← Product Code [NFT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NFT) · K182530

# BIOEASY Multi-Drug Test Cup (K182530)

_Shenzhen Bioeasy Biotechnology Co., Ltd. · NFT · Nov 9, 2018 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NFT/K182530

## Device Facts

- **Applicant:** Shenzhen Bioeasy Biotechnology Co., Ltd.
- **Product Code:** [NFT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NFT.md)
- **Decision Date:** Nov 9, 2018
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3100
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of: Drug(Identifier) Cut-off level Amphetamine 1000 ng/mL Oxazepam 300 ng/mL Cocaine 300 ng/mL Marijuana 50 ng/mL Methamphetamine 1000 ng/mL Morphine 300 ng/mL Oxycodone 100 ng/mL Secobarbital 300 ng/mL Buprenorphine 10 ng/mL Methylenedioxy-methamphetamine 500 ng/mL Phencyclidine 25 ng/mL Methadone 300 ng/mL Nortriptyline 1000 ng/mL d-Propoxyphene 300 ng/mL Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

## Device Story

Single-use lateral flow immunochromatographic assay cup for qualitative detection of drugs of abuse in human urine; utilizes competitive binding principle with monoclonal antibodies. Urine sample migrates via capillary action; target drugs below cutoff saturate binding sites, allowing antibody-coated particles to bind immobilized drug-conjugate, forming visible test line. Target drugs above cutoff saturate antibody sites, preventing test line formation. Control line confirms proper test performance. Used in point-of-care or home settings by lay users or professionals. Provides preliminary results; requires GC/MS or LC/MS confirmation. Aids in identifying potential drug presence for clinical consideration.

## Clinical Evidence

No clinical studies performed. Analytical performance validated via precision/reproducibility studies (25 days, 2 runs/day) and method comparison studies against LC/MS using 80 clinical samples per analyte. Lay user study conducted with 300 participants across diverse demographics, demonstrating high accuracy (90-100%) across various drug concentrations relative to cutoffs. Flesch-Kincaid reading grade level of 7 achieved for package insert.

## Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Single-use urine cup form factor. Materials: monoclonal mouse antibodies, drug-conjugates. Stability: 24 months at 4-30°C. No electronic components or software algorithms.

## Regulatory 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

- Rapid Single/Multi-drug Test Cup (k153050)

## Submission Summary (Full Text)

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

A. 510(k) Number:
k182530

B. Purpose for Submission
New device

C. Measurand
Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine. Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline, d-Propoxyphene.

D. Type of Test
Qualitative immunochromatographic assay

E. Applicant
Shenzhen Bioeasy Biotechnology Co., Ltd

F. Proprietary and Established Names
BIOEASY Multi-Drug Test Cup

G. Regulatory Information
|  Product Code | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  NFT Amphetamine | II | 21 CFR § 862.3100, Amphetamine Test System | Toxicology (91)  |
|  NFW Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids Test System | Toxicology (91)  |
|  NFY Cocaine | II | 21 CFR § 862.3250, Cocaine and Cocaine Metabolites Test System | Toxicology (91)  |
|  NGG Methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91)  |
|  NGI Morphine | II | 21 CFR § 862.3640, Morphine Test System | Toxicology (91)  |

1

{1}

2

|  Product Code | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  NFV
Oxazepam | II | 21 CFR § 862.3170,
Benzodiazepine Test System | Toxicology (91)  |
|  NGL
Oxycodone | II | 21 CFR § 862.3650,
Opiate Test System | Toxicology (91)  |
|  PTH
Secobarbital | II | 21 CFR § 862.3150,
Barbiturate Test System | Toxicology (91)  |
|  NGL
Buprenorphine | II | 21 CFR § 862.3650,
Opiate Test System | Toxicology (91)  |
|  NGG
Methylenedioxy-methamphetamine | II | 21 CFR § 862.3610,
Methamphetamine Test System | Toxicology (91)  |
|  NGM
Phencyclidine | unclassified | Enzyme Immunoassay
Phencyclidine | Toxicology (91)  |
|  PTG
Methadone | II | 21 CFR § 862.3620,
Methadone Test System | Toxicology (91)  |
|  QAW
Nortriptyline | II | 21 CFR, 862.3910,
Tricyclic Antidepressant Drugs Test
System | Toxicology (91)  |
|  QBF
Propoxyphene | II | 21 CFR, 862.3700,
Propoxyphene Test System | Toxicology (91)  |

## H. Intended Use

1. Intended Use

See Indications for Use below.

2. Indications for Use

BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative ad simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

|  Drug Identifier | Cut-off Level  |
| --- | --- |
|  Amphetamine | 1000ng/mL  |
|  Oxazepam | 300 ng/mL  |
|  Cocaine | 300 ng/mL  |
|  Marijuana | 50 ng/mL  |
|  Methamphetamine | 1000 ng/mL  |
|  Morphine | 300 ng/mL  |
|  Oxycodone | 100 ng/mL  |

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|  Drug Identifier | Cut-off Level  |
| --- | --- |
|  Secobarbital | 300 ng/mL  |
|  Buprenorphine | 10 ng/mL  |
|  Methylenedioxy-methamphetamine | 500 ng/mL  |
|  Phencyclidine | 25 ng/ml  |
|  Methadone | 300 ng/ml  |
|  Nortriptyline | 1000 ng/mL  |
|  d-Propoxyphene | 300 ng/mL  |

Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

I. Device Description:

The BIOEASY Multi-Drug Test Cup tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamines, Oxazepam, Cocaine, Marijuana, Methamphetamines, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline, and d-Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device, a package insert, and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

J. Substantial Equivalence Information:

1. Predicate device name:

Rapid Single/Multi-drug Test Cup

2. Predicate 510(k) number

k153050

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3. Comparison with predicate:

