Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)

K182738 · Hangzhou AllTest Biotech Co., Ltd. · DKZ · Mar 27, 2019 · Clinical Toxicology

Device Facts

• Record ID: K182738
• Device Name: Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)
• Applicant: Hangzhou AllTest Biotech Co., Ltd.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Mar 27, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

The Single and Multi-Drug Rapid Test Cup With Adulteration (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL. This assay 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) 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 indicated. For Prescription Use.

Device Story

Rapid lateral flow chromatographic immunoassay for qualitative detection of drugs/metabolites in urine. Input: urine sample. Principle: competitive binding immunoassay; drug-protein conjugates compete with drug/metabolites in sample for limited antibody binding sites on colloidal gold conjugate pads. Output: visual color bands on test strip. Absence of color band in test region indicates preliminary positive result; presence of band indicates negative result. Control region confirms proper test performance. Used in clinical settings (prescription) or home (OTC). Results provide preliminary data requiring GC/MS confirmation. Assists healthcare providers in clinical decision-making regarding drug abuse status.

Clinical Evidence

Clinical evidence includes a lay-user study with 245 participants (cup format) and 65 participants (panel format) across multiple sites. Samples were spiked with drugs at concentrations ranging from -100% to +100% of the cutoff. Results demonstrated high concordance with GC/MS reference values. No clinical sensitivity/specificity studies were required as this is a qualitative screening assay.

Technological Characteristics

Lateral flow, competitive binding immunoassay. Materials: membrane with immobilized drug-protein conjugates, anti-drug antibody-colloidal gold conjugate pads. Formats: cup, panel, dipstick. Single-use, disposable. No external instrumentation required. Shelf-life: 36 months at room temperature.

Indications for Use

Indicated for qualitative detection of single or multiple drugs and drug metabolites in urine for prescription or over-the-counter use. Target population includes individuals requiring drug screening. Contraindications: Not for definitive diagnosis; requires GC/MS confirmation.

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

• INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) (k173303)
• INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) (k173303)

Submission Summary (Full Text)

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# **510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE**

# **A. 510(k) Number:**

k182738

# **B. Purpose for Submission:**

New device

# **C. Measurements:**

Amphetamine, Secobarbital, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methadone, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine, Nortriptyline, Oxycodone, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine.

# **D. Type of Test:**

Qualitative lateral flow immunoassay

# **E. Applicant:**

Hangzhou AllTest Biotech Co., Ltd

# **F. Proprietary and Established Names:**

Single and Multi-Drug Rapid Test Panel With Adulteration (Urine)

Single and Multi-Drug Rapid Test Panel (Urine)

Single and Multi-Drug Rapid Test Cup With Adulteration (Urine)

Single and Multi-Drug Rapid Test Cup (Urine)

Single Drug Rapid Test Dipstick (Urine)

Single and Multi-Drug Home Rapid Test Panel (Urine)

Single and Multi-Drug Home Rapid Test Cup (Urine)

Single Drug Home Rapid Test Dipstick (Urine)

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# G. Regulatory Information:

| Product Codes | Class | Regulation Section | Regulation Name | Panel |
| --- | --- | --- | --- | --- |
| DKZ, NFT | II | 862.3100 | Amphetamine Test system | Toxicology (91) |
| DIS, PTH | II | 862.3150 | Barbiturate Test system | |
| JXM, NFV | II | 862.3170 | Benzodiazepines Test System | |
| DIO, NFY | II | 862.3250 | Cocaine and metabolites Test System | |
| DJR, PTG | II | 862.3620 | Methadone Test system | |
| LAF, DJC, NGG | II | 862.3610 | Methamphetamine Test System | |
| LDJ, NFW | II | 862.3870 | Cannabinoids Test System | |
| DNK, NGI | II | 862.3640 | Morphine Test System | |
| DJG, NGL | II | 862.3650 | Opiate Test System | |
| LCM, NGM | II | Unclassified | Enzyme immunoassay Phencyclidine | |
| LFG, QAW | II | 862.3910 | Tricyclic Antidepressant Drugs Test System | |

# H. Intended Use:

1. Intended use(s):

See indications for use.

2. Indication(s) for use:

# Single and Multi-Drug Rapid Test Cup With Adulteration (Urine)

The Single and Multi-Drug Rapid Test Cup With Adulteration (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.

This assay 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) 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 indicated.

For Prescription use.

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# Single and Multi-Drug Rapid Test Cup (Urine)

The Single and Multi-Drug Rapid Test Cup (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.

This assay 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) 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 indicated.

For Prescription use.

# Single and Multi-Drug Rapid Test Panel With Adulteration (Urine)

The Single and Multi-Drug Rapid Test Panel With Adulteration (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.

This assay 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) 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 indicated.

For Prescription use.

# Single and Multi-Drug Rapid Test Panel (Urine)

The Single and Multi-Drug Rapid Test Panel (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL,

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Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.

This assay 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) 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 indicated.

For Prescription use.

### Single Drug Rapid Test Dipstick (Urine)

The Single Drug Rapid Test Dipstick (Urine) are rapid chromatographic immunoassay for the qualitative detection of individual drug and drug metabolite(s) in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.

This assay 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) 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 indicated.

For Prescription use.

### Single and Multi-Drug Home Rapid Test Cup (Urine)

The Single and Multi-Drug Home Rapid Test Cup (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.

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This assay 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) 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 indicated.

For Over-the-Counter Use

### Single and Multi-Drug Home Rapid Test Panel (Urine)

The Single and Multi-Drug Home Rapid Test Panel (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.

This assay 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) 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 indicated.

For Over-the-Counter Use

### Single Drug Home Rapid Test Dipstick (Urine)

The Single Drug Home Drug Rapid Test Dipstick (Urine) are rapid chromatographic immunoassay for the qualitative detection of individual drug and drug metabolite(s) in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.

This assay 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) 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 indicated.

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For Over-the-Counter Use

# 3. Special conditions for use statement(s):

The Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine) Single and Multi-Drug Rapid Test Cup (Urine) and Single Drug Rapid Test Dipstick (Urine) are intended for prescription use.

The Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine) and Single Drug Home Rapid Test Dipstick (Urine) are intended for over the counter use.

# 4. Special instrument requirements:

Not applicable. These devices are single use and disposable.

# **I. Device Description:**

Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), and Single Drug Home Rapid Test Dipstick (Urine) are lateral flow-based, competitive immunochromatographic assays for the detection of Amphetamine, Secobarbital, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methadone, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine, Nortriptyline, Oxycodone, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine. The devices are intended for use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs in a urine sample. Information regarding confirmatory testing – the second step in the process is provided in the instructions for use.

The devices have been developed with the following calibrators and cutoffs:

| Test | Calibrator | Cut-off (ng/mL) |
| --- | --- | --- |
| Amphetamine | d-Amphetamine | 500 |
| Secobarbital | Secobarbital | 300 |
| Benzodiazepines | Oxazepam | 300 |
| Buprenorphine | Buprenorphine | 10 |
| Cocaine | Benzoylecgonine | 150 |

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| Marijuana | 11-nor-Δ9-THC-9 COOH | 50 |
| --- | --- | --- |
| Methadone | Methadone | 300 |
| Methamphetamine | d-Methamphetamine | 500 |
| Methylenedioxymethamphetamine | d,l-Methylenedioxymethamphetamine | 500 |
| Morphine | Morphine | 300 |
| Morphine | Morphine | 2000 |
| Phencyclidine | Phencyclidine | 25 |
| Nortriptyline | Nortriptyline | 1000 |
| Oxycodone | Oxycodone | 100 |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 |

The Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), the Single and Multi-Drug Rapid Test Panel (Urine) and the Single and Multi-Drug Home Rapid Test Panel (Urine) are dip card format devices that can each accommodate up to 15 drug device test strips, in different test configurations. The Multi-Drug Home Rapid Test Panel (Urine) device has labeling appropriate for OTC users.

The Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), the Single and Multi-Drug Home Rapid Test Cup (Urine) and the Single and Multi-Drug Home Rapid Test Cup (Urine) are cup format devices that can each accommodate up to 15 drug device test strips, in different test configurations. The Multi-Drug Home Rapid Test Cup (Urine) device has labeling appropriate for OTC users.

