← Product Code [DJG](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG) · K232228

# Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card (K232228)

_Shanghai Accurature Diagnostics Co., Ltd. · DJG · Feb 23, 2024 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG/K232228

## Device Facts

- **Applicant:** Shanghai Accurature Diagnostics Co., Ltd.
- **Product Code:** [DJG](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG.md)
- **Decision Date:** Feb 23, 2024
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3650
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

Multi-drug Urine Test Cup and Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxymethamphetamine, Methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana in human urine at the cut off concentrations of: Drug Abbreviation Cutoff Amphetamine AMP 1000 ng/mL Secobarbital BAR 300 ng/mL Buprenorphine BUP 10 ng/mL Oxazepam BZO 300 ng/mL Cocaine COC 300 ng/mL Methylenedioxymethamphetamine MDMA 500 ng/mL Methamphetamine MET 1000 ng/mL Morphine MOR 300 ng/mL Methadone MTD 300 ng/mL Oxycodone OXY 100 ng/mL Phencyclidine PCP 25 ng/mL Marijuana THC 50 ng/mL Configuration of the Multi-drug Urine Test Cup and Multi-drug Test Dip Card can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam Secobarbital 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 in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For prescription use only. Accurature Multi-drug Urine Test Cup and Accurature Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxy-methamphetamine, Methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana in human urine at the cut off concentrations of: Drug Abbreviation Cutoff Amphetamine AMP 1000 ng/mL Secobarbital BAR 300 ng/mL Buprenorphine BUP 10 ng/mL Oxazepam BZO 300 ng/mL Cocaine COC 300 ng/mL Methylenedioxymethamphetamine MDMA 500 ng/mL Methamphetamine MET 1000 ng/mL Morphine MOR 300 ng/mL Methadone MTD 300 ng/mL Oxycodone OXY 100 ng/mL Phencyclidine PCP 25 ng/mL Marijuana THC 50 ng/mL Configuration of the Accurature Multi-drug Urine Test Cup and Accurature Multi-drug Urine Test Dip Card can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam Secobarbital 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 in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For over-the-counter use.

## Device Story

Single-use lateral flow immunochromatographic assay; detects drugs of abuse in human urine via competitive binding. Urine specimen migrates via capillary action; drug in specimen competes with drug conjugate for antibody binding sites. Absence of colored line at test region indicates drug concentration above cutoff; presence of line indicates concentration below cutoff. Control line confirms proper wicking. Used in point-of-care or home settings; operated by clinicians or lay users. Provides preliminary results; requires confirmatory testing (GC/MS or LC/MS).

## Clinical Evidence

Bench testing only. Precision/reproducibility studies performed at three POC sites using spiked urine samples across 9 concentrations. Cross-reactivity and interference testing conducted. Method comparison study performed with 80 clinical samples per analyte compared to LC/MS. Lay user study performed with 603 participants across three sites.

## Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Single-use test cup or dip card format. No electronic components or software. Qualitative visual readout.

## Regulatory Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

## Special Controls

*Classification.* Class II (special controls). An opiate 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 Rapid Single/Multi-drug test Dipcard ([K153050](/device/K153050.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K232228

B Applicant

Shanghai Accurature Diagnostics Co., Ltd.

C Proprietary and Established Names

Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  DJG | Class II | 21 CFR 862.3650 - Opiate Test System | TX - Clinical Toxicology  |
|  DIO | Class II | 21 CFR 862.3250 - Cocaine and cocaine metabolite test system | TX - Clinical Toxicology  |
|  LDJ | Class II | 21 CFR 862.3870 - Cannabinoid test system | TX - Clinical Toxicology  |
|  LCM | Unclassified |  |   |
|  JXM | Class II | 21 CFR 862.3170 - Benzodiazepine test system | TX - Clinical Toxicology  |
|  LAF | Class II | 21 CFR 862.3610 - Methamphetamine test system | TX - Clinical Toxicology  |
|  DKZ | Class II | 21 CFR 862.3100 - Amphetamine test system | TX - Clinical Toxicology  |

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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K232228 - Page 2 of 32

|  DIS | Class II | 21 CFR 862.3150 - Barbiturate test system | TX - Clinical Toxicology  |
| --- | --- | --- | --- |
|  DJR | Class II | 21 CFR 862.3620 - Methadone test system | TX - Clinical Toxicology  |
|  JXN | Class II | 21 CFR 862.3700 - Propoxyphene test system | TX - Clinical Toxicology  |

## II Submission/Device Overview:

### A Purpose for Submission:
New Device

### B Measurand:
Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxymethamphetamine, Methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana

### C Type of Test:
Qualitative lateral flow immunochromatographic assay

## III Intended Use/Indications for Use:

### A Intended Use(s):
See Indications for Use below.

### B Indication(s) for Use:
Multi-drug Urine Test Cup and Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxymethamphetamine, Methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana in human urine at the cut off concentrations of:

|  Drug | Abbreviation | Cutoff  |
| --- | --- | --- |
|  Amphetamine | AMP | 1000 ng/mL  |
|  Secobarbital | BAR | 300 ng/mL  |
|  Buprenorphine | BUP | 10 ng/mL  |
|  Oxazepam | BZO | 300 ng/mL  |
|  Cocaine | COC | 300 ng/mL  |

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K232228 - Page 3 of 32

|  Methylenedioxymethamphetamine | MDMA | 500 ng/mL  |
| --- | --- | --- |
|  Methamphetamine | MET | 1000 ng/mL  |
|  Morphine | MOR | 300 ng/mL  |
|  Methadone | MTD | 300 ng/mL  |
|  Oxycodone | OXY | 100 ng/mL  |
|  Phencyclidine | PCP | 25 ng/mL  |
|  Marijuana | THC | 50 ng/mL  |

Configuration of the Multi-drug Urine Test Cup and Multi-drug Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam Secobarbital 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 in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

For prescription use only.

Accurature Multi-drug Urine Test Cup and Accurature Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxy-methamphetamine, Methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana in human urine at the cut off concentrations of:

|  Drug | Abbreviation | Cutoff  |
| --- | --- | --- |
|  Amphetamine | AMP | 1000 ng/mL  |
|  Secobarbital | BAR | 300 ng/mL  |
|  Buprenorphine | BUP | 10 ng/mL  |
|  Oxazepam | BZO | 300 ng/mL  |
|  Cocaine | COC | 300 ng/mL  |
|  Methylenedioxymethamphetamine | MDMA | 500 ng/mL  |
|  Methamphetamine | MET | 1000 ng/mL  |
|  Morphine | MOR | 300 ng/mL  |
|  Methadone | MTD | 300 ng/mL  |
|  Oxycodone | OXY | 100 ng/mL  |
|  Phencyclidine | PCP | 25 ng/mL  |
|  Marijuana | THC | 50 ng/mL  |

Configuration of the Accurature Multi-drug Urine Test Cup and Accurature Multi-drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam Secobarbital 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

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alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

For over-the-counter use.