Similarities:

|  Item | Device | Predicate - k153050  |
| --- | --- | --- |
|  Indication(s) for Use | For the qualitative determination of drugs of abuse in human urine. | Same  |
|  Calibrator and Cut-Off Values | Amphetamine (AMP): 1,000 ng/ml
Oxazepam (BZO): 300 ng/ml
Cocaine(COC): 300 ng/ml
Marijuana (THC): 50 ng/ml
Methamphetamine (MET): 1,000 ng/ml
Morphine (MOR): 300 ng/ml
Oxycodone(OXY): 100 ng/ml
Secobarbital (BAR): 300 ng/ml
Buprenorphine (BUP): 10 ng/ml
Methylenedioxy-methamphetamine(MDMA): 500 ng/ml
Phencyclidine (PCP): 25 ng/ml
Methadone (MTD): 300 ng/ml
Nortriptyline (TCA): 1000 ng/ml
Propoxyphene (PPX): 300 ng/ml | Same  |
|  Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same  |
|  Type of Test | Qualitative | Same  |
|  Specimen Type | Human Urine | Same  |
|  Intended Use | For over-the-counter | Same  |
|  Configurations | Cup | Same  |

Differences:

|  Item | Device | Predicate - k153050  |
| --- | --- | --- |
|  Number of drugs detected | 14 drugs of abuse | 16 drugs of abuse  |

K. Standard/Guidance Document Referenced (if applicable)

None identified.

4

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L. Test Principle:

The BIOEASY Multi-Drug Test Cup is a lateral flow chromatographic immunoassay. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test region. The colored line will not form in the test line region if the target drug level exceeds its cut-off concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate the tests have been performed properly.

M. Performance Characteristics (if/when applicable):

1. Analytical Performance

a. Precision Reproducibility

Precision studies were conducted for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off. The samples were prepared by spiking drug into negative urine samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and did not take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results are summarized in the following tables:

Amphetamine

|  Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cut off | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |

Secobarbital

|  Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cut off | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |

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Buprenorphine

|  Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cut off | cut off | +25% cut off | +50% cut off | + 75% cut off | +100% cut off  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |

Oxazepam

|  Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cut off | cut off | +25% cut off | +50% cut off | + 75% cut off | +100% cut off  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |

Cocaine

|  Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cut off | cut off | +25% cut off | +50% cut off | + 75% cut off | +100% cut off  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |

Methylenedioxy-methamphetamine

|  Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cut off | cut off | +25% cut off | +50% cut off | + 75% cut off | +100% cut off  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |

Methamphetamine

|  Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |

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Morphine

|  Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cut off | cut off | +25% cut off | +50% cut off | + 75% cut off | +100% cut off  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |

Methadone

|  Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cut off | cut off | +25% cut off | +50% cut off | + 75% cut off | +100% cut off  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |

Oxycodone

|  Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cut off | cut off | +25% cut off | +50% cut off | + 75% cut off | +100% cut off  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |

Phencyclidine

|  Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cut off | cut off | +25% cut off | +50% cut off | + 75% cut off | +100% cut off  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |

Propoxyphene

|  Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cut off | cut off | +25% cut off | +50% cut off | + 75% cut off | +100% cut off  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |

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8

# Nortriptyline

|  Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cut off | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |

# Marijuana

|  Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cut off | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |

b. Linearity/assay reportable range:

Not applicable, these devices are intended for qualitative use only.

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

The stability study protocols and acceptance criteria were reviewed and found to be acceptable.

d. Detection limit:

Not applicable.

e. Analytical specificity:

Cross-reactivity:

Analytical specificity studies were performed to determine whether drugs and drug metabolites within the same class of drugs or with similar molecular structures cross-react in the test systems. Reference standards for the various metabolites and compounds were prepared at 100 µg/mL in pooled negative human urine samples. Compounds that tested positive were serially diluted until a negative result was observed. Results shown are expressed as the minimum concentration producing a positive result in the indicated assay.

|  AMP(Amphetamine) (D – Amphetamine Cut-off=1000 ng/mL) | Result | %Cross- Reactivity  |
| --- | --- | --- |
|  D - Amphetamine | Positive at 1000 ng/mL | 100%  |
|  L - Amphetamine | Positive at 20000 ng/mL | 5%  |

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|  AMP(Amphetamine) (D – Amphetamine Cut-off=1000 ng/mL) | Result | %Cross-Reactivity  |
| --- | --- | --- |
|  DL - Amphetamine | Positive at 3000 ng/mL | 33%  |
|  Phentermine | Positive at 30000 ng/mL | 3.3%  |
|  Hydroxyamphetamine | Positive at 8000 ng/mL | 12.5%  |
|  Methylenedioxyamphetamine (MDA) | Positive at 20000 ng/mL | 5%  |
|  d-Methamphetamine | Positive> 100000 ng/mL | <1%  |
|  1-Methamphetamine | Positive> 100000 ng/mL | <1%  |
|  Ephedrine | Positive > 100000 ng/mL | <1%  |
|  Methylenedioxyethylamphetamine (MDE) | Positive> 100000 ng/mL | <1%  |
|  3,4-methylenedioxy-methamphetamine (MDMA) | Positive> 100000 ng/mL | <1%  |
|  BAR(Barbital) (Secobarbital, Cut-off=300 ng/mL) | Result | %Cross-Reactivity  |
| --- | --- | --- |
|  Secobarbital | Positive at 300 ng/mL | 100%  |
|  Amobarbital | Positive at 1000 ng/mL | 30%  |
|  Alphenal | Positive at 62.5 ng/mL | 480%  |
|  Aprobarbital | Positive at 250 ng/mL | 120%  |
|  Butabarbital | Positive at 100 ng/mL | 300%  |
|  Butethal | Positive at 500 ng/mL | 60%  |
|  Butalbital | Positive at 5000 ng/mL | 6%  |
|  Cyclopentobarbital | Positive at 500 ng/mL | 60%  |
|  Pentobarbital | Positive at 200 ng/mL | 150%  |
|  Phenobarbital | Positive at 300 ng/mL | 100%  |
|  BUP(Buprenorphine) (Buprenorphine, Cut-off=10 ng/mL) | Result | %Cross-Reactivity  |
| --- | --- | --- |
|  Buprenorphine | Positive at 10 ng/mL | 100%  |
|  Buprenorphine -3-D-Glucuronide | Positive at 10 ng/mL | 100%  |
|  Norbuprenorphine | Positive at 50 ng/mL | 20%  |
|  Norbuprenorphine-3-D-Glucuronide | Positive at 10 ng/mL | 10%  |
|  Morphine | Positive> 100000 ng/mL | <0.01%  |
|  Oxymorphone | Positive> 100000 ng/mL | <0.01%  |
|  Hydromorphone | Positive> 100000 ng/mL | <0.01%  |
|  BZO(Benzodiazepines) (Oxazepam, Cut-off=300 ng/mL) | Result | %Cross-Reactivity  |
| --- | --- | --- |
|  Oxazepam | Positive at 300 ng/mL | 100%  |
|  Alprazolam | Positive at 150 ng/mL | 200%  |
|  a-Hydroxyalprazolam | Positive at 1000 ng/mL | 30%  |