The Single Drug Rapid Test Dipstick (Urine) and the Single Drug Home Rapid Test Dipstick (Urine) are provided as single test strips (i.e. without a plastic housing), and as such each accommodate only one drug device test strip. The Single Drug Home Rapid Test Dipstick (Urine) device has labeling appropriate for OTC users.

### J. Substantial Equivalence Information:

1. Predicate device name(s):

INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)
INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)

2. Predicate 510(k) number(s):
k173303

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### 3. Comparison with predicate:

| Similarities and Differences | | |
| --- | --- | --- |
| Item | Candidate Device(s) (k182738) | Predicate Device(s) (k173303) |
| Indication(s) for Use | For the qualitative detection of single or multiple drugs and drug metabolites in urine | Same |
| Methodology | Lateral flow, competitive binding immunoassay based on the principle of antigen and antibody immunochemistry | Same |
| Cutoff Levels (ng/mL) | Secobarbital – 300 Benzodiazepines – 300 Buprenorphine – 10 Methylenedioxymethamphetamine – 500 Marijuana – 50 Methadone – 300 Morphine – 300 Morphine – 2000 Oxycodone – 100 Phencyclidine – 25 Nortriptyline – 1000 Amphetamine – 500 Cocaine – 150 Methamphetamine – 500 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine – 300 | Amphetamine – 1000 Barbiturates – 200 Benzodiazepines – 300 Buprenorphine – 10 Cocaine – 300 MDMA – 500 Marijuana – 50 Methadone – 300 Methamphetamine – 1000 Morphine – 2000 Oxycodone – 300 Phencyclidine – 25 Tricyclic Antidepressants – 1000 |
| Formats | Cup, Panel and Dipstick | Cup and Panel |

### K. Standard/Guidance Document Referenced (if applicable):

None referenced

### L. Test Principle:

The candidate devices are rapid lateral flow immunoassays in which drug-protein conjugates in the test device compete with drugs or drug metabolites that may be present in urine.

On each test strip, a drug-protein conjugate is added to the test band of the membrane known as the test region (T), and the anti-drug antibody-colloidal gold conjugate pads are placed at the forward end of the membrane. If target drugs are present in the urine specimen

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below its cut-off concentration, the solution of the colored antibody-colloidal gold conjugates moves along with the sample solution by capillary action across the membrane to the immobilized drug-protein conjugate zone on the test band region. The colored antibody-gold conjugates then complexes with the drug-protein conjugates to form visible lines.

Therefore, the formation of the visible precipitant in the test band indicates a negative result. Unbound target drug in urine competes with drug protein conjugates on the test band region for the limited antibody on the colored drug antibody-colloidal gold conjugate pad. If target drug is present in excess of the cutoff, the drug will saturate the limited antibody binding sites and the colored antibody-colloidal gold conjugate cannot bind to the drug-protein conjugate at the test region of the test strip. Therefore, absence of the color band on the test region indicates a preliminary positive result. A band should form in the control region (C) of the devices regardless of the presence of drug in the sample to indicate that the test has been performed properly.

### M. Performance Characteristics (if/when applicable):

#### 1. Analytical performance:

##### a. Precision/Reproducibility:

A precision/reproducibility study was performed using 3 lots per device format (cup and panel) five replicates per day for five consecutive days by 3 Point of care (POC) personnel, at 3 POC sites. Blinded, drug-free urine and commercial GC/MS confirmed spiked urine samples at the following concentrations were used: -100%, -75%, -50%, -25%, cutoff, +25%, +50% and +100% of the cutoff level.

Precision performance of the different trade name devices within a format (i.e. within the cup format or within the panel and dipstick formats) is the same (since these different trade name devices differ only by intended user, the presence absence of adulteration strips, or the presence of the plastic housing (in the case of the panel vs. dipstick formats)). Therefore, in the precision studies conducted by the sponsor, the Single and Multi-Drug Rapid Test Panel (Urine) results were found to support performance of the all test panel devices and dipstick devices, and the Single and Multi-Drug Rapid Test Cup (Urine) results are intended to support performance of the all cup devices.

Single and Multi-Drug Rapid Test Panel (Urine):

Amphetamine 500ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 44+/6- | 50+/0- | 25-/0+ | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 42+/8- | 50+/0- | 25-/0+ | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 41+/9- | 50+/0- | 25-/0+ | 50+/0- |

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Secobarbital 300ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 41+/1- | 50+/0- | 50+/0- | 50+/0- |

Benzodiazepines 300ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 40+/10- | 50+/0- | 50+/0- | 50+/0- |

Buprenorphine 10ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 43+/7- | 25-/0+ | 25-/0+ | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 44+/6- | 25-/0+ | 25-/0+ | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 41+/9- | 25-/0+ | 25-/0+ | 50+/0- |

Cocaine 150ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 43+/7- | 25-/0+ | 25-/0+ | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 41+/9- | 25-/0+ | 25-/0+ | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 45+/5- | 25-/0+ | 25-/0+ | 50+/0- |

Marijuana 50ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- |

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Methadone 300ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 42+/8- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 41+/9- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 40+/10- | 50+/0- | 50+/0- | 50+/0- |

Methamphetamine 500ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 44+/6- | 50+/0- | 25-/0+ | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 42+/8- | 50+/0- | 25-/0+ | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 42+/8- | 50+/0- | 25-/0+ | 50+/0- |

MDMA, Methylenedioxymethamphetamine 500ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 41+/9- | 25-/0+ | 25-/0+ | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 38+/12- | 25-/0+ | 25-/0+ | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 37+/13- | 25-/0+ | 25-/0+ | 50+/0- |

Morphine 300ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 24+/1- | 25+/0- | 25+/0- | 25+/0- |
| Lot 2 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 23+/2- | 25+/0- | 25+/0- | 25+/0- |
| Lot 3 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 23+/2- | 25+/0- | 25+/0- | 25+/0- |

Morphine 2,000ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 25+/0- | 25+/0- | 25+/0- |
| Lot 2 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 22+/3- | 25+/0- | 25+/0- | 25+/0- |
| Lot 3 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 22+/3- | 25+/0- | 25+/0- | 25+/0- |

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Phencyclidine 25ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 38+/12- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 42+/8- | 50+/0- | 50+/0- | 50+/0- |

Nortriptyline 1000ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 41+/9- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 40+/10- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 40+/10- | 50+/0- | 50+/0- | 50+/0- |

Oxycodone 100ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 40+/10- | 25-/0+ | 25-/0+ | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 40+/10- | 25-/0+ | 25-/0+ | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 42+/8- | 25-/0+ | 25-/0+ | 50+/0- |

EDDP, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 40+/10- | 25-/0+ | 25-/0+ | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 37+/13- | 25-/0+ | 25-/0+ | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 39+/11- | 25-/0+ | 25-/0+ | 50+/0- |

Single and Multi-Drug Rapid Test Cup (Urine):

Amphetamine 500ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 45+/5- | 50+/0- | 25-/0+ | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 43+/7- | 50+/0- | 25-/0+ | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 40+/10- | 50+/0- | 25-/0+ | 50+/0- |

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Secobarbital 300ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 41+/9- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 42+/8- | 50+/0- | 50+/0- | 50+/0- |

Benzodiazepines 300ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 41+/9- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- |

Buprenorphine 10ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 49+/1- | 25-/0+ | 25-/0+ | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 40+/10- | 25-/0+ | 25-/0+ | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 42+/8- | 25-/0+ | 25-/0+ | 50+/0- |

Cocaine 150ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 43+/7- | 25-/0+ | 25-/0+ | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 41+/9- | 25-/0+ | 25-/0+ | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 38+/12- | 25-/0+ | 25-/0+ | 50+/0- |

Marijuana 50ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 38+/12- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 40+/10- | 50+/0- | 50+/0- | 50+/0- |

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Methadone 300ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 42+/8- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 41+/9- | 50+/0- | 50+/0- | 50+/0- |

Methamphetamine 500ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 46+/4- | 50+/0- | 25-/0+ | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 41+/9- | 50+/0- | 25-/0+ | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 42+/8- | 50+/0- | 25-/0+ | 50+/0- |

MDMA, Methylenedioxymethamphetamine 500ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 41+/9- | 25-/0+ | 25-/0+ | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 43+/7- | 25-/0+ | 25-/0+ | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 40+/10- | 25-/0+ | 25-/0+ | 50+/0- |

