ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD

K140215 · Co-Innovation Biotech Co., Ltd. · DIS · Jun 16, 2014 · Clinical Toxicology

Device Facts

• Record ID: K140215
• Device Name: ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD
• Applicant: Co-Innovation Biotech Co., Ltd.
• Product Code: DIS · Clinical Toxicology
• Decision Date: Jun 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3150
• Device Class: Class 2

Indications for Use

The One Step Single/Multi-drug Test Cup and One Step 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: Barbiturates (BAR) 300 ng/mL, Benzodiazepines (BZO) 300 ng/mL, Methylenedioxymeth-amphetamine (MDMA) 500 ng/mL, Methadone (MTD) 300 ng/mL, Oxycodone (OXY) 100 ng/mL, Phencyclidine (PCP) 25 ng/mL. The tests are available in one of two formats: 1) Test Cup, 2) Test Dipcard, The test configuration comes with a single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for prescription use in clinical laboratories only and not for point-of-care use. This assay provides 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; competitive binding principle. Input: human urine sample. Device detects presence of specific drugs/metabolites at or above defined cut-off levels. Output: visual qualitative result (presence/absence of drug). Used in clinical laboratories by professional staff. No instrumentation required. Results are preliminary; require GC/MS confirmation. Clinical judgment required for interpretation. Benefits: rapid screening for drug abuse in clinical settings.

Clinical Evidence

Bench testing only. Precision studies conducted at 3 hospital laboratories over 10 days using 3 lots. Method comparison study performed using 80 clinical urine specimens per analyte compared to GC/MS reference method. Discordant results analyzed. Analytical specificity (cross-reactivity) and exogenous interference studies performed.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding. Qualitative visual read. Shelf-life: 24 months at 4-30°C. No electronic components or software.

Indications for Use

Indicated for the qualitative detection of drugs of abuse (Barbiturates, Benzodiazepines, MDMA, Methadone, Oxycodone, Phencyclidine) and their metabolites in human urine at specified cut-off concentrations. Intended for prescription use in clinical laboratories only; not for point-of-care use.

Regulatory Classification

Identification

A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A barbiturate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Predicate Devices

• UCP Home™ Drug Screening Test Cards (K091588)
• UCP Home™ Drug Screening Test Cup (K091588)

Submission Summary (Full Text)

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

A. 510(k) Number:
k140215

B. Purpose for Submission:
New Device

C. Measurand:
Barbiturates, Benzodiazepine, Methamphetamine, Methadone, Opiate, and Phencyclidine.

D. Type of Test:
Qualitative lateral flow chromatographic immunoassay.

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

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

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DIS | Class II | 21 CFR part 862.3150
Barbiturate test system | Toxicology (91) |
| JXM | Class II | 21 CFR part 862.3170
Benzodiazepine test system | Toxicology (91) |
| DJC | Class II | 21 CFR part 862.3610
Methamphetamine test system | Toxicology (91) |
| DJR | Class II | 21 CFR part 862.3620
Methadone test system | Toxicology (91) |
| DJG | Class II | 21 CFR part 862.3650
Opiate test system | Toxicology (91) |
| LCM | Unclassified | Phencyclidine | Toxicology (91) |

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H. Intended Use:

1. Intended use(s):

See Indications for Use below.

2. Indication(s) for use:

The One Step Single/Multi-drug Test Cup and One Step 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 |
| --- | --- | --- |
| Barbiturates (BAR) | Secobarbital | 300 ng/mL |
| Benzodiazepines (BZO) | Oxazepam | 300 ng/mL |
| Methylenedioxymeth-amphetamine (MDMA) | 3,4-Methylenedioxy-methamphetamine | 500 ng/mL |
| Methadone (MTD) | Methadone | 300 ng/mL |
| Oxycodone (OXY) | Oxycodone | 100 ng/mL |
| Phencyclidine (PCP) | Phencyclidine | 25 ng/mL |

The tests are available in one of two formats: 1) Test Cup, 2) Test Dipcard, The test configuration comes with a single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for prescription use in clinical laboratories only and not for point-of-care use.

This assay provides 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 in Clinical Laboratories.

4. Special instrument requirements:

Not applicable; this is a visually read single use device.

