UCP HOME DRUG SCREENING TEST; CARDS, CUPS

K130463 · Ucp Biosciences, Inc. · DKZ · May 15, 2013 · Clinical Toxicology

Device Facts

• Record ID: K130463
• Device Name: UCP HOME DRUG SCREENING TEST; CARDS, CUPS
• Applicant: Ucp Biosciences, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: May 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

The UCP Home Drug Screening Test Cups, UCP Home Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of the following drugs and their metabolites in human urine: [Table of drugs/cut-offs]. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The tests are intended for over-the-counter (OTC) use as the first step in a two step process to provide the 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 prescription use. The test also is intended for prescription use. The tests will vield preliminary positive results when the prescription drugs Barbiturates, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene 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 result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring the drug levels. For Over-The-Counter (OTC) use and prescription use For In Vitro Diagnostics only

Device Story

UCP Home Drug Screening Test Cards/Cups are lateral flow immunochromatographic assays for qualitative drug detection in human urine. Device uses competitive binding principle; visual interpretation of test lines indicates presence or absence of specific drugs/metabolites at defined cut-off levels. Designed for OTC consumer self-use or professional prescription use. User collects urine sample; applies to test card or cup; reads visual results. Preliminary positive results require laboratory confirmation via GC/MS or HPLC. Provides rapid, point-of-care screening to inform clinical decision-making or personal health awareness. Benefits include immediate, low-cost preliminary assessment of drug presence.

Clinical Evidence

No clinical trials performed. Evidence consists of analytical performance data (precision, cutoff, specificity) and a lay user study. Lay user study included 115 participants (ages 18-77) across three regions, testing urine samples spiked with various drug concentrations (0% to 300% of cutoff). Results showed high agreement with GC/MS confirmation for all analytes.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Form factor: test cups (up to 5 strips) or dipcards. Storage: 2-30°C. Shelf life: 18 months. Visual readout; no instrumentation required. Internal procedural control line included.

Indications for Use

Indicated for qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiates 2000, Oxycodone, Phencyclidine, Propoxyphene, and Tricyclic Antidepressants in human urine. Intended for OTC and prescription use as a first-step screening tool. Results are preliminary; confirmatory testing (e.g., GC/MS) required. Not for monitoring drug levels.

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)
• UCP Drug Screening Test Cups (k110515)

Reference Devices

• k091612
• k061457

Submission Summary (Full Text)

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

A. 510(k) Number:
k130463

B. Purpose for Submission:
Addition of Buprenorphine and Propoxyphene to Existing Device

C. Measurand:
Cannabinoids (THC) (delta-9-THC-COOH), Cocaine (benzoylecgonine), Amphetamine (d-amphetamine), Methamphetamine (d-methamphetamine), Opiate 2000 (morphine), Morphine 300 (morphine), Phencyclidine (phencyclidine), Barbiturates (secobarbital), Benzodiazepines (oxazepam), Buprenorphine (buprenorphine), Methadone (methadone), Oxycodone (oxycodone), Methylenedioxymethamphetamine (MDMA), Propoxyphene (propoxyphene), 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 Cards
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) |
| JXN | Class II | 21 CFR 862.3700 Propoxyphene 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, UCP Home Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of 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 |
| Buprenorphine | Buprenorphine | 10 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 |

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| Propoxyphene | Propoxyphene | 300 ng/mL |
| --- | --- | --- |
| Tricyclic Antidepressant | Nortriptyline | 1000 ng/mL |

The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The tests are 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 prescription use.

The tests will yield preliminary positive results when the prescription drugs Barbiturates, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, 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

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 and the UCP Home Drug Screening Test Cards are capable of measuring 14 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 and in a dipcard format for the UCP Home Drug Screening Test Cards. These tests include user instructions, collection cups, Drug Screening Test Card (in a foil pouch), 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.