Morphine 300ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 21+/4- | 25+/0- | 25+/0- | 25+/0- |
| Lot 2 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 23+/2- | 25+/0- | 25+/0- | 25+/0- |
| Lot 3 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 21+/4- | 25+/0- | 25+/0- | 25+/0- |

Morphine 2,000ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 21+/4- | 25+/0- | 25+/0- | 25+/0- |
| Lot 2 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 24+/1- | 25+/0- | 25+/0- | 25+/0- |
| Lot 3 | 25-/0+ | 25-/0+ | 25-/0+ | 25-/0+ | 23+/2- | 25+/0- | 25+/0- | 25+/0- |

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Phencyclidine 25ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 40+/10- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 42+/8- | 50+/0- | 50+/0- | 50+/0- |

Nortriptyline1000ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 41+/9- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 38+/12- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 37+/13- | 50+/0- | 50+/0- | 50+/0- |

Oxycodone 100ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 41+/9- | 25-/0+ | 25-/0+ | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 37+/13- | 25-/0+ | 25-/0+ | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 38+/12- | 25-/0+ | 25-/0+ | 50+/0- |

EDDP, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 40+/10- | 25-/0+ | 25-/0+ | 50+/0- |
| Lot 2 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 38+/12- | 25-/0+ | 25-/0+ | 50+/0- |
| Lot 3 | 25-/0+ | 50-/0+ | 25-/0+ | 25-/0+ | 40+/10- | 25-/0+ | 25-/0+ | 50+/0- |

b. Linearity/assay reportable range:

Not applicable.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The devices have internal process controls. A control line appears in the control region confirming that sufficient sample volume has been applied to the test strip and that the sample has migrated correctly on the test strip. Users are informed that the test is invalid if the colored line does not appear in the control region. There are no external controls supplied with the devices.

Accelerated testing demonstrated 36 months shelf-life at room temperature. Real time stability is on-going. Protocol and acceptance criteria were found to be

15

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acceptable.

# d. Detection limit:

See precision data in Section M.1.a., above, for assay performance around the claimed cutoff concentrations.

# e. Analytical specificity:

The analytical specificity performance of the different trade name devices within a format (i.e. within the cup format or within the panel and dipstick formats) is the same (since these different trade name devices differ only by intended user, the presence absence of adulteration strips, or the presence of the plastic housing (in the case of the panel vs. dipstick formats)). Therefore, in the cross-reactivity, interference and endogenous interferent studies conducted by the sponsor, the Single and Multi-Drug Rapid Test Panel (Urine) results were found to support performance of the all test panel devices and dipstick devices, and the Single and Multi-Drug Rapid Test Cup (Urine) results are intended to support performance of the all cup devices.

# Cross-reactivity:

Cross-reactivity was evaluated by spiking various concentration of similarly structured drug compounds into drug-free urine, using 3 lots of each device format (cup and panel). Results are expressed as the lowest concentration producing a positive result (ng/ml).

The cup and panel configurations demonstrate comparable performance. The results of one test configuration (Multi-Drug Rapid Test Cup) are presented in the table below.

Amphetamine 500 ng/mL

| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross reactivity |
| --- | --- | --- |
| d-Amphetamine | 500 | 100% |
| Methylenedioxyethylamphetamine (MDEA) | 100000 | 0.5% |
| d,l-Methamphetamine | >100000 | <0.5% |
| Phenylephrine | >100000 | <0.5% |
| d-Methamphetamine | >100000 | <0.5% |
| l-Methamphetamine | >100000 | <0.5% |
| d,l - Methylenedioxy methamphetamine | 100000 | 0.5% |
| l-Amphetamine | 500 | 100% |
| Ephedrine | >100000 | <0.5% |
| Pseudoephedrine | >100000 | <0.5% |

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| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross reactivity |
| --- | --- | --- |
| d, l-Amphetamine | 500 | 100% |
| d,l-3,4-Methylenedioxyamphetamine (MDA) | 25 | 2000% |
| Phentermine | 500 | 100% |

#### Secobarbital 300 ng/mL

| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| Secobarbital | 300 | 100% |
| Pentobarbital | 200 | 150% |
| Alphenal | 300 | 100% |
| Amobarbital | 300 | 100% |
| Aprobarbital | 300 | 100% |
| Barbital | 300 | 100% |
| Butabarbital | 500 | 60% |
| Butalbital | 2000 | 15% |
| Cyclopentabarbital | 500 | 60% |
| Phenobarbital | 200 | 150% |

#### Benzodiazepines 300 ng/mL

| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| Oxazepam | 300 | 100% |
| Alprazolam | 400 | 75% |
| Alpha-Hydroxyalprazolam | 300 | 100% |
| Bromazepam | 300 | 100% |
| Chlordiazepoxide | 1200 | 25% |
| Clobazam | 200 | 150% |
| Clonazepam | 10000 | 3% |
| Clorazepate | 300 | 100% |
| Desalkylflurazepam | >100000 | <0.3% |
| Diazepam | 300 | 100% |
| Estazolam | 100 | 300% |
| Flunitrazepam | 300 | 100% |
| Flurazepam | 300 | 100% |
| Lorazepam | 1000 | 30% |
| Lormetazepam | 100 | 300% |
| Midazolam | 1000 | 30% |
| Nitrazepam | 200 | 150% |
| Nordiazepam | 200 | 150% |

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| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| Temazepam | 100 | 300% |
| Triazolam | 300 | 100% |

Buprenorphine 10 ng/mL

| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| Buprenorphine | 10 | 100% |
| Buprenorphine 3- D-Glucuronide | 20 | 50% |
| Codeine | >100000 | <0.01% |
| Morphine | >100000 | <0.01% |
| Nalorphine | >100000 | <0.01% |
| Norbuprenorphine | 20 | 50% |
| Norbuprenorphine 3-D-lucuronide | 20 | 50% |

Cocaine 150 ng/mL

| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| Benzoylecgonine | 150 | 100% |
| Cocaine HCL | 125 | 120% |
| Cocaethylene | 250 | 60% |
| Ecgonine | >100000 | <0.15% |
| Norcocaine | >100000 | <0.15% |

(EDDP) 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300 ng/mL

| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| EDDP | 300 | 100% |
| Doxylamine | >100000 | <0.3% |
| Methadone | >100000 | <0.3% |
| Methadol | >100000 | <0.3% |

Methamphetamine 500 ng/mL

| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| d-Methamphetamine | 500 | 100% |
| l-Methamphetamine | 10000 | 5% |
| d,l-Amphetamine | 250 | 200% |
| Phentermine | >100000 | <0.5% |

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| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| d,l – Methamphetamine | 250 | 200% |
| d-Amphetamine | 100000 | 0.5% |
| l-Amphetamine | 100000 | 0.5% |
| Ephedrine | >100000 | <0.5% |
| Phenylephrine | >100000 | <0.5% |
| Pseudoephedrine | >100000 | <0.5% |
| 3,4- Methylenedioxymethamphetamine (MDMA) | 1000 | 50% |
| d,l- Methylenedioxy ethylamphetamine (MDEA) | 6000 | 8.3% |
| d,l-3,4-Methylenedioxyamphetamine (MDA) | >100000 | <0.5% |
| d-Methamphetamine | 500 | 100% |

Morphine 300 ng/mL

| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| Morphine | 300 | 100% |
| Codeine | 250 | 120% |
| 6-Acetylmorphine | 250 | 120% |
| Diacetylmorphine (Heroin) | 500 | 60% |
| Hydrocodone | 1000 | 30% |
| Hydromorphone | 10000 | 3% |
| Oxycodone | >100000 | <3% |
| Oxymorphone | >100000 | <3% |
| Procaine | >100000 | <3% |

Phencyclidine 25 ng/mL

| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| Phencyclidine | 25 | 100% |
| Pheniramine | 50000 | 0.05% |

Methadone 300 ng/mL

| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| Methadone | 300 | 100% |
| Doxylamine | >100000 | <0.3% |

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| Pheniramine | 100000 | 0.3% |
| --- | --- | --- |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | >100000 | <0.3% |

Oxycodone 100 ng/mL

| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| Oxycodone | 100 | 100% |
| Codeine | 100000 | 0.1% |
| Hydrocodone | 50000 | 0.2% |
| Oxymorphone | 100 | 100% |

