of<br>500ng/mL and 1000ng/mL |
| Type of Product | Analytical Reagents | Analytical Reagents |
| Measured Analytes | Amphetamine | Amphetamine |
| Test Matrix | Urine | Urine |
| Cutoff Levels | 500ng/mL and 1000ng/mL of<br>Amphetamine | 500ng/mL and 1000ng/mL of<br>Amphetamine |
| Test System | Homogeneous Enzyme Immunoassay | Homogenous 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<br>analytical results |
| Antibody | Mouse Monoclonal antibodies to<br>Amphetamine and Methamphetamine | Monoclonal antibody to Amphetamine |
| Storage | 2 – 8°C until expiration date | 2 – 8°C until expiration date |
| Calibrator Form | Liquid | Liquid |
| Calibrator Levels | Six (6) Levels | Two (2) Levels and Five (5) Levels |
| Control Levels | Five (5) Levels | Four (4) Levels |

- F. Comparison of the new device with the predicate device
G. The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Amphetamine Urine Enzyme Immunoassay to the predicate

- Precision/Cutoff Characterization Study was performed for 20 days, 2 runs per 1. day in duplicate (N=80) on concentration of ±25%, ±50%, ±75%, and ±100% of the cutoff. The study verified that the cutoff serves as a boundary between a negative and positive interpretation of a qualitative result. In addition, it also verified that product performance relative to the ability of the device to produce the same value during repeated measurements. The instruments used for this was Beckman Coulter AU 400e.

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| Table 1 - 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 | 48 Negative / 32 Positive |
| 625 | +25% | 80 | 80 Positive |
| 750 | +50% | 80 | 80 Positive |
| 875 | +75% | 80 | 80 Positive |
| 1000 | +100% | 80 | 80 Positive |

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

| Table 2 - 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 | 47 Negative / 33 Positive |
| 1250 | +25% | 80 | 80 Positive |
| 1500 | +50% | 80 | 80 Positive |
| 1750 | +75% | 80 | 80 Positive |
| 2000 | +100% | 80 | 80 Positive |

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

| Table 3 - 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 | 31 Negative / 49 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 - 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 | 36 Negative / 44 Positive |
| 1250 | +25% | 80 | 80 Positive |
| 1500 | +50% | 80 | 80 Positive |
| 1750 | +75% | 80 | 80 Positive |
| 2000 | +100% | 80 | 80 Positive |

- d. The following is a summary table of the Semi-Quantitative Analysis for the 1000ng/mL cutoff test data results
- 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. 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 5 - Structurally Related Compounds (for 500 ng/mL cutoff) - Qualitative | | | |
|-------------------------------------------------------------------------------|------------------------------|--------|----------------------|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| (+) Amphetamine | 500 | POS | 100.0 |
| (-) Amphetamine | 100,000 | POS | 0.5 |
| (±) Amphetamine | 1,300 | POS | 38.5 |
| MDA | 1,500 | POS | 33.3 |
| PMA | 2,000 | POS | 25.0 |
| Tyramine | 100,000 | POS | 0.5 |
| MDMA | 500,000 | POS | 0.1 |
| MDEA | 100,000 | POS | 0.5 |
| Phenylpropanolamine | 500,000 | POS | 0.1 |
| Phentermine | 1,000,000 | POS | 0.05 |
| (+) Methamphetamine | 1,000,000 | POS | 0.05 |
| (-) Methamphetamine | 1,000,000 | NEG | N.D. |
| (+) Ephedrine | 1,000,000 | NEG | N.D. |
| (-) Ephedrine | 1,000,000 | NEG | N.D. |
| (+) Pseudoephedrine | 1,000,000 | NEG | N.D. |
| (-) Pseudoephedrine | 1,000,000 | NEG | N.D. |
| Phenylephrine | 1,000,000 | NEG | N.D. |
| Diphenylhydramine | 1,000,000 | NEG | N.D. |
| Fenfluramine | 1,000,000 | NEG | N.D. |

