Wondfo T-Cup Multi-Drug Urine Test Cup

K182701 · Guangzhou Wondfo Biotech Co., Ltd. · NFT · Dec 3, 2018 · Clinical Toxicology

Device Facts

• Record ID: K182701
• Device Name: Wondfo T-Cup Multi-Drug Urine Test Cup
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: NFT · Clinical Toxicology
• Decision Date: Dec 3, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

Wondfo T-Cup® Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of: [Table of cut-off levels]. Wondfo T-Cup® Multi-Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Device Story

Rapid, single-use lateral flow immunoassay for qualitative detection of 15 drugs of abuse in human urine. Device consists of test cup with integrated test strips. User collects urine sample in cup; sample migrates via capillary action across membrane. Competitive binding principle: target drug in sample competes with drug-conjugate for limited antibody-coated particle binding sites. Absence of colored test line indicates drug presence above cutoff; presence of line indicates drug absence or concentration below cutoff. Control line confirms proper wicking. Intended for OTC use; results are preliminary and require professional confirmation. Provides rapid screening to assist in clinical decision-making regarding drug use.

Clinical Evidence

No clinical trials performed. Evidence includes analytical performance (precision, specificity, cross-reactivity) and a lay-user study (n=280) across 3 sites. Lay-user study demonstrated acceptable usability and comprehension, with performance consistent with analytical expectations at cutoff concentrations.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Form factor: test cup. Specimen: human urine. No external energy source. Stability: 4-30°C for 24 months. No software or electronic components.

Indications for Use

Indicated for qualitative, simultaneous detection of 15 specific drugs of abuse in human urine. Intended for both prescription and over-the-counter (OTC) use. Not intended to distinguish between prescription use and abuse.

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

• Advin Multi-Drug Screen Test Cup (k122809)

Submission Summary (Full Text)

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

A. 510(k) Number:
k182701

B. Purpose for Submission:
New device

C. Measurands:
Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids

D. Type of Test:
Qualitative, lateral flow immunoassay

E. Applicant:
Guangzhou Wondfo Biotech Co., Ltd.

F. Proprietary and Established Names:
Wondfo T-Cup® Multi-Drug Urine Test Cup

G. Regulatory Information:

| Product Code | Classification | Regulation | Panel |
| --- | --- | --- | --- |
| NFT | Class II | 21 CFR 862.3100, Amphetamine Test System | Toxicology (91) |
| NGL | Class II | 21 CFR 862.3650, Opiate Test System | Toxicology (91) |
| PTH | Class II | 21 CFR 862.3150, Barbiturate Test System | Toxicology (91) |
| NFV | Class II | 21 CFR 862.3170, Benzodiazepine Test System | Toxicology (91) |
| NFY | Class II | 21 CFR 862.3250, Cocaine and Cocaine Metabolites | Toxicology (91) |

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| PTG | Class II | 21 CFR 862.3620, Methadone Test System | Toxicology (91) |
| --- | --- | --- | --- |
| NGG | Class II | 21 CFR 862.3610, Methamphetamine Test System | Toxicology (91) |
| LCK | N/A | Unclassified | Toxicology (91) |
| QBF | Class II | 21 CFR 862.3700, Propoxyphene test system | Toxicology (91) |
| QAW | Class II | 21 CFR 862.3910, Tricyclic antidepressant drugs test | Toxicology (91) |
| NFW | Class II | 21 CFR 862.3870 Cannabinoids Test System | Toxicology (91) |

## H. Intended Use:

1. Intended use(s):

Refer to Indications for Use below.

2. Indication(s) for use:

Wondfo T-Cup® Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of:

| Analyte | Cutoff (ng/mL) |
| --- | --- |
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |

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| Analyte | Cutoff (ng/mL) |
| --- | --- |
| Nortriptyline (TCA) | 1000 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |

Wondfo T-Cup® Multi-Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only.

The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

3. Special conditions for use statement(s):

For over the counter use.

4. Special instrument requirements:

Not applicable.

I. Device Description:

The Wondfo T-Cup® Multi-Drug Urine Test Cup is a rapid, single-use in vitro diagnostic device. Each test kit contains a test device in one pouch. One pouch contains a test T-Cup and two desiccants, a package insert, and a urine cup for sample collection.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Advin Multi-Drug Screen Test Cup

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

k122809

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device | Predicate Device (k122809) |
| Intended Use | Qualitative detection of drugs of abuse in urine | Same |
| Test Principle | Competitive binding, lateral flow immunochromatographic assay | Same |
| Matrix | Urine | Same |
| Test drug cutoffs (ng/mL) | Amphetamine (AMP) – 1000 or 500 Buprenorphine (BUP) – 10 Secobarbital (BAR) – 300 Oxazepam (BZO) - 300 Cocaine (COC) – 300 or 150 diphenylpyrrolidine (EDDP) - 300 Methamphetamine (MET) – 1000 or 500 Methylenedioxymethamphetamine (MDMA) - 500 Methadone (MTD) - 300 Morphine (MOP 300/OPI 2000) – 2000 or 300 Oxycodone (OXY) - 100 Phencyclidine (PCP) - 25 Propoxyphene (PPX) - 300 Nortriptyline (TCA) - 1,000 Cannabinoids (THC) - 50 | Same |
| Differences | | |
| --- | --- | --- |
| Item | Candidate Device | Predicate Device (k122809) |
| Indications for Use | For over-the-counter use | Prescription use and over-the-counter use |
| Test formats | Test cup | Cup, dip card, cassette |
| Number of drugs detected | 15 | 16 |

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

None referenced.