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I. Device Description:

The One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitative detection of Barbiturates, Benzodiazepines, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine and their metabolites in human urine at or above the cut-off levels as indicated. The devices are available in one of two formats: 1) Test Cup, 2) Test Dipcard. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The tests are visually read.

J. Substantial Equivalence Information:

1. Predicate device name(s):

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

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

k091588

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device | Predicate |
| Indication for use | Qualitative detection of drugs-of-abuse in urine (Barbiturates, Benzodiazepines, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine) | Same |
| Intended Users | Prescription Use | Over the Counter (OTC) Use and Prescription Use |
| Specimen | Urine | Same |
| Cutoff | Barbiturates:300 ng/mL Benzodiazepines:300 ng/mL Methylenedioxymethamphetamine:500 ng/mL Methadone:300 ng/mL Oxycodone:100 ng/mL Phencyclidine:25 ng/mL | Same |
| Read time | 5 minutes | Same |
| Results | Qualitative | Same |

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| Methodology | Competitive binding, Lateral flow immunochromatographic assay based on the principle of antigen antibody immunochemistry | Same |
| --- | --- | --- |
| Configuration | Dipcard and Cup | Same |
| Differences | | |
| Item | Candidate Device | Predicate |
| The number of analytes in each device | 6 analytes | 12 analytes |

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

None were referenced.

# L. Test Principle:

The One Step Single/Multi-drug Test Cup and the One Step 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 positive result. Each strip in the 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:

Initial precision studies were performed using the single drug and multi-drug test formats. For these studies, drug free urine specimens were spiked with drug analyte at different concentrations containing 0, +/- 75% cutoff, +/- 50% cutoff, +/- 25% cutoff, +100% cutoff and cutoff of drug. The concentrations of the target drug were confirmed with GC/MS. In both the single drug test precision study and the multi-drug test precision study each concentration of urine specimen was divided into aliquots. Each aliquot was blindly labeled with a separate number by a nonparticipant and each aliquot was tested with one test format only (test dipcard or test cup). The study was conducted at 3 hospital laboratories. Two operators per location tested 3 aliquots at each concentration for each lot per day (3runs/day) for 10 non-consecutive days using one device lot per location. One operator tested the test dipcard format and

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the second operator tested the test cup format. Results from these initial studies are presented in the following tables:

Precision data of One Step Single-drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/ml | -25%cutoff | 60 | 6 | 54 | 8 | 52 | 4 | 56 |
| 300ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 38 | 22 |
| 375ng/ml | +25%cutoff | 60 | 52 | 8 | 54 | 6 | 52 | 8 |
| 450ng/ml | +50%cutoff | 60 | 58 | 2 | 60 | 0 | 56 | 4 |
| 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Single-drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/ml | -25%cutoff | 60 | 6 | 54 | 8 | 52 | 6 | 54 |
| 300ng/ml | cutoff | 60 | 36 | 24 | 36 | 24 | 36 | 24 |
| 375ng/ml | +25%cutoff | 60 | 54 | 6 | 54 | 6 | 52 | 8 |
| 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 56 | 4 |
| 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Multi-drug Test Dipcard (For BAR)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 4 | 56 | 6 | 54 | 8 | 52 |
| 1000ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 36 | 24 |
| 1250ng/ml | +25%cutoff | 60 | 52 | 8 | 54 | 6 | 54 | 6 |
| 1500ng/ml | +50%cutoff | 60 | 56 | 4 | 58 | 2 | 60 | 0 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Multi-drug Test Cup (For BAR)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 6 | 54 | 4 | 56 | 4 | 56 |
| 1000ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 36 | 24 |
| 1250ng/ml | +25%cutoff | 60 | 52 | 8 | 54 | 6 | 56 | 4 |
| 1500ng/ml | +50%cutoff | 60 | 58 | 2 | 56 | 4 | 60 | 0 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Single-drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/ml | -25%cutoff | 60 | 8 | 52 | 4 | 56 | 6 | 54 |
| 300ng/ml | cutoff | 60 | 38 | 22 | 34 | 26 | 36 | 24 |
| 375ng/ml | +25%cutoff | 60 | 54 | 6 | 52 | 8 | 52 | 8 |
| 450ng/ml | +50%cutoff | 60 | 56 | 4 | 58 | 2 | 60 | 0 |
| 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Single-drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/ml | -25%cutoff | 60 | 10 | 50 | 6 | 54 | 8 | 52 |
| 300ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 36 | 24 |
| 375ng/ml | +25%cutoff | 60 | 52 | 8 | 54 | 6 | 56 | 4 |
| 450ng/ml | +50%cutoff | 60 | 56 | 4 | 60 | 0 | 60 | 0 |
| 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Multi-drug Test Dipcard (For BZO)