N.D. =< 0.05%

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

| Table 6 - Structurally Related Compounds (for 1000 ng/mL cutoff) - Qualitative | | | |
|--------------------------------------------------------------------------------|------------------------------|--------|----------------------|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| (+) Amphetamine | 1000 | POS | 100.0 |
| (-) Amphetamine | 200,000 | POS | 0.5 |
| (+) Amphetamine | 2,500 | POS | 40.0 |
| MDA | 2,000 | POS | 50.0 |
| PMA | 4,000 | POS | 25.0 |
| Tyramine | 400,000 | POS | 0.3 |
| MDMA | 1,000,000 | NEG | N.D. |
| MDEA | 400,000 | POS | 0.3 |
| Phenylpropanolamine | 1,000,000 | NEG | N.D. |
| Phentermine | 1,000,000 | NEG | N.D. |
| (+) Methamphetamine | 1,000,000 | NEG | N.D. |
| (-) Methamphetamine | 1,000,000 | NEG | N.D. |
| (+) Ephedrine | 1,000,000 | NEG | N.D. |
| (-) Ephedrine | 1,000,000 | NEG | N.D. |
| (+) Pseudoephedrine | 1,000,000 | NEG | N.D. |
| (-) Pseudoephedrine | 1,000,000 | NEG | N.D. |
| Phenylephrine | 1,000,000 | NEG | N.D. |
| Diphenylhydramine | 1,000,000 | NEG | N.D. |
| Fenfluramine | 1,000,000 | NEG | N.D. |

N.D. =< 0.05%

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

| Table 7 - Structurally Related Compounds (for 500ng/mL cutoff) – Semi-Quantitative | | |
|------------------------------------------------------------------------------------|------------------------------|----------------------|
| Compound | Concentration Tested (ng/mL) | Cross-Reactivity (%) |
| (+) Amphetamine | 500 | 100.0 |
| (-) Amphetamine | 100,000 | 0.5 |
| (±) Amphetamine | 1,300 | 38.5 |
| MDA | 1,500 | 33.3 |
| PMA | 2,000 | 25.0 |
| Tyramine | 100,000 | 0.5 |
| MDMA | 500,000 | 0.1 |
| MDEA | 100,000 | 0.5 |
| Phenylpropanolamine | 500,000 | 0.1 |
| Phentermine | 1,000,000 | 0.05 |
| (+) Methamphetamine | 1,000,000 | 0.05 |
| (-) Methamphetamine | 1,000,000 | N.D. |
| (+) Ephedrine | 1,000,000 | N.D. |
| (-) Ephedrine | 1,000,000 | N.D. |
| (+) Pseudoephedrine | 1,000,000 | N.D. |
| (-) Pseudoephedrine | 1,000,000 | N.D. |

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| Table 7 - Structurally Related Compounds (for 500ng/mL cutoff) – Semi-Quantitative | | |
|------------------------------------------------------------------------------------|------------------------------|----------------------|
| Compound | Concentration Tested (ng/mL) | Cross-Reactivity (%) |
| Phenylephrine | 1,000,000 | N.D. |
| Diphenylhydramine | 1,000,000 | N.D. |
| Fenfluramine | 1,000,000 | N.D. |

N.D. = < 0.05%

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

| Table 8 - Structurally Related Compounds (for 1000ng/mL cutoff) - Semi-Quantitative | | |
|-------------------------------------------------------------------------------------|------------------------------|----------------------|
| Compound | Concentration Tested (ng/mL) | Cross-Reactivity (%) |
| (+) Amphetamine | 1000 | 100.0 |
| (-) Amphetamine | 200,000 | 0.5 |
| (±) Amphetamine | 2,500 | 40.0 |
| MDA | 2,000 | 50.0 |
| PMA | 4,000 | 25.0 |
| Tyramine | 400,000 | 0.3 |
| MDMA | 1,000,000 | N.D. |
| MDEA | 400,000 | 0.3 |
| Phenylpropanolamine | 1,000,000 | N.D. |
| Phentermine | 1,000,000 | N.D. |
| (+) Methamphetamine | 1,000,000 | N.D. |
| (-) Methamphetamine | 1,000,000 | N.D. |
| (+) Ephedrine | 1,000,000 | N.D. |
| (-) Ephedrine | 1,000,000 | N.D. |
| (+) Pseudoephedrine | 1,000,000 | N.D. |
| (-) Pseudoephedrine | 1,000,000 | N.D. |
| Phenylephrine | 1,000,000 | N.D. |
| Diphenylhydramine | 1,000,000 | N.D. |
| Fenfluramine | 1,000,000 | N.D. |