L. Test Principle:

Wondfo T-Cup® Multi-Drug Urine Test Cup is a lateral flow chromatographic immunoassay. When urine sample is added to the cup device, urine is absorbed into the test strip and migrates upwards by capillary action. If the concentration of target drug presented

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in the urine sample is below the cutoff level, the target drug will not saturate the binding sites of its specific monoclonal antibody-coated particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored band will be formed on the test line region. If the concentration of target is beyond the cutoff level, the target drug will saturate the binding sites of its specific monoclonal antibody-particles, thus the antibody-coated particles will not be captured by immobilized drug-conjugate hence no colored band will be formed on the test line region. A band should be formed on the control line region regardless of the presence of target drug or metabolite in the sample to indicate that the tests have been performed properly.

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

### 1. Analytical performance:

#### a. Precision/Reproducibility:

Precision studies were carried out for samples with concentrations of -100% cutoff, -75% cut off, -50% cutoff, -25% cutoff, cutoff, +25% cutoff, +50% cutoff, +75% cutoff and +100% cutoff. Samples with concentration of -100% cutoff were drug-free urines samples. Other samples were prepared by spiking target drug in drug-free urine samples. Each drug concentration was confirmed by LC/MS or GC/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test cups. The results of a representative lot are summarized in the following tables:

Precision Study Results of a representative lot:

| Drug | Result | +100% Cutoff | +75% Cutoff | +50% Cutoff | +25% Cutoff | Cutoff | -25% Cutoff | -50% Cutoff | -75% Cutoff | -100% Cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| BUP 10 | Neg | 0 | 0 | 0 | 0 | 9 | 50 | 50 | 50 | 50 |
| | Pos | 50 | 50 | 50 | 50 | 41 | 0 | 0 | 0 | 0 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| PCP 25 | Neg | 0 | 0 | 0 | 0 | 7 | 50 | 50 | 50 | 50 |
| | Pos | 50 | 50 | 50 | 50 | 43 | 0 | 0 | 0 | 0 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| THC 50 | Neg | 0 | 0 | 0 | 0 | 10 | 50 | 50 | 50 | 50 |
| | Pos | 50 | 50 | 50 | 50 | 40 | 0 | 0 | 0 | 0 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| OXY 100 | Neg | 0 | 0 | 0 | 0 | 9 | 50 | 50 | 50 | 50 |
| | Pos | 50 | 50 | 50 | 50 | 41 | 0 | 0 | 0 | 0 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| BAR 300 | Neg | 0 | 0 | 0 | 0 | 8 | 50 | 50 | 50 | 50 |
| | Pos | 50 | 50 | 50 | 50 | 42 | 0 | 0 | 0 | 0 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| BZO 300 | Neg | 0 | 0 | 0 | 0 | 7 | 50 | 50 | 50 | 50 |
| | Pos | 50 | 50 | 50 | 50 | 43 | 0 | 0 | 0 | 0 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| EDDP 300 | Neg | 0 | 0 | 0 | 0 | 9 | 50 | 50 | 50 | 50 |
| | Pos | 50 | 50 | 50 | 50 | 41 | 0 | 0 | 0 | 0 |

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| Drug | Result | +100% Cutoff | +75% Cutoff | +50% Cutoff | +25% Cutoff | Cutoff | -25% Cutoff | -50% Cutoff | -75% Cutoff | -100% Cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| MTD 300 | Neg | 0 | 0 | 0 | 0 | 9 | 50 | 50 | 50 | 50 |
| | Pos | 50 | 50 | 50 | 50 | 41 | 0 | 0 | 0 | 0 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| MOP 300 | Neg | 0 | 0 | 0 | 0 | 9 | 50 | 50 | 50 | 50 |
| | Pos | 50 | 50 | 50 | 50 | 41 | 0 | 0 | 0 | 0 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| PPX 300 | Neg | 0 | 0 | 0 | 0 | 11 | 50 | 50 | 50 | 50 |
| | Pos | 50 | 50 | 50 | 50 | 40 | 0 | 0 | 0 | 0 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| COC 150 | Neg | 0 | 0 | 0 | 0 | 10 | 50 | 50 | 50 | 50 |
| | Pos | 50 | 50 | 50 | 50 | 41 | 0 | 0 | 0 | 0 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| MDMA 500 | Neg | 0 | 0 | 0 | 0 | 11 | 50 | 50 | 50 | 50 |
| | Pos | 50 | 50 | 50 | 50 | 39 | 0 | 0 | 0 | 0 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| TCA 1000 | Neg | 0 | 0 | 0 | 0 | 10 | 50 | 50 | 50 | 50 |
| | Pos | 50 | 50 | 50 | 50 | 40 | 0 | 0 | 0 | 0 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| AMP 500 | Neg | 0 | 0 | 0 | 0 | 11 | 50 | 50 | 50 | 50 |
| | Pos | 50 | 50 | 50 | 50 | 39 | 0 | 0 | 0 | 0 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| MET 500 | Neg | 0 | 0 | 0 | 0 | 10 | 50 | 50 | 50 | 50 |
| | Pos | 50 | 50 | 50 | 50 | 40 | 0 | 0 | 0 | 0 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| OPI 2000 | Neg | 0 | 0 | 0 | 0 | 10 | 50 | 50 | 50 | 50 |
| | Pos | 50 | 50 | 50 | 50 | 40 | 0 | 0 | 0 | 0 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| COC 300 | Neg | 0 | 0 | 0 | 0 | 10 | 50 | 50 | 50 | 50 |
| | Pos | 50 | 50 | 50 | 50 | 40 | 0 | 0 | 0 | 0 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| AMP 1000 | Neg | 0 | 0 | 0 | 0 | 8 | 50 | 50 | 50 | 50 |
| | Pos | 50 | 50 | 50 | 50 | 42 | 0 | 0 | 0 | 0 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| MET 1000 | Neg | 0 | 0 | 0 | 0 | 7 | 50 | 50 | 50 | 50 |
| | Pos | 50 | 50 | 50 | 50 | 43 | 0 | 0 | 0 | 0 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |

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b. Linearity/assay reportable range:

Not applicable.

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

This device has internal process controls. A colored line appearing in the control region confirms sufficient sample volume and adequate membrane wicking. Users are informed that the test is invalid if a line fails to appear in the control region. There are no external controls supplied with the device.

Device stability has been evaluated through accelerated and long-term studies. Protocols and acceptance criteria were described and found to be acceptable. The manufacturer claims that the devices are stable for two years (24 months) when stored at $4 - 30^{\circ}\mathrm{C}$ .

d. Detection limit:

Not applicable.

e. Analytical specificity:

Analytical specificity for this device was determined through adding the potential interfering substances to drug-free urine samples. The relative cross-reactivity represents the minimum concentration necessary to yield a result similar to the cutoff level of the respective assay. Percent cross-reactivity, provided in the below table, was calculated as the concentration of analyte tested that yielded a positive result, divided by the cutoff concentration, multiplied by 100; compounds that did not yield a positive result at the highest concentration tested have relative cross reactivity results represented by a dash in the table below.

| Drug/Cutoff | Compound | Concentration (ng/mL) | Relative cross-reactivity (%) |
| --- | --- | --- | --- |
| BUP 10 | Buprenorphine -3-D-Glucuronide | 15 | 66.7% |
| | Norbuprenorphine | 20 | 50% |
| | Norbuprenorphine-3-D-Glucuronide | 200 | 5% |
| | Morphine | >100,000 | -- |
| | Oxymorphone | >100,000 | -- |
| | Hydromorphone | >100,000 | -- |
| PCP 10 | 4-Hydroxyphencyclidine | 12500 | 0.2% |
| THC 50 | 11-nor-Δ8-THC 50-9-COOH | 30 | 167% |
| | (-)-11-nor-9-carboxy-Δ 9-THC 50 | 50 | 100% |
| | 11-nor-Δ9-THC 50-carboxy glucuronide | 100 | 50% |

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| Drug/Cutoff | Compound | Concentration (ng/mL) | Relative cross-reactivity (%) |
| --- | --- | --- | --- |
| | 11-hydroxy-Δ9-Tetrahydrocannabinol | 5000 | 1% |
| | Δ8- Tetrahydrocannabinol | 1300 | 4% |
| | Δ9- Tetrahydrocannabinol | 5000 | 1% |
| | Cannabinol | 20000 | 0.25% |
| | Cannabidiol | 100000 | 0.05% |
| OXY 100 | Dihydrocodeine | 20000 | 0.5% |
| | Hydrocodone | 10000 | 1% |
| | Oxymorphone | 1000 | 10% |
| | Codeine | 100000 | 0.1% |
| | Hydromorphone | 32000 | 0.3125% |
| | Morphine | >100,000 | -- |
| | Acetylmorphine | >100,000 | -- |
| | Buprenorphine | >100,000 | -- |
| | Ethylmorphine | >100,000 | -- |
| | Thebaine | >100,000 | -- |
| COC 150 | Cocaine | 375 | 40% |
| | Cocaethylene | 6250 | 2.4% |
| | Ecgonine | 16000 | <1% |
| | Ecgonine methyl ester | >100,000 | -- |
| BAR 300 | Amobarbital | 10000 | 3% |
| | Alphenol | 150 | 200% |
| | Aprobarbital | 200 | 150% |
| | Butabarbital | 75 | 400% |
| | Butathal | 100 | 300% |
| | Butalbital | 2500 | 12% |
| | Cyclopentobarbital | 600 | 50% |
| | Pentobarbital | 2500 | 12% |
| | Phenobarbital | 10000 | 3% |
| BZO 300 | Alprazolam | 200 | 150% |
| | a-Hydroxyalprazolam | 1500 | 20% |
| | Bromazepam | 500 | 60% |
| | Chlordiazepoxide | 1500 | 20% |
| | Clobazam | 100 | 300% |
| | Clonazepam | 800 | 37.5% |
| | Clorazepate dipotassium | 200 | 150% |
| | Delorazepam | 1500 | 20% |
| | Desalkylflurazepam | 400 | 75% |
| | Diazepam | 200 | 150% |
| | Estazolam | 1000 | 30% |
| | Flunitrazepam | 2500 | 12% |
| | Midazolam | 12500 | 2.4% |

