Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard

K142800 · Co-Innovation Biotech Co., Ltd. · DKZ · Dec 11, 2014 · Clinical Toxicology

Device Facts

• Record ID: K142800
• Device Name: Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard
• Applicant: Co-Innovation Biotech Co., Ltd.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Dec 11, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

Rapid Single/Multi-drug test Cup and Rapid Single/Multi-drug test Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations: Marijuana (THC) 50ng/mL, Cocaine (COC) 300ng/mL, Amphetamine (AMP) 1000ng/mL, Methamphetamine (MET) 1000ng/mL, Morphine 2000 (MOP) 2000ng/mL, Barbiturates (BAR) 300ng/mL, Benzodiazepines (BZO) 300ng/mL, Methylenedioxymethamphetamine (MDMA) 500ng/mL, Methadone (MTD) 300ng/mL, Oxycodone (OXY) 100ng/mL, Phencyclidine (PCP) 25ng/mL. The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use including point of care sites and over-the-counter use. The tests will yield preliminary positive results when prescription drugs Barbiturates, Benzodiazepine, and Methadone are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturates and Benzodiazepine in urine. The assays provide only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Device Story

Lateral flow immunochromatographic assay for qualitative detection of drugs of abuse in human urine; competitive binding principle; monoclonal antibody-coated particles; drug-specific conjugate; visual read-out; no instrumentation required; single-use; available as Test Cup or Test Dipcard; used at point-of-care or home; provides preliminary results; requires GC/MS confirmation; aids clinical decision-making.

Clinical Evidence

Bench testing only. Accuracy evaluated by comparing device results to GC/MS analysis using 80 clinical urine specimens per drug. Precision and accuracy studies conducted at point-of-care sites by nurses. Home-use consumer study included 360 lay users (ages 18-65) to validate ease of use and instruction comprehension. No clinical prospective/retrospective trials required for this immunoassay type.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle; monoclonal antibody (mouse) coated particles; qualitative visual read-out; no instrumentation; shelf-life 24 months at 4-30°C.

Indications for Use

Indicated for qualitative detection of drugs and drug metabolites in human urine for prescription, point-of-care, and over-the-counter use.

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 Dip Card (k122809)
• Advin Multi-Drug Screen Test Cup (k122809)
• Advin Multi-Drug Screen Test Cassette (k122809)

Submission Summary (Full Text)

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

A. 510(k) Number:
k142800

B. Purpose for Submission:
New device

C. Measurand:
Amphetamine, Methamphetamine, Cocaine, Morphine, Cannabinoid, Barbiturates, Benzodiazepines, Methadone, Methylenedioxymethamphetamine, Oxycodone, Phencyclidine

D. Type of Test:
Qualitative lateral flow immunochromatographic assay

E. Applicant:
Co-Innovation Biotech Co., Ltd.

F. Proprietary and Established Names:
Rapid Single/Multi-drug Test Cup
Rapid Single/Multi-drug Test Dipcard

G. Regulatory Information:

| Product Code | Classification | Regulatory Section | Panel |
| --- | --- | --- | --- |
| DKZ | Class II | 862.3100 Amphetamine test system | Toxicology (91) |
| DJC | Class II | 862.3610 Methamphetamine test system | Toxicology (91) |
| DIO | Class II | 21 CFR 862.3250 Cocaine test system | Toxicology (91) |
| DNK | Class II | 21 CFR 862.3640 Morphine test system | Toxicology (91) |
| LDJ | Class II | 21 CFR 3870 Cannabinoid test | Toxicology (91) |

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| | | system | |
| --- | --- | --- | --- |
| DIS | Class II | 21 CFR 862.3150 Barbiturate test system | Toxicology (91) |
| JXM | Class II | 21 CFR 862.3170 Benzodiazepine test system | Toxicology (91) |
| DJR | Class II | 21 CFR 862.3620 Methadone test system | Toxicology (91) |
| DJG | Class II | 21 CFR 862.3650 Opiate test system | Toxicology (91) |
| LCM | Unclassified | Enzyme immunoassay, Phencyclidine test system | Toxicology (91) |

## H. Intended Use:

1. Intended use(s):

See Indications for Use below.

2. Indication(s) for use:

Rapid Single/Multi-drug test Cup and Rapid Single/Multi-drug test Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:

| Test | Calibrator | Cut-off level |
| --- | --- | --- |
| Marijuana (THC) | Delta-9-THC-COOH | 50ng/mL |
| Cocaine (COC) | Benzolecgonine | 300ng/mL |
| Amphetamine (AMP) | D-Amphetamine | 1000ng/mL |
| Methamphetamine (MET) | D-Methamphetamine | 1000ng/mL |
| Morphine 2000 (MOP) | Morphine | 2000ng/mL |
| Barbiturates (BAR) | Secobarbital | 300ng/mL |
| Benzodiazepines (BZO) | Oxazepam | 300ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 3,4-Methylenedioxymethamphetamine | 500ng/mL |
| Methadone (MTD) | Methadone | 300ng/mL |
| Oxycodone (OXY) | Oxycodone | 100ng/mL |
| Phencyclidine (PCP) | Phencyclidine | 25ng/mL |

The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use including point of care sites and over-the-counter use.

The tests will yield preliminary positive results when prescription drugs Barbiturates, Benzodiazepine, and Methadone are ingested, even at or above therapeutic doses. There

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are no uniformly recognized drug levels for Barbiturates and Benzodiazepine in urine.

The assays provide only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

3. Special conditions for use statement(s):

For prescription use, including point-of-care sites and over the counter use.

4. Special instrument requirements:

No applicable; these are visually read single use devices.