| 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 | 60 | 0 | 60 | 0 | 60 | 0 |
| 250ng/ml | -75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 4 | 56 | 4 | 56 | 6 | 54 |
| 1000ng/ml | cutoff | 60 | 34 | 26 | 34 | 26 | 38 | 22 |
| 1250ng/ml | +25%cutoff | 60 | 54 | 6 | 54 | 6 | 52 | 8 |
| 1500ng/ml | +50%cutoff | 60 | 58 | 2 | 56 | 4 | 58 | 2 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 60 | 0 | 60 | 0 | 60 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 60 | 0 | 60 | 0 | 60 |

Precision data of One Step Multi-drug Test Cup (For BZO)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 6 | 54 | 8 | 52 | 6 | 54 |
| 1000ng/ml | cutoff | 60 | 38 | 22 | 34 | 26 | 36 | 24 |
| 1250ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 54 | 6 |
| 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 56 | 4 | 58 | 2 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Single-drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 250ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 375ng/ml | -25%cutoff | 60 | 10 | 50 | 8 | 52 | 8 | 52 |
| 500ng/ml | cutoff | 60 | 34 | 26 | 32 | 28 | 36 | 24 |
| 625ng/ml | +25%cutoff | 60 | 48 | 12 | 52 | 8 | 50 | 10 |
| 750ng/ml | +50%cutoff | 60 | 56 | 4 | 54 | 6 | 54 | 6 |
| 875ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Single drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 250ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 375ng/ml | -25%cutoff | 60 | 6 | 54 | 8 | 52 | 10 | 50 |
| 500ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 32 | 28 |
| 625ng/ml | +25%cutoff | 60 | 52 | 8 | 50 | 10 | 48 | 12 |
| 750ng/ml | +50%cutoff | 60 | 58 | 2 | 56 | 4 | 54 | 6 |
| 875ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Multi-drug Test Dipcard (For MDMA)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 8 | 52 | 10 | 50 | 10 | 50 |
| 1000ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 32 | 28 |
| 1250ng/ml | +25%cutoff | 60 | 52 | 8 | 48 | 12 | 50 | 10 |
| 1500ng/ml | +50%cutoff | 60 | 54 | 6 | 56 | 4 | 58 | 2 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Multi-drug Test Cup (For MDMA)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 750ng/ml | -25%cutoff | 60 | 60 | 10 | 50 | 8 | 52 | 6 |
| 1000ng/ml | cutoff | 60 | 60 | 36 | 24 | 32 | 28 | 34 |
| 1250ng/ml | +25%cutoff | 60 | 60 | 50 | 10 | 54 | 6 | 52 |
| 1500ng/ml | +50%cutoff | 60 | 60 | 56 | 4 | 58 | 2 | 58 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Single-Drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/ml | -25%cutoff | 60 | 6 | 54 | 8 | 52 | 10 | 50 |
| 300ng/ml | cutoff | 60 | 32 | 28 | 34 | 26 | 36 | 24 |
| 375ng/ml | +25%cutoff | 60 | 50 | 10 | 52 | 8 | 54 | 6 |
| 450ng/ml | +50%cutoff | 60 | 56 | 4 | 54 | 6 | 58 | 2 |
| 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Single-Drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/ml | -25%cutoff | 60 | 8 | 52 | 6 | 54 | 6 | 54 |
| 300ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 36 | 24 |
| 375ng/ml | +25%cutoff | 60 | 54 | 6 | 52 | 8 | 54 | 6 |
| 450ng/ml | +50%cutoff | 60 | 58 | 2 | 56 | 4 | 58 | 2 |
| 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Multi-drug Test Dipcard (For MTD)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 6 | 54 | 10 | 50 | 8 | 52 |
| 1000ng/ml | cutoff | 60 | 32 | 28 | 36 | 24 | 34 | 26 |
| 1250ng/ml | +25%cutoff | 60 | 54 | 6 | 50 | 10 | 52 | 8 |
| 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 58 | 2 | 56 | 4 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Multi-drug Test Cup (For MTD)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 6 | 54 | 8 | 52 | 6 | 54 |
| 1000ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 34 | 26 |
| 1250ng/ml | +25%cutoff | 60 | 52 | 8 | 54 | 6 | 54 | 6 |