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| Drug/Cutoff | Compound | Concentration (ng/mL) | Relative cross-reactivity (%) |
| --- | --- | --- | --- |
| | Nitrazepam | 4000 | 7.5% |
| | Norchlordiazepoxide | 200 | 150% |
| | Nordiazepam | 500 | 60% |
| | Temazepam | 250 | 120% |
| | Triazolam | 1200 | 25% |
| | Demoxepam | 2000 | 15% |
| | Flurazepam | 500 | 60% |
| | D,L-Lorazepam | 1500 | 20% |
| EDDP 300 | Methadone | 300000 | 0.1% |
| | EMDP | 300000 | 0.1% |
| | Doxylamine | >100,000 | -- |
| MTD 300 | Doxylamine | 50000 | 0.6% |
| | EDDP | >100,000 | -- |
| MOP 300 | Normorphine | 300 | 100% |
| | s-Monoacetylmorphine | 300 | 100% |
| | Codeine | 300 | 100% |
| | Ethyl Morphine | 100 | 300% |
| | Heroin | 300 | 100% |
| | Hydrocodone | 5000 | 6% |
| | Hydromorphone | 1000 | 30% |
| | Morphinie-3-β-d-glucuronide | 1000 | 30% |
| | Oxycodone | >100000 | -- |
| | Oxymorphone | 100000 | 0.3% |
| | Thebaine | 3000 | 10% |
| | Levorphanol | 10000 | 3% |
| | 6-Monoacetylmorphine (6-MAM) | 150 | 200% |
| | Norcodeine | 6250 | 4.8% |
| | Procaine | 150000 | 0.2% |
| | d-Norpropoxyphene | 300 | 100% |
| MDMA 500 | 3,4-Methylenedioxyamphetamine HCl (MDA) | 3000 | 17% |
| | 3,4-Methylenedioxyethylamphetamine (MDEA) | 300 | 167% |
| | d-methamphetamine | >100,000 | -- |
| | d-amphetamine | >100,000 | -- |
| | l-methamphetamine | 50,000 | 1% |
| | l-amphetamine | >100,000 | -- |
| AMP 500 | l-Amphetamine | 25000 | 2% |
| | dl- Amphetamine | 1500 | 33% |
| | (+/-) 3,4-Methylenedioxyamphetamine | 2500 | 20% |

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| Drug/Cutoff | Compound | Concentration (ng/mL) | Relative cross-reactivity (%) |
| --- | --- | --- | --- |
| | (MDA) | | |
| | Phentermine | 1500 | 33% |
| | Hydroxyamphetamine | 8000 | 6.25% |
| | d-Methamphetamine | >100,000 | -- |
| | l-Methamphetamine | >100,000 | -- |
| | (+/-)3,4-Methylenedioxyethylamphetamine (MDE) | >100,000 | -- |
| | (+/-) 3,4-Methylenedioxymethamphetamine (MDMA) | >100,000 | -- |
| | Ephedrine | >100,000 | -- |
| | β-Phenylethylamine | 100000 | 0.5% |
| | Tyramine | 100000 | 0.5% |
| | p-Hydroxynorephedrine | 100000 | 0.5% |
| | Phenylpropanolamine | >100,000 | -- |
| | (±)Phenylpropanolamine | >100,000 | -- |
| | p-Hydroxyamphetamine | 100000 | 0.5% |
| | d/l-Norephedrine | 100000 | 0.5% |
| | Benzphetamine | >100,000 | -- |
| | l-Ephedrine | >100,000 | -- |
| | l-Epinephrine | >100,000 | -- |
| | d/l-Epinephrine | >100,000 | -- |
| MET 500 | D-Amphetamine | 25000 | 2% |
| | L-Amphetamine | 37500 | 1.3% |
| | Chloroquine | 10000 | 5% |
| | (+/-)-Ephedrine | 25000 | 2% |
| | D/L-Methamphetamine | 500 | 100% |
| | L-Methamphetamine | 10000 | 5% |
| | (+/-)3,4-Methylenedioxy-n-ethylamphetamine (MDEA) | 500 | 100% |
| | (+/-)3,4-Methylenedioxyamphetamine (MDA) | 500 | 100% |
| | (+/-) 3,4-Methylenedioxymethamphetamine (MDMA) | 2000 | 25% |
| | β-Phenylethylamine | 25000 | 2% |
| | Trimethobenzamide | 5000 | 10% |
| | d/l-Amphetamine | 75000 | 0.7% |
| | p-Hydroxymethamphetamine | 15000 | 3.3% |
| | Mephentermine | 25000 | 2% |