Morphine 2000 ng/mL

| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| Morphine | 2000 | 100% |
| Codeine | 5000 | 40% |
| Diacetylmorphine (Heroin) | >100000 | <2% |
| Hydrocodone | 10000 | 20% |
| Hydromorphone | 5000 | 40% |
| Oxycodone | >100000 | <2% |
| 6-Acetylmorphine | >100000 | <2% |
| Oxymorphone | >100000 | <2% |
| Normorphine | >100000 | <2% |
| Ethylmorphine | 500 | 400% |
| Norcodeine | 50000 | 4% |

Marijuana 50 ng/mL

| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| 11-nor-Δ9-THC-9-COOH | 50 | 100% |
| 11-nor-Δ8-THC-9-COOH | 20000 | 0.25% |
| Δ9 -Tetrahydrocannabinol | 100000 | 0.05% |
| Cannabidiol | >100000 | <0.05% |
| Cannabinol | >100000 | <0.05% |

20

{20}

(MDMA) Methylenedioxymethamphetamine 500 ng/mL

| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| d,l - Methylenedioxymethamphetamine (MDMA) | 500 | 100% |
| l-Methamphetamine | >100000 | <0.5% |
| Ephedrine | >100000 | <0.5% |
| Pseudoephedrine | >100000 | <0.5% |
| d,l- Amphetamine | >100000 | <0.5% |
| l-Amphetamine | >100000 | <0.5% |
| Phentermine | >100000 | <0.5% |
| d,l- Methamphetamine | >100000 | <0.5% |
| Phenylephrine | >100000 | <0.5% |
| Methylenedioxyethylamphetamine (MDEA) | 250 | 200% |
| d,l-3,4-Methylenedioxyamphetamine (MDA) | 1000 | 50% |
| d-Methamphetamine | >100000 | <0.5% |
| d-Amphetamine | >100000 | <0.5% |

Nortriptyline 1000 ng/mL

| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| Nortriptyline | 1000 | 100% |
| Amitriptyline | 2500 | 40% |
| Clomipramine | 100000 | 1% |
| Doxepine | >100000 | <1% |
| Desipramine | 800 | 125% |
| Imipramine | 500 | 200% |
| Promethazine | >100000 | <1% |
| Trimipramine | 50000 | 2% |

# Interference:

Interference was evaluated by spiking the potential interferents below into urine samples having test drug analytes at 25% below and 25% above the cutoff levels for each assay, using 3 lots of each device format (cup and panel). All potential interferents were tested at a concentration of 100 µg/mL, except for ethanol which was tested at a final concentration of 1%.

21

{21}

There were no interferences identified for any of the potential interferents provided in the tables below for each device, for either cup or panel configurations.

Amphetamine 500 ng/mL

| Acetylsalicylic Acid | 5, 5-Diphenylhydantoin | Octopamine |
| --- | --- | --- |
| Amoxicillin | Erythromycin | Papaverine |
| Ampicillin | Estradiol | Perphenazine |
| R-(-)-Apomorphine | Estrone | Phenelzine |
| L-Ascorbic Acid | Ethanol | Phenylethylamine |
| Aspirin | Fenofibrate | Promazine |
| Aspartame | Fentanyl | Promethazine |
| Atropine | Fotemustine | d,l-Propranolol |
| Baclofen | Furosemide | Pyridoxine |
| Benzocaine | Gemfibrozil | Pyrilamine |
| Benzoic Acid | Guaiacol glyceryl ether | Pyrogallol |
| Carisoprodol | Gentisic acid | Quinine |
| Chloramphenicol | Hydralazine | Quinolinic Acid |
| Chlordiazepoxide | Hydrocortisone | Ranitidine |
| (+)-Chlorpheniramine | 3-Hydroxytyramine | Salicylic Acid |
| Chlorpromazine | (+/-)-Isoproterenol | Sulindac |
| Clonidine | Ketamine | Tetracycline |
| Cortisone | Meprobamate | Tetrahydrozoline |
| (-)-Cotinine | Methylphenidate | Thiamine |
| Creatine Hydrate | Nalidixic Acid | Thioridazine |
| Cyclodextrin | Naltrexone | Tramadol |
| Deoxycorticosterone | (+)-Naproxen | Trifluoperazine |
| Dextromethorphan | Niacinamide | Tryptamine |
| Diclofenac | Nicotinic Acid | Zomepirac sodium salt |
| 4-Dimethyl-aminoantipyrine | Nifedipine | 19-Norethindrone |
| Noscapine | Cholesterol | Hemoglobin |
| Albumin | Creatinine | Uric Acid |
| Bilirubin | Glucose | Penicillin-G |

Secobarbital 300 ng/mL

| Acetylsalicylic Acid | 5, 5-Diphenylhydantoin | Octopamine |
| --- | --- | --- |
| Amoxicillin | Erythromycin | Papaverine |
| Ampicillin | Estradiol | Perphenazine |
| R-(-)-Apomorphine | Estrone | Phenelzine |
| L-Ascorbic Acid | Ethanol | Phenylethylamine |
| Aspirin | Fenofibrate | Promazine |
| Aspartame | Fentanyl | Promethazine |
| Atropine | Fotemustine | d,l-Propranolol |
| Baclofen | Furosemide | Pyridoxine |

22

{22}

| Benzocaine | Gemfibrozil | Pyrilamine |
| --- | --- | --- |
| Benzoic Acid | Guaiacolglyceryl ether | Pyrogallol |
| Carisoprodol | Gentisic acid | Quinine |
| Chloramphenicol | Hydralazine | Quinolinic Acid |
| Chlordiazepoxide | Hydrocortisone | Ranitidine |
| (+)-Chlorpheniramine | 3-Hydroxytyramine | Salicylic Acid |
| Chlorpromazine | (+/-)-Isoproterenol | Sulindac |
| Clonidine | Ketamine | Tetracycline |
| Cortisone | Meprobamate | Tetrahydrozoline |
| (-)-Cotinine | Methylphenidate | Thiamine |
| Creatine Hydrate | Nalidixic Acid | Thioridazine |
| Cyclodextrin | Naltrexone | Tramadol |
| Deoxycorticosterone | (+)-Naproxen | Trifluoperazine |
| Dextromethorphan | Niacinamide | Tryptamine |
| Diclofenac | Nicotinic Acid | Zomepirac sodium salt |
| 4-Dimethyl-aminoantipyrine | Nifedipine | 19-Norethindrone |
| Noscapine | Cholesterol | Hemoglobin |
| Albumin | Creatinine | Uric Acid |
| Bilirubin | Glucose | Penicillin-G |

Benzodiazepines 300 ng/mL

| Acetylsalicylic Acid | 5, 5-Diphenylhydantoin | Octopamine |
| --- | --- | --- |
| Amoxicillin | Erythromycin | Papaverine |
| Ampicillin | Estradiol | Perphenazine |
| R-(-)-Apomorphine | Estrone | Phenelzine |
| L-Ascorbic Acid | Ethanol | Phenylethylamine |
| Aspirin | Fenofibrate | Promazine |
| Aspartame | Fentanyl | Promethazine |
| Atropine | Fotemustine | d,l-Propranolol |
| Baclofen | Furosemide | Pyridoxine |
| Benzocaine | Gemfibrozil | Pyrogallol |
| Benzoic Acid | Guaiacolglyceryl ether | Quinine |
| Carisoprodol | Gentisic acid | Quinolinic Acid |
| Chloramphenicol | Hydralazine | Ranitidine |
| Chlordiazepoxide | Hydrocortisone | Salicylic Acid |
| (+)-Chlorpheniramine | 3-Hydroxytyramine | Tetracycline |
| Chlorpromazine | (+/-)-Isoproterenol | Tetrahydrozoline |
| Clonidine | Ketamine | Thiamine |
| Cortisone | Meprobamate | Thioridazine |
| (-)-Cotinine | Methylphenidate | Tramadol |
| Creatine Hydrate | Nalidixic Acid | Trifluoperazine |
| Cyclodextrin | Naltrexone | Tryptamine |
| Deoxycorticosterone | (+)-Naproxen | Zomepirac sodium salt |

23

{23}

| Dextromethorphan | Niacinamide | 19-Norethindrone |
| --- | --- | --- |
| Diclofenac | Nicotinic Acid | Hemoglobin |
| 4-Dimethyl-aminoantipyrine | Nifedipine | Uric Acid |
| Noscapine | Cholesterol | Penicillin-G |
| Albumin | Creatinine | Glucose |
| Bilirubin | | |