## C Special Conditions for Use Statement(s):
Rx and OTC

## D Special Instrument Requirements:
N/A

## IV Device/System Characteristics:

### A Device Description:
Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, and Accurature Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Marijuana, Cocaine, Methamphetamine, Morphine, Oxazepam, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone in human urine samples. The products are single-use in vitro diagnostic devices. The candidate device will be sold in two formats: Multi-drug Urine Test Dip Card and Multi-drug Urine Test Cup.

### B Principle of Operation:
The Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, and Accurature Multi-drug Urine Test Dip Card are immunoassays based on the competitive binding principle. Drugs that may be present in the urine specimen compete against their respective drug conjugate for binding sites on their specific antibody. During testing, a urine specimen migrates upward by capillary action. If present in the urine specimen below its cutoff concentration, a drug will not saturate the binding sites of its specific antibody coated on the particles. The antibody-coated particles will then be captured by the immobilized drug conjugate and a visible colored line will show up in the test line region of the specific drug strip. The colored line will not form in the test line region if the drug level is above its cutoff concentration because it will saturate all the binding sites of the antibody coated on the particles. A drug-positive urine specimen will not generate a colored line in the specific test line region of the strip because of drug competition, while a drug negative urine specimen or a specimen containing a drug concentration less than the cut-off will generate a line in the test line region. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

### V Substantial Equivalence Information:

#### A Predicate Device Name(s):
Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard

#### B Predicate 510(k) Number(s):
K153050

K232228 - Page 4 of 32

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C Comparison with Predicate(s):

|  Device & Predicate Device(s): | K232228 | K153050  |
| --- | --- | --- |
|  Device Trade Name | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card | Rapid Single/Multi-drug test Cup; Rapid Single/Multi-drug test Dipcard  |
|  General Device Characteristic Similarities |  |   |
|  Intended Use/Indications For Use | For the qualitative determination of Drug-of-abuse in human urine. | Same  |
|  Specimen | Human urine | Same  |
|  Methodology | Competitive binding, Lateral flow Immuno-chromatographic assay based on the principle of antigen antibody immunochemistry | Same  |
|  Cutoff | Amphetamine (AMP): 1000 ng/ml
Barbiturates (BAR): 300 ng/mL
Buprenorphine (BUP): 10 ng/ml
Benzodiazepines (BZO): 300 ng/mL
Cocaine (COC): 300 ng/ml
Methylenedioxymethamphetamine (MDMA): 500 ng/ml
Methamphetamine (MET): 1000 ng/ml
Morphine (MOR): 300 ng/mL
Methadone (MTD): 300 ng/ml
Oxycodone (OXY): 100 ng/ml
Phencyclidine (PCP): 25 ng/ml | Same  |

K232228 - Page 5 of 32

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|   | Marijuana (THC): 50 ng/ml |   |
| --- | --- | --- |
|  General Device Characteristic Differences |  |   |
|  Cutoff | Amphetamine (AMP): 1000 ng/ml
Barbiturates (BAR): 300 ng/mL
Buprenorphine (BUP): 10 ng/ml
Benzodiazepines (BZO): 300 ng/mL
Cocaine (COC): 300 ng/ml
Methylenedioxymethamphetamine (MDMA): 500 ng/ml
Methamphetamine (MET): 1000 ng/ml
Morphine (MOR): 300 ng/mL
Methadone (MTD): 300 ng/ml
Oxycodone (OXY): 100 ng/ml
Phencyclidine (PCP): 25 ng/ml
Marijuana (THC): 50 ng/ml | The number of drugs detected are different  |

VI Standards/Guidance Documents Referenced:

None

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

Precision studies were carried out at three Point-of-Care sites for samples with concentrations of -100% cutoff, -75% cutoff, -50% cutoff, -25% cutoff, cutoff, +25% cutoff, +50% cutoff, +75% cutoff and +100% cutoff. These samples were prepared by spiking drug in negative urine samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were

K232228 - Page 6 of 32

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tested in a blinded fashion. For each concentration, tests were performed in three runs per day for 10 days per device using 3 reagent lots by 6 operators. The results obtained are summarized in the following tables:

Test Cup:

|  Drug Test | % of cutoff | Number of Determinations per lot | Results  |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   |  Lot 1 |   | Lot 2 |   | Lot 3  |   |
|   |   |   |  + | - | + | - | + | -  |
|  AMP | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -25%cutoff | 90 | 9 | 81 | 8 | 82 | 9 | 81  |
|   |  cutoff | 90 | 73 | 17 | 72 | 18 | 73 | 17  |
|   |  +25%cutoff | 90 | 82 | 8 | 81 | 9 | 80 | 10  |
|   |  +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  BAR | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -25%cutoff | 90 | 10 | 80 | 8 | 82 | 9 | 81  |
|   |  cutoff | 90 | 72 | 18 | 73 | 17 | 73 | 17  |
|   |  +25%cutoff | 90 | 83 | 7 | 82 | 8 | 82 | 8  |
|   |  +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  BUP | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -25%cutoff | 90 | 9 | 81 | 8 | 82 | 8 | 82  |
|   |  cutoff | 90 | 73 | 17 | 74 | 16 | 74 | 16  |
|   |  +25%cutoff | 90 | 83 | 7 | 82 | 8 | 82 | 8  |
|   |  +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  BZO | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -25%cutoff | 90 | 7 | 83 | 7 | 83 | 8 | 82  |
|   |  cutoff | 90 | 71 | 19 | 72 | 18 | 72 | 18  |
|   |  +25%cutoff | 90 | 80 | 10 | 81 | 9 | 81 | 9  |
|   |  +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  COC | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |

K232228 - Page 7 of 32

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K232228 - Page 8 of 32
|   | -25%cutoff | 90 | 8 | 82 | 8 | 82 | 7 | 83  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | cutoff | 90 | 74 | 16 | 73 | 17 | 73 | 17  |
|   | +25%cutoff | 90 | 82 | 8 | 81 | 9 | 81 | 9  |
|   | +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   | +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   | +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  MDMA | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   | -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   | -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   | -25%cutoff | 90 | 10 | 80 | 10 | 80 | 9 | 81  |
|   | cutoff | 90 | 70 | 20 | 72 | 18 | 71 | 19  |
|   | +25%cutoff | 90 | 79 | 11 | 80 | 10 | 79 | 11  |
|   | +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   | +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   | +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  MET | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   | -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   | -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   | -25%cutoff | 90 | 9 | 81 | 8 | 82 | 8 | 82  |
|   | cutoff | 90 | 72 | 18 | 73 | 17 | 73 | 17  |
|   | +25%cutoff | 90 | 82 | 8 | 81 | 9 | 81 | 9  |
|   | +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   | +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   | +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  MOP | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   | -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   | -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   | -25%cutoff | 90 | 11 | 79 | 10 | 80 | 10 | 80  |
|   | cutoff | 90 | 71 | 19 | 70 | 20 | 71 | 19  |
|   | +25%cutoff | 90 | 82 | 8 | 83 | 7 | 82 | 8  |
|   | +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   | +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   | +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  MTD | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   | -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   | -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   | -25%cutoff | 90 | 7 | 83 | 8 | 82 | 8 | 82  |
|   | cutoff | 90 | 73 | 17 | 74 | 16 | 73 | 17  |
|   | +25%cutoff | 90 | 81 | 9 | 81 | 9 | 82 | 8  |
|   | +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   | +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   | +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  OXY | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   | -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   | -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   | -25%cutoff | 90 | 10 | 80 | 9 | 81 | 9 | 81  |
|   | cutoff | 90 | 71 | 19 | 72 | 18 | 72 | 18  |