{9}

|  BZO(Benzodiazepines)
(Oxazepam, Cut-off=300 ng/mL) | Result | %Cross-Reactivity  |
| --- | --- | --- |
|  Bromazepam | Positive at 1000 ng/mL | 30%  |
|  Chlordiazepoxide | Positive at 63 ng/mL | 476.2%  |
|  Clonazepam | Positive at 2500 ng/mL | 12%  |
|  Clobazam | Positive at 75 ng/mL | 400%  |
|  Clorazepate dipotassium | Positive at 100 ng/mL | 300%  |
|  Desalkylflurazepam | Positive at 500 ng/mL | 60%  |
|  Diazepam | Positive at 500 ng/mL | 60%  |
|  Estazolam | Positive at 500 ng/mL | 60%  |
|  Flunitrazepam | Positive > 50000 ng/mL | <0.6%  |
|  D,L-Lorazepam | Positive at 10000 ng/mL | 3%  |
|  Midazolam | Positive at 10000 ng/mL | 3%  |
|  Nitrazepam | Positive at 75 ng/mL | 400%  |
|  Norchlordiazepoxide | Positive at 62.5 ng/mL | 480%  |
|  Nordiazepam | Positive at 125 ng/mL | 240%  |
|  Temazepam | Positive at 75 ng/mL | 400%  |
|  Triazolam | Positive at 1000 ng/mL | 33%  |
|  COC(Cocaine)
(Benzoylecgonine, Cut-off=300 ng/mL) | Result | %Cross-Reactivity  |
| --- | --- | --- |
|  Benzoylecgonine | Positive at 300 ng/mL | 100%  |
|  Cocaine HCl | Positive at 750 ng/mL | 40%  |
|  Cocaethylene | Positive at 12500 ng/mL | 2.4%  |
|  Ecgonine | Positive at 32000 ng/mL | 0.9%  |
|  Norcocaine | Positive at 100000 ng/mL | 0.3%  |
|  MDMA(Methylenedioxymethamphetamine)
(Methylenedioxymethamphetamine, Cut-off=500 ng/mL) | Result | %Cross-Reactivity  |
| --- | --- | --- |
|  Methylenedioxymethamphetamine (MDMA) | Positive at 500 ng/mL | 100%  |
|  3,4-Methylenedioxyamphetamine (MDA) | Positive at 5000 ng/mL | 10%  |
|  3,4-Methylenedioxyethylamphetamine (MDEA) | Positive at 300 ng/mL | 166.7%  |
|  d-methamphetamine | Positive>50000 ng/mL | <1%  |
|  d-amphetamine | Positive>50000 ng/mL | <1%  |
|  l-amphetamine | Positive>50000 ng/mL | <1%  |
|  l-methamphetamine | Positive>50000 ng/mL | <1%  |

{10}

|  MET(Methamphetamine) (D(+)-Methamphetamine, Cut-off=1000 ng/mL) | Result | %Cross-Reactivity  |
| --- | --- | --- |
|  D(+)-Methamphetamine | Positive at 1000 ng/mL | 100%  |
|  (+/-)3,4-Methylenedioxy-n-ethylamphetamine (MDEA) | Positive at 10000 ng/mL | 10%  |
|  D/L-Methamphetamine | Positive at 1000 ng/mL | 100%  |
|  p-Hydroxymethamphetamine | Positive at 10000 ng/mL | 10%  |
|  D-Amphetamine | Positive>100000 ng/mL | <1%  |
|  L-Amphetamine | Positive>100000 ng/mL | <1%  |
|  Chloroquine | Positive at 50000 ng/mL | 2%  |
|  (+/-)-Ephedrine | Positive at 4000 ng/mL | 25%  |
|  L-Methamphetamine | Positive at 10000 ng/mL | 10%  |
|  (+/-)3,4-Methylenedioxyamphetamine (MDA) | Positive>100000 ng/mL | <1%  |
|  β-Phenylethylamine | Positive at 7500 ng/mL | 13.3%  |
|  Trimethobenzamide | Positive at 20000 ng/mL | 5%  |
|  (+/-)3,4-methylenedioxymethamphetamine (MDMA) | Positive at 10000 ng/mL | 10%  |
|  MOP(Morphine) (Morphine, Cut-off=300 ng/mL) | Result | %Cross-Reactivity  |
| --- | --- | --- |
|  Morphine | Positive at 300 ng/mL | 100%  |
|  Codeine | Positive at 300 ng/mL | 100%  |
|  Ethylmorphine | Positive at 310 ng/mL | 96.8%  |
|  Hydrocodone | Positive at 25000 ng/mL | 1.2%  |
|  Hydromorphone | Positive at 10000 ng/mL | 3%  |
|  Levorphanol | Positive >100000 ng/mL | <0.3%  |
|  6-Acetylmorphine | Positive at 250 ng/mL | 120%  |
|  Morphine-3-β-D-glucuronide | Positive at 10000 ng/mL | 3%  |
|  Normorphine | Positive at 100000 ng/mL | 0.3%  |
|  Oxycodone | Positive >10000 ng/mL | <3%  |
|  Oxymorphone | Positive >10000 ng/mL | <3%  |
|  Procaine | Positive >10000 ng/mL | 3%  |
|  Thebaine | Positive >10000 ng/mL | <3%  |
|  Heroin | Positive at 500 ng/mL | 60%  |
|  MTD(Methadone) (Methadone, Cut-off=300 ng/mL) | Result | %Cross-Reactivity  |
| --- | --- | --- |
|  Methadone | Positive at 300 ng/mL | 100%  |
|  Doxylamine | Positive at 5000 ng/mL | 6%  |
|  LAAM | Positive at 10000 ng/mL | 3%  |
|  Alpha Methadol | Positive at 2000 ng/mL | 15%  |