Cocaine 150 ng/mL

| Acetylsalicylic Acid | 5, 5-Diphenylhydantoin | Octopamine |
| --- | --- | --- |
| Amoxicillin | Erythromycin | Papaverine |
| Ampicillin | Estradiol | Perphenazine |
| R-(-)-Apomorphine | Estrone | Phenelzine |
| L-Ascorbic Acid | Ethanol | Phenylethylamine |
| Aspirin | Fenofibrate | Promazine |
| Aspartame | Fentanyl | Promethazine |
| Atropine | Fotemustine | d,l-Propranolol |
| Baclofen | Furosemide | Pyridoxine |
| Benzocaine | Gemfibrozil | Pyrilamine |
| Benzoic Acid | Guaiacolglyceryl ether | Pyrogallol |
| Carisoprodol | Gentisic acid | Quinine |
| Chloramphenicol | Hydralazine | Quinolinic Acid |
| Chlordiazepoxide | Hydrocortisone | Ranitidine |
| (+)-Chlorpheniramine | 3-Hydroxytyramine | Salicylic Acid |
| Chlorpromazine | (+/-)-Isoproterenol | Sulindac |
| Clonidine | Ketamine | Tetracycline |
| Cortisone | Meprobamate | Tetrahydrozoline |
| (-)-Cotinine | Methylphenidate | Thiamine |
| Creatine Hydrate | Nalidixic Acid | Thioridazine |
| Cyclodextrin | Naltrexone | Tramadol |
| Deoxycorticosterone | (+)-Naproxen | Trifluoperazine |
| Dextromethorphan | Niacinamide | Tryptamine |
| Diclofenac | Nicotinic Acid | Zomepirac sodium salt |
| 4-Dimethyl-aminoantipyrine | Nifedipine | 19-Norethindrone |
| Noscapine | Cholesterol | Hemoglobin |
| Albumin | Creatinine | Uric Acid |
| Bilirubin | Glucose | Penicillin-G |

Marijuana 50 ng/mL

| Acetylsalicylic Acid | 5, 5-Diphenylhydantoin | Octopamine |
| --- | --- | --- |
| Amoxicillin | Erythromycin | Papaverine |
| Ampicillin | Estradiol | Perphenazine |
| R-(-)-Apomorphine | Estrone | Phenylethylamine |

24

{24}

| L-Ascorbic Acid | Fenofibrate | Promazine |
| --- | --- | --- |
| Aspirin | Fentanyl | Promethazine |
| Aspartame | Fotemustine | d,l-Propranolol |
| Atropine | Furosemide | Pyridoxine |
| Baclofen | Gemfibrozil | Pyrilamine |
| Carisoprodol | Guaiacolglyceryl ether | Pyrogallol |
| Chloramphenicol | Gentisic acid | Quinolinic Acid |
| Chlordiazepoxide | Hydralazine | Ranitidine |
| (+)-Chlorpheniramine | Hydrocortisone | Salicylic Acid |
| Chlorpromazine | 3-Hydroxytyramine | Sulindac |
| Clonidine | (+/-)-Isoproterenol | Tetracycline |
| Cortisone | Ketamine | Tetrahydrozoline |
| (-)-Cotinine | Meprobamate | Thiamine |
| Creatine Hydrate | Methylphenidate | Thioridazine |
| Cyclodextrin | Nalidixic Acid | Tramadol |
| Deoxycorticosterone | Naltrexone | Trifluoperazine |
| Dextromethorphan | (+)-Naproxen | Tryptamine |
| Diclofenac | Niacinamide | Zomepirac sodium salt |
| 4-Dimethyl-aminoantipyrine | Nicotinic Acid | 19-Norethindrone |
| Albumin | Cholesterol | Hemoglobin |
| Creatinine | Penicillin-G | Uric Acid |
| Glucose | | |

Morphine 2000 ng/mL

| Acetylsalicylic Acid | 5, 5-Diphenylhydantoin | Octopamine |
| --- | --- | --- |
| Amoxicillin | Erythromycin | Papaverine |
| Ampicillin | Estradiol | Perphenazine |
| R-(-)-Apomorphine | Estrone | Phenelzine |
| L-Ascorbic Acid | Ethanol | Phenylethylamine |
| Aspirin | Fenofibrate | Promazine |
| Aspartame | Fentanyl | Promethazine |
| Atropine | Fotemustine | d,l-Propranolol |
| Baclofen | Furosemide | Pyridoxine |
| Benzocaine | Gemfibrozil | Pyrilamine |
| Benzoic Acid | Guaiacolglyceryl ether | Pyrogallol |
| Carisoprodol | Gentisic acid | Quinine |
| Chloramphenicol | Hydralazine | Quinolinic Acid |
| Chlordiazepoxide | Hydrocortisone | Ranitidine |
| (+)-Chlorpheniramine | 3-Hydroxytyramine | Salicylic Acid |
| Chlorpromazine | (+/-)-Isoproterenol | Sulindac |
| Clonidine | Ketamine | Tetracycline |
| Cortisone | Meprobamate | Tetrahydrozoline |
| (-)-Cotinine | Methylphenidate | Thiamine |

25

{25}

| Creatine Hydrate | Nalidixic Acid | Thioridazine |
| --- | --- | --- |
| Cyclodextrin | Naltrexone | Tramadol |
| Deoxycorticosterone | (+)-Naproxen | Trifluoperazine |
| Dextromethorphan | Niacinamide | Tryptamine |
| Diclofenac | Nicotinic Acid | Zomepirac sodium salt |
| 4-Dimethyl-aminoantipyrine | Nifedipine | 19-Norethindrone |
| Noscapine | Cholesterol | Hemoglobin |
| Albumin | Creatinine | Uric Acid |
| Bilirubin | Glucose | Penicillin-G |

Morphine 300 ng/mL

| Acetylsalicylic Acid | 5, 5-Diphenylhydantoin | Octopamine |
| --- | --- | --- |
| Amoxicillin | Erythromycin | Papaverine |
| Ampicillin | Estradiol | Perphenazine |
| R-(-)-Apomorphine | Estrone | Phenelzine |
| L-Ascorbic Acid | Ethanol | Phenylethylamine |
| Aspirin | Fenofibrate | Promazine |
| Aspartame | Fentanyl | Promethazine |
| Atropine | Fotemustine | d,l-Propranolol |
| Baclofen | Furosemide | Pyridoxine |
| Benzocaine | Gemfibrozil | Pyrilamine |
| Benzoic Acid | Guaiacolglyceryl ether | Pyrogallol |
| Carisoprodol | Gentisic acid | Quinine |
| Chloramphenicol | Hydralazine | Quinolinic Acid |
| Chlordiazepoxide | Hydrocortisone | Ranitidine |
| (+)-Chlorpheniramine | 3-Hydroxytyramine | Salicylic Acid |
| Chlorpromazine | (+/-)-Isoproterenol | Sulindac |
| Clonidine | Ketamine | Tetracycline |
| Cortisone | Meprobamate | Tetrahydrozoline |
| (-)-Cotinine | Methylphenidate | Thiamine |
| Creatine Hydrate | Nalidixic Acid | Thioridazine |
| Cyclodextrin | Naltrexone | Tramadol |
| Deoxycorticosterone | (+)-Naproxen | Trifluoperazine |
| Dextromethorphan | Niacinamide | Tryptamine |
| Diclofenac | Nicotinic Acid | Zomepirac sodium salt |
| 4-Dimethyl-aminoantipyrine | Nifedipine | 19-Norethindrone |
| Noscapine | Cholesterol | Hemoglobin |
| Albumin | Creatinine | Uric Acid |
| Bilirubin | Glucose | Penicillin-G |