| 1500ng/ml | +50%cutoff | 60 | 56 | 4 | 58 | 2 | 56 | 4 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Single-drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 50ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/ml | -25%cutoff | 60 | 6 | 54 | 2 | 58 | 4 | 56 |
| 100ng/ml | cutoff | 60 | 34 | 26 | 38 | 22 | 36 | 24 |
| 125ng/ml | +25%cutoff | 60 | 56 | 4 | 56 | 4 | 58 | 2 |
| 150ng/ml | +50%cutoff | 60 | 58 | 2 | 58 | 2 | 60 | 0 |
| 175ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 200ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Single-drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 50ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/ml | -25%cutoff | 60 | 4 | 56 | 4 | 56 | 6 | 54 |
| 100ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 38 | 22 |
| 125ng/ml | +25%cutoff | 60 | 58 | 2 | 56 | 4 | 56 | 4 |
| 150ng/ml | +50%cutoff | 60 | 60 | 0 | 58 | 2 | 58 | 2 |
| 175ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 200ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Multi-drug Test Dipcard (For OXY)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 2 | 58 | 6 | 54 | 4 | 56 |
| 1000ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 34 | 26 |
| 1250ng/ml | +25%cutoff | 60 | 56 | 4 | 58 | 2 | 58 | 2 |
| 1500ng/ml | +50%cutoff | 60 | 58 | 2 | 60 | 0 | 60 | 0 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Multi-drug Test Cup (For OXY)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 6 | 54 | 4 | 56 | 6 | 54 |
| 1000ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 36 | 24 |
| 1250ng/ml | +25%cutoff | 60 | 58 | 2 | 58 | 2 | 56 | 4 |
| 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 58 | 2 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Single-drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 12.5ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 18.8ng/ml | -25%cutoff | 60 | 4 | 56 | 2 | 58 | 4 | 56 |
| 25ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 32 | 28 |
| 31.3ng/ml | +25%cutoff | 60 | 52 | 8 | 54 | 6 | 54 | 6 |
| 37.5ng/ml | +50%cutoff | 60 | 56 | 4 | 60 | 0 | 58 | 2 |
| 43.8ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 50ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Single-drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 12.5ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 18.8ng/ml | -25%cutoff | 60 | 4 | 56 | 4 | 56 | 2 | 58 |
| 25ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 38 | 22 |
| 31.3ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 58 | 2 |
| 37.5ng/ml | +50%cutoff | 60 | 58 | 2 | 58 | 2 | 60 | 0 |
| 43.8ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 50ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Multi-drug Test Dipcard (For PCP)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 2 | 58 | 4 | 56 | 2 | 58 |
| 1000ng/ml | cutoff | 60 | 38 | 22 | 32 | 28 | 34 | 26 |
| 1250ng/ml | +25%cutoff | 60 | 54 | 6 | 52 | 8 | 56 | 4 |
| 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 58 | 2 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Multi-drug Test Cup (For PCP)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 2 | 58 | 2 | 58 | 4 | 56 |
| 1000ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 34 | 26 |
| 1250ng/ml | +25%cutoff | 60 | 58 | 2 | 54 | 6 | 56 | 4 |
| 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 58 | 2 | 60 | 0 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

The original precision study data showed numerous negative results in the specimens containing drug concentrations at $+50\%$ above the cutoff. A root cause analysis was conducted by the sponsor to determine the cause of these results. The root cause was identified to be inconsistent and inadequate volume of aliquoted samples. The sponsor revised the precision study protocol to specify a sample volume per vial and supplemental precision studies were conducted to verify that the root cause was

{16}

correctly identified.