{11}

|  MTD(Methadone) (Methadone, Cut-off=300 ng/mL) | Result | %Cross-Reactivity  |
| --- | --- | --- |
|  EDDP | Positive >100000 ng/mL | <0.3%  |
|  EMDP | Positive >100000 ng/mL | <0.3%  |
|  OXY(Oxycodone) (Oxycodone, Cut-off=300 ng/mL) | Result | %Cross-Reactivity  |
| --- | --- | --- |
|  Oxycodone | Positive at 100 ng/mL | 100%  |
|  Dihydrocodeine | Positive >100000 ng/mL | <0.1%  |
|  Codeine | Positive >100000 ng/mL | <0.1%  |
|  Hydromorphone | Positive >100000 ng/mL | <0.1%  |
|  Morphine | Positive >100000 ng/mL | <0.1%  |
|  Buprenorphine | Positive >100000 ng/mL | <0.1%  |
|  Ethylmorphine | Positive >100000 ng/mL | <0.1%  |
|  Oxymorphone | Positive at 250 ng/mL | 40%  |
|  Hydrocodone | Positive at 3125 ng/mL | 3.2%  |
|  PCP(Phencyclidine) (Phencyclidine, Cut-off=25 ng/mL) | Result | %Cross-Reactivity  |
| --- | --- | --- |
|  Phencyclidine | Positive at 25 ng/mL | 100%  |
|  4-Hydroxyphencyclidine | Positive at 75 ng/mL | 33.3%  |
|  PPX(Propoxyphene) (d-Propoxyphene, Cut-off=300ng/mL) | Result | %Cross-Reactivity  |
| --- | --- | --- |
|  d-Propoxyphene | Positive at 300 ng/mL | 100%  |
|  D-Norpropoxyphene | Positive at 333 ng/mL | 90.1%  |
|  TCA(Nortriptyline) (Nortriptyline, Cut-off=1000 ng/mL) | Result | %Cross-Reactivity  |
| --- | --- | --- |
|  Nortriptyline | Positive at 1000 ng/mL | 100%  |
|  Amitriptyline | Positive at 750 ng/mL | 133.3%  |
|  Clomipramine | Positive at 10000 ng/mL | 10%  |
|  Desipramine | Positive at 200 ng/mL | 500%  |
|  Doxepin | Positive at 1250 ng/mL | 80%  |
|  Imipramine | Positive at 625 ng/mL | 160%  |
|  Maprotiline | Positive at 2000 ng/mL | 50%  |
|  Nordoxepin | Positive at 1000 ng/mL | 100%  |
|  Promazine | Positive at 1500 ng/mL | 66.7%  |
|  Promethazine | Positive at 25000 ng/mL | 4%  |
|  Trimipramine | Positive at 3000 ng/mL | 33.3%  |
|  Cyclobenzaprine | Positive at 5000 ng/mL | 20%  |

{12}

13

|  TCA(Nortriptyline) (Nortriptyline, Cut-off=1000 ng/mL) | Result | %Cross-Reactivity  |
| --- | --- | --- |
|  Norclomipramine | Positive at 3000 ng/mL | 33.3%  |
|  THC(Cannabinoids) (11-nor-Δ9-THC-9-COOH, Cut-off = 50 ng/mL) | Result | % Cross-Reactivity  |
| --- | --- | --- |
|  11-nor-Δ9-THC-9-COOH | Positive at 50 ng/mL | 100%  |
|  11-Hydroxy-Δ9-Tetrahydrocannabinol | Positive at 50 ng/mL | 100%  |
|  11-Nor-Δ8-Tetrahydrocannabinol-9-COOH | Positive at 50 ng/mL | 100%  |
|  Cannabinol | Positive at 20000 ng/mL | 0.25%  |
|  Δ8-Tetrahydrocannabinol | Positive at 15000 ng/mL | 0.33%  |
|  Δ9-Tetrahydrocannabinol | Positive at 15000 ng/mL | 0.33%  |
|  Cannabidiol | Positive>100000 ng/mL | <0.05%  |
|  11-Nor-Δ9-THC-carboxy glucuronide | Positive at 75 ng/mL | 66.7%  |
|  (-)-11-nor-9-carboxy-Δ 9-THC | Positive at 50 ng/mL | 100%  |
|  11-nor-Δ9-THC-9-COOH | Positive at 50 ng/mL | 100%  |
|  11-Hydroxy-Δ9-Tetrahydrocannabinol | Positive at 50 ng/mL | 100%  |
|  11-Nor-Δ8-Tetrahydrocannabinol-9-COOH | Positive at 50 ng/mL | 100%  |
|  Cannabinol | Positive at 20000 ng/mL | 0.25%  |