N.D. =< 0.05%

- 3. Interference Structurally non-similar compounds, endogenous compounds, the effect of pH and the effect of specific gravity was evaluated by spiking the potential interferent into drug free urine containing the target analyte at ±25% of the cutoff. All potential interferents analyzed verified that assay performance is unaffected by externally ingested compounds or an internally existing physiological condition. The instrument used for this test was a Beckman Coulter AU 400e.
- a. The following is a summary table of the structurally non-similar compounds for the 500ng/mL cutoff :

| Table 9 - Structurally Non-Similar Compounds (for 500ng/mL cutoff) | | | | | |
|--------------------------------------------------------------------|---------------------------------|------------------------|---------------|------------------------|---------------|
| Compound | Concentration<br>Tested (ng/mL) | -25% Cutoff (375ng/mL) | | +25% Cutoff (625ng/mL) | |
| 4-Bromo- 2 ,5 ,<br>Dimethoxyphenethylamine | 100,000 | Negative | No | Positive | No |
| 6-Acetylmorphine | 100,000 | Negative | No | Positive | No |
| 7-Aminoclonazepam | 100,000 | Negative | No | Positive | No |
| Table 9 - Structurally Non-Similar Compounds (for 500ng/mL cutoff) | | | | | |
| Compound | Concentration<br>Tested (ng/mL) | -25% Cutoff (375ng/mL) | | +25% Cutoff (625ng/mL) | |
| | | Result | Interference? | Result | Interference? |
| Acetaminophen | 500,000 | Negative | No | Positive | No |
| Acetylsalicyclic Acid | 500,000 | Negative | No | Positive | No |
| Alprazolam | 100,000 | Negative | No | Positive | No |
| Amitriptyline | 100,000 | Negative | No | Positive | No |
| Amobarbital | 100,000 | Negative | No | Positive | No |
| Benzoylecgonine | 500,000 | Negative | No | Positive | No |
| Benzylpiperazine | 100,000 | Negative | No | Positive | No |
| Bromazepam | 100,000 | Negative | No | Positive | No |
| Buprenorphine | 100,000 | Negative | No | Positive | No |
| Bupropion | 100,000 | Negative | No | Positive | No |
| Butabarbital | 100,000 | Negative | No | Positive | No |
| Caffeine | 100,000 | Negative | No | Positive | No |
| Carbamazepine | 100,000 | Negative | No | Positive | No |
| Chlorpromazine | 100,000 | Negative | No | Positive | No |
| Chrlordiazepoxide | 100,000 | Negative | No | Positive | No |
| cis-Tramadol | 100,000 | Negative | No | Positive | No |
| Clobazam | 100,000 | Negative | No | Positive | No |
| Clomipramine | 100,000 | Negative | No | Positive | No |
| Clonazepam | 100,000 | Negative | No | Positive | No |
| Cocaine | 100,000 | Negative | No | Positive | No |
| Codeine | 100,000 | Negative | No | Positive | No |
| Cyclobenzaprine | 100,000 | Negative | No | Positive | No |
| N-Demethyltapentadol | 100,000 | Negative | No | Positive | No |
| Delta-9-THC | 100,000 | Negative | No | Positive | No |
| Desipramine | 100,000 | Negative | No | Positive | No |
| Dextromethorphan | 100,000 | Negative | No | Positive | No |
| Diazepam | 100,000 | Negative | No | Positive | No |
| Dihydrocodeine | 100,000 | Negative | No | Positive | No |
| Doxepin | 100,000 | Negative | No | Positive | No |
| EDDP | 100,000 | Negative | No | Positive | No |
| Ethyl ẞ-D-glucuronide | 100,000 | Negative | No | Positive | No |
| Ethylmorphine | 100,000 | Negative | No | Positive | No |
| Flunitrazepam | 100,000 | Negative | No | Positive | No |