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|   | +25%cutoff | 90 | 82 | 8 | 81 | 9 | 82 | 8  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  PCP | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -25%cutoff | 90 | 9 | 81 | 10 | 80 | 9 | 81  |
|   |  cutoff | 90 | 72 | 18 | 71 | 19 | 71 | 19  |
|   |  +25%cutoff | 90 | 83 | 7 | 82 | 8 | 82 | 8  |
|   |  +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  THC | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -25%cutoff | 90 | 7 | 83 | 6 | 84 | 8 | 82  |
|   |  cutoff | 90 | 74 | 16 | 75 | 15 | 74 | 16  |
|   |  +25%cutoff | 90 | 81 | 9 | 82 | 8 | 82 | 8  |
|   |  +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |

Test Dip Card:

|  Drug Test | % of cutoff | Number of Determinations per lot | Results  |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   |  Lot 1 |   | Lot 2 |   | Lot 3  |   |
|   |   |   |  + | - | + | - | + | -  |
|  AMP | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -25%cutoff | 90 | 11 | 79 | 9 | 81 | 11 | 79  |
|   |  cutoff | 90 | 70 | 20 | 72 | 18 | 71 | 19  |
|   |  +25%cutoff | 90 | 83 | 7 | 83 | 7 | 79 | 11  |
|   |  +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  BAR | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -25%cutoff | 90 | 11 | 79 | 12 | 78 | 7 | 83  |
|   |  cutoff | 90 | 76 | 14 | 78 | 12 | 75 | 15  |
|   |  +25%cutoff | 90 | 79 | 11 | 79 | 11 | 83 | 7  |
|   |  +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  BUP | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |

K232228 - Page 9 of 32

{9}

K232228 - Page 10 of 32
|  |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -25%cutoff | 90 | 12 | 78 | 8 | 82 | 7 | 83  |
|   |  cutoff | 90 | 73 | 17 | 74 | 16 | 74 | 16  |
|   |  +25%cutoff | 90 | 80 | 10 | 83 | 7 | 78 | 12  |
|   |  +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  BZO | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -25%cutoff | 90 | 9 | 81 | 11 | 79 | 8 | 82  |
|   |  cutoff | 90 | 72 | 18 | 77 | 13 | 74 | 16  |
|   |  +25%cutoff | 90 | 83 | 7 | 81 | 9 | 78 | 12  |
|   |  +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  COC | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -25%cutoff | 90 | 12 | 78 | 8 | 82 | 7 | 83  |
|   |  cutoff | 90 | 71 | 19 | 71 | 19 | 72 | 18  |
|   |  +25%cutoff | 90 | 80 | 10 | 79 | 11 | 80 | 10  |
|   |  +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  MDMA | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -25%cutoff | 90 | 9 | 81 | 9 | 81 | 7 | 83  |
|   |  cutoff | 90 | 76 | 14 | 73 | 17 | 71 | 19  |
|   |  +25%cutoff | 90 | 82 | 8 | 80 | 10 | 80 | 10  |
|   |  +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  MET | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -25%cutoff | 90 | 11 | 79 | 10 | 80 | 12 | 78  |
|   |  cutoff | 90 | 70 | 20 | 75 | 15 | 76 | 14  |
|   |  +25%cutoff | 90 | 79 | 11 | 78 | 12 | 80 | 10  |
|   |  +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  MOP | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -25%cutoff | 90 | 7 | 83 | 9 | 81 | 12 | 78  |

{10}

|   | cutoff | 90 | 71 | 19 | 72 | 18 | 73 | 17  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  +25%cutoff | 90 | 80 | 10 | 81 | 9 | 82 | 8  |
|   |  +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  MTD | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -25%cutoff | 90 | 9 | 81 | 12 | 78 | 10 | 80  |
|   |  cutoff | 90 | 76 | 14 | 70 | 20 | 76 | 14  |
|   |  +25%cutoff | 90 | 83 | 7 | 80 | 10 | 83 | 7  |
|   |  +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  OXY | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -25%cutoff | 90 | 10 | 80 | 10 | 80 | 8 | 82  |
|   |  cutoff | 90 | 70 | 20 | 71 | 19 | 74 | 16  |
|   |  +25%cutoff | 90 | 79 | 11 | 82 | 8 | 79 | 11  |
|   |  +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  PCP | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -25%cutoff | 90 | 12 | 78 | 12 | 78 | 9 | 81  |
|   |  cutoff | 90 | 77 | 13 | 73 | 17 | 71 | 19  |
|   |  +25%cutoff | 90 | 80 | 10 | 78 | 12 | 83 | 7  |
|   |  +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|  THC | Negative | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -75%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -50%cutoff | 90 | 0 | 90 | 0 | 90 | 0 | 90  |
|   |  -25%cutoff | 90 | 12 | 78 | 7 | 83 | 8 | 82  |
|   |  cutoff | 90 | 74 | 16 | 78 | 12 | 73 | 17  |
|   |  +25%cutoff | 90 | 78 | 12 | 77 | 11 | 83 | 7  |
|   |  +50%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +75%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |
|   |  +100%cutoff | 90 | 90 | 0 | 90 | 0 | 90 | 0  |

2. Linearity:

N/A

K232228 - Page 11 of 32

{11}

3. Analytical Specificity/Interference:

Cross-Reactivity:
To test cross-reactivity, drug metabolites and other structurally related compounds that are likely to cross-react in urine samples were spiked into negative urine and were tested using three lots of each device. The lowest concentration that caused a positive result for each compound is listed below. The highest concentration tested is shown if no cross reactivity was observed.