## Interference

Potential interfering substances found in human urine of physiological or pathological conditions were added at a concentration of 100 µg/mL (albumin was tested at 100 mg/dL) to drug-free urine and urine with target drug concentrations at 25% below and 25% above Cut-off levels. These urine samples were tested using three batches of each device. No interference was observed for any compounds tested, and the list of compounds tested is provided in the following table:

|  Acetaminophen | β-Estradiol | Oxalic acid  |
| --- | --- | --- |
|  Acetophenetidin | Erythromycin | Oxolinic acid  |
|  N-Acetylprocainamide | Ethanol | Oxymetazoline  |
|  Acetylsalicylic acid | Fenoprofen | Papaverine  |
|  Albumin (100 mg/dL) | Furosemide | Penicillin G  |
|  Aminopyrine | Gentisic acid | Perphenazine  |
|  Amoxicillin | Hemoglobin | Phenelzine  |
|  Ampicillin | Hydralazine | Prednisone  |
|  Apomorphine | Hydrochlorothiazide | (±)-Propranolol  |
|  Ascorbic acid | Hydrocortisone | Pseudoephedrine  |
|  Aspartame | O-Hydroxyhippuric acid | Quinine  |
|  Atropine | 3-Hydroxytyramine | Ranitidine  |
|  Benzilic acid | Ibuprofen | Salicylic acid  |

{13}

|  Benzoic acid | Isoproterenol | Serotonin (5-Hydroxytyramine)  |
| --- | --- | --- |
|  Bilirubin | Isoxsuprine | Sulfamethazine  |
|  Chloral hydrate | Ketamine | Sulindac  |
|  Chloramphenicol | Ketoprofen | Tetrahydrocortisone 3-(β-Dglucuronide)  |
|  Chlorothiazide | Labetalol | Tetrahydrocortisone 3-acetate  |
|  Chlorpromazine | Loperamide | Tetrahydrozoline  |
|  Cholesterol | Meperidine | Thiamine  |
|  Clonidine | Meprobamate | Thioridazine  |
|  Cortisone | Methoxyphenamine | Triamterene  |
|  (-)-Cotinine | Nalidixic acid | Trifluoperazine  |
|  Creatinine | Naloxone | Trimethoprim  |
|  Deoxycorticosterone | Naltrexone | DL-Tryptophan  |
|  Dextromethorphan | Naproxen | Tyramine  |
|  Diclofenac | Niacinamide | DL-Tyrosine  |
|  Diflunisal | Nifedipine | Uric acid  |
|  Digoxin | Norethindrone | Verapamil  |
|  Diphenhydramine | Noscapine | Zomepirac  |
|  Ecgonine methyl ester | (±)-Octopamine |   |

f. Effect of Urine Specific Gravity and Urine pH

To investigate potential interferences due to urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity, or urine samples with pH 4 to 9, were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device. For all devices and all lots tested, results were all positive for samples at +25% Cut-Off and all negative for samples below 25% Cut-Off.

g. Assay Cut-off

See M.1.a., above.

2. Comparison Studies

Method comparison studies for the BOEASY Multi-Drug Test Cup tests were performed in-house with three laboratory assistants for each device. Operators ran 80(40 negative and 40 positive) unaltered clinical samples for each target drug. The samples were blind-labeled and compared to results obtained by LC/MS. The results are presented in the tables below:

{14}

Amphetamine

|   |  | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%)  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 2 | 19 | 19  |
|   |  Negative | 5 | 16 | 17 | 2 | 0  |
|  Viewer B | Positive | 0 | 0 | 4 | 20 | 19  |
|   |  Negative | 5 | 16 | 15 | 1 | 0  |
|  Viewer C | Positive | 0 | 0 | 3 | 19 | 19  |
|   |  Negative | 5 | 16 | 16 | 2 | 0  |

Discordant Results

|  Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results  |
| --- | --- | --- | --- |
|  Viewer A | AMPC439 | 981 | Positive  |
|  Viewer A | AMPC449 | 768 | Positive  |
|  Viewer B | AMPC439 | 981 | Positive  |
|  Viewer B | AMPC449 | 768 | Positive  |
|  Viewer B | AMPC412 | 976 | Positive  |
|  Viewer B | AMPC387 | 981 | Positive  |
|  Viewer C | AMPC412 | 976 | Positive  |
|  Viewer C | AMPC493 | 961 | Positive  |
|  Viewer C | AMPC387 | 981 | Positive  |
|  Viewer A | AMPC341 | 1010 | Negative  |
|  Viewer A | AMPC482 | 1010 | Negative  |
|  Viewer B | AMPC482 | 1010 | Negative  |
|  Viewer C | AMPC341 | 1010 | Negative  |
|  Viewer C | AMPC352 | 1120 | Negative  |

{15}

Secobarbital

|   |  | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%)  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 2 | 17 | 22  |
|   |  Negative | 6 | 15 | 17 | 1 | 0  |
|  Viewer B | Positive | 0 | 0 | 2 | 16 | 22  |
|   |  Negative | 6 | 15 | 17 | 2 | 0  |
|  Viewer C | Positive | 0 | 0 | 1 | 17 | 22  |
|   |  Negative | 6 | 15 | 18 | 1 | 0  |

Discordant Results

|  Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results  |
| --- | --- | --- | --- |
|  Viewer A | BARC477 | 291 | Positive  |
|  Viewer A | BARC375 | 265 | Positive  |
|  Viewer B | BARC477 | 291 | Positive  |
|  Viewer B | BARC375 | 265 | Positive  |
|  Viewer C | BARC364 | 269 | Positive  |
|  Viewer A | BARC384 | 312 | Negative  |
|  Viewer B | BARC384 | 312 | Negative  |

Buprenorphine

|   |  | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%)  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 1 | 20 | 18  |
|   |  Negative | 5 | 18 | 16 | 2 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 20 | 18  |
|   |  Negative | 5 | 18 | 17 | 2 | 0  |
|  Viewer C | Positive | 0 | 0 | 2 | 21 | 18  |
|   |  Negative | 5 | 18 | 15 | 1 | 0  |