5. Device Description:

The Rapid Single/Multi-drug test Cup and Rapid Single/Multi-drug test Dipcard are competitive binding, lateral flow immunochromatographic assays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Methamphetamine, Morphine, Barbiturates, Benzodiazepines, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine and their metabolites (specifically THC) at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument. The devices are available in one of two formats: 1) Test Cup and 2) Test Dipcard. The test configurations consist of single drug screening tests or any combinations of multiple drug screening tests.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Advin Multi-Drug Screen Test Dip Card

Advin Multi-Drug Screen Test Cup

Advin Multi-Drug Screen Test Cassette

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

k122809

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Candidate: Rapid Single/Multi-drug Test Cup and Dipcard k142165 | Predicate: Advin Multi-Drug Screen Test Dip Card, Cup and Cassette k122089 |
| Indication for use | Qualitative detection of drugs-of-abuse in urine | Same |
| Intended Users | OTC and Prescription Use | Same |

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| Similarities | | |
| --- | --- | --- |
| Item | Candidate: Rapid Single/Multi-drug Test Cup and Dipcard k142165 | Predicate: Advin Multi-Drug Screen Test Dip Card, Cup and Cassette k122089 |
| Specimen | Urine | Same |
| Read time | 5 minutes | Same |
| Results | Qualitative | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assay based on the principle of antigen antibody immunochemistry | Same |
| Differences | | |
| --- | --- | --- |
| Item | Rapid Single/Multi-drug Test Cup and Dipcard k142165 | Advin Multi-Drug Screen Test Dip Card, Cup and Cassette k122089 |
| Cutoff | Cocaine: 300 ng/mL Methamphetamine: 1000 ng/mL Amphetamine: 1000 ng/mL Morphine: 2000 ng/mL Marijuana: 50 ng/mL Barbiturates: 300 ng/mL Benzodiazepines: 300 ng/mL Methylenedioxymethamphetamine: 500 ng/mL Methadone: 300 ng/mL Oxycodone: 100 ng/mL Phencyclidine: 25 ng/mL | Cocaine: 150 ng/mL Methamphetamine: 1000 ng/mL Amphetamine: 500 ng/mL Morphine: 300 ng/mL Marijuana: 50 ng/mL Barbiturates: 300 ng/mL Benzodiazepines: 300 ng/mL Methylenedioxymethamphetamine: 500 ng/mL Methadone: 300 ng/mL Oxycodone: 100 ng/mL Phencyclidine: 25 ng/mL |
| Configurations | Dipcard and Cup | Cassette, Dipcard and Cup |

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

None were referenced.

# L. Test Principle:

The Rapid Single/Multi-drug test Cup and the Rapid Single/Multi-drug test Dipcard 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 monoclonal antibody (mouse) 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 indicating a negative result. 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, indicating a preliminary positive result. Each

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device contains a procedural control that appears in the control line region regardless of the presence of drug, 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 the single drug and multi-drug test formats. Drug free specimens were spiked with analytes at 0, ±75% cutoff, ±50% cutoff, ±25% cutoff and +100% cutoff of drug. The concentrations of the target drugs were confirmed with GC/MS. In both the single drug test and multi-drug test precision studies each concentration of the urine specimen was divided into aliquots. Each aliquot was blindly labeled by a nonparticipant. Separate sets of blinded coded samples were assigned and randomized prior to testing. The study was conducted by 6 operators at 3 Point-of-Care sites. Two operators per location tested 3 aliquots at each concentration for each lot per day (3 runs/day) for 10 non-consecutive days using one device lot per location. One operator tested the test dipcard format and the second operator tested the test cup format. Results from these studies are presented in the following tables:

Precision data of Rapid Single-drug Amphetamine (AMP) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 250ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/mL | -25% | 60 | 8 | 52 | 6 | 54 | 10 | 50 |
| 1000ng/mL | Cutoff | 60 | 36 | 24 | 34 | 26 | 36 | 24 |
| 1250ng/mL | +25% | 60 | 50 | 10 | 52 | 8 | 54 | 6 |
| 1500ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1750ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Single-drug Amphetamine (AMP) test (CUP)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 250ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/mL | -25% | 60 | 6 | 54 | 8 | 52 | 8 | 52 |
| 1000ng/mL | Cutoff | 60 | 34 | 26 | 36 | 24 | 32 | 28 |

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Precision data of Rapid Multi-drug Amphetamine (AMP) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 250ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/mL | -25% | 60 | 10 | 50 | 8 | 52 | 6 | 54 |
| 1000ng/mL | Cutoff | 60 | 36 | 24 | 32 | 28 | 34 | 26 |
| 1250ng/mL | +25% | 60 | 56 | 4 | 54 | 6 | 54 | 6 |
| 1500ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1750ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Multi-drug Amphetamine (AMP) test (CUP)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 250ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/mL | -25% | 60 | 6 | 54 | 6 | 54 | 8 | 52 |
| 1000ng/mL | Cutoff | 60 | 34 | 26 | 38 | 22 | 36 | 24 |
| 1250ng/mL | +25% | 60 | 54 | 6 | 58 | 2 | 56 | 4 |
| 1500ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1750ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Single-drug Cocaine (COC) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/mL | -25% | 60 | 6 | 54 | 4 | 56 | 8 | 52 |
| 300ng/mL | Cutoff | 60 | 34 | 26 | 36 | 24 | 34 | 26 |
| 375ng/mL | +25% | 60 | 54 | 6 | 56 | 4 | 56 | 4 |