Supplemental precision studies were conducted for the single drug and multi-drug test formats using drug free urine specimens spiked with one drug analyte at different concentrations containing 0, +/- 75% cutoff, +/- 50% cutoff, +/- 25% cutoff, +100% cutoff and cutoff of drug. The concentrations of the target drug were confirmed with GC/MS. In both the single drug test precision study and the multi-drug test precision study each concentration of urine specimen was divided into aliquots. Each aliquot was blindly labeled with a separate number by a nonparticipant and each aliquot was tested with one test format only (test dipcard or test cup). The study was conducted at 3 hospital laboratories. Two operators per location tested 3 aliquots at each concentration for each lot per day (3runs/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 supplemental precision studies are presented in the following tables:

Precision data of One Step Single-drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/ml | -25%cutoff | 60 | 6 | 54 | 4 | 56 | 6 | 54 |
| 300ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 38 | 22 |
| 375ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 54 | 6 |
| 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Single-drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/ml | -25%cutoff | 60 | 6 | 54 | 4 | 56 | 6 | 54 |
| 300ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 38 | 22 |
| 375ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 54 | 6 |
| 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Multi-drug Test Dipcard (For BAR)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 6 | 54 | 4 | 56 | 4 | 56 |
| 1000ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 36 | 24 |
| 1250ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 56 | 4 |
| 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Multi-drug Test Cup (For BAR)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 6 | 54 | 4 | 56 | 4 | 56 |
| 1000ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 36 | 24 |
| 1250ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 56 | 4 |
| 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Single-drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/ml | -25%cutoff | 60 | 6 | 54 | 4 | 56 | 4 | 56 |
| 300ng/ml | cutoff | 60 | 38 | 22 | 40 | 20 | 36 | 24 |
| 375ng/ml | +25%cutoff | 60 | 54 | 6 | 54 | 6 | 56 | 4 |
| 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Single-drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/ml | -25%cutoff | 60 | 6 | 54 | 8 | 52 | 4 | 56 |
| 300ng/ml | cutoff | 60 | 36 | 24 | 36 | 24 | 38 | 22 |
| 375ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 58 | 2 |
| 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Multi-drug Test Dipcard (For BZO)

| 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 | 60 | 0 | 60 | 0 | 60 | 0 |
| 250ng/ml | -75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 500ng/ml | -50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 750ng/ml | -25%cutoff | 60 | 60 | 4 | 56 | 6 | 54 | 8 |
| 1000ng/ml | cutoff | 60 | 60 | 36 | 24 | 38 | 22 | 34 |
| 1250ng/ml | +25%cutoff | 60 | 60 | 56 | 4 | 54 | 6 | 54 |
| 1500ng/ml | +50%cutoff | 60 | 60 | 60 | 0 | 60 | 0 | 60 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 60 | 0 | 60 | 0 | 60 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 60 | 0 | 60 | 0 | 60 |