{16}

Discordant Results

|  Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results  |
| --- | --- | --- | --- |
|  Viewer A | BUPC379 | 9.67 | Positive  |
|  Viewer C | BUPC359 | 8.94 | Positive  |
|  Viewer C | BUPC379 | 9.67 | Positive  |
|  Viewer A | BUPC322 | 10.1 | Negative  |
|  Viewer A | BUPC429 | 11.2 | Negative  |
|  Viewer B | BUPC322 | 10.1 | Negative  |
|  Viewer B | BUPC348 | 10.2 | Negative  |
|  Viewer C | BUPC348 | 10.2 | Negative  |

Oxazepam

|   |  | Negative | Low Negative by LC/MS (less than-50%) | Near Cutoff Negative by LC/MS (Between-50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and+50%) | High Positive by LC/MS (greater than+50%)  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 2 | 20 | 18  |
|   |  Negative | 5 | 15 | 18 | 2 | 0  |
|  Viewer B | Positive | 0 | 0 | 1 | 21 | 18  |
|   |  Negative | 5 | 15 | 19 | 1 | 0  |
|  Viewer C | Positive | 0 | 0 | 2 | 21 | 18  |
|   |  Negative | 5 | 15 | 18 | 1 | 0  |

Discordant Results

|  Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results  |
| --- | --- | --- | --- |
|  Viewer A | BZOC343 | 298 | Positive  |
|  Viewer A | BZOC322 | 296 | Positive  |
|  Viewer B | BZOC322 | 296 | Positive  |
|  Viewer C | BZOC343 | 298 | Positive  |
|  Viewer C | BZOC435 | 292 | Positive  |
|  Viewer A | BZOC301 | 314 | Negative  |
|  Viewer A | BZOC348 | 312 | Negative  |

{17}

18

|  Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results  |
| --- | --- | --- | --- |
|  Viewer B | BZOC348 | 312 | Negative  |
|  Viewer C | BZOC301 | 314 | Negative  |

Cocaine

|   |  | Negative | Low Negative by LC/MS (less than-50%) | Near Cutoff Negative by LC/MS (Between-50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and+50%) | High Positive by LC/MS (greater than+50%)  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 2 | 21 | 19  |
|   |  Negative | 6 | 17 | 15 | 0 | 0  |
|  Viewer B | Positive | 0 | 0 | 2 | 20 | 19  |
|   |  Negative | 6 | 17 | 15 | 1 | 0  |
|  Viewer C | Positive | 0 | 0 | 1 | 20 | 19  |
|   |  Negative | 6 | 17 | 14 | 1 | 0  |

Discordant Results

|  Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results  |
| --- | --- | --- | --- |
|  Viewer A | COCC368 | 298 | Positive  |
|  Viewer A | COCC340 | 294 | Positive  |
|  Viewer B | COCC368 | 298 | Positive  |
|  Viewer B | COCC315 | 282 | Positive  |
|  Viewer C | COCC340 | 294 | Positive  |
|  Viewer B | COCC317 | 301 | Negative  |
|  Viewer C | COCC317 | 301 | Negative  |

{18}

Methylnedioxymethamphetamine

|   |  | Negative | Low Negative by LC/MS(less than-50%) | Near Cutoff Negative by LC/MS (Between-50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and+50%) | High Positive by LC/MS (greater than+50%)  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 1 | 19 | 20  |
|   |  Negative | 5 | 16 | 18 | 1 | 0  |
|  Viewer B | Positive | 0 | 0 | 2 | 19 | 20  |
|   |  Negative | 5 | 16 | 17 | 1 | 0  |
|  Viewer C | Positive | 0 | 0 | 2 | 19 | 20  |
|   |  Negative | 5 | 16 | 17 | 1 | 0  |

Discordant Results

|  Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results  |
| --- | --- | --- | --- |
|  Viewer A | MDMAC310 | 490 | Positive  |
|  Viewer B | MDMAC306 | 497.5 | Positive  |
|  Viewer B | MDMAC365 | 484.5 | Positive  |
|  Viewer C | MDMAC310 | 490 | Positive  |
|  Viewer C | MDMAC306 | 497.5 | Positive  |
|  Viewer A | MDMAC316 | 505 | Negative  |
|  Viewer B | MDMAC316 | 505 | Negative  |
|  Viewer C | MDMAC484 | 565 | Negative  |

Methamphetamine

|   |  | Negative | Low Negative by LC/MS (less than-50%) | Near Cutoff Negative by LC/MS (Between-50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and+50%) | High Positive by LC/MS (greater than+50%)  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 2 | 20 | 18  |
|   |  Negative | 5 | 16 | 17 | 2 | 0  |
|  Viewer B | Positive | 0 | 0 | 1 | 21 | 18  |
|   |  Negative | 5 | 16 | 18 | 1 | 0  |
|  Viewer C | Positive | 0 | 0 | 1 | 21 | 18  |
|   |  Negative | 5 | 16 | 18 | 1 | 0  |

{19}

Discordant Results

|  Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results  |
| --- | --- | --- | --- |
|  Viewer A | METC498 | 921 | Positive  |
|  Viewer A | METC479 | 984 | Positive  |
|  Viewer B | METC467 | 973 | Positive  |
|  Viewer C | METC479 | 984 | Positive  |
|  Viewer A | METC343 | 1020 | Negative  |
|  Viewer A | METC473 | 1110 | Negative  |
|  Viewer B | METC473 | 1110 | Negative  |

Morphine

|   |  | Negative | Low Negative by LC/MS (less than-50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and+50%) | High Positive by LC/MS (greater than +50%)  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 2 | 18 | 21  |
|   |  Negative | 5 | 16 | 17 | 1 | 0  |
|  Viewer B | Positive | 0 | 0 | 2 | 18 | 21  |
|   |  Negative | 5 | 16 | 17 | 1 | 0  |
|  Viewer C | Positive | 0 | 0 | 2 | 17 | 21  |
|   |  Negative | 5 | 16 | 17 | 2 | 0  |