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Precision data of Rapid Single-drug Cocaine (COC) test (CUP)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/mL | -25% | 60 | 8 | 52 | 6 | 54 | 4 | 56 |
| 300ng/mL | Cutoff | 60 | 36 | 24 | 34 | 26 | 38 | 22 |
| 375ng/mL | +25% | 60 | 56 | 4 | 54 | 6 | 52 | 8 |
| 450ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 525ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Multi-drug Cocaine (COC) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/mL | -25% | 60 | 8 | 52 | 6 | 54 | 4 | 56 |
| 300ng/mL | Cutoff | 60 | 34 | 26 | 36 | 24 | 32 | 28 |
| 375ng/mL | +25% | 60 | 56 | 4 | 54 | 6 | 52 | 8 |
| 450ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 525ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Multi-drug Cocaine (COC) test (CUP)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/mL | -25% | 60 | 6 | 54 | 4 | 56 | 6 | 54 |
| 300ng/mL | Cutoff | 60 | 34 | 26 | 36 | 24 | 34 | 26 |
| 375ng/mL | +25% | 60 | 54 | 6 | 56 | 4 | 56 | 4 |
| 450ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 525ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of Rapid Single-drug Metamphetamine (MET) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 250ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/mL | -25% | 60 | 4 | 56 | 4 | 56 | 6 | 54 |
| 1000ng/mL | Cutoff | 60 | 36 | 24 | 34 | 26 | 34 | 26 |
| 1250ng/mL | +25% | 60 | 56 | 4 | 56 | 4 | 54 | 6 |
| 1500ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1750ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Single-drug Metamphetamine (MET) test (Cup)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 250ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/mL | -25% | 60 | 4 | 56 | 8 | 52 | 6 | 54 |
| 1000ng/mL | Cutoff | 60 | 34 | 26 | 36 | 24 | 38 | 22 |
| 1250ng/mL | +25% | 60 | 54 | 6 | 56 | 4 | 58 | 2 |
| 1500ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1750ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Multi-drug Metamphetamine (MET) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 250ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/mL | -25% | 60 | 6 | 54 | 8 | 52 | 4 | 56 |
| 1000ng/mL | Cutoff | 60 | 38 | 22 | 36 | 24 | 36 | 24 |
| 1250ng/mL | +25% | 60 | 54 | 6 | 56 | 4 | 56 | 4 |
| 1500ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1750ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of Rapid Multi-drug Metamphetamine (MET) test (Cup)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 250ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/mL | -25% | 60 | 4 | 56 | 6 | 54 | 6 | 54 |
| 1000ng/mL | Cutoff | 60 | 34 | 26 | 38 | 22 | 36 | 24 |
| 1250ng/mL | +25% | 60 | 56 | 4 | 58 | 2 | 58 | 2 |
| 1500ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1750ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Single-drug Morphine (MOP) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 1000ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 1500ng/mL | -25% | 60 | 10 | 50 | 8 | 52 | 6 | 54 |
| 2000ng/mL | Cutoff | 60 | 44 | 16 | 42 | 18 | 40 | 20 |
| 2500ng/mL | +25% | 60 | 56 | 4 | 54 | 6 | 54 | 6 |
| 3000ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 3500ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 4000ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Single-drug Morphine (MOP) test (CUP)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 1000ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 1500ng/mL | -25% | 60 | 8 | 52 | 10 | 50 | 8 | 52 |
| 2000ng/mL | Cutoff | 60 | 42 | 18 | 44 | 16 | 44 | 16 |
| 2500ng/mL | +25% | 60 | 54 | 6 | 56 | 4 | 56 | 4 |
| 3000ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 3500ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 4000ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of Rapid Multi-drug Morphine (MOP) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 1000ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 1500ng/mL | -25% | 60 | 8 | 52 | 10 | 50 | 8 | 52 |
| 2000ng/mL | Cutoff | 60 | 42 | 18 | 40 | 20 | 44 | 16 |
| 2500ng/mL | +25% | 60 | 54 | 6 | 56 | 4 | 56 | 4 |
| 3000ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 3500ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 4000ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Multi-drug Morphine (MOP) test (CUP)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 1000ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 1500ng/mL | -25% | 60 | 6 | 54 | 8 | 52 | 10 | 50 |
| 2000ng/mL | Cutoff | 60 | 40 | 20 | 44 | 16 | 42 | 18 |
| 2500ng/mL | +25% | 60 | 56 | 4 | 54 | 6 | 54 | 6 |
| 3000ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 3500ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 4000ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Single-drug Marijuana (THC) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 12.5ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 25ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 37.5ng/mL | -25% | 60 | 6 | 54 | 4 | 56 | 8 | 52 |
| 50ng/mL | Cutoff | 60 | 34 | 26 | 38 | 22 | 36 | 24 |
| 62.5ng/mL | +25% | 60 | 50 | 10 | 52 | 8 | 54 | 6 |
| 75ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 87.5ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 100ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of Rapid Single-drug Marijuana (THC) test (CUP)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 12.5ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 25ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 37.5ng/mL | -25% | 60 | 8 | 52 | 6 | 54 | 6 | 54 |
| 50ng/mL | Cutoff | 60 | 36 | 24 | 38 | 22 | 36 | 24 |
| 62.5ng/mL | +25% | 60 | 52 | 8 | 56 | 4 | 54 | 6 |
| 75ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 87.5ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 100ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Multi-drug Marijuana (THC) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 12.5ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 25ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 37.5ng/mL | -25% | 60 | 8 | 52 | 4 | 56 | 6 | 54 |
| 50ng/mL | Cutoff | 60 | 36 | 24 | 34 | 26 | 38 | 22 |
| 62.5ng/mL | +25% | 60 | 50 | 10 | 52 | 8 | 54 | 6 |
| 75ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 87.5ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 100ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Multi-drug Marijuana (THC) test (CUP)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 12.5ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 25ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 37.5ng/mL | -25% | 60 | 6 | 54 | 8 | 52 | 4 | 56 |
| 50ng/mL | Cutoff | 60 | 38 | 22 | 36 | 24 | 36 | 24 |
| 62.5ng/mL | +25% | 60 | 52 | 8 | 56 | 4 | 54 | 6 |
| 75ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 87.5ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 100ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of Rapid Single-drug Barbiturates (BAR) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/mL | -25% | 60 | 6 | 54 | 4 | 56 | 4 | 56 |
| 300ng/mL | Cutoff | 60 | 38 | 22 | 36 | 24 | 34 | 26 |
| 375ng/mL | +25% | 60 | 56 | 4 | 54 | 6 | 56 | 4 |
| 450ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 525ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Single-drug Barbiturates (BAR) test (CUP)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/mL | -25% | 60 | 4 | 56 | 6 | 54 | 4 | 56 |
| 300ng/mL | Cutoff | 60 | 38 | 22 | 38 | 22 | 36 | 24 |
| 375ng/mL | +25% | 60 | 54 | 6 | 56 | 4 | 58 | 2 |
| 450ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 525ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Multi-drug Barbiturates (BAR) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/mL | -25% | 60 | 4 | 56 | 6 | 54 | 8 | 52 |
| 300ng/mL | Cutoff | 60 | 36 | 24 | 34 | 26 | 38 | 22 |
| 375ng/mL | +25% | 60 | 56 | 4 | 54 | 6 | 54 | 6 |
| 450ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 525ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of Rapid Multi-drug Barbiturates (BAR) test (CUP)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/mL | -25% | 60 | 6 | 54 | 2 | 58 | 4 | 56 |
| 300ng/mL | Cutoff | 60 | 38 | 22 | 36 | 24 | 34 | 26 |
| 375ng/mL | +25% | 60 | 58 | 2 | 54 | 6 | 56 | 4 |
| 450ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 525ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Single-drug Benzodiazepines (BZO) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/mL | -25% | 60 | 8 | 52 | 6 | 54 | 4 | 56 |
| 300ng/mL | Cutoff | 60 | 36 | 24 | 38 | 22 | 36 | 24 |
| 375ng/mL | +25% | 60 | 54 | 6 | 54 | 6 | 56 | 4 |
| 450ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 525ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Single-drug Benzodiazepines (BZO) test (CUP)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/mL | -25% | 60 | 6 | 54 | 4 | 56 | 6 | 54 |
| 300ng/mL | Cutoff | 60 | 38 | 22 | 36 | 24 | 34 | 26 |
| 375ng/mL | +25% | 60 | 56 | 4 | 54 | 6 | 52 | 8 |
| 450ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 525ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of Rapid Multi-drug Benzodiazepines (BZO) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/mL | -25% | 60 | 6 | 54 | 4 | 56 | 6 | 54 |
| 300ng/mL | Cutoff | 60 | 38 | 22 | 34 | 26 | 36 | 24 |
| 375ng/mL | +25% | 60 | 56 | 4 | 54 | 6 | 56 | 4 |
| 450ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 525ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Multi-drug Benzodiazepines (BZO) test (CUP)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/mL | -25% | 60 | 8 | 52 | 4 | 56 | 6 | 54 |
| 300ng/mL | Cutoff | 60 | 36 | 24 | 36 | 24 | 38 | 22 |
| 375ng/mL | +25% | 60 | 52 | 8 | 54 | 6 | 56 | 4 |
| 450ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 525ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Single-drug Methylenediozymethamphetamine (MDMA) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 125ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 250ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 375ng/mL | -25% | 60 | 6 | 54 | 8 | 52 | 10 | 50 |
| 500ng/mL | Cutoff | 60 | 34 | 26 | 36 | 24 | 32 | 28 |
| 625ng/mL | +25% | 60 | 54 | 6 | 56 | 4 | 52 | 8 |
| 750ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 875ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1000ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Page 14 of 33