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Precision data of One Step Multi-drug Test Cup (For BZO)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 6 | 54 | 4 | 56 | 4 | 56 |
| 1000ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 36 | 24 |
| 1250ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 58 | 2 |
| 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Single-drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 250ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 375ng/ml | -25%cutoff | 60 | 8 | 52 | 6 | 54 | 4 | 56 |
| 500ng/ml | cutoff | 60 | 34 | 26 | 34 | 26 | 36 | 24 |
| 625ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 58 | 2 |
| 750ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 875ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Single drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 250ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 375ng/ml | -25%cutoff | 60 | 6 | 54 | 4 | 56 | 8 | 52 |
| 500ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 34 | 26 |
| 625ng/ml | +25%cutoff | 60 | 56 | 4 | 58 | 2 | 54 | 6 |
| 750ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 875ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Multi-drug Test Dipcard (For MDMA)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 6 | 54 | 8 | 52 | 6 | 54 |
| 1000ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 34 | 26 |
| 1250ng/ml | +25%cutoff | 60 | 58 | 2 | 56 | 4 | 54 | 6 |
| 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Multi-drug Test Cup (For MDMA)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 6 | 54 | 4 | 56 | 8 | 52 |
| 1000ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 34 | 26 |
| 1250ng/ml | +25%cutoff | 60 | 56 | 4 | 58 | 2 | 54 | 6 |
| 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Single-Drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/ml | -25%cutoff | 60 | 6 | 54 | 6 | 54 | 8 | 52 |
| 300ng/ml | cutoff | 60 | 34 | 26 | 32 | 28 | 36 | 24 |
| 375ng/ml | +25%cutoff | 60 | 52 | 8 | 54 | 6 | 56 | 4 |
| 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Single-Drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 225ng/ml | -25%cutoff | 60 | 6 | 54 | 4 | 56 | 6 | 54 |
| 300ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 38 | 22 |
| 375ng/ml | +25%cutoff | 60 | 56 | 4 | 58 | 2 | 56 | 4 |
| 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Multi-drug Test Dipcard (For MTD)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 4 | 56 | 8 | 52 | 6 | 54 |
| 1000ng/ml | cutoff | 60 | 38 | 22 | 34 | 26 | 36 | 24 |
| 1250ng/ml | +25%cutoff | 60 | 58 | 2 | 54 | 6 | 56 | 4 |
| 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Multi-drug Test Cup (For MTD)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 6 | 54 | 6 | 54 | 4 | 56 |
| 1000ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 38 | 22 |
| 1250ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 58 | 2 |
| 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Single-drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 50ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/ml | -25%cutoff | 60 | 6 | 54 | 4 | 56 | 2 | 58 |
| 100ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 36 | 24 |
| 125ng/ml | +25%cutoff | 60 | 56 | 4 | 58 | 2 | 58 | 2 |
| 150ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 175ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 200ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Single-drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 50ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/ml | -25%cutoff | 60 | 2 | 58 | 4 | 56 | 6 | 54 |
| 100ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 36 | 24 |
| 125ng/ml | +25%cutoff | 60 | 58 | 2 | 56 | 4 | 58 | 2 |
| 150ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 175ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 200ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Multi-drug Test Dipcard (For OXY)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 2 | 58 | 4 | 56 | 4 | 56 |
| 1000ng/ml | cutoff | 60 | 38 | 22 | 38 | 22 | 36 | 24 |
| 1250ng/ml | +25%cutoff | 60 | 58 | 2 | 56 | 4 | 56 | 4 |
| 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Multi-drug Test Cup (For OXY)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 4 | 56 | 2 | 58 | 2 | 58 |
| 1000ng/ml | cutoff | 60 | 38 | 22 | 40 | 20 | 36 | 24 |
| 1250ng/ml | +25%cutoff | 60 | 58 | 2 | 56 | 4 | 58 | 2 |
| 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Single-drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 12.5ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 18.8ng/ml | -25%cutoff | 60 | 2 | 58 | 4 | 56 | 2 | 58 |
| 25ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 36 | 24 |
| 31.3ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 58 | 2 |
| 37.5ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 43.8ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 50ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Single-drug (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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 12.5ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 18.8ng/ml | -25%cutoff | 60 | 4 | 56 | 2 | 58 | 4 | 56 |
| 25ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 38 | 22 |
| 31.3ng/ml | +25%cutoff | 60 | 56 | 4 | 58 | 2 | 58 | 2 |
| 37.5ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 43.8ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 50ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

Precision data of One Step Multi-drug Test Dipcard (For PCP)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 4 | 56 | 2 | 58 | 4 | 56 |
| 1000ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 38 | 22 |
| 1250ng/ml | +25%cutoff | 60 | 56 | 4 | 56 | 4 | 58 | 2 |
| 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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Precision data of One Step Multi-drug Test Cup (For PCP)

| 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%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 750ng/ml | -25%cutoff | 60 | 6 | 54 | 4 | 56 | 2 | 58 |
| 1000ng/ml | cutoff | 60 | 36 | 24 | 36 | 24 | 38 | 22 |
| 1250ng/ml | +25%cutoff | 60 | 58 | 2 | 56 | 4 | 54 | 6 |
| 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |

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 One Step Single/Multi-drug Test Cup and the One Step 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 $4 \sim 30^{\circ} \mathrm{C}$ for both the Test Cup and Dipcard formats.

d. Detection limit:

Not applicable these are qualitative devices.

e. Analytical specificity:

I. Cross Reactivity with related substances

Analytical Cross-reactivity (specificity) studies were conducted. Drugs and drug metabolites within the same class of drugs, or with similar molecular structures that may cross-react were studied. When a positive result from a compound was observed, the interferent was serially diluted with a drug-free specimen until a

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negative result was obtained. The concentration of the compounds that produced a response approximately equivalent to the cutoff concentrations of the assay 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 in the tables below.