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| Drug/Cutoff | Compound | Concentration (ng/mL) | Relative cross-reactivity (%) |
| --- | --- | --- | --- |
| | (1R,2S)-(-)-Ephedrine | 50000 | 1% |
| | l-Phenylephrine | 100000 | 0.5% |
| | (-)-Methamphetamine | 12500 | 4% |
| TCA 1000 | Nordoxepine | 1000 | 100% |
| | Trimipramine | 3000 | 33.3% |
| | Amitriptyline | 1500 | 66.7% |
| | Promazine | 1500 | 66.7% |
| | Desipramine | 200 | 500% |
| | Imipramine | 400 | 250% |
| | Clomipramine | 12500 | 8% |
| | Doxepine | 2000 | 50% |
| | Maprotiline | 2000 | 50% |
| | Promethazine | 25000 | 4% |
| | Cyclobenzaprine | 800 | 125% |
| | Norclomipramine | 12500 | 8% |
| COC 300 | Cocaine | 750 | 40% |
| | Cocaethylene | 12500 | 2.4% |
| | Ecgonine | 32000 | <1% |
| | Ecgonine methyl Ester | >100000 | -- |
| Amp 1000 | 1-Amphetamine | 50000 | 2% |
| | d1-Amphetamine | 3000 | 33.3% |
| | Phentermine | 3000 | 33.3% |
| | (+/-) 3,4-Methylenedioxyamphetamine (MDA) | 5000 | 20% |
| | Hydroxyamphetamine | >100000 | -- |
| | d-Methamphetamine | >100000 | -- |
| | l-Methamphetamine | >100000 | -- |
| | Ephedrine | >100000 | -- |
| | (+/-) 3,4-Methylenedioxymethamphetamine (MDMA) | 100000 | 20% |
| | β-Phenylethylamine | 100000 | 1% |
| | Tyramine | 100000 | 1% |
| | p-Hydroxynorephedrine | 100000 | 1% |
| | Phenylpropanolamine | >100000 | -- |
| | (±)Phenylpropanolamine | >100000 | -- |
| | p-Hydroxyamphetamine | 100000 | 1% |
| | d/l-Norephedrine | 100000 | 1% |
| | Benzphetamine | >100000 | -- |
| | l-Ephedrine | >100000 | -- |
| l-Epinephrine | >100000 | -- | |

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| Drug/Cutoff | Compound | Concentration (ng/mL) | Relative cross-reactivity (%) |
| --- | --- | --- | --- |
| | d/l-Epinephrine | >100000 | -- |
| | Hydroxyamphetamine | 8000 | 12.5% |
| MET 1000 | (+/-)3,4-Methylenedioxy-n-ethylamphetamine (MDEA) | 1000 | 100% |
| | D/L-Methamphetamine | 1000 | 100% |
| | p-Hydroxymethamphetamine | 30000 | 3.3% |
| | D-Amphetamine | >100000 | -- |
| | L-Amphetamine | 75000 | 1.3% |
| | Chloroquine | 50000 | 2% |
| | (+/-)-Ephedrine | 50000 | 2% |
| | (-)-Methamphetamine | 25000 | 4% |
| | (+/-) 3,4-Methylenedioxyamphetamine (MDA) | 1000 | 100% |
| | (+/-) 3,4-Methylenedioxymethamphetamine (MDMA) | 4000 | 25% |
| | β-Phenylethylamine | 50000 | 2% |
| | Trimethobenzamide | 10000 | 10% |
| | d,l-Amphetamine | 100000 | 1% |
| | Mephetermine | 50000 | 2% |
| | (1R,2S)-(-)-Ephedrine | >100000 | -- |
| | l-phenylephrine | >100000 | -- |
| | L-Methamphetamine | 25000 | 4% |
| OPI 2000 | Codeine | 2000 | 100% |
| | Ethyl Morphine | 1500 | 133% |
| | Hydrocodone | 12500 | 16% |
| | Hydromorphone | 3500 | 57% |
| | Levorphanol | 75000 | 2.7% |
| | 6-Monoacetylmorphine (6-MAM) | 1500 | 133% |
| | Morphine 3-β-D-glucuronide | 2000 | 100% |
| | Norcodeine | 12500 | 16% |
| | Normorphine | 50000 | 4% |
| | Oxycodone | 25000 | 8% |
| | Oxymorphone | 25000 | 8% |
| | Procaine | 150000 | 1.3% |
| | Thebaine | 5000 | 40% |
| | Heroin | 2000 | 100% |
| | s-Monoacetylmorphine | 2000 | 100% |

Potential interference from compounds chemically dissimilar to the target drugs and

{12}

from endogenous agents was performed by spiking the substances into pooled urine containing target drugs at near-cutoff concentrations (at $+25\%$ and $-25\%$ of cutoff). Unless otherwise indicated, substances were tested for potential interference at concentrations of $100~\mu \mathrm{g / mL}$

The following substances demonstrated no positive or negative interference on the assays encompassed in this submission.