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Precision data of Rapid Single-drug Methylenediozymethamphetamine (MDMA) test (CUP)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 125ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 250ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 375ng/mL | -25% | 60 | 8 | 52 | 6 | 54 | 6 | 54 |
| 500ng/mL | Cutoff | 60 | 36 | 24 | 34 | 26 | 36 | 24 |
| 625ng/mL | +25% | 60 | 52 | 8 | 54 | 6 | 56 | 4 |
| 750ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 875ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1000ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Multi-drug Methylenediozymethamphetamine (MDMA) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 125ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 250ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 375ng/mL | -25% | 60 | 10 | 50 | 6 | 54 | 8 | 52 |
| 500ng/mL | Cutoff | 60 | 36 | 24 | 34 | 26 | 34 | 26 |
| 625ng/mL | +25% | 60 | 52 | 8 | 56 | 4 | 54 | 6 |
| 750ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 875ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1000ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Multi-drug Methylenediozymethamphetamine (MDMA) test (CUP)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 125ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 250ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 375ng/mL | -25% | 60 | 8 | 52 | 10 | 50 | 6 | 54 |
| 500ng/mL | Cutoff | 60 | 32 | 28 | 34 | 26 | 36 | 24 |
| 625ng/mL | +25% | 60 | 56 | 4 | 54 | 6 | 52 | 8 |
| 750ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 875ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1000ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Page 15 of 33

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Precision data of Rapid Single-drug Methadone (MTD) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/mL | -25% | 60 | 4 | 56 | 2 | 58 | 6 | 54 |
| 300ng/mL | Cutoff | 60 | 32 | 28 | 36 | 24 | 34 | 26 |
| 375ng/mL | +25% | 60 | 56 | 4 | 54 | 6 | 58 | 2 |
| 450ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 525ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Single-drug Methadone (MTD) test (CUP)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/mL | -25% | 60 | 6 | 54 | 4 | 56 | 4 | 56 |
| 300ng/mL | Cutoff | 60 | 34 | 26 | 38 | 22 | 36 | 24 |
| 375ng/mL | +25% | 60 | 54 | 6 | 58 | 2 | 56 | 4 |
| 450ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 525ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Multi-drug Methadone (MTD) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/mL | -25% | 60 | 6 | 54 | 4 | 56 | 2 | 58 |
| 300ng/mL | Cutoff | 60 | 36 | 24 | 34 | 26 | 36 | 24 |
| 375ng/mL | +25% | 60 | 56 | 4 | 58 | 2 | 56 | 4 |
| 450ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 525ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Page 16 of 33

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Precision data of Rapid Multi-drug Methadone (MTD) test (CUP)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/mL | -25% | 60 | 2 | 58 | 4 | 56 | 4 | 56 |
| 300ng/mL | Cutoff | 60 | 38 | 22 | 34 | 26 | 36 | 24 |
| 375ng/mL | +25% | 60 | 58 | 2 | 54 | 6 | 56 | 4 |
| 450ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 525ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Single-drug Oxycodone (OXY) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 25ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 50ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/mL | -25% | 60 | 2 | 58 | 6 | 54 | 4 | 56 |
| 100ng/mL | Cutoff | 60 | 34 | 26 | 36 | 24 | 34 | 26 |
| 125ng/mL | +25% | 60 | 54 | 6 | 56 | 4 | 58 | 2 |
| 150ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 175ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 200ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Single-drug Oxycodone (OXY) test (CUP)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 25ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 50ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/mL | -25% | 60 | 6 | 54 | 4 | 56 | 8 | 52 |
| 100ng/mL | Cutoff | 60 | 36 | 24 | 38 | 22 | 34 | 26 |
| 125ng/mL | +25% | 60 | 56 | 4 | 56 | 4 | 58 | 2 |
| 150ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 175ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 200ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Page 17 of 33

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Precision data of Rapid Multi-drug Oxycodone (OXY) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 25ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 50ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/mL | -25% | 60 | 8 | 52 | 4 | 56 | 6 | 54 |
| 100ng/mL | Cutoff | 60 | 38 | 22 | 36 | 24 | 34 | 26 |
| 125ng/mL | +25% | 60 | 56 | 4 | 58 | 2 | 54 | 6 |
| 150ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 175ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 200ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Multi-drug Oxycodone (OXY) test (CUP)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 25ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 50ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/mL | -25% | 60 | 6 | 54 | 8 | 52 | 4 | 56 |
| 100ng/mL | Cutoff | 60 | 34 | 26 | 36 | 24 | 38 | 22 |
| 125ng/mL | +25% | 60 | 54 | 6 | 58 | 2 | 56 | 4 |
| 150ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 175ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 200ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Single-drug Phencyclidine (PCP) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 6.3ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 12.5ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 18.8ng/mL | -25% | 60 | 6 | 54 | 6 | 54 | 4 | 56 |
| 25ng/mL | Cutoff | 60 | 38 | 22 | 36 | 24 | 38 | 22 |
| 31.3ng/mL | +25% | 60 | 56 | 4 | 56 | 4 | 58 | 2 |
| 37.5ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 43.8ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 50ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Page 18 of 33