Barbiturates (BAR) Test

| Compound | Concentration equivalent to cutoff(ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Secobarbital | 300 | 100% |
| Amobarbital | 500 | 60% |
| Alphenol | 150 | 200% |
| Aprobarbital | 200 | 150% |
| Butabarbital | 75 | 400% |
| Butalbital | 1,500 | 20% |
| Butethal | 100 | 300% |
| Cyclopentobarbital | 600 | 50% |
| Pentobarbital | 700 | 42.9% |
| Phenobarbital | 300 | 100% |

Benzodiazepines (BZO) Test

| Compound | Concentration equivalent to cutoff(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% |

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31

| 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% |

Methylenedioxymethamphetamine (MDMA) Test

| Compound | Concentration equivalent to cutoff(ng/mL) | % Cross- Reactivity |
| --- | --- | --- |
| (+/-)3,4Methylenedioxymethamphetamine (MDMA) | 500 | 100% |
| 3,4-methylenedioxy-amphetamine (MDA) | 2200 | 22.7% |
| 3,4-Methylenedioxy ethylamphetamine (MDEA) | 240 | 208.3% |
| D-methamphetamine (MAMP) | 100000 | 0.5% |
| The compound (D-Amphetamine) showed no cross-reactivity in the assay at a concentration of 100000 ng/mL. | | |

Methadone (MTD) Test

| Compound | Concentration equivalent to cutoff(ng/mL) | % Cross- Reactivity |
| --- | --- | --- |
| Methadone | 300 | 100% |
| (+/-)2-Ethylidene-1,5-dimethyl- 3,3-diphenylpyrrolinium | 50000 | 0.6% |
| Doxylamine | 50000 | 0.6% |

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Oxycodone (OXY) Test

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

Phencyclidine (PCP) Test

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

## II. Exogenous Interference

Drug free specimens containing drug concentrations at +/- 50% of the cutoff were spiked with each compound at a concentration of 100 ug/mL. The concentrations of target drug were confirmed with GC/MS. Each sample was tested in 3 replicates. The common compounds listed in this table were found not to interfere with test results at a test concentration of 100 µg/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 |

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| 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 | Sulindac |
| Cimetidine | Lisinopril | Tetracycline |
| Citalopram | Loperamide | Tetrahydrozoline |
| Cortisone | Meperidine | Thioridazine |
| Creatinine | Meprobamate | d, l-Thyroxine |
| Deoxycorticosterone | Methoxyphenamine | Tolbutamine |
| Dexamethasone | Methylphenidate | Tolbutamide |
| Dextromethorphan | Nadolol | Trifluoperazine |
| Diclofenac | Nalidixic acid | Tryptamine |
| Diflunisal | Naproxen | Uric acid |
| Digoxin | Niacinamide | Verapamil |
| Diphenhydramine | Nicotine | Zomepirac |
| Ephedrine | Nifedipine | |

pH and specific gravity conditions:

To evaluate the effects of variable range of pH and specific gravity conditions that might exist within the body, two pools of specimen were altered to reflect the physiological conditions. One pool was altered to contain a drug concentration $+50\%$ of the cutoff and the other pool was altered to contain a drug concentration $-50\%$ of the cutoff. The performances of the test device under varying pH (3-9) and specific gravity $(0.900 - 1.050~\mathrm{g / mL})$ conditions were studied and it was observed that pH ranges from pH 3 to pH 9 and specific gravity ranges from $1.002 - 1.040~\mathrm{g / mL}$ did not affect the expected testing results.

# f. Assay cut-off:

The test cut-off was determined according to the precision study. See precision studies above in section 1.M.1.a.