| Fluoxetine | 100,000 | Negative | No | Positive | No |
| Flurazepam | 100,000 | Negative | No | Positive | No |
| Heroin | 100,000 | Negative | No | Positive | No |
| Hexobarbital | 100,000 | Negative | No | Positive | No |
| Hydrocodone | 100,000 | Negative | No | Positive | No |
| Hydromorphone | 100,000 | Negative | No | Positive | No |
| 11-hydroxy-delta-9-THC | 100,000 | Negative | No | Positive | No |
| Ibuprofen | 100,000 | Negative | No | Positive | No |
| Imipramine | 100,000 | Negative | No | Positive | No |
| Ketamine | 100,000 | Negative | No | Positive | No |
| Levorphanol Tartrate | 100,000 | Negative | No | Positive | No |
| Table 9 - Structurally Non-Similar Compounds (for 500ng/mL cutoff) | | | | | |
| | Concentration | -25% Cutoff (375ng/mL) | | +25% Cutoff (625ng/mL) | |
| Compound | Tested (ng/mL) | Result | Interference? | Result | Interference? |
| Lidocaine | 100,000 | Negative | No | Positive | No |
| Lorazepam | 100,000 | Negative | No | Positive | No |
| LSD | 100,000 | Negative | No | Positive | No |
| Maprotiline | 100,000 | Negative | No | Positive | No |
| Meperidine | 100,000 | Negative | No | Positive | No |
| Meprobamate | 100,000 | Negative | No | Positive | No |
| Methadone | 500,000 | Negative | No | Positive | No |
| Methaquolone | 100,000 | Negative | No | Positive | No |
| Methylphenidate | 100,000 | Negative | No | Positive | No |
| Morphine | 100,000 | Negative | No | Positive | No |
| Morphine-6 -glucuronide | 100,000 | Negative | No | Positive | No |
| Nalorphine | 100,000 | Negative | No | Positive | No |
| Naloxone | 100,000 | Negative | No | Positive | No |
| Naltrexone | 100,000 | Negative | No | Positive | No |
| Nitrazepam | 100,000 | Negative | No | Positive | No |
| Norbuprenorphine | 100,000 | Negative | No | Positive | No |
| Norcodeine | 100,000 | Negative | No | Positive | No |
| Nordiazepam | 100,000 | Negative | No | Positive | No |
| Normorphine | 100,000 | Negative | No | Positive | No |
| Norpropoxyphene | 100,000 | Negative | No | Positive | No |
| Nortriptyline | 100,000 | Negative | No | Positive | No |
| Oxazepam | 100,000 | Negative | No | Positive | No |
| Oxycodone | 100,000 | Negative | No | Positive | No |
| Oxymorphone | 100,000 | Negative | No | Positive | No |
| PCP | 100,000 | Negative | No | Positive | No |
| Pentazocine | 100,000 | Negative | No | Positive | No |
| Pentobarbital | 100,000 | Negative | No | Positive | No |
| Phenobarbital | 100,000 | Negative | No | Positive | No |
| Phenytoin | 100,000 | Negative | No | Positive | No |
| Prazepam | 100,000 | Negative | No | Positive | No |
| Propranolol | 100,000 | Negative | No | Positive | No |
| Protriptyline | 100,000 | Negative | No | Positive | No |
| Ranitidine | 100,000 | Negative | No | Positive | No |
| Ritalinic Acid | 100,000 | Negative | No | Positive | No |
| Secobarbial | 100,000 | Negative | No | Positive | No |
| Sufentanil Citrate | 100,000 | Negative | No | Positive | No |
| Temazepam | 100,000 | Negative | No | Positive | No |
| 11-nor-9 carboxy THC | 100,000 | Negative | No | Positive | No |
| Thioridazine | 100,000 | Negative | No | Positive | No |
| Triazolam | 100,000 | Negative | No | Positive | No |
| Trifluoromethylphenyl- | 100,000 | Negative | No | Positive | No |
| piperazine | | | | | |
| Trimipramine | 100,000 | Negative | No | Positive | No |
| Venlafaxine | 100,000 | Negative | No | Positive | No |