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Precision data of Rapid Single-drug Phencyclidine (PCP) test (CUP)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 6.3ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 12.5ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 18.8ng/mL | -25% | 60 | 4 | 56 | 4 | 56 | 6 | 54 |
| 25ng/mL | Cutoff | 60 | 36 | 24 | 38 | 22 | 34 | 26 |
| 31.3ng/mL | +25% | 60 | 54 | 6 | 56 | 4 | 56 | 4 |
| 37.5ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 43.8ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 50ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Multi-drug Phencyclidine (PCP) test (Dipcard)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Dipcard Lot 1 | | Test Dipcard Lot 2 | | Test Dipcard Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 6.3ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 12.5ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 18.8ng/mL | -25% | 60 | 2 | 58 | 4 | 56 | 6 | 54 |
| 25ng/mL | Cutoff | 60 | 36 | 24 | 38 | 22 | 34 | 26 |
| 31.3ng/mL | +25% | 60 | 58 | 2 | 56 | 4 | 54 | 6 |
| 37.5ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 43.8ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 50ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of Rapid Multi-drug Phencyclidine (PCP) test (CUP)

| Approximate Concentration of sample | % of cutoff | Number of determinations | Test Cup Lot 1 | | Test Cup Lot 2 | | Test Cup Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Pos | Neg | Pos | Neg | Pos | Neg |
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 6.3ng/mL | -75% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 12.5ng/mL | -50% | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 18.8ng/mL | -25% | 60 | 4 | 56 | 4 | 56 | 6 | 54 |
| 25ng/mL | Cutoff | 60 | 38 | 22 | 36 | 24 | 34 | 26 |
| 31.3ng/mL | +25% | 60 | 56 | 4 | 54 | 6 | 52 | 8 |
| 37.5ng/mL | +50% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 43.8ng/mL | +75% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 50ng/mL | +100% | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Page 19 of 33

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b. Linearity/assay reportable range:

Not Applicable.

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

External controls are not supplied with this device. The labeling provides information on where external controls can be obtained.

Stability:

Accelerated and real time studies have been conducted for The Rapid Single/Multi-drug Test Cup and the Rapid Single/Multi-drug Test Dipcard devices. Protocols and acceptance criteria were reviewed and found to be acceptable. The information supports the following expiration date for the unopened (shelf-life) stability: 24 months under 4 to 30° C for both the Test Cup and Dipcard formats.

d. Detection limit:

Not applicable. These are qualitative devices.

e. Analytical specificity:

I. Cross Reactivity

Cross reactivity with structurally similar compounds was tested for each device. Each compound was spiked into drug-free urine. If any positive result was observed, the compounds were further diluted with known drug-free urine. The lowest concentration that produced a positive result was identified as the cross-reactive concentration and the percent (%) cross-reactivity was determined. The study results for both formats (dipcard and cup) were the same and are reported below:

Cross reactivity test data for Rapid Single/Multi-drug test for Amphetamine (AMP)

| Compound | Concentration (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| d-Amphetamine | 1000 | 100% |
| l-Amphetamine | 50000 | 2% |
| d,l-Amphetamine | 2500 | 40% |
| 3,4-methylenedioxyamphetamine (MDA) | 2000 | 50% |
| The compounds (d-methaphetamine, l-methamphetamine, 3,4-methylenedioxymethamphetamine (MDMA), methylenedioxyethylamphetamine (MDEA) showed no cross-reactivity in the assay at concentration of 100μg/mL. | | |

{20}

Cross reactivity test data for Rapid Single/Multi-drug test for Cocaine (COC)

| Compound | Concentration (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Benzoylecgonine | 300 | 100% |
| Cocaine | 800 | 37.5% |
| Cocaethylene | 12500 | 2.4% |
| Ecgonine HCl | 35000 | 0.9% |

Cross reactivity test data for Rapid Single/Multi-drug test for Metamphetamine (MET)

| Compound | Concentration (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| d-methamphetamine | 1000 | 100% |
| l-methamphetamine | 8000 | 12.5% |
| p-hydroxymethamphetamine | 30000 | 3.3% |
| 3,4-methylenedioxyumethamphet (MDMA) | 2000 | 50% |
| 3,4-Methylenedioxyethylamphetamine (MDEA) | 50000 | 2% |
| The compounds (d-amphetamine, l-amphetamine, 3,4-methylenedioxyamphetamine (MDA) showed no cross-reactivity in the assay at concentration of 100μg/mL. | | |

Cross reactivity test data for Rapid Single/Multi-drug test for Morphine (MOP)

| Compound | Concentration (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Morphine | 2000 | 100% |
| Codeine | 2000 | 100% |
| Hydrocodone | 15000 | 13.3% |
| Hydromorphine | 10000 | 20% |
| 6-Monoacetylmorphine (6-MAN) | 5000 | 40% |
| Morphine 3-β-D-glucuronide | 2000 | 100% |
| Oxycodone | >100000 | 2% |
| Hydromorphone | 10000 | 20% |

Cross reactivity test data for Rapid Single/Multi-drug test for Marijuana (THC)

| Compound | Concentration (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| 11-nor-Δ⁹-THC-9-COOH | 50 | 100% |
| 11-nor-Δ⁸-THC-9-COOH | 50 | 100% |
| Δ⁹-THC | 15000 | 0.3% |
| Δ⁸-THC | 10000 | 0.5% |

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Page 22 of 33

| Cannabinol | 20000 | 0.3% |
| --- | --- | --- |
| The compound Cannabidiol showed now cross reactivity in the assay at a concentration of 100μg/mL. | | |

Cross reactivity test data for Rapid Single/Multi-drug test for Barbiturate (BAR)

| Compound | Concentration (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Secobarbital | 300 | 100% |
| Amobarbital | 500 | 60% |
| Alphenol | 150 | 200% |
| Aprobarbital | 200 | 150% |
| Butabarbital | 75 | 400% |
| Butalbital | 1500 | 20% |
| Butethal | 100 | 300% |
| Cyclopentobarbital | 600 | 50% |
| Pentobarbital | 700 | 42.9% |
| Phenobarbital | 300 | 100% |