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2. Comparison studies:

a. Method comparison with predicate device:

The study was performed using unaltered clinical urine specimens compared to GC/MS. Samples were divided by concentration into five categories as stated in the tables below. The samples were further 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. Tests were performed at two hospital laboratories by 4 lab technicians (2 operators per site). One site tested the dipcard format and the other site tested the test cup format. For each drug analyte, a total of 80 specimens were tested using the single-drug and multi-drug test dipcard and the test cup formats. The results are presented below:

Comparison Data of One Step Single drug Test Cup

| One Step Single drug Test Cup | GC/MS | | | | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Drug free by GC/MS analysis | Less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative Between 50% below the cutoff and the cutoff concentration | Near Cutoff Positive Between the cutoff and 50% above the cutoff concentration | | High Positive greater than 50% above the cutoff concentration |
| 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 | |

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Analysis of Discordant Results with One Step Single drug Test Cup

| One Step Single drug Test Cup | | | GC/MS Analysis | |
| --- | --- | --- | --- | --- |
| Drug Test | Cutoff (ng/mL) | Test Result | Drug Concentration (ng/mL) | Drug in Urine |
| BZO | 300 | Positive | 188 | Oxazepam |
| MDMA | 500 | Negative | 715 | 3,4-Methylenedioxy-methamphetamine |
| MTD | 300 | Positive | 209 | Methadone |
| PCP | 25 | Positive | 23 | Phencyclidine |

Comparison Data of One Step Single drug Test Dipcard

| One Step Single drug Test Dipcard | GC/MS | | | | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Drug free by GC/MS analysis | Less than half the cutoff concentration by GC/MS | Near Cutoff Negative Between 50% below the cutoff and the cutoff | Near Cutoff Positive Between the cutoff and 50% above the cutoff concentration | | High Positive greater than 50% above the cutoff concentration |
| 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 | |

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Analysis of Discordant Results with One Step Single drug Test Dipcard

| One Step Single drug Test Dipcard | | | GC/MS Analysis | |
| --- | --- | --- | --- | --- |
| Drug Test | Cutoff (ng/mL) | Test Result | Drug Concentration (ng/mL) | Drug in Urine |
| BZO | 300 | Positive | 188 | Oxazepam |
| MDMA | 500 | Negative | 715 | 3,4-Methylenedioxy-methamphetamine |
| MTD | 300 | Positive | 209 | Methadone |
| PCP | 25 | Positive | 23 | Phencyclidine |

Comparison Data of One Step Multi drug Test Cup

| One Step Multi drug Test Cup | GC/MS | | | | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Drug free by GC/MS analysis | Less than half the cutoff concentration by GC/MS | Near Cutoff Negative Between 50% below the cutoff and the cutoff | Near Cutoff Positive Between the cutoff and 50% above the cutoff concentration | | High Positive greater than 50% above the cutoff concentration |
| 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 | |

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Analysis of Discordant Results with One Step Multi drug Test Cup

| One Step Multi-drug Test Cup | | | GC/MS Analysis | |
| --- | --- | --- | --- | --- |
| Drug Test | Cutoff (ng/mL) | Test Result | Drug Concentration (ng/mL) | Drug in Urine |
| BZO | 300 | Positive | 188 | Oxazepam |
| MDMA | 500 | Negative | 715 | 3,4-Methylenedioxy-methamphetamine |
| MTD | 300 | Positive | 209 | Methadone |
| PCP | 25 | Positive | 23 | Phencyclidine |

Comparison Data of One Step Multi drug Test Dipcard

| One Step Multi drug Test Dipcard | GC/MS | | | | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Drug free by GC/MS analysis | Less than half the cutoff concentration by GC/MS | Near Cutoff Negative Between 50% below the cutoff and the cutoff | Near Cutoff Positive Between the cutoff and 50% above the cutoff concentration | | High Positive greater than 50% above the cutoff concentration |
| 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 | |

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38

Analysis of Discordant Results with One Step Multi-drug Test Dipcard

| One Step Multi-drug Test Dipcard | | | GC/MS Analysis | |
| --- | --- | --- | --- | --- |
| Drug Test | Cutoff (ng/mL) | Test Result | Drug Concentration (ng/mL) | Drug in Urine |
| BZO | 300 | Positive | 188 | Oxazepam |
| MDMA | 500 | Negative | 715 | 3,4-Methylenedioxy-methamphetamine |
| MTD | 300 | Positive | 209 | Methadone |
| PCP | 25 | Positive | 23 | Phencyclidine |

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):
Not applicable.

4. Clinical cut-off:
Not applicable.

5. Expected values/Reference range:
Not applicable.

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

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