Discordant Results

|  Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results  |
| --- | --- | --- | --- |
|  Viewer A | MOPC355 | 287 | Positive  |
|  Viewer A | MOPC429 | 298 | Positive  |
|  Viewer B | MOPC408 | 286 | Positive  |
|  Viewer B | MOPC429 | 298 | Positive  |
|  Viewer C | MOPC408 | 286 | Positive  |
|  Viewer C | MOPC433 | 276 | Positive  |
|  Viewer A | MOPC393 | 301 | Negative  |
|  Viewer B | MOPC416 | 339 | Negative  |
|  Viewer C | MOPC416 | 339 | Negative  |
|  Viewer C | MOPC393 | 301 | Negative  |

{20}

Methadone

|   |  | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%)  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 2 | 21 | 18  |
|   |  Negative | 5 | 15 | 18 | 1 | 0  |
|  Viewer B | Positive | 0 | 0 | 2 | 20 | 18  |
|   |  Negative | 5 | 15 | 18 | 2 | 0  |
|  Viewer C | Positive | 0 | 0 | 3 | 22 | 18  |
|   |  Negative | 5 | 15 | 17 | 0 | 0  |

Discordant results

|  Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results  |
| --- | --- | --- | --- |
|  Viewer A | MTDC314 | 289 | Positive  |
|  Viewer A | MTDC389 | 299 | Positive  |
|  Viewer B | MTDC314 | 289 | Positive  |
|  Viewer B | MTDC408 | 290 | Positive  |
|  Viewer C | MTDC389 | 299 | Positive  |
|  Viewer C | MTDC373 | 279 | Positive  |
|  Viewer C | MTDC408 | 290 | Positive  |
|  Viewer A | MTDC447 | 309 | Negative  |
|  Viewer B | MTDC447 | 309 | Negative  |
|  Viewer B | MTDC427 | 336 | Negative  |

{21}

Oxycodone

|   |  | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%)  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 4 | 18 | 22  |
|   |  Negative | 6 | 15 | 15 | 0 | 0  |
|  Viewer B | Positive | 0 | 0 | 3 | 18 | 22  |
|   |  Negative | 6 | 15 | 16 | 0 | 0  |
|  Viewer C | Positive | 0 | 0 | 3 | 18 | 22  |
|   |  Negative | 6 | 15 | 16 | 0 | 0  |

Discordant Results

|  Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results  |
| --- | --- | --- | --- |
|  Viewer A | OXYC467 | 97.5 | Positive  |
|  Viewer A | OXYC369 | 94.6 | Positive  |
|  Viewer A | OXYC334 | 98.4 | Positive  |
|  Viewer A | OXYC470 | 95.1 | Positive  |
|  Viewer B | OXYC467 | 97.5 | Positive  |
|  Viewer B | OXYC310 | 96.1 | Positive  |
|  Viewer B | OXYC470 | 95.1 | Positive  |
|  Viewer C | OXYC310 | 96.1 | Positive  |
|  Viewer C | OXYC369 | 94.6 | Positive  |
|  Viewer C | OXYC334 | 98.4 | Positive  |

{22}

Phencyclidine

|   |  | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%)  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 1 | 18 | 20  |
|   |  Negative | 3 | 18 | 18 | 2 | 0  |
|  Viewer B | Positive | 0 | 0 | 2 | 20 | 20  |
|   |  Negative | 3 | 18 | 17 | 0 | 0  |
|  Viewer C | Positive | 0 | 0 | 2 | 19 | 20  |
|   |  Negative | 3 | 18 | 17 | 1 | 0  |

Discordant Results

|  Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results  |
| --- | --- | --- | --- |
|  Viewer A | PCPC441 | 24.8 | Positive  |
|  Viewer B | PCPC411 | 24.7 | Positive  |
|  Viewer B | PCPC441 | 24.8 | Positive  |
|  Viewer C | PCPC462 | 24.7 | Positive  |
|  Viewer C | PCPC411 | 24.7 | Positive  |
|  Viewer A | PCPC477 | 25.3 | Negative  |
|  Viewer A | PCPC368 | 27.8 | Negative  |
|  Viewer C | PCPC477 | 25.3 | Negative  |

{23}

Propoxyphene

|   |  | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%)  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 1 | 18 | 20  |
|   |  Negative | 5 | 15 | 19 | 2 | 0  |
|  Viewer B | Positive | 0 | 0 | 2 | 19 | 20  |
|   |  Negative | 5 | 15 | 18 | 1 | 0  |
|  Viewer C | Positive | 0 | 0 | 1 | 19 | 20  |
|   |  Negative | 5 | 15 | 19 | 1 | 0  |

Discordant Results

|  Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results  |
| --- | --- | --- | --- |
|  Viewer A | PPXC472 | 286 | Positive  |
|  Viewer B | PPXC472 | 286 | Positive  |
|  Viewer B | PPXC320 | 278 | Positive  |
|  Viewer C | PPXC320 | 278 | Positive  |
|  Viewer A | PPXC493 | 318 | Negative  |
|  Viewer A | PPXC382 | 306 | Negative  |
|  Viewer B | PPXC382 | 306 | Negative  |
|  Viewer C | PPXC493 | 318 | Negative  |

{24}

# Nortriptyline

|   |  | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%)  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 2 | 20 | 19  |
|   |  Negative | 5 | 15 | 18 | 1 | 0  |
|  Viewer B | Positive | 0 | 0 | 2 | 18 | 19  |
|   |  Negative | 5 | 15 | 18 | 3 | 0  |
|  Viewer C | Positive | 0 | 0 | 2 | 19 | 19  |
|   |  Negative | 5 | 15 | 18 | 2 | 0  |