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| Table 10 - Structurally Non-Similar Compounds (for 1000ng/mL cutoff) | | | | | |
|----------------------------------------------------------------------|---------------------------------|----------------------------------|-----------------------------------------|-----------------------------------|------------------------------------------|
| Compound | Concentration<br>Tested (ng/mL) | -25% Cutoff (750ng/mL) | | +25% Cutoff (1250ng/mL) | |
| | | Result | Interference? | Result | Interference? |
| 4-Bromo- 2 ,5 ,<br>Dimethoxyphenethylamine | 100,000 | Negative | No | Positive | No |
| 6-Acetylmorphine | 100,000 | Negative | No | Positive | No |
| 7-Aminoclonazepam | 100,000 | Negative | No | Positive | No |
| Acetaminophen | 500,000 | Negative | No | Positive | No |
| Acetylsalicyclic Acid | 500,000 | Negative | No | Positive | No |
| Alprazolam | 100,000 | Negative | No | Positive | No |
| Amitriptyline | 100,000 | Negative | No | Positive | No |
| Amobarbital | 100,000 | Negative | No | Positive | No |
| Benzoylecgonine | 500,000 | Negative | No | Positive | No |
| Benzylpiperazine | 100,000 | Negative | No | Positive | No |
| Bromazepam | 100,000 | Negative | No | Positive | No |
| Buprenorphine | 100,000 | Negative | No | Positive | No |
| Bupropion | 100,000 | Negative | No | Positive | No |
| Butabarbital | 100,000 | Negative | No | Positive | No |
| Caffeine | 100,000 | Negative | No | Positive | No |
| Carbamazepine | 100,000 | Negative | No | Positive | No |
| Chlorpromazine | 100,000 | Negative | No | Positive | No |
| Chlordiazepoxide | 100,000 | Negative | No | Positive | No |
| cis-Tramadol | 100,000 | Negative | No | Positive | No |
| Clobazam | 100,000 | Negative | No | Positive | No |
| Clomipramine | 100,000 | Negative | No | Positive | No |
| Clonazepam | 100,000 | Negative | No | Positive | No |
| Cocaine | 100,000 | Negative | No | Positive | No |
| Codeine | 100,000 | Negative | No | Positive | No |
| Cyclobenzaprine | 100,000 | Negative | No | Positive | No |
| N-Demethyltapentadol | 100,000 | Negative | No | Positive | No |
| Delta-9-THC | 100,000 | Negative | No | Positive | No |
| Desipramine | 100,000 | Negative | No | Positive | No |
| Dextromethorphan | 100,000 | Negative | No | Positive | No |
| Diazepam | 100,000 | Negative | No | Positive | No |
| Dihydrocodeine | 100,000 | Negative | No | Positive | No |
| Doxepin | 100,000 | Negative | No | Positive | No |
| EDDP | 100,000 | Negative | No | Positive | No |
| Ethyl ẞ-D-glucuronide | 100,000 | Negative | No | Positive | No |
| Ethylmorphine | 100,000 | Negative | No | Positive | No |
| Flunitrazepam | 100,000 | Negative | No | Positive | No |
| Fluoxetine | 100,000 | Negative | No | Positive | No |
| Flurazepam | 100,000 | Negative | No | Positive | No |
| Heroin | 100,000 | Negative | No | Positive | No |
| Hexobarbital | 100,000 | Negative | No | Positive | No |
| Table 10 - Structurally Non-Similar Compounds (for 1000ng/mL cutoff) | | | | | |
| Compound | Concentration<br>Tested (ng/mL) | | -25% Cutoff (750ng/mL) | | +25% Cutoff (1250ng/mL) |
| | | Result | Interference? | Result | Interference? |
| Hydrocodone | 100,000 | Negative | No | Positive | No |
| Hydromorphone | 100,000 | Negative | No | Positive | No |
| 11-hydroxy-delta-9-THC | 100,000 | Negative | No | Positive | No |
| Ibuprofen | 100,000 | Negative | No | Positive | No |
| Imipramine | 100,000 | Negative | No | Positive | No |
| Ketamine | 100,000 | Negative | No | Positive | No |
| Levorphanol Tartrate | 100,000 | Negative | No | Positive | No |
| Lidocaine | 100,000 | Negative | No | Positive | No |
| Lorazepam | 100,000 | Negative | No | Positive | No |
| LSD | 100,000 | Negative | No | Positive | No |
| Maprotiline | 100,000 | Negative | No | Positive | No |
| Meperidine | 100,000 | Negative | No | Positive | No |
| Meprobamate | 100,000 | Negative | No | Positive | No |
| Methadone | 500,000 | Negative | No | Positive | No |
| Methaquolone | 100,000 | Negative | No | Positive | No |
| Methylphenidate | 100,000 | Negative | No | Positive | No |
| Morphine | 100,000 | Negative | No | Positive | No |
| Morphine-6 -glucuronide | 100,000 | Negative | No | Positive | No…