Test Cup:

|  AMP | Result Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  D - Amphetamine | 1000 | 100%  |
|  L - Amphetamine | 20000 | 5%  |
|  DL - Amphetamine | 1000 | 10%  |
|  Phentermine | 1300 | 77%  |
|  Hydroxyamphetamine | 700 | 143%  |
|  Methylenedioxyamphetamine (MDA) | 1800 | 56%  |
|  d-Methamphetamine | >100000 | <1%  |
|  1-Methamphetamine | >100000 | <1%  |
|  Ephedrine | >100000 | <1%  |
|  Methylenedioxyethylamphetamine | >100000 | <1%  |
|  3,4-methylenedioxymethamphetamine (MDMA) | >100000 | <1%  |
|  BAR | Result Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  Secobarbital | 300 | 100%  |
|  Amobarbital | 300 | 100%  |
|  Alphenal | 750 | 40%  |
|  Aprobarbital | 300 | 100%  |
|  Butabarbital | 2500 | 12%  |
|  Butethal | 2500 | 12%  |
|  Butalbital | 2500 | 12%  |
|  Cyclopentobarbital | 600 | 50%  |
|  Pentobarbital | 2500 | 12%  |
|  Phenobarbital | 300 | 100%  |
|  BOP | Result Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  Buprenorphine | 10 | 100%  |
|  Buprenorphine -3-D-Glucuronide | 10 | 100%  |
|  Norbuprenorphine | 20 | 50%  |
|  Norbuprenorphine-3-D-Glucuronide | 25 | 40%  |
|  Morphine | >100000 | Not detected  |

K232228 - Page 12 of 32

{12}

|  Oxy | Result
Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  Alprazolam | 200 | 150%  |
|  Bromazepam | 1,500 | 19%  |
|  Chlordiazepoxide HCL | 1,500 | 19%  |
|  Clobazam | 100 | 300%  |
|  Clonazepam | 750 | 38%  |
|  Clorazepate Dipotassium | 200 | 150%  |
|  Delorazepam | 1,500 | 19%  |
|  Desalkylflurazepam | 400 | 75%  |
|  Diazepam | 200 | 150%  |
|  Estazolam | 2,500 | 12%  |
|  Flunitrazepam | 400 | 75%  |
|  A-Hydroxyalprazolam | 1260 | 24%  |
|  (±) Lorazepam | 1,500 | 19%  |
|  RS-Lorazepam glucuronide | 160 | 188%  |
|  Midazolam | 12,500 | 2%  |
|  Nitrazepam | 100 | 300%  |
|  Norchlordiazepoxide | 200 | 150%  |
|  Nordiazepam | 400 | 75%  |
|  Oxazepam | 300 | 100%  |
|  Temazepam | 100 | 300%  |
|  Triazolam | 2,500 | 12%  |
|  COC | Result
Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  Benzoylecogonine | 300 | 100%  |
|  Cocaethylene | 300 | 100%  |
|  Cocaine HCl | 300 | 100%  |
|  Ecgonine HCl | 35,000 | 1%  |
|  MDMA | Result
Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  D,L-3,4-Methylenedioxymethamphetamine (MDMA) | 500 | 100%  |
|  3,4-Methylenedioxyamphetamine HCI (MDA) | 3,000 | 17%  |
|  3,4-Methylenedioxyethylam-phetamine (MDEA) | 300 | 167%  |
|  d-methamphetamine | 3000 | 17%  |
|  d-amphetamine | >100000 | Not detected  |

K232228 - Page 13 of 32

{13}

|  l-amphetamine | >100000 | Not detected  |
| --- | --- | --- |
|  l-methamphetamine | >100000 | Not detected  |
|  MET | Result Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  D-Methamphetamine | 1,000 | 100%  |
|  (+/-)3,4-Methylenedioxy-n-ethylamphetamine(MDEA) | 20,000 | 5%  |
|  Procaine (Novocaine) | 60,000 | 2%  |
|  Trimethobenzamide | 20,000 | 5%  |
|  Methamphetamine | 1000 | 100%  |
|  Ranitidine (Zantac) | 50,000 | 2%  |
|  (+/-)3,4-Methylenedioxymethamphetamine (MDMA) | 3000 | 33%  |
|  Chloroquine | 50,000 | 2%  |
|  Ephedrine | 100,000 | 1%  |
|  Fenfluramine | 50,000 | 2%  |
|  p-Hydroxymethamphetamine | 10,000 | 10%  |
|  MOP | Result Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  Morphine | 300 | 100%  |
|  O6-Acetylmorphine | 500 | 60%  |
|  Codeine | 300 | 100%  |
|  Ethyl Morphine | 6500 | 5%  |
|  Heroin | 600 | 50%  |
|  Hydromorphone | 3120 | 10%  |
|  Hydrocodone | 50000 | 0.60%  |
|  Levorphanol | 1500 | 20%  |
|  Oxycodone | 30000 | 1%  |
|  Procaine | 15000 | 2%  |
|  Thebaine | 6500 | 5%  |
|  morphine 3-β-D-glucuronide | 300 | 100%  |
|  MTD | Result Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  Methadone | 300 | 100%  |
|  Doxylamine | 5,000 | 6%  |
|  EDDP | >100000 | Not Detected  |
|  EMDP | >100000 | Not Detected  |
|  LAAM HCl | >100000 | Not Detected  |
|  Alpha Methadol | >100000 | Not Detected  |

K232228 - Page 14 of 32

{14}

|  OXY | Result
Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  Oxycodone | 100 | 100%  |
|  Codeine | 50,000 | 0.20%  |
|  Ethyl Morphine | 75,000 | 0.10%  |
|  Thebaine | 50,000 | 0.20%  |
|  Oxymorphone | 750 | 13%  |
|  Dihydrocodeine | 12500 | 0.80%  |
|  Hydromorphone | >100000 | Not Detected  |
|  Hydrocodone | >100000 | Not Detected  |
|  Morphine | >100000 | Not Detected  |
|  Acetylmorphine | >100000 | Not Detected  |
|  Buprenorphine | >100000 | Not Detected  |
|  Ethylmorphine | >100000 | Not Detected  |
|  Naloxone | 50,000 | 0.2%  |
|  Naltrexone | 50,000 | 0.2%  |
|  PCP | Result
Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  Phencyclidine | 25 | 100%  |
|  4-Hydroxy Phencyclidine | 100 | 25%  |
|  THC | Result
Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  11-nor-Δ9-THC-9-COOH | 50 | 100%  |
|  Delta-9-Tetrahydrocannabinol | 50,000 | 0.10%  |
|  11-nor-delta-9-THC-carboxyglucuronide | 75 | 67%  |
|  (-)- 11-nor-9-carboxy-delta9-THC | 75 | 67%  |
|  11-Nor-Δ9-Tetrahydrocannabinol | 50 | 100%  |
|  11-Hydroxy-Δ9-Tetrahydrocannabinol | 5,000 | 1%  |
|  11-Nor-Δ8-Tetrahydrocannabinol | 50 | 100%  |
|  Δ8-THC-COOH | 50,000 | 0.10%  |

Test Dip Card:

|  AMP | Result
Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  D - Amphetamine | 1000 | 100%  |
|  L - Amphetamine | 20000 | 5%  |
|  DL - Amphetamine | 1000 | 10%  |
|  Phentermine | 1300 | 77%  |
|  Hydroxyamphetamine | 700 | 143%  |
|  Methylenedioxyamphetamine (MDA) | 1800 | 56%  |

