UCP HOME DRUG SCREENING TEST CUPS

K122419 · Ucp Biosciences, Inc. · DKZ · Nov 30, 2012 · Clinical Toxicology

Device Facts

• Record ID: K122419
• Device Name: UCP HOME DRUG SCREENING TEST CUPS
• Applicant: Ucp Biosciences, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Nov 30, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

UCP Home Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the detection the following drugs and their metabolites in human urine: Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiates 2000, Oxycodone, Phencyclidine, Tricyclic Antidepressant. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing - the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for health care professional users. The tests will yield preliminary positive results when the prescription drugs Barbiturates, Benzodiazepines, Oxycodone, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Oxycodone, Tricyclic Antidepressant in urine. The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.

Device Story

UCP Home Drug Screening Test Cups are lateral flow immunochromatographic assays; detect drugs/metabolites in human urine via competitive binding. Device accepts urine sample; produces visual qualitative result (presence/absence at specific cut-off). Used by OTC consumers or healthcare professionals; no instrumentation required. Provides preliminary results; requires GC/MS or HPLC confirmation for positive findings. Assists in identifying potential drug presence; supports clinical decision-making when combined with professional judgment.

Clinical Evidence

No clinical trials performed. Evidence consists of analytical performance (precision, cross-reactivity, interference, cutoff validation) and a lay user study (n=115) comparing device results to GC/MS. Lay user study demonstrated high agreement with GC/MS across all analytes and concentrations. Post-study questionnaire confirmed 99.1% comprehension of instructions and results.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Visual qualitative readout. No energy source required. Multi-drug cup configuration (up to three tests per strip).

Indications for Use

Indicated for qualitative detection of drugs and metabolites in human urine for OTC consumers and healthcare professionals. Target drugs: Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiates, Oxycodone, Phencyclidine, Tricyclic Antidepressants. Intended as first step in two-step process; requires confirmatory testing.

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

• UCP Home™ Drug Screening Test Cards/UCP Home™ Drug Screening Test Cups (k091588)

Submission Summary (Full Text)

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

A. 510(k) Number:
k122419

B. Purpose for Submission:
New device

C. Measurand:
Amphetamine (d-amphetamine), Barbiturates (secobarbital), Benzodiazepines (oxazepam), Cocaine (benzoylecgonine), Methamphetamine (d-methamphetamine), Methylenedioxymethamphetamine (MDMA), Methadone (methadone), Opiate 2000 (morphine), Morphine 300 (morphine), Oxycodone (oxycodone), Phencyclidine (phencyclidine), and Cannabinoids (THC) (delta-9-THC-COOH) and Tricyclic Antidepressants (nortriptyline).

D. Type of Test:
Qualitative immunochromatographic assay

E. Applicant:
UCP Biosciences, Inc

F. Proprietary and Established Names
UCP Home Drug Screening Test Cups

G. Regulatory Information:

| Product | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DKZ | Class II | 21 CFR 862.3100 Amphetamine test system | 91 (Toxicology) |
| DIS | Class II | 21 CFR 862.3150 Barbiturate test system | 91 (Toxicology) |
| JXM | Class II | 21 CFR 862.3170 Benzodiazepine test system | 91 (Toxicology) |

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| DIO | Class II | 21 CFR 862.3250 Cocaine and cocaine metabolite test system | 91 (Toxicology) |
| --- | --- | --- | --- |
| DJC | Class II | 21 CFR 862.3610 Methamphetamine test system | 91 (Toxicology) |
| DJR | Class II | 21 CFR 862.3620 Methadone test system | 91 (Toxicology) |
| DJG | Class II | 21 CFR 862.3650 Opiate test system. | 91 (Toxicology) |
| LCM | | Unclassified, Enzyme immunoassay, phencyclidine | 91 (Toxicology) |
| LDJ | Class II | 21 CFR 862.3870 Cannabinoid test system | 91 (Toxicology) |
| LFG | Class II | 21 CFR 862.3910 Tricyclic antidepressant drugs test system | 91 (Toxicology) |

## H. Intended Use:

1. Intended Use(s):

See indications for use below.

2. Indication(s) for use:

The UCP Home Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the detection the following drugs and their metabolites in human urine:

| Test | Calibrator | Cut-off |
| --- | --- | --- |
| Amphetamine | D-Amphetamine | 1000 ng/mL |
| Barbiturates | Secobarbital | 300 ng/mL |
| Benzodiazepines | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | Delta-9-THC-COOH | 50 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| Methamphetamine | D-Methamphetamine | 1000 ng/mL |
| MDMA | MDMA | 500 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Opiates 2000 | Morphine | 2000 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Phencyclidine | Phencyclidine | 25 ng/mL |
| Tricyclic | Nortiptyline | 1000 ng/mL |
| Antidepressant | | |

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The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing – the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for health care professional users.

The tests will yield preliminary positive results when the prescription drugs Barbiturates, Benzodiazepines, Oxycodone, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Oxycodone, Tricyclic Antidepressant in urine. The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.

3. Special conditions for use statement(s):

For over-the-counter use and prescription use by health care professional users

4. Special instrument requirements:

Not applicable, as the device is a visually-read single use device.

I. Device Description:

The UCP Home Drug Screening Test Cups is capable of measuring 12 drugs listed in the intended use at a time. The UCP Home Drug Screening Test Cups can contain up to five strips that are capable of measuring up to three drugs per strip. The test includes user instructions, collection cups, transportation bag with absorbent pad, mailing box and identification labels with personal identification number to be used when sending positive urine specimens to the laboratory for confirmation.