Cross reactivity test data for Rapid Single/Multi-drug test for Benzodiazepines (BZO)

| Compound | Concentration (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Oxazepam | 300 | 100% |
| Alprazolam | 200 | 150% |
| α-Hydroxyalprazolam | 1100 | 27.3% |
| Bromazepam | 1000 | 30% |
| Chlordiazepoxide | 2000 | 15% |
| Clobazam | 100 | 300% |
| Clonazepam | 800 | 37.5% |
| Clorazepate | 200 | 150% |
| Delorazepam | 1600 | 18.8% |
| Desalkylflurazepam | 400 | 75% |
| Diazepam | 200 | 150% |
| Estazolam | 1000 | 30% |
| Flunitrazepam | 350 | 85.7% |
| Lorazepam | 1200 | 25% |
| Midazolam | 2500 | 12% |
| Nitrazepam | 100 | 300% |
| Nordiazepam | 400 | 75% |
| Temazepam | 120 | 250% |
| Triazolam | 1000 | 30% |

{22}

Cross reactivity test data for Rapid Single/Multi-drug test for Methylenedioxymetamphetamine (MDMA) test

| Compound | Concentration (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| (±) 3,4-Methylenedioxymethamphetamine (MDMA) | 500 | 100% |
| 3,4-methylenedioxyamphetamine (MDA) | 2200 | 22.7% |
| 3,4-methylenedioxyethylamphetamine (MDEA) | 240 | 208.3% |
| d-methamphetamine (MAMP) | 100000 | 0.3% |
| The compounds d-amphetamine, l-amphetamine and l-methamphetamine showed now cross reactivity in the assay at a concentration of 100μg/mL. | | |

Cross reactivity test data for Rapid Single/Multi-drug test for Methadone (MTD) test

| Compound | Concentration (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Methadone | 300 | 100% |
| (±)2-Ethyl-1,5-dimethy 1-3-3-diphenylpyrrolinium | 50000 | 0.6% |
| Doxylamine | 50000 | 0.6% |

Cross reactivity test data for Rapid Single/Multi-drug test for Oxycodone (OXY) test

| Compound | Concentration (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Oxycodone | 100 | 100% |
| Naloxone | 50000 | 0.2% |
| Naltrexone | 50000 | 0.2% |
| Morphine 3-β-D-glucuronide | 50000 | 0.2% |
| Hydrocodone | 3000 | 3.3% |
| Hydromorphone | 75000 | 0.1% |
| Oxymorphone | 1000 | 10% |

Cross reactivity test data for Rapid Single/Multi-drug test for Phencyclidine (PCP) test

| Compound | Concentration (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Phencyclidine | 25 | 100% |
| 4-Hydroxyphencyclidine | 15000 | 0.2% |

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# II. Exogenous Interference:

Interference from structurally similar and dissimilar compounds was evaluated by spiking them at a concentration of $100\mu \mathrm{g / mL}$ into urine containing drug concentrations at $\pm 50\%$ of the cutoff. The concentrations of the target drugs were confirmed with GC/MS. Each sample was tested in 3 replicates using each device format (dipcard and cup). The compounds listed in this table were found not to interfere with test results at a test concentration of $100\mu \mathrm{g / mL}$ .

| Acetaminophen | β-Estradiol | Norethindrone |
| --- | --- | --- |
| Acetophenetidin | Estrone-3-sulfate | Noscapine |
| Amoxicillin | Ethyl-p-aminobenzoate | d,l-Octopamine |
| Ampicillin | Erythromycin | Oxalic acid |
| Aspirin | Fenoprofen | Oxolinic acid |
| Atenolol | Flucloxacillin | Oxymetazoline |
| Atorvastatin | Fluoxetine | Oxytetracycline |
| Azlocillin | Furosemide | Papaverine |
| Benzilic acid | Gentisic acid | Penicillin-G |
| Benzylpenicillin | Hemoglobin | Pentazocine |
| Benzoic acid | Hydralazine | Perphenazine |
| Bilirubin | Hydrochlorothiazide | Phenelzine |
| Benzydamine | Hydrocortisone | Prednisolone |
| Caffeine | o-Hydroxyhippuric acid | Prednisone |
| Carbamazepine | p-Hydroxytyramine | d,l-Propanolol |
| Cephalexin | Ibuprofen | d-Pseudoephedrine |
| Chloralhydrate | Indomethacin | Quinacrine |
| Chloramphenicol | Iproniazid | Quinine |
| Chlorothiazide | d,l-Isoproterenol | Quindine |
| Chlorpheniramine | Isoxsuprine | Ranitidine |
| d,l-Chlorpromazine | Ketamine | Salicylic acid |
| Cholesterol | Ketoprofen | Serotonin |
| Clonidine | Labetalol | Sulfamethazine |
| Cimetidine | Lisinopril | Sulindac |
| Citalopram | Loperamide | Tetracycline |
| Cortisone | Meperidine | Tetrahydrozoline |
| Creatinine | Meprobamate | Thioridazine |
| Deoxycorticosterone | Methoxyphenamine | d, l-Thyroxine |
| Dexamethasone | Methylphenidate | Tolbutamine |

{24}

| Dextromethorphan | Nadolol | Tolbutamide |
| --- | --- | --- |
| Diclofenac | Nalidixic acid | Trifluoperazine |
| Diflunisal | Naproxen | Tryptamine |
| Digoxin | Niacinamide | Uric acid |
| Diphenhydramine | Nicotine | Verapamil |
| Ephedrine | Nifedipine | Zomepirac |

III. Effect of urinary pH: The pH of an aliquot of negative a urine pool adjusted to a pH range of 3 to 9 in 1 pH unit increments was spiked with ±50% cutoffs and each device format (dipcard and cup) was evaluated. All concentrations were confirmed by GC/MS. No interference was observed from pH for the target drugs.

IV. Effect of urinary specific gravity: Each device format (dipcard and cup) was evaluated for interference from specific gravity. Drug free urine was adjusted to ±50% cutoffs and concentrations confirmed by GC/MS. The specific gravity studies were conducted on specific gravity ranges from 1.002 to 1.040 and no interference was observed from specific gravity for the target drugs.

f. Assay cut-off:

The test cut-off was evaluated in the precision studies. See precision studies above in section 1.M.1.a.