K232228 - Page 15 of 32

{15}

K232228 - Page 16 of 32

|  d-Methamphetamine | >100000 | <1%  |
| --- | --- | --- |
|  1-Methamphetamine | >100000 | <1%  |
|  Ephedrine | >100000 | <1%  |
|  Methylenedioxyethylamphetamine | >100000 | <1%  |
|  3,4-methylenedioxymethamphetamine (MDMA) | >100000 | <1%  |
|  BAR | Result Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  Secobarbital | 300 | 100%  |
|  Amobarbital | 300 | 100%  |
|  Alphenal | 750 | 40%  |
|  Aprobarbital | 300 | 100%  |
|  Butabarbital | 2500 | 12%  |
|  Butethal | 2500 | 12%  |
|  Butalbital | 2500 | 12%  |
|  Cyclopentobarbital | 600 | 50%  |
|  Pentobarbital | 2500 | 12%  |
|  BOP | Result Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  Buprenorphine | 10 | 100%  |
|  Buprenorphine -3-D-Glucuronide | 10 | 100%  |
|  Norbuprenorphine | 20 | 50%  |
|  Norbuprenorphine-3-D-Glucuronide | 25 | 40%  |
|  Morphine | >100000 | Not detected  |
|  Oxymorphone | >100000 | Not detected  |
|  Hydromorphone | >100000 | Not detected  |
|  BZO | Result Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  Alprazolam | 200 | 150%  |
|  Bromazepam | 1,500 | 19%  |
|  Chlordiazepoxide HCL | 1,500 | 19%  |
|  Clobazam | 100 | 300%  |
|  Clonazepam | 750 | 38%  |
|  Clorazepate Dipotassium | 200 | 150%  |
|  Delorazepam | 1,500 | 19%  |
|  Desalkylflurazepam | 400 | 75%  |
|  Diazepam | 200 | 150%  |
|  Estazolam | 2,500 | 12%  |
|  Flunitrazepam | 400 | 75%  |
|  A-Hydroxyalprazolam | 1260 | 24%  |
|  (±) Lorazepam | 1,500 | 19%  |
|  RS-Lorazepam glucuronide | 160 | 188%  |

{16}

|  Midazolam | 12,500 | 2%  |
| --- | --- | --- |
|  Nitrazepam | 100 | 300%  |
|  Norchlordiazepoxide | 200 | 150%  |
|  Nordiazepam | 400 | 75%  |
|  Oxazepam | 300 | 100%  |
|  Temazepam | 100 | 300%  |
|  Triazolam | 2,500 | 12%  |
|  COC | Result Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  Benzoylecogonine | 300 | 100%  |
|  Cocaethylene | 300 | 100%  |
|  Cocaine HCl | 300 | 100%  |
|  MDMA | Result Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  D,L-3,4-Methylenedioxymethamphetamine (MDMA) | 500 | 100%  |
|  3,4-Methylenedioxyamphetamine HCI (MDA) | 3,000 | 17%  |
|  3,4-Methylenedioxyethylam-phetamine (MDEA) | 300 | 167%  |
|  d-methamphetamine | 3000 | 17%  |
|  d-amphetamine | >100000 | Not detected  |
|  l-amphetamine | >100000 | Not detected  |
|  l-methamphetamine | >100000 | Not detected  |
|  MET | Result Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  D-Methamphetamine | 1,000 | 100%  |
|  (+/-)3,4-Methylenedioxy-n-ethylamphetamine(MDEA) | 20,000 | 5%  |
|  Procaine (Novocaine) | 60,000 | 2%  |
|  Trimethobenzamide | 20,000 | 5%  |
|  Methamphetamine | 1000 | 100%  |
|  Ranitidine (Zantac) | 50,000 | 2%  |
|  (+/-)3,4-Methylenedioxymethamphetamine (MDMA) | 3000 | 33%  |
|  Chloroquine | 50,000 | 2%  |
|  Ephedrine | 100,000 | 1%  |
|  Fenfluramine | 50,000 | 2%  |

K232228 - Page 17 of 32

{17}

|  p-Hydroxymethamphetamine | 10,000 | 10%  |
| --- | --- | --- |
|  MOP | Result Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  Morphine | 300 | 100%  |
|  O6-Acetylmorphine | 500 | 60%  |
|  Codeine | 300 | 100%  |
|  Ethyl Morphine | 6500 | 5%  |
|  Heroin | 600 | 50%  |
|  Hydromorphone | 3120 | 10%  |
|  Hydrocodone | 50000 | 0.60%  |
|  Levorphanol | 1500 | 20%  |
|  Oxycodone | 30000 | 1%  |
|  Procaine | 15000 | 2%  |
|  Thebaine | 6500 | 5%  |
|  MTD | Result Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  Methadone | 300 | 100%  |
|  Doxylamine | 5,000 | 6%  |
|  EDDP | >100000 | Not Detected  |
|  EMDP | >100000 | Not Detected  |
|  LAAM HCl | >100000 | Not Detected  |
|  Alpha Methadol | >100000 | Not Detected  |
|  OXY | Result Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  Oxycodone | 100 | 100%  |
|  Codeine | 50,000 | 0.20%  |
|  Ethyl Morphine | 75,000 | 0.10%  |
|  Thebaine | 50,000 | 0.20%  |
|  Oxymorphone | 750 | 13%  |
|  Dihydrocodeine | 12500 | 0.80%  |
|  Hydromorphone | >100000 | Not Detected  |
|  Hydrocodone | >100000 | Not Detected  |
|  Morphine | >100000 | Not Detected  |
|  Acetylmorphine | >100000 | Not Detected  |
|  Buprenorphine | >100000 | Not Detected  |
|  Ethylmorphine | >100000 | Not Detected  |
|  PCP | Result Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  Phencyclidine | 25 | 100%  |
|  4-Hydroxy Phencyclidine | 100 | 25%  |

K232228 - Page 18 of 32

{18}

|  THC | Result Positive at (ng/ml) | %Cross-Reactivity  |
| --- | --- | --- |
|  11-nor-Δ9-THC-9-COOH | 50 | 100%  |
|  Delta-9-Tetrahydrocannabinol | 50,000 | 0.10%  |
|  11-nor-delta-9-THC-carboxyglucuronide | 75 | 67%  |
|  (-)- 11-nor-9-carboxy-delta9-THC | 75 | 67%  |
|  11-Nor-Δ9-Tetrahydrocannabinol | 50 | 100%  |
|  11-Hydroxy-Δ9-Tetrahydrocannabinol | 5,000 | 1%  |
|  11-Nor-Δ8-Tetrahydrocannabinol | 50 | 100%  |
|  Δ8-THC-COOH | 50,000 | 0.10%  |

## Interfering substances:

Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and urine samples with concentrations of the target drugs at 25% below and 25% above Cutoff levels. These urine samples were tested using three lots of each device. The compounds were tested at 100 µg/mL (unless otherwise noted in the table). No interference was observed for any of the compounds tested, and the list of compounds is provided in the following table.