26

{26}

Methadone 300 ng/mL

| Acetylsalicylic Acid | 5, 5-Diphenylhydantoin | Octopamine |
| --- | --- | --- |
| Amoxicillin | Erythromycin | Papaverine |
| Ampicillin | Estradiol | Perphenazine |
| R-(-)-Apomorphine | Estrone | Phenelzine |
| L-Ascorbic Acid | Ethanol | Phenylethylamine |
| Aspirin | Fenofibrate | Promazine |
| Aspartame | Fentanyl | Promethazine |
| Atropine | Fotemustine | d,l-Propranolol |
| Baclofen | Furosemide | Pyridoxine |
| Benzocaine | Gemfibrozil | Pyrilamine |
| Benzoic Acid | Guaiacolglyceryl ether | Pyrogallol |
| Carisoprodol | Gentisic acid | Quinine |
| Chloramphenicol | Hydralazine | Quinolinic Acid |
| Chlordiazepoxide | Hydrocortisone | Ranitidine |
| (+)-Chlorpheniramine | 3-Hydroxytyramine | Salicylic Acid |
| Chlorpromazine | (+/-)-Isoproterenol | Sulindac |
| Clonidine | Ketamine | Tetracycline |
| Cortisone | Meprobamate | Tetrahydrozoline |
| (-)-Cotinine | Methylphenidate | Thiamine |
| Creatine Hydrate | Nalidixic Acid | Thioridazine |
| Cyclodextrin | Naltrexone | Tramadol |
| Deoxycorticosterone | (+)-Naproxen | Trifluoperazine |
| Dextromethorphan | Niacinamide | Tryptamine |
| Diclofenac | Nicotinic Acid | Zomepirac sodium salt |
| 4-Dimethyl-aminoantipyrine | Nifedipine | 19-Norethindrone |
| Noscapine | Cholesterol | Hemoglobin |
| Albumin | Creatinine | Uric Acid |
| Bilirubin | Glucose | Penicillin-G |

Methamphetamine 500 ng/mL

| Acetylsalicylic Acid | 5, 5-Diphenylhydantoin | Octopamine |
| --- | --- | --- |
| Amoxicillin | Erythromycin | Papaverine |
| Ampicillin | Estradiol | Perphenazine |
| R-(-)-Apomorphine | Estrone | Phenelzine |
| L-Ascorbic Acid | Ethanol | Phenylethylamine |
| Aspirin | Fenofibrate | Promazine |
| Aspartame | Fentanyl | Promethazine |
| Atropine | Fotemustine | d,l-Propranolol |
| Baclofen | Furosemide | Pyridoxine |
| Benzocaine | Gemfibrozil | Pyrilamine |
| Benzoic Acid | Guaiacolglyceryl ether | Pyrogallol |
| Carisoprodol | Gentisic acid | Quinine |

27

{27}

| Chloramphenicol | Hydralazine | Quinolinic Acid |
| --- | --- | --- |
| Chlordiazepoxide | Hydrocortisone | Ranitidine |
| (+)-Chlorpheniramine | 3-Hydroxytyramine | Salicylic Acid |
| Chlorpromazine | (+/-)-Isoproterenol | Sulindac |
| Clonidine | Ketamine | Tetracycline |
| Cortisone | Meprobamate | Tetrahydrozoline |
| (-)-Cotinine | Methylphenidate | Thiamine |
| Creatine Hydrate | Nalidixic Acid | Thioridazine |
| Cyclodextrin | Naltrexone | Tramadol |
| Deoxycorticosterone | (+)-Naproxen | Trifluoperazine |
| Dextromethorphan | Niacinamide | Tryptamine |
| Diclofenac | Nicotinic Acid | Zomepirac sodium salt |
| 4-Dimethyl-aminoantipyrine | Nifedipine | 19-Norethindrone |
| Noscapine | Cholesterol | Hemoglobin |
| Albumin | Creatinine | Uric Acid |
| Bilirubin | Glucose | Penicillin-G |

Nortriptyline 1000 ng/mL

| Acetylsalicylic Acid | 5, 5-Diphenylhydantoin | Octopamine |
| --- | --- | --- |
| Amoxicillin | Erythromycin | Papaverine |
| Ampicillin | Estradiol | Perphenazine |
| R-(-)-Apomorphine | Estrone | Phenelzine |
| L-Ascorbic Acid | Ethanol | Phenylethylamine |
| Aspirin | Fenofibrate | d,l-Propranolol |
| Aspartame | Fentanyl | Pyridoxine |
| Atropine | Fotemustine | Pyrilamine |
| Baclofen | Furosemide | Pyrogallol |
| Benzocaine | Gemfibrozil | Quinine |
| Benzoic Acid | Guaiacolglyceryl ether | Quinolinic Acid |
| Carisoprodol | Gentisic acid | Ranitidine |
| Chloramphenicol | Hydralazine | Salicylic Acid |
| Chlordiazepoxide | Hydrocortisone | Sulindac |
| (+)-Chlorpheniramine | 3-Hydroxytyramine | Tetracycline |
| Chlorpromazine | (+/-)-Isoproterenol | Tetrahydrozoline |
| Clonidine | Ketamine | Thiamine |
| Cortisone | Meprobamate | Thioridazine |
| (-)-Cotinine | Methylphenidate | Tramadol |
| Creatine Hydrate | Nalidixic Acid | Trifluoperazine |
| Cyclodextrin | Naltrexone | Tryptamine |
| Deoxycorticosterone | (+)-Naproxen | Zomepirac sodium salt |
| Dextromethorphan | Niacinamide | 19-Norethindrone |
| Diclofenac | Nicotinic Acid | Hemoglobin |
| 4-Dimethyl- | Nifedipine | Uric Acid |

28

{28}

| aminoantipyrine | | |
| --- | --- | --- |
| Noscapine | Cholesterol | Penicillin-G |
| Albumin | Creatinine | Glucose |
| Bilirubin | | |

(EDDP) 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine \(300\mathrm{ng / mL}\)

| Acetylsalicylic Acid | 5, 5-Diphenylhydantoin | Octopamine |
| --- | --- | --- |
| Amoxicillin | Erythromycin | Papaverine |
| Ampicillin | Estradiol | Perphenazine |
| R-(-)-Apomorphine | Estrone | Phenelzine |
| L-Ascorbic Acid | Ethanol | Phenylethylamine |
| Aspirin | Fenofibrate | Promazine |
| Aspartame | Fentanyl | Promethazine |
| Atropine | Fotemustine | d,l-Propranolol |
| Baclofen | Furosemide | Pyridoxine |
| Benzoic Acid | Gemfibrozil | Pyrilamine |
| Carisoprodol | Guaiacolglyceryl ether | Pyrogallol |
| Chloramphenicol | Gentisic acid | Quinolinic Acid |
| Chlordiazepoxide | Hydralazine | Ranitidine |
| (+)-Chlorpheniramine | Hydrocortisone | Salicylic Acid |
| Chlorpromazine | 3-Hydroxytyramine | Sulindac |
| Clonidine | (+/-)-Isoproterenol | Tetracycline |
| Cortisone | Ketamine | Tetrahydrozoline |
| (-)-Cotinine | Meprobamate | Thiamine |
| Creatine Hydrate | Methylphenidate | Thioridazine |
| Cyclodextrin | Nalidixic Acid | Tramadol |
| Deoxycorticosterone | Naltrexone | Trifluoperazine |
| Dextromethorphan | (+)-Naproxen | Tryptamine |
| Diclofenac | Niacinamide | Zomepirac sodium salt |
| 4-Dimethyl-aminoantipyrine | Nicotinic Acid | 19-Norethindrone |
| Noscapine | Nifedipine | Hemoglobin |
| Albumin | Cholesterol | Uric Acid |
| Bilirubin | Creatinine | Penicillin-G |
| Glucose | | |

Phencyclidine 25 ng/mL

| Acetylsalicylic Acid | 5, 5-Diphenylhydantoin | Papaverine |
| --- | --- | --- |
| Ampicillin | Estradiol | Perphenazine |
| R-(-)-Apomorphine | Estrone | Phenylethylamine |
| L-Ascorbic Acid | Fenofibrate | d,l-Propranolol |
| Aspartame | Fentanyl | Pyrilamine |
| Atropine | Fotemustine | Pyrogallol |
| Chlordiazepoxide | Furosemide | Quinolinic Acid |

29

{29}

| (+)-Chlorpheniramine | Gemfibrozil | Ranitidine |
| --- | --- | --- |
| Chlorpromazine | Gentisic acid | Salicylic Acid |
| Clonidine | Hydralazine | Sulindac |
| Creatine Hydrate | Hydrocortisone | Tetracycline |
| Cyclodextrin | 3-Hydroxytyramine | Thiamine |
| Deoxycorticosterone | (+/-)-Isoproterenol | Trifluoperazine |
| Dextromethorphan | Ketamine | 19-Norethindrone |
| 4-Dimethyl-aminoantipyrine | Meprobamate | Hemoglobin |
| Albumin | Naltrexone | Uric Acid |
| Nicotinic Acid | Creatinine | Glucose |