| Acetaminophen | Acetophenetidin | Acetylsalicylic Acid |
| --- | --- | --- |
| Acyclovir | Amiodarone Hydrochloride | Apomorphine |
| Afrin | Albumin | Amlodipine Mesylate |
| Aminophylline | Amoxicillin | Aripiprazole |
| Aminopyrine | Ampicillin | Aspartame |
| Benzilic Acid | Atropine | Atomoxetine |
| Benzoic Acid | Carbamazepine | Atorvastatin Calcium |
| Bilirubin | Cefradine | Chloramphenicol |
| Bupropion | Cephalexin | Chlorothiazide |
| Captopril | Chloral Hydrate | Chloroquine |
| Ciprofloxacin Hydrochloride | Clonidine | Cholesterol |
| Citalopram | Clopidogrel Hydrogen Sulphate | (-) Cotinine |
| Clarithromycin | Clozapine | chlorpheniramine |
| Deoxy-corticosterone | D,L-Tyrosine | D,L-Octopamine |
| Dextromethorphan | Digoxin | D,L-Propranolol |
| Diclofenac | Diphenhydramine | D-Norpropoxy- phene |
| Diflunisal | Dirithromycin | Domperidone |
| D-Pseudo- ephedrine | Ecgonine Methyl Ester | Doxylamine |
| Duloxetine | Effexor | Epinephrine Hydrochloride |
| Dicyclomine | Enalapril Maleate | Erythromycin |
| β-Estradiol | Fentanyl Citrate | Esomeprazole Magnesium |
| Ethanol | Fluoxetine Hydrochloride | Furosemide |
| Fenofibrate | Fluvoxamine | Gabapentin |
| Fenoprofen | Glucose | Gentisic Acid |
| Glibenclamide | Haloperidol | 3-Hydroxy-tyramine |
| Gliclazide | Hemoglobin | Isosorbide Dinitrate |
| Glipizide | Ketamine | Isoxsuprine |
| Ibuprofen | Kratom powder | Lamotrigine |
| Ketoconazole | Labetalol | Levofloxacin Hydrochloride |

{13}

| Ketoprofen | Liverite | Levonorgestrel |
| --- | --- | --- |
| Lidocaine Hydrochloride | Loperamide | Levothyroxine Sodium |
| Lisinopril | Loratadine | Minocycline |
| Lithium Carbonate | Naproxen | Nalidixic Acid |
| Metoprolol Tartrate | Mifepristone | Niacinamide |
| Magnesium | Mirtazapine | Nifedipine |
| Meperidine | Montelukast Sodium | Nikethamide |
| Meprobamate | Phenelzine | Sulfamethazine |
| Mosapride Citrate | Pioglitazone Hydrochloride | Sulindac |
| Maprotiline | Piracetam | Tetrahydrocortisone 3 - acetate |
| Nimodipine | Pravastatin Sodium | Tetrahydrocortisone 3- (β-D-glucuronide) |
| Norethindrone | Prednisone | Tetrahydrozoline |
| N-Acetylprocain-amide | Propylthiouracil | Tetracycline |
| O-Hydroxyhippu-ric Acid | Promethazine | Thiamine |
| Olanzapine | Quetiapine Fumarate | Thioridazine |
| Omeprazole | Quinine | Topiramate |
| Oxalic Acid | Ranitidine | Tramadol Hydrochloride |
| Oxolinic Acid | Rifampicin | Trazodone Hydrochloride |
| Oxymetazoline | Risperidone | Triamterene |
| Ondansetran | Salicylic Acid | Trifluoperazine |
| Paliperidone | Serotonin | Trimethoprim |
| Pantoprazole | Sertraline Hydrochloride | Uric Acid |
| Papaverine | Sildenafil Citrate | Valproate |
| Paroxetine Hydrochloride | Simvastatin | Verapamil |
| Penfluridol | Sodium Valproate | Vitamin B2 |
| PenicillinV Potassium | Spironolactone | Vitamin C |
| Penicillin-G | | |

Interference by pH and specific gravity were also evaluated using pooled urine specimens containing target drugs at near-cutoff concentrations (at $+25\%$ and $-25\%$ of cutoff). The results demonstrated that pH levels of 4 to 9 and specific gravity levels of 1.003 to 1.035 do not affect the results of the assays.

f. Assay cut-off:

For characterization of how the device performs analytically around the claimed cutoff concentration, please refer to section M.1.a., above.

{14}

2. Comparison studies:

a. Method comparison with predicate device:

The method comparison study of the Wondfo T-Cup® Multi-Drug Urine Test cup was performed by three operators with 80 unaltered urine samples. The samples were blind labeled and compared to LC/MS or GC/MS results. The results are shown in the table below.

| Drug | Result | Drug-free by GC/MS | Low Neg by GC/MS (less than -50%) | Near Cutoff Neg by GC/MS (Between -50% and the Cutoff) | Near Cutoff Pos by GC/MS (Between the cutoff and +50%) | High Pos by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| AMP 500 | Pos | 0 | 0 | 2 | 30 | 10 |
| | Neg | 10 | 17 | 11 | 0 | 0 |
| | | | | | | |
| BUP 10 | Pos | 0 | 0 | 3 | 29 | 10 |
| | Neg | 10 | 18 | 9 | 1 | 0 |
| | | | | | | |
| BAR 300 | Pos | 0 | 0 | 1 | 28 | 11 |
| | Neg | 10 | 19 | 10 | 1 | 0 |
| | | | | | | |
| BZO 300 | Pos | 0 | 0 | 2 | 29 | 10 |
| | Neg | 10 | 15 | 13 | 1 | 0 |
| | | | | | | |
| COC 150 | Pos | 0 | 0 | 2 | 31 | 9 |
| | Neg | 10 | 18 | 10 | 0 | 0 |
| | | | | | | |
| EDDP 300 | Pos | 0 | 0 | 1 | 32 | 8 |
| | Neg | 0 | 0 | 1 | 32 | 8 |
| | | | | | | |
| MET 500 | Pos | 0 | 0 | 2 | 20 | 20 |
| | Neg | 10 | 15 | 13 | 0 | 0 |
| | | | | | | |
| MDMA 500 | Pos | 0 | 0 | 2 | 30 | 10 |
| | Neg | 10 | 18 | 10 | 0 | 0 |
| | | | | | | |
| MOP 300 | Pos | 0 | 0 | 0 | 28 | 10 |
| | Neg | 10 | 18 | 12 | 2 | 0 |
| | | | | | | |
| MTD 300 | Pos | 0 | 0 | 2 | 27 | 12 |
| | Neg | 10 | 18 | 10 | 1 | 0 |
| | | | | | | |
| OXY 100 | Pos | 0 | 0 | 0 | 29 | 10 |