# Discordant Results

|  Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results  |
| --- | --- | --- | --- |
|  Viewer A | TCAC319 | 979 | Positive  |
|  Viewer A | TCAC470 | 944 | Positive  |
|  Viewer B | TCAC319 | 979 | Positive  |
|  Viewer B | TCAC346 | 958 | Positive  |
|  Viewer C | TCAC346 | 958 | Positive  |
|  Viewer C | TCAC470 | 944 | Positive  |
|  Viewer A | TCAC479 | 1190 | Negative  |
|  Viewer B | TCAC398 | 1050 | Negative  |
|  Viewer B | TCAC331 | 1180 | Negative  |
|  Viewer B | TCAC479 | 1190 | Negative  |
|  Viewer C | TCAC398 | 1050 | Negative  |
|  Viewer C | TCAC331 | 1180 | Negative  |

{25}

Marijuana

|   |  | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%)  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 2 | 19 | 18  |
|   |  Negative | 6 | 14 | 18 | 3 | 0  |
|  Viewer B | Positive | 0 | 0 | 2 | 20 | 18  |
|   |  Negative | 6 | 14 | 18 | 2 | 0  |
|  Viewer C | Positive | 0 | 0 | 2 | 19 | 18  |
|   |  Negative | 6 | 14 | 18 | 3 | 0  |

Discordant Results

|  Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results  |
| --- | --- | --- | --- |
|  Viewer A | THCC402 | 46 | Positive  |
|  Viewer A | THCC368 | 48.8 | Positive  |
|  Viewer B | THCC363 | 46.95 | Positive  |
|  Viewer B | THCC402 | 46 | Positive  |
|  Viewer C | THCC363 | 46.95 | Positive  |
|  Viewer C | THCC368 | 48.8 | Positive  |
|  Viewer A | THCC478 | 55.5 | Negative  |
|  Viewer A | THCC493 | 50.5 | Negative  |
|  Viewer A | THCC496 | 57.5 | Negative  |
|  Viewer B | THCC478 | 55.5 | Negative  |
|  Viewer B | THCC318 | 56 | Negative  |
|  Viewer C | THCC493 | 50.5 | Negative  |
|  Viewer C | THCC318 | 56 | Negative  |
|  Viewer C | THCC496 | 57.5 | Negative  |

Lay user study

A lay user study was performed at three intended user sites with 300 lay persons. The lay users had diverse ages and educational and professional backgrounds. Urine samples were prepared at multiple concentrations (Negative, +/-75%, +/-50%, +/-25% of the cutoff) by spiking drugs into drug free pooled specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was

{26}

provided with the package insert, one blind labeled sample and a device, and no additional training. Summary results are shown below.

The results summary for AMP:

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS (ng/mL) | Lay Person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 261 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 507 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 771 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 1290 | 19 | 1 | 95  |
|  +50% Cutoff | 40 | 1560 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 1870 | 20 | 0 | 100  |

The results summary for BAR:

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS(ng/mL) | Lay Person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 75.9 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 150 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 220 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 360 | 19 | 1 | 95  |
|  +50% Cutoff | 40 | 429 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 501 | 20 | 0 | 100  |

The results summary for COC:

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS(ng/mL) | Lay Person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 81.5 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 151 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 225 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 395 | 19 | 1 | 95  |

{27}

The results summary for BUP:

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS(ng/mL) | Lay Person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 2.57 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 5.14 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 6.76 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 12.8 | 19 | 1 | 95  |
|  +50% Cutoff | 40 | 15.1 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 17.2 | 20 | 0 | 100  |

The results summary for MET:

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS(ng/mL) | Lay Person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 268 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 526 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 769 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 1270 | 19 | 1 | 95  |
|  +50% Cutoff | 40 | 1560 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 1780 | 20 | 0 | 100  |

The results summary for MTD:

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS(ng/mL) | Lay Person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 76.8 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 147 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 226 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 375 | 19 | 1 | 95  |
|  +50% Cutoff | 40 | 441 | 40 | 0 | 100  |

{28}

The results summary for MOP:

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS(ng/mL) | Lay Person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 79 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 158 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 246 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 389 | 20 | 0 | 100  |
|  +50% Cutoff | 40 | 469 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 530 | 20 | 0 | 100  |

The results summary for OXY:

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS(ng/mL) | Lay Person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 24.5 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 49.3 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 71.1 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 118 | 19 | 1 | 95  |
|  +50% Cutoff | 40 | 147 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 169 | 20 | 0 | 100  |

The results summary for PCP:

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS(ng/mL) | Lay Person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 6.27 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 12.5 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 17.9 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 30.8 | 19 | 1 | 95  |
|  +50% Cutoff | 40 | 36.4 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 42.8 | 20 | 0 | 100  |

{29}

The results summary for THC:

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS(ng/mL) | Lay Person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 13 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 25.3 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 41 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 65 | 19 | 1 | 95  |
|  +50% Cutoff | 40 | 79 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 93 | 20 | 0 | 100  |

The results summary for BZO:

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS(ng/mL) | Lay Person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 70.8 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 148 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 224 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 390 | 19 | 1 | 95  |
|  +50% Cutoff | 40 | 452 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 504 | 20 | 0 | 100  |

The results summary for MDMA:

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS(ng/mL) | Lay Person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 137 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 250 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 351 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 600 | 19 | 1 | 95  |
|  +50% Cutoff | 40 | 745 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 925 | 20 | 0 | 100  |

{30}

The results summary for TCA:

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS(ng/mL) | Lay Person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 273 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 509 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 809 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 1190 | 18 | 2 | 90  |
|  +50% Cutoff | 40 | 1510 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 1680 | 20 | 0 | 100  |

The results summary for PPX:

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS(ng/mL) | Lay Person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 77.4 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 150 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 227 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 351 | 19 | 1 | 95  |
|  +50% Cutoff | 40 | 420 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 492 | 20 | 0 | 100  |

Lay users also completed surveys on the ease of understanding the package insert instructions, and the results were found to be acceptable. A Flesch-Kincaid reading analysis was performed on the package insert and the scores revealed a reading grade level of 7.

3. Clinical Studies

Not applicable.

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable.

O. Conclusion:

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

---

**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NFT/K182530](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NFT/K182530)

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