|  Acetaminophen | O-Hydroxyhippuric Acid | Labetalol | D-Norpropoxyphene  |
| --- | --- | --- | --- |
|  Acyclovir | Olanzapine | Liverite | Domperidone  |
|  Afrin | Omeprazole | Loperamide | Doxylamine  |
|  Aminophylline | Oxalic Acid | Loratadine | Epinephrine Hydrochloride  |
|  Aminopyrine | Oxolinic Acid | Naproxen | Erythromycin  |
|  Benzilic Acid | Oxymetazoline | Mifepristone | Esomeprazole Magnesium  |
|  Benzoic Acid | Ondansetran | Mirtazapine | Furosemide  |
|  Bilirubin | Paliperidone | Montelukast Sodium | Gabapentin  |
|  Bupropion | Pantoprazole | Phenelzine | Gentisic Acid  |
|  Captopril | Papaverine | Pioglitazone Hydrochloride | 3-Hydroxy-tyramine  |
|  Ciprofloxacin Hydrochloride | Paroxetine Hydrochloride | Piracetam | Isosorbide Dinitrate  |
|  Citalopram | Penfluridol | Pravastatin Sodium | Isoxuprine  |
|  Clarithromycin | PenicillinV Potassium | Prednisone | Lamotrigine  |
|  Deoxy-corticosterone | Penicillin-G | Propylthiouracil | Levofloxacin Hydrochloride  |
|  Dextromethorphan | Acetophenetidin | Promethazine | Levonorgestrel  |
|  Diclofenac | Amiodarone Hydrochloride | Quetiapine Fumarate | Levothyroxine Sodium  |
|  Diflunisal | Albumin | Quinine | Minocycline  |

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|  D-Pseudo- ephedrine | Amoxicillin | Ranitidine | Nalidixic Acid  |
| --- | --- | --- | --- |
|  Duloxetine | Ampicillin | Rifampicin | Niacinamide  |
|  Dicyclomine | Atropine | Risperidone | Nifedipine  |
|  β-Estradiol | Carbamazepine | Salicylic Acid | Nikethamide  |
|  Ethanol | Cefradine | Serotonin | Sulfamethazine  |
|  Fenofibrate | Cephalexin | Sertraline Hydrochloride | Sulindac  |
|  Fenoprofen | Chloral Hydrate | Sildenafil Citrate | Tetrahydrocortisone 3 -acetate  |
|  Glibenclamide | Clonidine | Simvastatin | Tetrahydrocortisone 3-(β-D-glucuronide)  |
|  Gliclazide | Clopidogrel Hydrogen Sulphate | Sodium Valproate | Tetrahydrozoline  |
|  Glipizide | Clozapine | Spironolactone | Tetracycline  |
|  Ibuprofen | D,L-Tyrosine | Acetylsalicylic Acid | Thiamine  |
|  Ketoconazole | Digoxin | Apomorphine | Thioridazine  |
|  Ketoprofen | Diphenhydramine | Amlodipine Mesylate | Topiramate  |
|  Lidocaine Hydrochloride | Dirithromycin | Aripiprazole | Tramadol Hydrochloride  |
|  Lisinopril | Ecgonine Methyl Ester | Aspartame | Trazodone Hydrochloride  |
|  Lithium Carbonate | Effexor | Atomoxetine | Triamterene  |
|  Metoprolol Tartrate | Enalapril Maleate | Atorvastatin Calcium | Trifluoperazine  |
|  Magnesium | Fentanyl Citrate | Chloramphenicol | Trimethoprim  |
|  Meperidine | Fluoxetine Hydrochloride | Chlorothiazide | Uric Acid  |
|  Meprobamate | Fluvoxamine | Chloroquine | Valproate  |
|  Mosapride Citrate | Glucose | Cholesterol | Verapamil  |
|  Maprotiline | Haloperidol | (-) Cotinine | Vitamin B2  |
|  Nimodipine | Hemoglobin | chlorpheniramine | Vitamin C  |
|  Norethindrone | Ketamine | D,L-Octopamine |   |
|  N-Acetylprocain- amide | Kratom powder | D,L-Propranolol |   |

## Effect of Urinary Specific Gravity and pH:

To investigate the effect of urine specific gravity and urine pH, urine samples, with specific gravity ranging from 1.000 to 1.035 or urine samples with pH ranging from 4 to 9 were spiked with the target drugs to concentrations at 50% below and 50% above Cutoff levels. These samples were tested using three lots of each device. Results were all positive for samples at +50% Cutoff and all negative for samples at -50% Cutoff.

## 4. Assay Reportable Range:

Not Applicable.

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5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

The device is traceable to commercially available reference materials.

6. Detection Limit:

Not applicable.

7. Assay Cut-Off:

Refer to Section VII.A.1

## B Comparison Studies:

1. Method Comparison with Predicate Device:

Method comparison:

Method comparison studies were performed by three operators. Eighty (80) unaltered clinical samples were run for each target drug. The samples were tested in a blinded fashion and compared to LC/MS results. The results are presented in the tables below:

Amphetamine Cup:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |

Secobarbital Cup:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |

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Buprenorphine Cup:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |

Oxazepam Cup:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |

Cocaine Cup:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 18 | 20  |
|   |  Negative | 10 | 20 | 10 | 2 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |

Methylenedioxy-methamphetamine Cup:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 18 | 20  |
|   |  Negative | 10 | 20 | 10 | 2 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 18 | 20  |
|   |  Negative | 10 | 20 | 10 | 2 | 0  |

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Methamphetamine Cup:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 18 | 20  |
|   |  Negative | 10 | 20 | 10 | 2 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 18 | 20  |
|   |  Negative | 10 | 20 | 10 | 2 | 0  |

Morphine Cup:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 18 | 20  |
|   |  Negative | 10 | 20 | 10 | 2 | 0  |

Methadone Cup:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 18 | 20  |
|   |  Negative | 10 | 20 | 10 | 2 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |

Oxycodone Cup:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |

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Phencyclidine Cup:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 18 | 20  |
|   |  Negative | 10 | 20 | 10 | 2 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 18 | 20  |
|   |  Negative | 10 | 20 | 10 | 2 | 0  |

Marijuana Cup:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |

Amphetamine Dip Card:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |

Secobarbital Dip Card:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |

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Buprenorphine Dip Card:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |

Oxazepam Dip Card:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 18 | 20  |
|   |  Negative | 10 | 20 | 10 | 2 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |

Cocaine Dip Card:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |

Methylenedioxy-methamphetamine Dip Card:

|  Test Cup | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- |

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Methamphetamine Dip Card:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |

Morphine Dip Card:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |

Methadone Dip Card:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 18 | 20  |
|   |  Negative | 10 | 20 | 10 | 2 | 0  |

Oxycodone Dip Card:

|  Test Cup | Drug-free | <50% below cutoff | Between 50% of | Between cutoff and | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 19  |
|   |  Negative | 10 | 20 | 10 | 1  |
|  Viewer B | Positive | 0 | 0 | 0 | 20  |
|   |  Negative | 10 | 20 | 10 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 18  |
|   |  Negative | 10 | 20 | 10 | 2  |

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|   |   |  |  | cutoff and cutoff | 50% above cutoff |   |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 18 | 20  |
|   |  Negative | 10 | 20 | 10 | 2 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |

Phencyclidine Dip Card:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |

Marijuana Dip Card:

|  Test Cup |   | Drug-free | <50% below cutoff | Between 50% of cutoff and cutoff | Between cutoff and 50% above cutoff | >50% above cutoff  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 0 | 19 | 20  |
|   |  Negative | 10 | 20 | 10 | 1 | 0  |
|  Viewer B | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |
|  Viewer C | Positive | 0 | 0 | 0 | 20 | 20  |
|   |  Negative | 10 | 20 | 10 | 0 | 0  |

2. Lay user study

A lay user study was performed using the Multi-Drug Test Cup/Dip Card at three intended use sites with 603 lay persons. The lay users had diverse ages and educational and professional backgrounds. Urine samples were prepared at multiple concentrations (Negative (-100%), +/-75%, +/-50%, +/-25% of the cutoff) by spiking drugs into drug free pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers and tested in a blinded fashion.