J. Substantial Equivalence Information:

1. Predicate device names(s)

UCP Home™ Drug Screening Test Cards
UCP Home™ Drug Screening Test Cup

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2. Predicate K number(s):

k091588

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device | Predicate (k091588) |
| Intended Use | Same | Qualitative determination of drugs in human urine |
| Methodology | Same | Lateral flow immunochromatographic |
| Type of assay | Same | Qualitative |
| Matrix | Same | Urine |
| Cutoff | Same | Amphetamine: 1000 ng/mL |
| | Same | Barbiturates: 300 ng/mL |
| | Same | Benzodiazepines: 300 ng/mL |
| | Same | Cocaine: 300 ng/mL |
| | Same | Cannabinoids (THC): 50 ng/mL |
| | Same | Methadone: 300 ng/mL |
| | Same | Methamphetamine: 1000 ng/mL |
| | Same | MDMA: 500 ng/mL |
| | Same | Morphine: 300 ng/mL |
| | Same | Opiate: 2000 ng/mL |
| | Same | Oxycodone: 100 ng/mL |
| | Same | Phencyclidine: 25 ng/mL |
| | Same | Tricyclic Antidepressants: 1000 |
| Intended user | Same | Over-the-counter (OTC) users and Professional users |
| Endpoint | Same | Colored lines |
| Differences | | |
| Item | Candidate Device | Predicate |
| Drug(s) per strip | Up to three drugs per strip | One drug per strip |

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

None were referenced.

L. Test Principle:

The UCP Home™ Drug Screening Cups employ lateral flow immunochromatographic

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technology based on the principle of competitive binding. Drugs, if present in concentrations below the cutoff level, will not saturate the binding sites of antibody coated particles in the device. The antibody-coated particles will then be captured by immobilized drug-specific conjugate and a colored line will appear in the test line region. The colored line will not form if the sample contains drug in excess of the cutoff level because the drug will saturate all the binding sites of the drug-specific antibody. Each strip in the device contains a procedural control that appears in the control line region indicating that the sample has migrated properly on the test strip.

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

### 1. Analytical performance:

#### a. Precision/Reproducibility:

Precision studies were performed using drug-free urine spiked to the following concentrations: negative (0%), 50% below the cutoff, 25% below the cutoff, 25% above the cutoff, 50% above the cutoff for each analyte and each device. Sample concentrations were confirmed by GC/MS. The samples were aliquots, coded, randomized and blinded. Each specimen, at each concentration analyte, was tested by total sixty (60) test devices from three different lots by three operators within 10 to 20 non-consecutive days. The results are displayed in the tables below:

**Amphetamine**

| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 1/19 | 95% |
| | +50% | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 0/20 | 100% |
| | +50% | 20 | 0/20 | 100% |
| | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |

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Lot 3
| +25% | 20 | 0/20 | 100% |
| --- | --- | --- | --- |
| +50% | 20 | 0/20 | 100% |

Barbiturates:

| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 1/19 | 95% |
| | +50% | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 1/19 | 95% |
| | +50% | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 2/18 | 90% |
| | +50% | 20 | 0/20 | 100% |

Benzodiazepines

| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 19/1 | 95% |
| | +25% | 20 | 0/20 | 100% |
| | +50% | 20 | 0/20 | 100% |

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| Lot 2 | Negative | 20 | 20/0 | 100% |
| --- | --- | --- | --- | --- |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 0/20 | 100% |
| | +50% | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 0/20 | 100% |
| | +50% | 20 | 0/20 | 100% |

## Cocaine

| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 0/20 | 100% |
| | +50% | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 2/18 | 90% |
| | +50% | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 1/19 | 95% |
| | +50% | 20 | 0/20 | 100% |

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Marijuana (THC)

| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 1/19 | 95% |
| | +50% | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 0/20 | 100% |
| | +50% | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 1/19 | 95% |
| | +50% | 20 | 0/20 | 100% |

Methadone

| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 0/20 | 100% |
| | +50% | 20 | 0/20 | 100% |
| | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |

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| Lot 2 | +25% | 20 | 0/20 | 100% |
| --- | --- | --- | --- | --- |
| | +50% | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 0/20 | 100% |
| | +50% | 20 | 0/20 | 100% |

# Methamphetamine

| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 0/20 | 100% |
| | +50% | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 2/18 | 90% |
| | +50% | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 0/20 | 100% |
| | +50% | 20 | 0/20 | 100% |

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MDMA

| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 0/20 | 100% |
| | +50% | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 0/20 | 100% |
| | +50% | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 0/20 | 100% |
| | +50% | 20 | 0/20 | 100% |

# Morphine

| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 2/18 | 90% |
| | +50% | 20 | 0/20 | 100% |
| | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |

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| Lot 2 | +25% | 20 | 0/20 | 100% |
| --- | --- | --- | --- | --- |
| | +50% | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 1/19 | 95% |
| | +50% | 20 | 0/20 | 100% |

Opiates 2000

| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 18/2 | 90% |
| | +25% | 20 | 0/20 | 100% |
| | +50% | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 0/20 | 100% |
| | +50% | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 19/1 | 95% |
| | +25% | 20 | 0/20 | 100% |
| | +50% | 20 | 0/20 | 100% |

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# Oxycodone

| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25 | 20 | 0/20 | 100 |
| | +50 | 20 | 0/20 | 100 |
| Lot 2 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 19/1 | 95 |
| | +25 | 20 | 0/20 | 100 |
| | +50 | 20 | 0/20 | 100 |
| Lot 3 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25 | 20 | 0/20 | 100 |
| | +50 | 20 | 0/20 | 100 |

# Phencyclidine

| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 18/2 | 90% |
| | +25% | 20 | 0/20 | 100% |
| | +50% | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 0/20 | 100% |

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| | +50% | 20 | 0/20 | 100% |
| --- | --- | --- | --- | --- |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 19/1 | 95% |
| | +25% | 20 | 0/20 | 100% |
| | +50% | 20 | 0/20 | 100% |

## Tricyclic Antidepressants

| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 0/20 | 100% |
| | +50% | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 1/19 | 95% |
| | +50% | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% | 20 | 20/0 | 100% |
| | -25% | 20 | 20/0 | 100% |
| | +25% | 20 | 0/20 | 100% |
| | +50% | 20 | 0/20 | 100% |

b. Linearity/assay reportable range:
Not applicable, the devices are intended for qualitative use.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):
External control materials are not supplied with this device; however, this device has internal

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process controls. A colored line appearing in the control region reflects that sufficient sample volume was applied and that adequate membrane wicking occurred. Users are informed that the test is invalid if a line fails to appear in the control region. For professional users, the sponsor states in the labeling when external QC materials should be tested.