Oxycodone 100 ng/mL

| Acetylsalicylic Acid | 5, 5-Diphenylhydantoin | Octopamine |
| --- | --- | --- |
| Amoxicillin | Erythromycin | Papaverine |
| Ampicillin | Estradiol | Perphenazine |
| R-(-)-Apomorphine | Estrone | Phenelzine |
| L-Ascorbic Acid | Ethanol | Phenylethylamine |
| Aspirin | Fenofibrate | Promazine |
| Aspartame | Fentanyl | Promethazine |
| Atropine | Fotemustine | d,l-Propranolol |
| Baclofen | Furosemide | Pyridoxine |
| Benzocaine | Gemfibrozil | Pyrilamine |
| Benzoic Acid | Guaiacolglyceryl ether | Pyrogallol |
| Carisoprodol | Gentisic acid | Quinine |
| Chloramphenicol | Hydralazine | Quinolinic Acid |
| Chlordiazepoxide | Hydrocortisone | Ranitidine |
| (+)-Chlorpheniramine | 3-Hydroxytyramine | Salicylic Acid |
| Chlorpromazine | (+/-)-Isoproterenol | Sulindac |
| Clonidine | Ketamine | Tetracycline |
| Cortisone | Meprobamate | Tetrahydrozoline |
| (-)-Cotinine | Methylphenidate | Thiamine |
| Creatine Hydrate | Nalidixic Acid | Thioridazine |
| Cyclodextrin | (+)-Naproxen | Tramadol |
| Deoxycorticosterone | Niacinamide | Trifluoperazine |
| Dextromethorphan | Nicotinic Acid | Zomepirac sodium salt |
| Diclofenac | Nifedipine | 19-Norethindrone |
| 4-Dimethyl-aminoantipyrine | Cholesterol | Hemoglobin |
| Noscapine | Creatinine | Uric Acid |
| Albumin | Glucose | Penicillin-G |
| Bilirubin | | |

30

{30}

Methylenedioxymethamphetamine 500 ng/mL

| Acetylsalicylic Acid | 5, 5-Diphenylhydantoin | Papaverine |
| --- | --- | --- |
| Amoxicillin | Estradiol | Perphenazine |
| Ampicillin | Estrone | Phenylethylamine |
| R-(-)-Apomorphine | Fenofibrate | Promazine |
| L-Ascorbic Acid | Fentanyl | Promethazine |
| Aspirin | Fotemustine | d,l-Propranolol |
| Aspartame | Furosemide | Pyridoxine |
| Atropine | Gemfibrozil | Pyrilamine |
| Baclofen | Guaiacolglyceryl ether | Pyrogallol |
| Carisoprodol | Gentisic acid | Quinolinic Acid |
| Chloramphenicol | Hydralazine | Ranitidine |
| Chlordiazepoxide | Hydrocortisone | Salicylic Acid |
| (+)-Chlorpheniramine | 3-Hydroxytyramine | Sulindac |
| Chlorpromazine | (+/-)-Isoproterenol | Tetracycline |
| Clonidine | Ketamine | Tetrahydrozoline |
| Cortisone | Meprobamate | Thiamine |
| (-)-Cotinine | Methylphenidate | Thioridazine |
| Creatine Hydrate | Naltrexone | Tramadol |
| Cyclodextrin | (+)-Naproxen | Trifluoperazine |
| Deoxycorticosterone | Niacinamide | Tryptamine |
| Dextromethorphan | Nicotinic Acid | Zomepirac sodium salt |
| Diclofenac | Nifedipine | 19-Norethindrone |
| 4-Dimethyl-aminoantipyrine | Creatinine | Uric Acid |
| Albumin | Glucose | Hemoglobin |
| Bilirubin | | |

Buprenorphine 10 ng/mL

| Acetylsalicylic Acid | 5, 5-Diphenylhydantoin | Octopamine |
| --- | --- | --- |
| Amoxicillin | Erythromycin | Papaverine |
| Ampicillin | Estradiol | Perphenazine |
| R-(-)-Apomorphine | Estrone | Phenelzine |
| L-Ascorbic Acid | Ethanol | Phenylethylamine |
| Aspirin | Fenofibrate | Promazine |
| Aspartame | Fentanyl | Promethazine |
| Atropine | Fotemustine | d,l-Propranolol |
| Baclofen | Furosemide | Pyridoxine |
| Benzocaine | Gemfibrozil | Pyrilamine |
| Benzoic Acid | Guaiacolglyceryl ether | Pyrogallol |
| Carisoprodol | Gentisic acid | Quinine |
| Chloramphenicol | Hydralazine | Quinolinic Acid |
| Chlordiazepoxide | Hydrocortisone | Ranitidine |

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| (+)-Chlorpheniramine | 3-Hydroxytyramine | Salicylic Acid |
| --- | --- | --- |
| Chlorpromazine | (+/-)-Isoproterenol | Sulindac |
| Clonidine | Ketamine | Tetracycline |
| Cortisone | Meprobamate | Tetrahydrozoline |
| (-)-Cotinine | Methylphenidate | Thiamine |
| Creatine Hydrate | Nalidixic Acid | Thioridazine |
| Cyclodextrin | Naltrexone | Tramadol |
| Deoxycorticosterone | (+)-Naproxen | Trifluoperazine |
| Dextromethorphan | Niacinamide | Zomepirac sodium salt |
| Diclofenac | Nicotinic Acid | 19-Norethindrone |
| 4-Dimethyl-aminoantipyrine | Nifedipine | Hemoglobin |
| Noscapine | Cholesterol | Uric Acid |
| Albumin | Creatinine | Penicillin-G |
| Bilirubin | Glucose | |

#### Endogenous Interferents:

The effect of pH was evaluated by preparing samples with test drug analytes at +/-25% of the cutoff for all devices and adjusting the pH to 2.00 to 9.00, in increments of 1 pH unit. There were no interferences observed.

The effect of specific gravity was evaluated by preparing samples with test drug analytes at +/-25% of the cutoff for all devices and adjusting the specific gravity to 1.001, 1.010, 1.015, 1.020, 1.025, and 1.030. There were no interferences observed.

#### f. Assay cut-off:

Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section M.1.a., above.

### 2. Comparison studies:

#### a. Method comparison with predicate device:

Method comparison studies were performed at the manufacturer's site using three operators for each device format (cup and panel). Operators tested a minimum of 40 unaltered positive and 40 unaltered negative clinical samples for each drug. The samples were blind labeled and compared to GC/MS results.

Accuracy performance of the different trade name devices within a format (i.e. within the cup format or within the panel and dipstick formats) is the same (since these different trade name devices differ only by intended user, the presence absence of adulteration strips, or the presence of the plastic housing (in the case of the panel vs. dipstick formats)). Therefore, in the method comparison study conducted by the

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sponsor, the Single and Multi-Drug Rapid Test Panel (Urine) results were found to support performance of the all test panel devices and dipstick devices, and the Single and Multi-Drug Rapid Test Cup (Urine) results are intended to support performance of the all cup devices. The results are presented in the tables below.

Amphetamine 500 ng/mL Panel Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 0 | 6 | 43 |
| NEG | 45 | 8 | 0 | 0 |

Amphetamine 500 ng/mL Cup Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 1* | 6 | 58 |
| NEG | 45 | 7 | 0 | 0 |

*Discordant Results (Amphetamine) Cup Format

| Specimen | GC/MS Result | Device Results |
| --- | --- | --- |
| 47 | 329 | Positive |

Amphetamine 500 ng/mL Dipstick Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 0 | 6 | 43 |
| NEG | 45 | 8 | 0 | 0 |

Secobarbital 300 ng/mL Panel Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 0 | 9 | 34 |
| NEG | 45 | 7 | 0 | 0 |

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Secobarbital 300 ng/mL Cup Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 0 | 9 | 40 |
| NEG | 45 | 9 | 0 | 0 |

Secobarbital 300 ng/mL Dipstick Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 0 | 9 | 34 |
| NEG | 45 | 7 | 0 | 0 |

Benzodiazepines 300 ng/mL: The results for the Panel, Cup, and Dipstick formats were identical and are provided in the table below.