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Test Cup:

|  Drugs | % of Cutoff | Number of samples | Lay person results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  AMP | -100% Cutoff | 20 | 0 | 20 | 100  |
|   |  -75% Cutoff | 20 | 0 | 20 | 100  |
|   |  -50% Cutoff | 161 | 0 | 161 | 100  |
|   |  -25% Cutoff | 20 | 0 | 20 | 100  |
|   |  +25% Cutoff | 20 | 19 | 1 | 95  |
|   |  +50% Cutoff | 42 | 42 | 0 | 100  |
|   |  +75% Cutoff | 20 | 20 | 0 | 100  |
|  BAR | -100% Cutoff | 20 | 0 | 20 | 100  |
|   |  -75% Cutoff | 20 | 0 | 20 | 100  |
|   |  -50% Cutoff | 161 | 0 | 161 | 100  |
|   |  -25% Cutoff | 20 | 0 | 20 | 100  |
|   |  +25% Cutoff | 20 | 20 | 0 | 100  |
|   |  +50% Cutoff | 42 | 42 | 0 | 100  |
|   |  +75% Cutoff | 20 | 20 | 0 | 100  |
|  BUP | -100% Cutoff | 20 | 0 | 20 | 100  |
|   |  -75% Cutoff | 20 | 0 | 20 | 100  |
|   |  -50% Cutoff | 161 | 0 | 161 | 100  |
|   |  -25% Cutoff | 20 | 0 | 20 | 100  |
|   |  +25% Cutoff | 20 | 20 | 0 | 100  |
|   |  +50% Cutoff | 42 | 42 | 0 | 100  |
|   |  +75% Cutoff | 20 | 0 | 20 | 100  |
|  BZO | -100% Cutoff | 20 | 0 | 20 | 100  |
|   |  -75% Cutoff | 20 | 0 | 20 | 100  |
|   |  -50% Cutoff | 161 | 0 | 161 | 100  |
|   |  -25% Cutoff | 20 | 0 | 20 | 100  |
|   |  +25% Cutoff | 20 | 19 | 1 | 95  |
|   |  +50% Cutoff | 42 | 42 | 0 | 100  |
|   |  +75% Cutoff | 20 | 20 | 0 | 100  |
|  COC | -100% Cutoff | 20 | 0 | 20 | 100  |
|   |  -75% Cutoff | 20 | 0 | 20 | 100  |
|   |  -50% Cutoff | 161 | 0 | 161 | 100  |
|   |  -25% Cutoff | 20 | 0 | 20 | 100  |
|   |  +25% Cutoff | 20 | 20 | 0 | 100  |
|   |  +50% Cutoff | 42 | 42 | 0 | 100  |
|   |  +75% Cutoff | 20 | 0 | 20 | 100  |
|   | -100% Cutoff | 20 | 0 | 20 | 100  |
|   |  -75% Cutoff | 20 | 0 | 20 | 100  |
|   |  -50% Cutoff | 161 | 0 | 161 | 100  |
|   |  -25% Cutoff | 20 | 0 | 20 | 100  |

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|  MDMA | +25% Cutoff | 20 | 20 | 0 | 100  |
| --- | --- | --- | --- | --- | --- |
|   | +50% Cutoff | 42 | 42 | 0 | 100  |
|   | +75% Cutoff | 20 | 0 | 20 | 100  |
|  MET | -100% Cutoff | 20 | 0 | 20 | 100  |
|   | -75% Cutoff | 20 | 0 | 20 | 100  |
|   | -50% Cutoff | 161 | 0 | 161 | 100  |
|   | -25% Cutoff | 20 | 0 | 20 | 100  |
|   | +25% Cutoff | 20 | 20 | 0 | 100  |
|   | +50% Cutoff | 42 | 42 | 0 | 100  |
|   | +75% Cutoff | 20 | 0 | 20 | 100  |
|  MOP | -100% Cutoff | 20 | 0 | 20 | 100  |
|   | -75% Cutoff | 20 | 0 | 20 | 100  |
|   | -50% Cutoff | 161 | 0 | 161 | 100  |
|   | -25% Cutoff | 20 | 0 | 20 | 100  |
|   | +25% Cutoff | 20 | 20 | 0 | 100  |
|   | +50% Cutoff | 42 | 42 | 0 | 100  |
|   | +75% Cutoff | 20 | 0 | 20 | 100  |
|  MTD | -100% Cutoff | 20 | 0 | 20 | 100  |
|   | -75% Cutoff | 20 | 0 | 20 | 100  |
|   | -50% Cutoff | 161 | 0 | 161 | 100  |
|   | -25% Cutoff | 20 | 0 | 20 | 100  |
|   | +25% Cutoff | 20 | 19 | 1 | 95  |
|   | +50% Cutoff | 42 | 42 | 0 | 100  |
|   | +75% Cutoff | 20 | 0 | 20 | 100  |
|  OXY | -100% Cutoff | 20 | 0 | 20 | 100  |
|   | -75% Cutoff | 20 | 0 | 20 | 100  |
|   | -50% Cutoff | 161 | 0 | 161 | 100  |
|   | -25% Cutoff | 20 | 0 | 20 | 100  |
|   | +25% Cutoff | 20 | 20 | 0 | 100  |
|   | +50% Cutoff | 42 | 42 | 0 | 100  |
|   | +75% Cutoff | 20 | 0 | 20 | 100  |
|  PCP | -100% Cutoff | 20 | 0 | 20 | 100  |
|   | -75% Cutoff | 20 | 0 | 20 | 100  |
|   | -50% Cutoff | 161 | 0 | 161 | 100  |
|   | -25% Cutoff | 20 | 0 | 20 | 100  |
|   | +25% Cutoff | 20 | 20 | 0 | 100  |
|   | +50% Cutoff | 42 | 42 | 0 | 100  |
|   | +75% Cutoff | 20 | 0 | 20 | 100  |
|  THC | -100% Cutoff | 20 | 0 | 20 | 100  |
|   | -75% Cutoff | 20 | 0 | 20 | 100  |
|   | -50% Cutoff | 161 | 0 | 161 | 100  |
|   | -25% Cutoff | 20 | 0 | 20 | 100  |