## Stability

Accelerated and real time stability studies have been conducted. Stability protocols and acceptance criteria were reviewed and found acceptable. The information supports that UCP Home Drug Screening Test Cups unopened stability is 18 months. Real time stability testing is ongoing.

## d. Detection limit:

Analytical performance of the device around the cutoff is described in Section f. (Assay cut-off) below.

## e. Analytical specificity:

Cross-reactivity was established by spiking similarly structured compounds into drug free urine at various concentrations. These solutions were tested using 3 lots of the UCP Home Drug Screening Test Cups. Results are expressed as a minimum concentration of metabolite or compound required to produce a response approximately equivalent to the cutoff concentration of the assay. The percent cross-reactivity of those compounds is presented below. This information is also provided in the labeling of the device.

Amphetamine:

| Compounds | Response equivalent to cutoff (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| D-Amphetamine | 1000 | 100% |
| D,L-Amphetamine | 2500 | 40% |
| L-Amphetamine | 50000 | 2% |
| D-Methamphetamine | >100000 | <1% |
| L-Methamphetamine | >100000 | <1% |
| (±)3,4- Methylenedioxyamphetamine (MDA) | 2000 | 50% |
| Ephedrine | >100000 | <1% |
| 3,4-Methylenedioxythylamphetamine (MDEA) | >100000 | <1% |

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# Methamphetamine

| Compounds | Response equivalent to cutoff (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| (±) Methamphetamine | 2,000 | 50% |
| (+) Methamphetamine | 1000 | 100% |
| (±) 3,4-Methylenedioxymethamphetamine (MDMA) | 2,000 | 50% |
| Ranidine (Zantac) | >100,000 | <1% |
| 3,4-Methylenedioxyamphetamine (MDA) | >100,000 | <1% |
| D-Amphetamine | >100,000 | <1% |
| L-Amphetamine | >100,000 | <1% |
| Ephedrine | >100,000 | <1% |

# Barbiturates

| Compounds | Response equivalent to cutoff (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Secobarbital | 300 | 100% |
| Phenobarbital | 2500 | 12% |
| Butalbital | 500 | 60% |
| Pentobarbital | 1500 | 20% |
| Amobarbital | 2500 | 12% |
| Cyclopentobarbital | 500 | 60% |
| Butethal | 800 | 37.5% |
| Barbital | 300 | 100% |
| Butabarbital | 1500 | 20% |

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Benzodiazepines

| Compounds | Response equivalent to cutoff (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Oxazepam | 300 | 100% |
| Alprazolam | 200 | 150% |
| α-Hydroxyalprazolam | 1000 | 30% |
| Bromazepam | 250 | 120% |
| Chlordiazepoxide | 2500 | 12% |
| Clobazam | 100 | 300% |
| Clonazepam | 850 | 35.3% |
| Clorazepate | 250 | 120% |
| Delorazepam | 1600 | 18.8% |
| Diazepam | 200 | 150% |
| Estazolam | 200 | 150% |
| Flunitrazepam | 300 | 100% |
| Lorazepam | 1000 | 30% |
| Midazolam | 1500 | 20% |
| Nitrazepam | 100 | 300% |
| Nordiazepam | 400 | 75% |
| Temazepam | 150 | 200% |
| Triazolam | 500 | 60% |

Cocaine

| Compounds | Response equivalent to cutoff (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Cocaine | >100000 | <1% |
| Benzoylecgonine | 300 | 100% |
| Ecgonine HCI | 35000 | 0.86% |

16

{16}

Marijuana

| Compounds | Response equivalent to cutoff (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| 11-nor-Δ⁸-THC-9-COOH | 50 | 100% |
| 11-nor-Δ⁹-THC-9-COOH | 50 | 100% |
| Δ⁸-Tetrahydrocannabinol | 8000 | 0.6% |
| Δ⁹-Tetrahydrocannabinol | 10000 | 0.5% |
| Cannabinol | 10000 | 0.5% |
| Cannabidiol | 100000 | <1% |

Methadone

| Compounds | Response equivalent to cutoff (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Methadone | 300 | 100% |
| (±)2-Ethyl-1,5-dimethyl-3,3-diphenylpyrrolinium | 50000 | 0.6% |
| Doxylamine | 50000 | 0.6% |

MDMA

| Compounds | Response equivalent to cutoff (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| (+/-)3,4-Methylenedioxymethamphetamine (MDMA) | 500 | 100% |
| D-Amphetamine | >100000 | <1% |
| L-Methamphetamine | 100000 | <1% |
| 3,4-Methylenedioxyethylamphetamine (MDEA) | 200 | 250% |
| 3,4-Methylenedioxyamphetamine (MDA) | 2000 | 25% |

{17}

18

# Morphine

| Compounds | Response equivalent to cutoff | % Cross-reactivity |
| --- | --- | --- |
| Morphine | 300 | 100% |
| Codeine | 300 | 100% |
| Heroin | 300 | 100% |
| Hydrocodone | 2000 | 15% |
| Hydromorphone | 3500 | 8.6% |
| Morphine 3-β-D-glucuronide | 300 | 100% |
| 6-Monoacetylmorphine | 600 | 50% |
| Normorphone | 100000 | <1% |
| Oxycodone | 10000 | 3% |
| Oxymorphone | 50000 | <1% |
| Thebaine | 7000 | 4.3% |

# Opiates 2000

| Compounds | Response equivalent to cutoff (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Morphine | 2000 | 100% |
| Codeine | 2000 | 100% |
| Heroin | 2000 | 100% |
| Hydrocodone | 10000 | 20% |
| Hydromorphone | 7000 | 28.6% |
| Morphine 3-β-D-glucuronide | 2000 | 100% |
| 6-Monoacetylmorphine | 5000 | 40% |
| Normorphone | 100000 | 2% |
| Oxycodone | 20000 | 10% |
| Oxymorphone | 100000 | 2% |
| Thebaine | 70000 | 2.9% |

{18}

19

Oxycodone

| Compounds | Response equivalent to cutoff (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Oxycodone | 100 | 100% |
| Morphine | 50000 | <1% |
| Codeine | 25000 | <1% |
| Morphine 3-β-D-glucuronide | 50000 | <1% |
| Hydrocodone | 1600 | 6.25% |
| Hydromorphone | 15000 | 0.7% |
| Normorphone | 100000 | <1% |
| Oxymorphone | 1500 | 6.7% |