2. Comparison studies:

a. Method comparison with predicate device:

The sponsor conducted method comparison studies using unaltered clinical specimens compared to GC/MS. Each sample was divided into 2 sets, one for cup format testing and one for dipcard format testing. All aliquots were blindly labeled by a nonparticipant and samples were randomized prior to testing. The study was conducted by 4 nurses at two POC sites. The single and multi-drug dipcard tests were tested at one site and the single and multi-drug cup tests were tested at the second site. Different nurses evaluated each test. For each drug analyte, a total of 80 specimens were tested for each of the single drug and multi-drug dipcard and the single drug and multi-drug cup tests. Results were the same for single and multi-drug test cups and also the same for single and multi-drug test dipcards. The results are presented below:

Page 25 of 33

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| Rapid Single/Multi drug Test Cup | GC/MS | | | | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Negative (drug free) | Negative (< -50% cut off) | Near cutoff negative (-50% cutoff to cutoff) | Near cutoff positive (cutoff to +50% cutoff) | | Positive (> +50% cutoff) |
| AMP | + | 0 | 0 | 0 | 6 | 34 | 80 |
| | - | 33 | 2 | 5 | 0 | 0 | |
| COC | + | 0 | 0 | 0 | 6 | 35 | 80 |
| | - | 33 | 1 | 6 | 0 | 0 | |
| MET | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 30 | 3 | 6 | 0 | 0 | |
| MOP | + | 0 | 0 | 1 | 6 | 34 | 80 |
| | - | 30 | 4 | 5 | 0 | 0 | |
| THC | + | 0 | 0 | 0 | 6 | 33 | 80 |
| | - | 34 | 1 | 5 | 1 | 0 | |
| BAR | + | 0 | 0 | 0 | 6 | 34 | 80 |
| | - | 33 | 0 | 7 | 0 | 0 | |
| BZO | + | 0 | 0 | 1 | 7 | 33 | 80 |
| | - | 31 | 0 | 8 | 0 | 0 | |
| MDMA | + | 0 | 0 | 0 | 5 | 34 | 80 |
| | - | 32 | 3 | 5 | 1 | 0 | |
| MTD | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 32 | 2 | 5 | 0 | 0 | |
| OXY | + | 0 | 0 | 0 | 6 | 34 | 80 |
| | - | 35 | 0 | 5 | 0 | 0 | |
| PCP | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 35 | 0 | 4 | 0 | 0 | |
| Rapid Single/Multi drug Test Dipcard | GC/MS | | | | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Negative (drug free) | Negative (< -50% cut off) | Near cutoff negative (-50% cutoff to cutoff) | Near cutoff positive (cutoff to +50% cutoff) | | Positive (> +50% cutoff) |
| AMP | + | 0 | 0 | 0 | 6 | 34 | 80 |
| | - | 33 | 2 | 5 | 0 | 0 | |
| COC | + | 0 | 0 | 0 | 6 | 35 | 80 |
| | - | 33 | 1 | 6 | 0 | 0 | |
| MET | + | 0 | 0 | 1 | 5 | 35 | 80 |

{26}

Analysis of Discordant Results

| Rapid Single/Multi Drug Test | | | | GC/MS Analysis | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Format | Cutoff (ng/mL) | Test Result | Drug Concentration (ng/mL) | Drug in Urine | |
| MET | Dipcard | 1000 | Positive | 867 | Methamphetamine | |
| | Cup | 1000 | Positive | 867 | Methamphetamine | |
| MOP | Dipcard | 2000 | Positive | 1742 | Morphine | |
| | Cup | 2000 | Positive | 1742 | Morphine | |
| THC | Dipcard | 50 | Negative | 61 | 11-nor-Δ9-THC-9-COOH | |
| | Cup | 50 | Negative | 61 | 11-nor-Δ9-THC-9-COOH | |
| BZO | Dipcard | 300 | Positive | 188 | Oxazepam | |
| | Cup | 300 | Positive | 188 | Oxazepam | |
| MDMA | Dipcard | 500 | Negative | 715 | 3,4-methylenedioxymethamphetamine | |
| | Cup | 500 | Negative | 715 | 3,4-methylenedioxymethamphetamine | |
| MTD | Dipcard | 300 | Positive | 209 | Methadone | |
| | Cup | 300 | Positive | 209 | Methadone | |
| PCP | Dipcard | 25 | Positive | 23 | Phencyclidine | |
| | Cup | 25 | Positive | 23 | Phencyclidine | |

b. Matrix comparison:

No applicable.

{27}

Page 28 of 33

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):

Home Use Consumer Study:

Groups of three hundred and sixty (360) lay users were used to test both the single drug and multi-drug test devices. Different groups tested the Dipcard format and Cup formats. Drug free specimens were spiked with analytes at 0, ±75% cutoff, ±50% cutoff, ±25% cutoff and +100% cutoff of drug. The concentrations of the target drugs were confirmed with GC/MS. In both the single drug test and multi-drug test user study each concentration of the urine specimen was divided into aliquots. Each aliquot was blindly labeled by a nonparticipant. Separate sets of blinded coded samples were assigned and randomized prior to testing. Each lay user was provided the package insert in English to perform the test, 1 blind labeled sample and a device. Results of the study are presented below:

Home Use Consumer studies data of Rapid Single-drug Test (AMP)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 500 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 750 | -25% | 60 | 8 | 52 | 87 | 7 | 53 | 88 |
| 1250 | +25% | 60 | 51 | 9 | 85 | 50 | 10 | 83 |
| 1500 | +50% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |
| 2000 | +100% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |

Home Use Consumer studies data of Rapid Multi-drug Test (AMP)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 500 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 750 | -25% | 60 | 6 | 54 | 90 | 9 | 51 | 85 |
| 1250 | +25% | 60 | 53 | 7 | 88 | 54 | 6 | 90 |
| 1500 | +50% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |
| 2000 | +100% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |

{28}

Home Use Consumer studies data of Rapid Single-drug Test (COC)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 150 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 225 | -25% | 60 | 5 | 55 | 92 | 6 | 54 | 90 |
| 375 | +25% | 60 | 54 | 6 | 90 | 56 | 4 | 93 |
| 450 | +50% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |
| 600 | +100% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |

Home Use Consumer studies data of Rapid Multi-drug Test (COC)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 150 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 225 | -25% | 60 | 4 | 56 | 93 | 6 | 54 | 90 |
| 375 | +25% | 60 | 53 | 7 | 88 | 56 | 4 | 93 |
| 450 | +50% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |
| 600 | +100% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |

Home Use Consumer studies data of Rapid Single-drug Test (MET)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 500 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 750 | -25% | 60 | 6 | 54 | 90 | 4 | 56 | 93 |
| 1250 | +25% | 60 | 53 | 7 | 88 | 55 | 5 | 92 |
| 1500 | +50% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |
| 2000 | +100% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |

Home Use Consumer studies data of Rapid Multi-drug Test (MET)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 500 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 750 | -25% | 60 | 5 | 55 | 92 | 4 | 56 | 93 |
| 1250 | +25% | 60 | 54 | 6 | 90 | 58 | 2 | 97 |
| 1500 | +50% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |
| 2000 | +100% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |

Home Use Consumer studies data of Rapid Single-drug Test (MOP2000)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 1000 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |

Page 29 of 33

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Home Use Consumer studies data of Rapid Multi-drug Test (MOP2000)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 1000 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 1500 | -25% | 60 | 7 | 53 | 88 | 6 | 54 | 90 |
| 2500 | +25% | 60 | 57 | 3 | 95 | 55 | 5 | 92 |
| 3000 | +50% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |
| 4000 | +100% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |

Home Use Consumer studies data of Rapid Single-drug Test (THC)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 25 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 37.5 | -25% | 60 | 7 | 53 | 88 | 6 | 54 | 90 |
| 62.5 | +25% | 60 | 50 | 10 | 83 | 52 | 8 | 87 |
| 75 | +50% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |
| 100 | +100% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |

Home Use Consumer studies data of Rapid Multi-drug Test (THC)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 25 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 37.5 | -25% | 60 | 8 | 52 | 87 | 4 | 56 | 93 |
| 62.5 | +25% | 60 | 53 | 7 | 88 | 54 | 6 | 90 |
| 75 | +50% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |
| 100 | +100% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |

Home Use Consumer studies data of Rapid Single-drug Test (BAR)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 150 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 225 | -25% | 60 | 5 | 55 | 92 | 6 | 54 | 90 |
| 375 | +25% | 60 | 54 | 6 | 90 | 56 | 4 | 93 |
| 450 | +50% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |
| 600 | +100% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |

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Home Use Consumer studies data of Rapid Multi-drug Test (BAR)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 150 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 225 | -25% | 60 | 4 | 56 | 93 | 5 | 55 | 92 |
| 375 | +25% | 60 | 57 | 3 | 95 | 54 | 6 | 90 |
| 450 | +50% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |
| 600 | +100% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |

Home Use Consumer studies data of Rapid Single-drug Test (BZO)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 150 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 225 | -25% | 60 | 7 | 53 | 88 | 8 | 52 | 87 |
| 375 | +25% | 60 | 56 | 4 | 93 | 55 | 5 | 92 |
| 450 | +50% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |
| 600 | +100% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |

Home Use Consumer studies data of Rapid Multi-drug Test (BZO)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 150 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 225 | -25% | 60 | 6 | 54 | 90 | 5 | 55 | 92 |
| 375 | +25% | 60 | 54 | 6 | 90 | 56 | 4 | 93 |
| 450 | +50% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |
| 600 | +100% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |

Home Use Consumer studies data of Rapid Single-drug Test (MDMA)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 250 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 375 | -25% | 60 | 6 | 54 | 90 | 5 | 55 | 92 |
| 625 | +25% | 60 | 53 | 7 | 88 | 56 | 4 | 93 |
| 750 | +50% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |
| 1000 | +100% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |

Home Use Consumer studies data of Rapid Multi-drug Test (MDMA)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 250 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |

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Home Use Consumer studies data of Rapid Single-drug Test (MTD)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 150 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 225 | -25% | 60 | 4 | 56 | 93 | 6 | 54 | 90 |
| 375 | +25% | 60 | 54 | 6 | 90 | 57 | 3 | 95 |
| 450 | +50% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |
| 600 | +100% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |

Home Use Consumer studies data of Rapid Multi-drug Test (MTD)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 150 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 225 | -25% | 60 | 3 | 57 | 95 | 5 | 55 | 92 |
| 375 | +25% | 60 | 56 | 4 | 93 | 54 | 6 | 90 |
| 450 | +50% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |
| 600 | +100% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |

Home Use Consumer studies data of Rapid Single-drug Test (OXY)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 50 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 75 | -25% | 60 | 4 | 56 | 93 | 5 | 55 | 92 |
| 125 | +25% | 60 | 57 | 3 | 95 | 56 | 4 | 93 |
| 150 | +50% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |
| 200 | +100% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |

Home Use Consumer studies data of Rapid Multi-drug Test (OXY)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 50 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 75 | -25% | 60 | 6 | 54 | 90 | 4 | 56 | 93 |
| 125 | +25% | 60 | 55 | 5 | 92 | 56 | 4 | 93 |
| 150 | +50% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |
| 200 | +100% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |

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Home Use Consumer studies data of Rapid Single-drug Test (PCP)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 12.5 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 18.8 | -25% | 60 | 3 | 57 | 95 | 4 | 56 | 93 |
| 31.3 | +25% | 60 | 54 | 6 | 90 | 56 | 4 | 93 |
| 37.5 | +50% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |
| 50 | +100% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |

Home Use Consumer studies data of Rapid Multi-drug Test (PCP)

| Conc (ng/mL) | % of cutoff | N | Dipcard | | Agreement (%) | Cup | | Agreement (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | | Positive | Negative | |
| 0 | Neg | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 12.5 | -50% | 60 | 0 | 60 | 100 | 0 | 60 | 100 |
| 18.8 | -25% | 60 | 6 | 54 | 90 | 5 | 55 | 92 |
| 31.3 | +25% | 60 | 57 | 3 | 95 | 54 | 6 | 90 |
| 37.5 | +50% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |
| 50 | +100% | 60 | 60 | 0 | 100 | 60 | 0 | 100 |

After testing, the participants were asked to fill out a questionnaire in English. The results showed that 100% of respondents stated the tests were easy to use and the instructions were clear. A SMOG readability assessment was performed on the Instructions Insert and resulted in a reading level of 6.

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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