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Test Dip Card:

|  Drugs | % of Cutoff | Number of samples | Lay person results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  AMP | -100% Cutoff | 20 | 0 | 20 | 100  |
|   |  -75% Cutoff | 19 | 0 | 19 | 100  |
|   |  -50% Cutoff | 160 | 0 | 160 | 100  |
|   |  -25% Cutoff | 20 | 0 | 20 | 100  |
|   |  +25% Cutoff | 20 | 20 | 0 | 100  |
|   |  +50% Cutoff | 41 | 41 | 0 | 100  |
|   |  +75% Cutoff | 20 | 20 | 0 | 100  |
|  BAR | -100% Cutoff | 20 | 0 | 20 | 100  |
|   |  -75% Cutoff | 19 | 0 | 19 | 100  |
|   |  -50% Cutoff | 160 | 0 | 160 | 100  |
|   |  -25% Cutoff | 20 | 0 | 20 | 100  |
|   |  +25% Cutoff | 20 | 20 | 0 | 100  |
|   |  +50% Cutoff | 41 | 41 | 0 | 100  |
|   |  +75% Cutoff | 20 | 20 | 0 | 100  |
|  BUP | -100% Cutoff | 20 | 0 | 20 | 100  |
|   |  -75% Cutoff | 19 | 0 | 19 | 100  |
|   |  -50% Cutoff | 160 | 0 | 160 | 100  |
|   |  -25% Cutoff | 20 | 0 | 20 | 100  |
|   |  +25% Cutoff | 20 | 19 | 1 | 95  |
|   |  +50% Cutoff | 41 | 41 | 0 | 100  |
|   |  +75% Cutoff | 20 | 20 | 0 | 100  |
|  BZO | -100% Cutoff | 20 | 0 | 20 | 100  |
|   |  -75% Cutoff | 19 | 0 | 19 | 100  |
|   |  -50% Cutoff | 160 | 0 | 160 | 100  |
|   |  -25% Cutoff | 20 | 0 | 20 | 100  |
|   |  +25% Cutoff | 20 | 20 | 0 | 100  |
|   |  +50% Cutoff | 41 | 41 | 0 | 100  |
|   |  +75% Cutoff | 20 | 20 | 0 | 100  |
|  COC | -100% Cutoff | 20 | 0 | 20 | 100  |
|   |  -75% Cutoff | 19 | 0 | 19 | 100  |
|   |  -50% Cutoff | 160 | 0 | 160 | 100  |
|   |  -25% Cutoff | 20 | 0 | 20 | 100  |
|   |  +25% Cutoff | 20 | 20 | 0 | 100  |
|   |  +50% Cutoff | 41 | 41 | 0 | 100  |
|   |  +75% Cutoff | 20 | 20 | 0 | 100  |
|   | -100% Cutoff | 20 | 0 | 20 | 100  |
|   |  -75% Cutoff | 19 | 0 | 19 | 100  |

K232228 - Page 30 of 32

{30}

K232228 - Page 31 of 32
|  |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- |
|  MDMA | -50% Cutoff | 160 | 0 | 160 | 100  |
|   |  -25% Cutoff | 20 | 0 | 20 | 100  |
|   |  +25% Cutoff | 20 | 20 | 0 | 100  |
|   |  +50% Cutoff | 41 | 41 | 0 | 100  |
|   |  +75% Cutoff | 20 | 20 | 0 | 100  |
|  MET | -100% Cutoff | 20 | 0 | 20 | 100  |
|   |  -75% Cutoff | 19 | 0 | 19 | 100  |
|   |  -50% Cutoff | 160 | 0 | 160 | 100  |
|   |  -25% Cutoff | 20 | 0 | 20 | 100  |
|   |  +25% Cutoff | 20 | 20 | 0 | 100  |
|   |  +50% Cutoff | 41 | 41 | 0 | 100  |
|   |  +75% Cutoff | 20 | 20 | 0 | 100  |
|  MOP | -100% Cutoff | 20 | 0 | 20 | 100  |
|   |  -75% Cutoff | 19 | 0 | 19 | 100  |
|   |  -50% Cutoff | 160 | 0 | 160 | 100  |
|   |  -25% Cutoff | 20 | 0 | 20 | 100  |
|   |  +25% Cutoff | 20 | 20 | 0 | 100  |
|   |  +50% Cutoff | 41 | 41 | 0 | 100  |
|   |  +75% Cutoff | 20 | 20 | 0 | 100  |
|  MTD | -100% Cutoff | 20 | 0 | 20 | 100  |
|   |  -75% Cutoff | 19 | 0 | 19 | 100  |
|   |  -50% Cutoff | 160 | 0 | 160 | 100  |
|   |  -25% Cutoff | 20 | 0 | 20 | 100  |
|   |  +25% Cutoff | 20 | 20 | 0 | 100  |
|   |  +50% Cutoff | 41 | 41 | 0 | 100  |
|   |  +75% Cutoff | 20 | 20 | 0 | 100  |
|  OXY | -100% Cutoff | 20 | 0 | 20 | 100  |
|   |  -75% Cutoff | 19 | 0 | 19 | 100  |
|   |  -50% Cutoff | 160 | 0 | 160 | 100  |
|   |  -25% Cutoff | 20 | 0 | 20 | 100  |
|   |  +25% Cutoff | 20 | 20 | 0 | 100  |
|   |  +50% Cutoff | 41 | 41 | 0 | 100  |
|   |  +75% Cutoff | 20 | 20 | 0 | 100  |
|  PCP | -100% Cutoff | 20 | 0 | 20 | 100  |
|   |  -75% Cutoff | 19 | 0 | 19 | 100  |
|   |  -50% Cutoff | 160 | 0 | 160 | 100  |
|   |  -25% Cutoff | 20 | 0 | 20 | 100  |
|   |  +25% Cutoff | 20 | 20 | 0 | 100  |
|   |  +50% Cutoff | 41 | 41 | 0 | 100  |
|   |  +75% Cutoff | 20 | 20 | 0 | 100  |
|   | -100% Cutoff | 20 | 0 | 20 | 100  |
|   |  -75% Cutoff | 19 | 0 | 19 | 100  |
|   |  -50% Cutoff | 160 | 0 | 160 | 100  |
|   |  -25% Cutoff | 20 | 0 | 20 | 100  |

{31}

|  THC | +25% Cutoff | 20 | 20 | 0 | 100  |
| --- | --- | --- | --- | --- | --- |
|   |  +50% Cutoff | 41 | 41 | 0 | 100  |
|   |  +75% Cutoff | 20 | 20 | 0 | 100  |

3. Matrix Comparison:
Not applicable.

C Clinical Studies:
1. Clinical Sensitivity:
Not applicable.
2. Clinical Specificity:
Not applicable.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable.

D Clinical Cut-Off:
Not applicable.

E Expected Values/Reference Range:
Not applicable.

VIII Proposed Labeling:
The labeling support the finding of substantial equivalence for this device.

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

K232228 - Page 32 of 32

---

**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG/K232228](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG/K232228)

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