Phencyclidine

| Compounds | Response equivalent to cutoff (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Phencyclidine | 25 | 100% |
| 4-Hydroxyphencyclidine | 15000 | <1% |

Tricyclic Antidepressants

| Compounds | Response equivalent to cutoff (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Notriptiline | 1000 | 100% |
| Trimipramine | 4500 | 22% |
| Amitriptyline | 1000 | 100% |
| Promazine | 3000 | 33.33% |
| Desipramine | 1000 | 100% |
| Imipramine | 1000 | 100% |
| Clomipramine | 7500 | 13.33% |
| Doxepin | 3000 | 33.33% |
| Maprotiline | 50000 | 2% |

{19}

20

Structurally un-related and interference:

The following unrelated compounds were found not to cross-react with UCP Home Drug Screening Test Cups when tested spiked (100 mg/mL) into drug free urine or urine spiked with each drug at ±50%, ±25% of the cut-off values:

Acetaminophen, Acetylsalicylic Acid, Amikacin, Ampicillin, Arterenal, Aspirin, Atropine, Benzoic Acid, Oxalic Acid, Caffeine, Methanol, Ethanol, Lidocaine, Thioridazine, Trifluoperazine, Penicillin-G, Phenylpropanalamine, Ranitidine, Salicyclic Acid, Albumin, Bilirubin, Creatinine, Hemoglobin, Glucose, Vitamin C (L-Ascorbic Acid), and Uric Acid

Evaluation of Specific Gravity and pH on the test results:

To evaluate the effect of pH value on the test results, negative urine samples were adjusted to pH levels 4.5, 5.0, 6.0, 7.0, 8.0, and 9.0. The samples were then spiked with each drug at ±50%, ±25% of the cut-off values. Testing was performed on 3 lots of UCP Home Drug Screening Test Cups.

To evaluate the effect of specific gravity, the urine samples having specific gravities of 1.005, 1.01, 1.02, 1.025, and 1.030, 1.032, and 1.035 were spiked with each drug at ±50%, ±25% of the cut-off values. Testing was performed on 3 lots of UCP Home Drug Screening Test Cups.

The testing results demonstrate that varying pHs and specific gravities do not affect urine testing results around each analyte cut-off.

f. Assay cut-off:

Cutoff studies were performed by validating the test performance around the claimed cutoff concentration of each test. The targeted drugs were spiked into human urine known to be drug-free in each test to the following concentrations: 0, +/-50% of the cutoff, +/-25% of the cutoff.

The concentrations of each drug were confirmed by GC/MS. To determine the analytical sensitivity, 20 replicates at each concentration of each drug were run by 3 operators with total 60 replicates from three lots. The results were summarized below:

{20}

Amphetamine Cutoff Study:

| | Concentration (ng/mL) | Total numbers of Determinations | Results #Neg/#Pos | Positive (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 2/18 | 90% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 1/19 | 95% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 19/1 | 95% |
| | Cutoff | 20 | 1/19 | 95% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |

Barbiturates Cutoff Study:

| | Concentration (ng/mL) | Total numbers of Determinations | Results #Neg/#Pos | Positive (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 18/2 | 90% |
| | Cutoff | 20 | 2/18 | 90% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 1/19 | 95% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 19/1 | 95% |
| | Cutoff | 20 | 1/19 | 95% |

{21}

22

| +25% Cutoff | 20 | 0/20 | 100% |
| --- | --- | --- | --- |
| +50% Cutoff | 20 | 0/20 | 100% |

Benzodiazepine Cutoff Study:

| | Concentration (ng/mL) | Total numbers of Determinations | Results #Neg/#Pos | Positive (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 3/17 | 85% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 1/19 | 95% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 1/19 | 95% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |

{22}

23

Cocaine Cutoff Study:

| | Concentration (ng/mL) | Total numbers of Determinations | Results #Neg/#Pos | Positive (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 2/18 | 90% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 2/18 | 90% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 1/19 | 95% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |

{23}

Marijuana Cutoff Study:

| | Concentration (ng/mL) | Total numbers of Determinations | Results #Neg/#Pos | Positive (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 19/1 | 95% |
| | Cutoff | 20 | 2/18 | 90% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 2/18 | 90% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 19/1 | 95% |
| | Cutoff | 20 | 1/19 | 95% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |

{24}

Methadone Cutoff Study:

| | Concentration (ng/mL) | Total numbers of Determinations | Results #Neg/#Pos | Positive (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 2/18 | 90% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 2/18 | 90% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 1/19 | 95% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |

{25}

Methamphetamine Cutoff Study:

| | Concentration (ng/mL) | Total numbers of Determinations | Results #Neg/#Pos | Positive (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 3/17 | 85% |
| | +25% Cutoff | 20 | 1/19 | 95% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 2/18 | 90% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 2/18 | 90% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |

26

{26}

MDMA Cutoff Study:

| | Concentration (ng/mL) | Total numbers of Determinations | Results #Neg/#Pos | Positive (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 2/18 | 90% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 2/18 | 90% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 1/19 | 95% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |

{27}

Morphine Cutoff Study:

| | Concentration (ng/mL) | Total numbers of Determinations | Results #Neg/#Pos | Positive (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 2/18 | 90% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 19/1 | 95% |
| | Cutoff | 20 | 2/18 | 90% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 2/18 | 90% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |

{28}

Opiates 2000 Cutoff Study:

| | Concentration (ng/mL) | Total numbers of Determinations | Results #Neg/#Pos | Positive (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 1/19 | 95% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 2/18 | 90% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 2/18 | 90% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |

{29}

Oxycodone Cutoff Study:

| | Concentration (ng/mL) | Total numbers of Determinations | Results #Neg/#Pos | Positive (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 3/17 | 85% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 2/18 | 90% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 2/18 | 90% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |

{30}

Phencyclidine Cutoff Study:

| | Concentration (ng/mL) | Total numbers of Determinations | Results #Neg/#Pos | Positive (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 3/17 | 85% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 2/18 | 90% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 2/18 | 90% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |

{31}

Tricyclic Antidepressants Cutoff Study:

| | Concentration (ng/mL) | Total numbers of Determinations | Results #Neg/#Pos | Positive (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 19/1 | 95% |
| | Cutoff | 20 | 3/17 | 85% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 2 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 20/0 | 100% |
| | Cutoff | 20 | 3/17 | 85% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |
| Lot 3 | Negative | 20 | 20/0 | 100% |
| | -50% Cutoff | 20 | 20/0 | 100% |
| | -25% Cutoff | 20 | 19/1 | 95% |
| | Cutoff | 20 | 1/19 | 95% |
| | +25% Cutoff | 20 | 0/20 | 100% |
| | +50% Cutoff | 20 | 0/20 | 100% |

# 2. Comparison studies:

# a. Method comparison with predicate device:

The method comparison for UCP Home Drug Screening Test Cups was performed in-house with total 120 (60 negative and 60 positive) unaltered clinical samples by three operators, two operators have relevant experience, one operator has no experience other than reading the instructions for use. The samples were blinded and device results were compared to GC/MS results. The results are presented in the table below:

{32}

33

Amphetamine:

| | | Negative Urine | Near Cutoff Negative by GC/MS (Between - 50% and the cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | Total accuracy rate |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Positive results | 0 | 0 | 3 | 16 | 97.5% |
| | Negative results | 16 | 4 | 1 | 0 | |
| Operator 2 | Positive results | 0 | 0 | 4 | 16 | 100% |
| | Negative results | 16 | 4 | 0 | 0 | |
| Operator 3 | Positive results | 0 | 0 | 3 | 16 | 97.5% |
| | Negative results | 16 | 4 | 1 | 0 | |
| Combined results from three operators | Positive results | 0 | 0 | 10 | 48 | 98.3% |
| | Negative results | 48 | 12 | 2 | 0 | |
| Accuracy Rate | | 100% | 100% | 83.3% | 100% | |

{33}

Barbiturates:

| | | Negative Urine | Near Cutoff Negative by GC/MS (Between - 50% and the cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | Total accuracy rate |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Positive results | 0 | 1 | 4 | 16 | 97.5% |
| | Negative results | 16 | 3 | 0 | 0 | |
| Operator 2 | Positive results | 0 | 0 | 4 | 16 | 100% |
| | Negative results | 16 | 4 | 0 | 0 | |
| Operator 3 | Positive results | 0 | 0 | 4 | 16 | 100% |
| | Negative results | 16 | 4 | 0 | 0 | |
| Combined results from three operators | Positive results | 0 | 1 | 12 | 48 | 99.2% |
| | Negative results | 48 | 11 | 0 | 0 | |
| Accuracy Rate | | 100% | 91.7% | 100% | 100% | |

{34}

Benzodiazepines:

| | | Negative Urine | Near Cutoff Negative by GC/MS (Between - 50% and the cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | Total accuracy rate |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Positive results | 0 | 1 | 3 | 16 | 95% |
| | Negative results | 16 | 3 | 1 | 0 | |
| Operator 2 | Positive results | 0 | 0 | 4 | 16 | 100% |
| | Negative results | 16 | 4 | 0 | 0 | |
| Operator 3 | Positive results | 0 | 1 | 4 | 16 | 97.5% |
| | Negative results | 16 | 3 | 0 | 0 | |
| Combined results from three operators | Positive results | 0 | 2 | 11 | 48 | 97.5% |
| | Negative results | 48 | 10 | 1 | 0 | |
| Accuracy Rate | | 100% | 83.3% | 91.7% | 100% | |

35

{35}

36

Cocaine:

| | | Negative Urine | Near Cutoff Negative by GC/MS (Between - 50% and the cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | Total accuracy rate |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Positive results | 0 | 0 | 4 | 16 | 100% |
| | Negative results | 16 | 4 | 0 | 0 | |
| Operator 2 | Positive results | 0 | 0 | 4 | 16 | 100% |
| | Negative results | 16 | 4 | 0 | 0 | |
| Operator 3 | Positive results | 0 | 0 | 4 | 16 | 100% |
| | Negative results | 16 | 4 | 0 | 0 | |
| Combined results from three operators | Positive results | 0 | 0 | 12 | 48 | 100% |
| | Negative results | 48 | 12 | 0 | 0 | |
| Accuracy Rate | | 100% | 100% | 100% | 100% | |

{36}

37

Methadone:

| | | Negative Urine | Near Cutoff Negative by GC/MS (Between - 50% and the cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | Total accuracy rate |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Positive results | 0 | 0 | 4 | 16 | 100% |
| | Negative results | 16 | 4 | 0 | 0 | |
| Operator 2 | Positive results | 0 | 1 | 4 | 16 | 97.5% |
| | Negative results | 16 | 3 | 0 | 0 | |
| Operator 3 | Positive results | 0 | 0 | 4 | 16 | 100% |
| | Negative results | 16 | 4 | 0 | 0 | |
| Combined results from three operators | Positive results | 0 | 1 | 12 | 48 | 99.2% |
| | Negative results | 48 | 11 | 0 | 0 | |
| Accuracy Rate | | 100% | 91.7 | 100% | 100% | |

{37}

MDMA:

| | | Negative Urine | Near Cutoff Negative by GC/MS (Between - 50% and the cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | Total accuracy rate |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Positive results | 0 | 1 | 4 | 16 | 97.5% |
| | Negative results | 16 | 3 | 0 | 0 | |
| Operator 2 | Positive results | 0 | 0 | 3 | 16 | 97.5% |
| | Negative results | 16 | 4 | 1 | 0 | |
| Operator 3 | Positive results | 0 | 0 | 4 | 16 | 100% |
| | Negative results | 16 | 4 | 0 | 0 | |
| Combined results from three operators | Positive results | 0 | 1 | 11 | 48 | 98.3% |
| | Negative results | 48 | 11 | 1 | 0 | |
| Accuracy Rate | | 100% | 91.7% | 91.7% | 100% | |