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 28* | 11* | 2 | 9 |
| NEG | 50 | 0 | 0 | 0 |

*Discordant Results Benzodiazepines 300 ng/mL

| ID | | GC/MS | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Neg/Pos | Oxazepam (ng/mL) | Alprazolam (ng/mL) | Clonazepam (ng/mL) | Nordiazepam (ng/mL) | Lorazepam (ng/mL) | Temazepam (ng/mL) |
| 50 | Pos | 0 | 268 | NA | NA | NA | NA |
| 51 | Pos | 0 | NA | 247 | NA | NA | NA |
| 54 | Pos | 0 | 507 | NA | NA | NA | NA |
| 55 | Pos | 0 | 1220 | NA | NA | NA | NA |
| 60 | Pos | 0 | 938 | NA | NA | NA | NA |
| 61 | Pos | 0 | 1150 | NA | NA | NA | NA |
| 74 | Pos | 0 | NA | NA | NA | NA | 195 |
| 75 | Pos | 0 | NA | NA | NA | NA | 266 |
| 80 | Pos | 0 | 241 | NA | NA | NA | 71 |
| 81 | Pos | 0 | 158 | NA | NA | 177 | 87 |
| 85 | Pos | 0 | NA | 404 | NA | NA | NA |

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| ID | | GC/MS | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Neg/Pos | Oxazepam(ng/mL) | Alprazolam(ng/mL) | Clonazepam(ng/mL) | Nordiazepam(ng/mL) | Lorazepam(ng/mL) | Temazepam(ng/mL) |
| 86 | Pos | 0 | NA | 481 | NA | NA | NA |
| 88 | Pos | 0 | 5169 | NA | NA | NA | NA |
| 89 | Pos | 0 | 1093 | NA | NA | NA | NA |
| 91 | Pos | 0 | NA | 1074 | NA | NA | NA |
| 92 | Pos | 0 | NA | 432 | NA | NA | NA |
| 95 | Pos | 0 | 554 | 273 | NA | NA | NA |
| 96 | Pos | 0 | NA | 1114 | NA | NA | NA |
| 97 | Pos | 0 | NA | 506 | NA | NA | NA |
| 99 | Pos | 0 | 196 | NA | NA | NA | 63 |
| 76 | Pos | 15 | NA | NA | NA | NA | 462 |
| 77 | Pos | 26 | NA | NA | NA | 23 | 864 |
| 78 | Pos | 66 | NA | NA | NA | 67 | 1417 |
| 53 | Pos | 78 | 70 | NA | 33 | NA | 61 |
| 73 | Pos | 82 | NA | NA | NA | 67 | 3232 |
| 72 | Pos | 118 | NA | NA | NA | 102 | 3744 |
| 70 | Pos | 137 | NA | NA | NA | 212 | 3117 |
| 98 | Pos | 140 | NA | NA | NA | 108 | 2000+ |
| 82 | Pos | 150 | 99 | 404 | 26 | 111 | 54 |
| 52 | Pos | 161 | NA | 481 | 36 | 139 | 62 |
| 68 | Pos | 167 | NA | NA | NA | 148 | 3953 |
| 69 | Pos | 190 | NA | NA | NA | 293 | 3529 |
| 62 | Pos | 212 | NA | NA | 50 | NA | 208 |
| 100 | Pos | 216 | NA | NA | 50 | NA | 218 |
| 66 | Pos | 218 | NA | NA | NA | 138 | 134 |
| 84 | Pos | 224 | NA | NA | 49 | 201 | 86 |
| 83 | Pos | 246 | NA | NA | 42 | 175 | 85 |
| 67 | Pos | 257 | NA | NA | NA | 217 | >4000 |
| 63 | Pos | 282 | 268 | NA | 71 | 167 | 181 |

Cocaine 150 ng/mL Panel Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 0 | 4 | 41 |
| NEG | 45 | 4 | 0 | 0 |

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Cocaine 150 ng/mL Cup Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 0 | 4 | 41 |
| NEG | 45 | 4 | 0 | 0 |

Cocaine 150 ng/mL Dipstick Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 0 | 4 | 41 |
| NEG | 45 | 4 | 0 | 0 |

Marijuana 50 ng/mL Panel Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 0 | 6 | 41 |
| NEG | 45 | 7 | 2* | 0 |

*Discordant Results (Marijuana) Panel Format

| Specimen | GC/MS Result | Device Results |
| --- | --- | --- |
| 53 | 65.5 | Negative |
| 59 | 55.8 | Negative |

Marijuana 50 ng/mL Cup Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 0 | 9 | 43 |
| NEG | 45 | 9 | 0 | 0 |

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Marijuana 50 ng/mL Dipstick Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 0 | 6 | 41 |
| NEG | 45 | 7 | 2* | 0 |

*Discordant Results (Marijuana) Dipstick Format

| Specimen | GC/MS Result | Device Results |
| --- | --- | --- |
| 53 | 65.5 | Negative |
| 59 | 55.8 | Negative |

Morphine 2000 ng/mL Panel Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 0 | 4 | 41 |
| NEG | 45 | 4 | 0 | 0 |

Morphine 2000 ng/mL Cup Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 0 | 4 | 42 |
| NEG | 45 | 5 | 0 | 0 |

Morphine 2000 ng/mL Dipstick Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 0 | 4 | 41 |
| NEG | 45 | 4 | 0 | 0 |

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Morphine 300 ng/mL Panel Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 0 | 4 | 41 |
| NEG | 45 | 4 | 0 | 0 |

Morphine 300 ng/mL Cup Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 0 | 4 | 57 |
| NEG | 45 | 6 | 0 | 0 |

Morphine 300 ng/mL Dipstick Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 0 | 4 | 51 |
| NEG | 45 | 4 | 0 | 0 |

Methamphetamine 500 ng/mL Panel Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 1* | 3 | 50 |
| NEG | 45 | 3 | 0 | 0 |

*Discordant Results (Methamphetamine) Panel Format

| Specimen | GC/MS Result | Device Results |
| --- | --- | --- |
| 47 | 254 | Positive |

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Methamphetamine 500 ng/mL Cup Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 1* | 3 | 72 |
| NEG | 45 | 3 | 0 | 0 |

*Discordant Results (Methamphetamine) Cup Format

| Specimen | GC/MS Result | Device Results |
| --- | --- | --- |
| 47 | 254 | Positive |

Methamphetamine 500 ng/mL Dipstick Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 1* | 4 | 49 |
| NEG | 45 | 3 | 0 | 0 |

*Discordant Results (MET) Dipstick Format

| Specimen | GC/MS Result | Device Results |
| --- | --- | --- |
| 47 | 254 | Positive |

Methadone 300 ng/mL Panel Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 3* | 13 | 39 |
| NEG | 45 | 9 | 0 | 0 |

*Discordant Results (Methadone) Format: Panel

| Specimen | GC/MS Result | Device Results |
| --- | --- | --- |
| 50 | 285 | Positive |
| 51 | 196 | Positive |
| 52 | 291 | Positive |

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Methadone 300 ng/mL Cup Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 3* | 13 | 39 |
| NEG | 45 | 9 | 0 | 0 |

*Discordant Results (Methadone) Format: Cup

| Specimen | GC/MS Result | Device Results |
| --- | --- | --- |
| 50 | 285 | Positive |
| 51 | 196 | Positive |
| 52 | 291 | Positive |

Methadone 300 ng/mL Dipstick Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 3* | 13 | 39 |
| NEG | 45 | 9 | 0 | 0 |

*Discordant Results (Methadone) Format: Dipstick

| Specimen | GC/MS Result | Device Results |
| --- | --- | --- |
| 49 | 285 | Positive |
| 50 | 196 | Positive |
| 51 | 291 | Positive |

Phencyclidine 25 ng/mL Panel Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 0 | 12 | 42 |
| NEG | 45 | 8 | 0 | 0 |

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Phencyclidine 25 ng/mL Cup Format

| Candidate Device Result | Concentration Range by GC/MS (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 50%) | High Positive (≥50% cutoff) |
| POS | 0 | 0 | 12 | 42 |
| NEG | 45 | 8 | 0 | 0 |

Phencyclidine 25 ng/mL Dipstick Format

| Candidate Device Result | Co…