{15}

16

| Drug | Result | Drug-free by GC/MS | Low Neg by GC/MS (less than -50%) | Near Cutoff Neg by GC/MS (Between -50% and the Cutoff) | Near Cutoff Pos by GC/MS (Between the cutoff and +50%) | High Pos by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| | Neg | 10 | 18 | 12 | 1 | 0 |
| | | | | | | |
| PCP 25 | Pos | 0 | 0 | 1 | 28 | 10 |
| | Neg | 10 | 20 | 9 | 2 | 0 |
| | | | | | | |
| PPX 300 | Pos | 0 | 0 | 2 | 31 | 8 |
| | Neg | 10 | 17 | 11 | 1 | 0 |
| | | | | | | |
| TCA 1000 | Pos | 0 | 0 | 2 | 29 | 10 |
| | Neg | 10 | 18 | 10 | 1 | 0 |
| | | | | | | |
| THC 50 | Pos | 0 | 0 | 3 | 28 | 10 |
| | Neg | 10 | 19 | 8 | 2 | 0 |
| | | | | | | |
| AMP 1000 | Pos | 0 | 0 | 2 | 28 | 10 |
| | Neg | 10 | 16 | 12 | 2 | 0 |
| | | | | | | |
| COC 300 | Pos | 0 | 0 | 3 | 27 | 11 |
| | Neg | 10 | 13 | 14 | 2 | 0 |
| | | | | | | |
| MET 1000 | Pos | 0 | 0 | 3 | 23 | 15 |
| | Neg | 10 | 18 | 9 | 2 | 0 |
| | | | | | | |
| OPI 2000 | Pos | 0 | 0 | 3 | 29 | 10 |
| | Neg | 10 | 18 | 9 | 1 | 0 |

Summary of Discordant Results:

| Drug test | Sample ID | Analyte detected | LC/MS Result | Device Result |
| --- | --- | --- | --- | --- |
| AMP 500 | 10062 | Amphetamine | 479.507 | Pos |
| | 10021 | Amphetamine | 480.687 | Pos |
| | | | | |
| BUP 10 | 10140 | Buprenorphine | 10.039 | Neg |
| | 10099 | Buprenorphine | 8.071 | Pos |
| | 10090 | Buprenorphine | 8.226 | Pos |
| | 10101 | Buprenorphine | 9.000 | Pos |
| | | | | |
| BAR 300 | 100177 | Barbiturates | 306.032 | Neg |
| | | | | |
| BZO 300 | 10279 | Benzodiazepines | 289.534 | Pos |
| | 10293 | Benzodiazepines | 307.387 | Neg |

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| Drug test | Sample ID | Analyte detected | LC/MS Result | Device Result |
| --- | --- | --- | --- | --- |
| | 10310 | Benzodiazepines | 274.237 | Pos |
| | | | | |
| COC 150 | 11397 | Cocaine | 146.311 | Pos |
| | 11414 | Cocaine | 145.437 | Pos |
| | | | | |
| EDDP 300 | 10359 | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 246.613 | Pos |
| | | | | |
| MET 500 | 11452 | Methamphetamine | 384.376 | Pos |
| | | | | |
| MDMA 500 | 10477 | 3,4-Methylenedioxymethamphetamine | 409.82 | Pos |
| | 10456 | | 417.972 | Pos |
| | | | | |
| MOP 300 | 10541 | Morphine | 303.693 | Neg |
| | 10514 | Morphine | 307.303 | Neg |
| | | | | |
| MTD 300 | 10566 | Methadone | 282.733 | Pos |
| | | | | |
| OXY 100 | 10688 | Oxycodone | 113.792 | Neg |
| | | | | |
| PCP 25 | 10797 | Phencyclidine | 20.203 | Pos |
| | 10736 | Phencyclidine | 25.049 | Neg |
| | 10725 | Phencyclidine | 25.105 | Neg |
| | | | | |
| PPX 300 | 10802 | Propoxyphene | 241.706 | Pos |
| | 10820 | Propoxyphene | 252.045 | Pos |
| | 10863 | Propoxyphene | 314.373 | Neg |
| | | | | |
| TCA 1000 | 10917 | Tri-cyclic Antidepressants | 796.893 | Pos |
| | 10951 | Tri-cyclic Antidepressants | 812.065 | Pos |
| | 10893 | Tri-cyclic Antidepressants | 1007.857 | Neg |
| | | | | |
| THC 50 | 11020 | Marijuana | 40.238 | Pos |
| | 11011 | Marijuana | 43.304 | Pos |
| | 10971 | Marijuana | 45.118 | Pos |
| | 11001 | Marijuana | 51.112 | Neg |
| | 10975 | Marijuana | 50.639 | Neg |
| | | | | |
| AMP 1000 | 11077 | Amphetamine | 739.221 | Pos |