38

{38}

Methamphetamine:

| | | Negative Urine | Near Cutoff Negative by GC/MS (Between - 50% and the cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | Total accuracy rate |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Positive results | 0 | 0 | 4 | 16 | 100% |
| | Negative results | 16 | 4 | 0 | 0 | |
| Operator 2 | Positive results | 0 | 0 | 3 | 16 | 97.5% |
| | Negative results | 16 | 4 | 1 | 0 | |
| Operator 3 | Positive results | 0 | 0 | 4 | 16 | 100% |
| | Negative results | 16 | 4 | 0 | 0 | |
| Combined results from three operators | Positive results | 0 | 0 | 11 | 48 | 99.2% |
| | Negative results | 48 | 12 | 1 | 0 | |
| Accuracy Rate | | 100% | 100% | 91.7% | 100% | |

39

{39}

40

Morphine:

| | | Negative Urine | Near Cutoff Negative by GC/MS (Between -50% and the cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | Total accuracy rate |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Positive results | 0 | 1 | 4 | 16 | 97.5% |
| | Negative results | 16 | 3 | 0 | 0 | |
| Operator 2 | Positive results | 0 | 0 | 3 | 16 | 100% |
| | Negative results | 16 | 4 | 1 | 0 | |
| Operator 3 | Positive results | 0 | 0 | 4 | 16 | 100% |
| | Negative results | 16 | 4 | 0 | 0 | |
| Combined results from three operators | Positive results | 0 | 1 | 12 | 48 | 99.2% |
| | Negative results | 48 | 11 | 0 | 0 | |
| Accuracy Rate | | 100% | 91.7% | 100% | 100% | |

{40}

Opiates 2000:

| | | Negative Urine | Near Cutoff Negative by GC/MS (Between - 50% and the cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | Total accuracy rate |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Positive results | 0 | 1 | 4 | 16 | 97.5% |
| | Negative results | 16 | 3 | 0 | 0 | |
| Operator 2 | Positive results | 0 | 1 | 4 | 16 | 97.5% |
| | Negative results | 16 | 3 | 0 | 0 | |
| Operator 3 | Positive results | 0 | 0 | 4 | 16 | 100% |
| | Negative results | 16 | 4 | 0 | 0 | |
| Combined results from three operators | Positive results | 0 | 2 | 12 | 48 | 98.3% |
| | Negative results | 48 | 10 | 0 | 0 | |
| Accuracy Rate | | 100% | 83.3% | 100% | 100% | |

41

{41}

Marijuana (THC):

| | | Negative Urine | Near Cutoff Negative by GC/MS (Between - 50% and the cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | Total accuracy rate |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Positive results | 0 | 1 | 4 | 16 | 97.5% |
| | Negative results | 16 | 3 | 0 | 0 | |
| Operator 2 | Positive results | 0 | 0 | 3 | 16 | 97.5% |
| | Negative results | 16 | 4 | 1 | 0 | |
| Operator 3 | Positive results | 0 | 0 | 3 | 16 | 97.5% |
| | Negative results | 16 | 4 | 1 | 0 | |
| Combined results from three operators | Positive results | 0 | 1 | 10 | 48 | 97.5% |
| | Negative results | 48 | 11 | 2 | 0 | |
| Accuracy Rate | | 100% | 91.7% | 83.3% | 100% | |

{42}

Phencyclidine:

| | | Negative Urine | Near Cutoff Negative by GC/MS (Between - 50% and the cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | Total accuracy rate |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Positive results | 0 | 0 | 4 | 16 | 100% |
| | Negative results | 16 | 4 | 0 | 0 | |
| Operator 2 | Positive results | 0 | 0 | 3 | 16 | 97.5% |
| | Negative results | 16 | 4 | 1 | 0 | |
| Operator 3 | Positive results | 0 | 0 | 4 | 16 | 100% |
| | Negative results | 16 | 4 | 0 | 0 | |
| Combined results from three operators | Positive results | 0 | 0 | 11 | 48 | 99.2% |
| | Negative results | 48 | 12 | 1 | 0 | |
| Accuracy Rate | | 100% | 100% | 91.7% | 100% | |

43

{43}

Oxycodone:

| | | Negative Urine | Near Cutoff Negative by GC/MS (Between - 50% and the cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | Total accuracy rate |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Positive results | 0 | 0 | 4 | 16 | 100% |
| | Negative results | 16 | 4 | 0 | 0 | |
| Operator 2 | Positive results | 0 | 1 | 4 | 16 | 97.5% |
| | Negative results | 16 | 3 | 0 | 0 | |
| Operator 3 | Positive results | 0 | 0 | 4 | 16 | 100% |
| | Negative results | 16 | 4 | 0 | 0 | |
| Combined results from three operators | Positive results | 0 | 1 | 12 | 48 | 99.2% |
| | Negative results | 48 | 11 | 0 | 0 | |
| Accuracy Rate | | 100% | 91.7% | 100% | 100% | |

44

{44}

Tricyclic Antidepressant:

| | | Negative Urine | Near Cutoff Negative by GC/MS (Between - 50% and the cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | Total accuracy rate |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Positive results | 0 | 0 | 3 | 16 | 97.5% |
| | Negative results | 16 | 4 | 1 | 0 | |
| Operator 2 | Positive results | 0 | 0 | 3 | 16 | 97.5% |
| | Negative results | 16 | 4 | 1 | 0 | |
| Operator 3 | Positive results | 0 | 1 | 4 | 16 | 97.5% |
| | Negative results | 16 | 3 | 0 | 0 | |
| Combined results from three operators | Positive results | 0 | 1 | 10 | 48 | 97.5% |
| | Negative results | 48 | 11 | 2 | 0 | |
| Accuracy Rate | | 100% | 91.7% | 83.3% | 100% | |