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J. Substantial Equivalence Information:

1. Predicate device names(s)

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

2. Predicate K number(s):

k091588

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device (k130463) | Predicate (k091588) |
| Intended use | Intended for qualitative detection of drugs and their metabolites in human urine | Same |
| Test Principle | Lateral flow immunochromatographic technology based on the principle of competitive binding | Same |
| Type of assay | Qualitative | Same |
| Matrix | Urine | Same |
| Cutoff | 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 |

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| | Oxycodone: 100 ng/mL | | Same |
| --- | --- | --- | --- |
| | Phencyclidine: 25 ng/mL | | Same |
| | Tricyclic Antidepressants: 1000 ng/mL | | Same |
| Intended user | Over-the-counter (OTC) users and Professional users | | Same |
| Storage | 2 to 30 °C | | Same |
| Endpoint | Colored lines | | Same |
| Read time | 5 minutes | | Same |
| Differences | | | |
| Item | | Device (k130463) | Predicate (k091588) |
| Drugs | | Contains additional OTC drugs buprenorphine and propoxyphene | Does not contain drugs buprenorphine and propoxyphene |

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

None were referenced.

L. Test Principle:

The UCP Home™ Drug Screening Cups and The UCP Home™ Drug Screening Test Cards employ lateral flow immunochromatographic 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:

This submission is for the addition of buprenorphine and propoxyphene to a previously cleared device. Performance characteristics for each of the drugs are found in the

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following 510(k) numbers: k091588 for all analytes except for buprenorphine and propoxyphene. Please see k091612 for buprenorphine and k061457 for propoxyphene.

b. Linearity/assay reportable range:
Not applicable. The tests are for qualitative use.

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

Control Materials
External control materials are not supplied with this device; however, this device has internal 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 prescription use, 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 and UCP Home Drug Screening Test Cards have unopened stabilities of 18 months. Real time stability testing is ongoing.

d. Detection limit:
See k091588 for all analytes except for buprenorphine and propoxyphene. Please see k091612 for buprenorphine, and k061457 for propoxyphene.

e. Analytical specificity:
See k091588 for all analytes except for buprenorphine and propoxyphene. Please see k091612 for buprenorphine, and k061457 for propoxyphene.

f. Assay cut-off:
See k091588 for all analytes except for buprenorphine and propoxyphene. Please see k091612 for buprenorphine, and k061457 for propoxyphene.

2. Comparison studies:

a. Method comparison with predicate device:
See k091588 for all analytes except for buprenorphine and propoxyphene. Please see k091612 for buprenorphine, and k061457 for propoxyphene.

b. Lay user study:
1) The Consumer study in UCP Home Drug Screening Test Cards:

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The study was conducted among 115 lay persons in the three geographic regions. Fifty seven females and fifty eight males from ages ranging from 18 and 77 years participated in the studies. Fifty seven participants had a high school education or less, fifty eight participants had finished college courses. None of the participants had experiences using drug testing products before. The urine samples were prepared to contain strong negative (0% of cutoff), a very weak negative (50% of cutoff), a weak negative (75% of cutoff), a very weak positive (125% of cutoff), a weak positive (150% of cutoff) and high positive (300% of Cutoff). The urine samples with various drug concentrations were prepared by spiking pure drugs or drug metabolites into drug free human urine, the final drug concentrations in each urine sample were confirmed by GC/MS except for TCA. TCA concentrations in the urine samples was confirmed by HPLC. Each participant was asked to read the test instruction before performing the test, and then run the test independently without additional help. The test results by the lay users are summarized as below:

| Test Card | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Amphetamines | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 15 | 3 | 83.3% |
| | +25% | 18 | 3 | 15 | 83.3% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |
| Test Card | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Barbiturates | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 16 | 2 | 88.9% |
| | +25% | 18 | 3 | 15 | 83.3% |
| | +50% | 17 | 0 | 17 | 100% |
| | +300% | 16 | 0 | 16 | 100% |
| Test Card | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Benzodiazepines | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 1 | 17 | 94.4% |
| | +25% | 18 | 4 | 14 | 77.8% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |

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| Test Card | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Buprenorphine | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 15 | 3 | 83.3% |
| | +25% | 18 | 1 | 17 | 94.4% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |
| Test Card | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Cocaine | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 2 | 16 | 88.9% |
| | +25% | 18 | 3 | 15 | 83.3% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |
| Test Card | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Methadone | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 16 | 2 | 88.9% |
| | +25% | 18 | 2 | 16 | 88.9% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |
| Test Card | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Methamphetamine | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 15 | 3 | 83.3% |
| | +25% | 18 | 3 | 15 | 83.3% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |

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| Test Card | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| MDMA | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 14 | 4 | 77.8% |
| | +25% | 18 | 2 | 16 | 88.9% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |
| Test Card | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Morphine | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 17 | 1 | 94.4% |
| | +25% | 18 | 3 | 15 | 83.3% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |
| Test Card | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Oxycodone | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 16 | 2 | 88.9% |
| | +25% | 18 | 3 | 15 | 83.3% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |
| Test Card | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Opiates | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 15 | 3 | 83.3% |
| | +25% | 18 | 3 | 15 | 83.3% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |

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| Test Card | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Phencyclidine | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 16 | 2 | 88.9% |
| | +25% | 18 | 2 | 16 | 88.9% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |
| Test Card | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Propoxyphene | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 17 | 1 | 94.4% |
| | +25% | 18 | 2 | 16 | 88.9% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |
| Test Card | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Tricyclic Antidepressants | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 16 | 2 | 88.9% |
| | +25% | 18 | 3 | 15 | 83.3% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |
| Test Card | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| THC | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 15 | 3 | 83.3% |
| | +25% | 18 | 2 | 16 | 88.9% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |

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| Cup | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Amphetamine | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 16 | 2 | 88.9% |
| | +25% | 18 | 3 | 15 | 83.3% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |
| Cup | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Barbiturates | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 14 | 4 | 77.8% |
| | +25% | 18 | 2 | 16 | 88.9% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |
| Cup | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Benzodiazepines | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 17 | 1 | 94.4% |
| | +25% | 18 | 3 | 15 | 83.3% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |
| Cup | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Buprenorphine | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 16 | 2 | 88.9% |
| | +25% | 18 | 1 | 17 | 94.4% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |

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| Cup | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Cocaine | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 14 | 4 | 77.8% |
| | +25% | 18 | 1 | 17 | 94.4% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |
| Cup | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Methadone | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 16 | 2 | 88.9% |
| | +25% | 18 | 2 | 16 | 88.9% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |
| Cup | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Methamphetamine | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 16 | 2 | 88.9% |
| | +25% | 18 | 3 | 15 | 83.3% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |
| Cup | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| MDMA | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 17 | 1 | 94.4% |
| | +25% | 18 | 2 | 16 | 88.9% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |

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| Cup | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Morphine | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 15 | 3 | 83.3% |
| | +25% | 18 | 3 | 15 | 83.3% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |
| Cup | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Oxycodone | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 16 | 2 | 88.9% |
| | +25% | 18 | 3 | 15 | 83.3% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |
| Cup | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Opiates | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 15 | 3 | 83.3% |
| | +25% | 18 | 3 | 15 | 83.3% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |
| Cup | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Phencyclidine | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 16 | 2 | 88.9% |
| | +25% | 18 | 2 | 16 | 88.9% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |

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| Cup | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Propoxyphene | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 17 | 1 | 94.4% |
| | +25% | 18 | 2 | 16 | 88.9% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |
| Cup | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Tricyclic Antidepressants | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 16 | 2 | 88.9% |
| | +25% | 18 | 3 | 15 | 83.3% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |
| Cup | | Number of samples | OTC user | | % Agreement with GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| THC | Negative | 140 | 140 | 0 | 100% |
| | -50% | 17 | 17 | 0 | 100% |
| | -25% | 18 | 15 | 3 | 83.3% |
| | +25% | 18 | 2 | 16 | 88.9% |
| | +50% | 18 | 0 | 18 | 100% |
| | +300% | 17 | 0 | 17 | 100% |

c. Matrix Comparison:

Not applicable. The assay is intended for urine samples.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable.

b. Clinical specificity:

Not applicable.

{14}

b. 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.

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.

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