17

{17}

| Drug test | Sample ID | Analyte detected | LC/MS Result | Device Result |
| --- | --- | --- | --- | --- |
| | 11092 | Amphetamine | 797.646 | Pos |
| | 11057 | Amphetamine | 1025.544 | Neg |
| | 11112 | Amphetamine | 1017.953 | Neg |
| | | | | |
| COC 300 | 11143 | Cocaine | 283.934 | Pos |
| | 11126 | Cocaine | 292.623 | Pos |
| | 11147 | Cocaine | 293.871 | Pos |
| | 11160 | Cocaine | 309.73 | Neg |
| | 11182 | Cocaine | 320.007 | Neg |
| | | | | |
| MET 1000 | 11216 | Methamphetamine | 873.409 | Pos |
| | 11250 | Methamphetamine | 888.241 | Pos |
| | 11213 | Methamphetamine | 890.705 | Pos |
| | 11215 | Methamphetamine | 1036.001 | Neg |
| | 11240 | Methamphetamine | 1022.392 | Neg |
| | | | | |
| OPI 2000 | 11354 | Opiates | 1830.086 | Pos |
| | 11335 | Opiates | 1882.994 | Pos |
| | 11297 | Opiates | 1947.150 | Pos |
| | 11295 | Opiates | 2015.745 | Neg |

b. Matrix comparison:

Not applicable.

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):

A lay user study was performed involving a total of 280 participants from 3 sites. 89 males and 51 females tested T-Cup® Multi-Drug Urine Test Cup Configuration 1 (including AMP 500, MET 500, MOP 300, COC 150); 84 male and 56 females tested T-Cup® Multi-Drug Urine Test Cup Configuration 2 (Group 2, including AMP 1000, MET 1000, MOP 2000 (OPI), COC 300). Each participant was provided one package insert, one blind labeled test solution, and one test device. Test solutions were randomly assigned to participants, one for each. Following testing, users completed a study questionnaire to assess usability and user comprehension, and the results from this questionnaire were found to be acceptable. Participants aged 20 and

{18}

over, with diverse educational backgrounds, were recruited. Results from the lay user testing are provided in the below table:

| Drug | Result | -100% Cutoff | -75% Cutoff | -50% Cutoff | -25% Cutoff | +25% Cutoff | +50% Cutoff | +75% Cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| AMP 500 | Neg | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| BAR 300 | Neg | 40 | 40 | 40 | 36 | 4 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 4 | 36 | 40 | 40 |
| | Total | 40 | 40 | 40 | 40 | 40 | 40 | 40 |
| BZO 300 | Neg | 40 | 40 | 40 | 36 | 4 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 4 | 36 | 40 | 40 |
| | Total | 40 | 40 | 40 | 40 | 40 | 40 | 40 |
| BUP 10 | Neg | 40 | 40 | 40 | 35 | 2 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 5 | 38 | 40 | 40 |
| | Total | 40 | 40 | 40 | 40 | 40 | 40 | 40 |
| COC 150 | Neg | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| EDDP 300 | Neg | 40 | 40 | 40 | 36 | 2 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 4 | 38 | 40 | 40 |
| | Total | 40 | 40 | 40 | 40 | 40 | 40 | 40 |
| MDMA 500 | Neg | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| MET 500 | Neg | 20 | 20 | 20 | 17 | 2 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 3 | 18 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| MOP 300 | Neg | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| MTD 300 | Neg | 40 | 40 | 40 | 35 | 5 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 5 | 35 | 40 | 40 |
| | Total | 40 | 40 | 40 | 40 | 40 | 40 | 40 |
| OXY 100 | Neg | 40 | 40 | 40 | 35 | 2 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 5 | 38 | 40 | 40 |
| | Total | 40 | 40 | 40 | 40 | 40 | 40 | 40 |
| PCP 25 | Neg | 40 | 40 | 40 | 35 | 2 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 5 | 38 | 40 | 40 |
| | Total | 40 | 40 | 40 | 40 | 40 | 40 | 40 |
| PPX 300 | Neg | 40 | 40 | 40 | 36 | 5 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 4 | 35 | 40 | 40 |
| | Total | 40 | 40 | 40 | 40 | 40 | 40 | 40 |
| TCA 1000 | Neg | 40 | 40 | 40 | 39 | 2 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 1 | 38 | 40 | 40 |

{19}

| Drug | Result | -100% Cutoff | -75% Cutoff | -50% Cutoff | -25% Cutoff | +25% Cutoff | +50% Cutoff | +75% Cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Total | 40 | 40 | 40 | 40 | 40 | 40 | 40 |
| THC 50 | Neg | 40 | 40 | 40 | 34 | 4 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 6 | 36 | 40 | 40 |
| | Total | 40 | 40 | 40 | 40 | 40 | 40 | 40 |
| AMP 1000 | Neg | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| COC 300 | Neg | 20 | 20 | 20 | 17 | 2 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 3 | 18 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| MET 1000 | Neg | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| OPI 2000 | Neg | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |

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 Parts 801 and 809, as applicable.

O. Conclusion:

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