45

{45}

Discordant table in the method comparison study using unaltered clinical samples:

| Sample Numbers | Drug Test | Cutoff value (ng/mL) | Result (POS/NEG) | Drug/Metabolite GC/MS value (ng/mL) | |
| --- | --- | --- | --- | --- | --- |
| | | | | Drug /Metabolite | GC/MS value (ng/ml) |
| AMP-61 | Amphetamine | 1000 | Negative | D-Amphetamine | 1215 |
| AMP-69 | Amphetamine | 1000 | Negative | D-Amphetamine | 1215 |
| BAR-55 | Barbiturates | 300 | Positive | Secobarbital | 285 |
| BZO-51 | Benzodiazepines | 300 | Positive | Oxazepam | 289 |
| BZO-58 | Benzodiazepines | 300 | Positive | Oxazepam | 289 |
| BZO-66 | Benzodiazepines | 300 | Negative | Diazepam | 209 |
| MTD-50 | Methadone | 300 | Positive | Methadone | 230 |
| MDMA-52 | MDMA | 500 | Positive | MDMA | 480 |
| MDMA-63 | MDMA | 500 | Negative | MDMA | 525 |
| MET-62 | Methamphetamine | 1000 | Negative | D-Methamphetamine | 1195 |
| MOP-51 | Morphine | 300 | Positive | Morphine | 285 |
| OPI-53 | Opiates 2000 | 2000 | Positive | Codeine | 1952 |
| OPI-55 | Opiates 2000 | 2000 | Positive | Morphine | 1852 |
| THC-52 | THC | 50 | Positive | Delta-9-THC-COOH | 45 |
| THC-62 | THC | 50 | Negative | Delta-9-THC-COOH | 55 |
| THC-66 | THC | 50 | Negative | Delta-9-THC-COOH | 55 |
| PCP-63 | Phencyclidine | 25 | Negative | Phencyclidine | 26 |
| OXY-56 | Oxycodone | 100 | Positive | Oxycodone | 87 |
| TCA-54 | Tricyclic Antidepressant | 1000 | Positive | Nortriptyline | 836 |
| TCA-64 | Tricyclic Antidepressant | 1000 | Negative | Amitriptyline | 1215 |
| TCA-70 | Tricyclic Antidepressant | 1000 | Negative | Amitriptyline | 1215 |

{46}

b. Lay user study:

A lay user study was conducted in three locations with 115 lay persons. Fifty-eight females and fifty-seven males from ages of 18 to 77 years of age, with a range of educational backgrounds participated in the study. None of the participants had experience with a point of care drug testing product.

Quality control samples for test cups were prepared to contain a strong negative (0% of the cutoff), a very weak negative (-50% of cutoff), a weak negative (-25% of cutoff), a weak positive (+25% of cutoff), a strong positive (+50% of cutoff) and a very strong positive (+300% of the cutoff) of each drug. Pure drug or metabolite was spiked into drug free human urine. All specimens (except TCA samples) were verified by GC/MS. TCA samples were verified by HPLC. There were 456 observations. The results are summarized below:

47

{47}

| Drug | Results | Drug Concentration | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Negative | -50% | -25% | +25% | +50% | +300% |
| AMP | Positive | 0 | 0 | 2 | 16 | 18 | 17 |
| | Negative | 140 | 17 | 16 | 2 | 0 | 0 |
| | Total | 140 | 17 | 18 | 18 | 18 | 17 |
| | Agreement with GC/MS | 100% | 100% | 88.9% | 88.9% | 100% | 100% |
| BAR | Positive | 0 | 0 | 3 | 15 | 18 | 17 |
| | Negative | 140 | 17 | 15 | 3 | 0 | 0 |
| | Total | 140 | 17 | 18 | 18 | 18 | 17 |
| | Agreement with GC/MS | 100% | 100% | 83.3% | 83.3% | 100% | 100% |
| BZO | Positive | 0 | 0 | 2 | 14 | 18 | 17 |
| | Negative | 140 | 17 | 16 | 4 | 0 | 0 |
| | Total | 140 | 17 | 18 | 18 | 18 | 17 |
| | Agreement with GC/MS | 100% | 100% | 88.9% | 77.8% | 100% | 100% |
| COC | Positive | 0 | 0 | 4 | 15 | 18 | 17 |
| | Negative | 140 | 17 | 14 | 3 | 0 | 0 |
| | Total | 140 | 17 | 18 | 18 | 18 | 17 |
| | Agreement with GC/MS | 100% | 100% | 77.8% | 83.3% | 100% | 100% |
| MTD | Positive | 0 | 0 | 1 | 16 | 18 | 17 |
| | Negative | 140 | 17 | 17 | 2 | 0 | 0 |
| | Total | 140 | 17 | 18 | 18 | 18 | 17 |
| | Agreement with GC/MS | 100% | 100% | 94.4% | 88.9% | 100% | 100% |
| MET | Positive | 0 | 0 | 2 | 16 | 18 | 17 |
| | Negative | 140 | 17 | 16 | 2 | 0 | 0 |
| | Total | 140 | 17 | 18 | 18 | 18 | 17 |
| | Agreement with GC/MS | 100% | 100% | 88.9% | 88.9% | 100% | 100% |

{48}

| MDMA | Positive | 0 | 0 | 3 | 15 | 18 | 17 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Negative | 140 | 17 | 15 | 3 | 0 | 0 |
| MOP | Total | 140 | 17 | 18 | 18 | 18 | 17 |
| | Agreement with GC/MS | 100% | 100% | 83.3% | 83.3% | 100% | 100% |
| OXY | Positive | 0 | 0 | 2 | 15 | 18 | 17 |
| | Negative | 140 | 17 | 16 | 3 | 0 | 0 |
| OPI | Total | 140 | 17 | 18 | 18 | 18 | 17 |
| | Agreement with GC/MS | 100% | 100% | 88.9% | 83.3% | 100% | 100% |
| PCP | Positive | 0 | 0 | 2 | 16 | 18 | 17 |
| | Negative | 140 | 17 | 16 | 2 | 0 | 0 |
| TCA | Total | 140 | 17 | 18 | 18 | 18 | 17 |
| | Agreement with GC/MS | 100% | 100% | 88.9% | 83.3% | 100% | 100% |

{49}

Discordant table in the lay user study:

| No | Drug Test | Cutoff value (ng/mL) | Result (POS/NEG) | Drug/Metabolite GC/MS value | |
| --- | --- | --- | --- | --- | --- |
| | | | | Drug or Metabolite | GC/MS value (ng/ml) |
| 1. | Amphetamine | 1000 | Positive | D-Amphetamine | 750 |
| 2. | Amphetamine | 1000 | Positive | D-Amphetamine | 750 |
| 3. | Amphetamine | 1000 | Negative | D-Amphetamine | 1250 |
| 4. | Amphetamine | 1000 | Negative | D-Amphetamine | 1250 |
| 5. | Barbiturates | 300 | Positive | Secobarbital | 225 |
| 6. | Barbiturates | 300 | Positive | Secobarbital | 225 |
| 7. | Barbiturates | 300 | Positive | Cyclopentobarbital | 375 |
| 8. | Barbiturates | 300 | Negative | Secobarbital | 375 |
| 9. | Barbiturates | 300 | Negative | Secobarbital | 375 |
| 10. | Barbiturates | 300 | Negative | Cyclopentobarbital | 625 |
| 11. | Benzodiazepines | 300 | Positive | Oxazepam | 225 |
| 12. | Benzodiazepines | 300 | Positive | Estazolam | 150 |
| 13. | Benzodiazepines | 300 | Negative | Oxazepam | 375 |
| 14. | Benzodiazepines | 300 | Negative | Oxazepam | 375 |
| 15. | Benzodiazepines | 300 | Negative | Oxazepam | 375 |
| 16. | Benzodiazepines | 300 | Negative | Estazolam | 250 |
| 17. | Cocaine | 300 | Positive | Benzoylecgonine | 225 |
| 18. | Cocaine | 300 | Positive | Benzoylecgonine | 225 |
| 19. | Cocaine | 300 | Positive | Benzoylecgonine | 225 |
| 20. | Cocaine | 300 | Positive | Benzoylecgonine | 225 |
| 21. | Cocaine | 300 | Negative | Benzoylecgonine | 375 |
| 22. | Cocaine | 300 | Negative | Benzoylecgonine | 375 |
| 23. | Cocaine | 300 | Negative | Benzoylecgonine | 375 |
| 24. | Methadone | 300 | Positive | Methadone | 225 |
| 25. | Methadone | 300 | Negative | Methadone | 375 |
| 26. | Methadone | 300 | Negative | Methadone | 375 |
| 27. | Methamphetamine | 1000 | Positive | D-Methamphetamine | 750 |
| 28. | Methamphetamine | 1000 | Positive | D-Methamphetamine | 750 |
| 29. | Methamphetamine | 1000 | Negative | D-Methamphetamine | 1250 |

{50}

| 30. | Methamphetamine | 1000 | Negative | D- Methamphetamine | 1250 |
| --- | --- | --- | --- | --- | --- |
| 31. | MDMA | 500 | Positive | MDMA | 375 |
| 32. | MDMA | 500 | Positive | MDMA | 375 |
| 33. | MDMA | 500 | Positive | MDMA | 375 |
| 34. | MDMA | 500 | Negative | MDMA | 625 |
| 35. | MDMA | 500 | Negative | MDMA | 625 |
| 36. | MDMA | 500 | Negative | MDMA | 625 |
| 37. | Morphine | 300 | Positive | Morphine | 225 |
| 38. | Morphine | 300 | Positive | Morphine | 225 |
| 39. | Morphine | 300 | Negative | Morphine | 375 |
| 40. | Morphine | 300 | Negative | Morphine | 375 |
| 41. | Morphine | 300 | Negative | Codeine | 375 |
| 42. | Oxycodone | 100 | Positive | Oxycodone | 75 |
| 43. | Oxycodone | 100 | Positive | Oxycodone | 75 |
| 44. | Oxycodone | 100 | Negative | Oxycodone | 125 |
| 45. | Oxycodone | 100 | Negative | Oxycodone | 125 |
| 46. | Oxycodone | 100 | Negative | Oxycodone | 125 |
| 47. | Opiates 2000 | 2000 | Positive | Morphine | 1500 |
| 48 | Opiates 2000 | 2000 | Positive | Codeine | 1500 |
| 49. | Opiates 2000 | 2000 | Negative | Morphine | 2500 |
| 50. | Opiates 2000 | 2000 | Negative | Morphine | 2500 |
| 51. | Phencyclidine | 25 | Positive | Phencyclidine | 18.75 |
| 52. | Phencyclidine | 25 | Positive | Phencyclidine | 18.75 |
| 53. | Phencyclidine | 25 | Positive | Phencyclidine | 18.75 |
| 54. | Phencyclidine | 25 | Negative | Phencyclidine | 31.25 |
| 55. | Phencyclidine | 25 | Negative | Phencyclidine | 31.25 |
| 56. | Phencyclidine | 25 | Negative | Phencyclidine | 31.25 |
| 57. | Tricyclic Antidepressant | 1000 | Positive | Nortriptyline | 750 |
| 58. | Tricyclic Antidepressant | 1000 | Positive | Imipramine | 750 |
| 59. | Tricyclic Antidepressant | 1000 | Negative | Nortriptyline | 1250 |
| 60. | Tricyclic Antidepressant | 1000 | Negative | Nortriptyline | 1250 |

{51}

52

| 61. | Tricyclic Antidepressant | 1000 | Negative | Desipramine | 1250 |
| --- | --- | --- | --- | --- | --- |
| 62. | THC | 50 | Positive | Delta-9-THC-COOH | 37.5 |
| 63. | THC | 50 | Positive | Delta-9-THC-COOH | 37.5 |
| 64. | THC | 50 | Negative | Delta-9-THC-COOH | 62.5 |

A Flesh-Kincaid reading analysis was performed on package inserts and the score revealed a reading grade level of 7.

Each participant was given a pre and post-study questionnaire. The pre-study questionnaire collected personal information about each participant. The post-study questionnaire was used to determine if the lay users understood the test instruction and the meaning of the results. Consumers were asked questions about the test, control line, prescription drug and food interference and confirmation of results. The results from the post-questionnaire were acceptable as nearly all of the participants answered the questions correctly (99.1%).

b. Matrix comparison:
Not applicable. The assay is intended for urine samples.

3. Clinical studies:
a. Clinical Sensitivity:
Not applicable.
b. Clinical specificity:
Not applicable.
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable.

4. Clinical cut-off
Not applicable.

5. Expected values/Reference range:
Not applicable.

{52}

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

53