Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a lateral flow immunoassay, which is a chemical test, not a software-based technology like AI/ML. There is no mention of AI, ML, or image processing.

Therapeutic

No.
This device is designed to detect the presence of drug metabolites in human urine, making it a diagnostic device, not one for treatment or therapy.

Diagnostic

Yes
The document explicitly states, "These tests are intended for in vitro diagnostics use."

SaMD (Software as a Medical Device)

No

The device is described as a lateral flow chromatographic immunoassay in both test cup and test dipcard formats, which are physical, hardware-based devices for detecting drug metabolites in urine. It explicitly states the tests are performed "without the use of an instrument," further indicating it is not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "These tests are intended for in vitro diagnostics use."
Nature of the Test: The device is designed to detect the presence of drug metabolites in human urine, which is a biological sample tested in vitro (outside the body) to provide information about a person's health status or condition.
Regulatory Context: The document describes performance studies, including accuracy compared to a confirmatory method (GC/MS), precision, and a home use consumer study, which are typical requirements for IVD devices seeking regulatory clearance (like a 510(k) in the US, as suggested by the mention of predicate devices with K numbers).
Intended Use and Setting: The intended use for prescription use, point of care sites, and over-the-counter use are all common settings for IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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

The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use including point of care sites and over-the-counter use. The tests will yield preliminary positive results when prescription drugs Barbiturates, Benzodiazepine, and Methadone are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturates and Benzodiazepine in urine.

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

Product codes (comma separated list FDA assigned to the subject device)

DKZ, DJC, DIS, DIO, JXM, LDJ, DJR, DJG, LCM, DNK

Device Description

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Methamphetamine, Barbiturates, Benzodiazepines, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine and their metabolites ( specifically THC ) at or above the cut-off levels as indicated. The tests are performed without the use of an instrument.

The test cup and test dipcard formats use identical test strips made with the same chemical formulation and manufacturing procedures.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use (Part 21 CFR 801 Subpart D) and Over-The-Counter Use (21 CFR 801 Subpart C), including point of care sites.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Precision Studies:
Sample Size: 1620 observations (60 determinations per lot for 3 lots across 9 concentrations for each drug)
Data Source: Drug-free human urine spiked with analytes at 0, +/-75% cutoff, +/-25% cutoff, and +100% cutoff concentrations. Concentrations confirmed with GC/MS.
Annotation Protocol: Blindly labeled by a nonparticipant. Separate sets of blinded coded samples were assigned and randomized prior to testing. Tested by 6 operators at 3 Point-of-Care sites, with two operators per location testing 3 aliquots at each concentration for each lot per day (3 runs/day) for 10 non-consecutive days using one device lot per location. One operator tested the test dipcard format and the second operator tested the test cup format.

Accuracy Testing (Clinical Urine Specimens):
Sample Size: 80 clinical urine specimens for each drug.
Data Source: Clinical urine samples analyzed by GC/MS. Samples were divided into five categories by concentration: drug free, less than half the cutoff, near cutoff negative, near cutoff positive, and high positive.
Annotation Protocol: All samples were blindly labeled by a nonparticipant. Separate sets of the blind coded were assigned. Samples were also randomized prior to testing. The study was conducted by 4 nurses at two Point-of-Care sites. The test dipcard format was performed at one site and the test cup format at the second site. Each operator only performed one test format and different nurses tested each format.

Home Use Consumer Study:
Sample Size: 360 lay users from age 18 to 65 years.
Data Source: Urine samples prepared at concentrations of 0, +/- 50% cutoff, +/- 25% cutoff, and +100% cutoff by spiking drug into drug-free urine specimens. Concentrations of target drugs confirmed with GC/MS.
Annotation Protocol: Each participant performed only 1 test on provided specimen with one format of Rapid Single/Multidrug Test (Dipcard, Cup) using the English package insert as guide to perform the test. They were asked to fill out an English questionnaire after finishing the test.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

1. Cross-reactivity with structurally similar compounds:
Study Type: In-house laboratory testing.
Sample Size: 2 lots of test Dipcard and 1 lot of test Cup were used. Each sample was tested in 5 replicates using 3 lots of Test Cup and Test Dipcard.
Key Results: Tables detailing the lowest concentration that produced a positive result and the percentage of cross-reactivity for various compounds with Amphetamine, Cannabinoids (THC), Cocaine, Methamphetamine, Morphine 2000, Barbiturates, Benzodiazepines, Methylenedioxymethamphetamine, Methadone, Oxycodone, and Phencyclidine.

2. Interference:
Study Type: In-house laboratory testing.
Sample Size: Not explicitly stated as a number, but tests were performed with various compounds added to drug-free urine or drug-positive urine.
Key Results: None of the listed compounds (e.g., Acetaminophen, Aspirin, Caffeine, Ibuprofen) at a concentration of 100µg/mL were shown to interfere with the test results when present in drug-free urine or urine containing drugs at ±50% cutoff levels.

3. Effect of Urinary pH:
Study Type: In-house laboratory testing.
Sample Size: Aliquots of negative urine pool adjusted to pH 3 to 9 in 1 pH unit increments, spiked with each drug at 50% below and 50% above cutoff levels. Each sample tested by two lots of the corresponding Rapid Single/Multi-drug Test Cup and Test Dipcard.
Key Results: Varying ranges of pH do not interfere with the performance of the test.

4. Effect of Urinary Specific Gravity:
Study Type: In-house laboratory testing.
Sample Size: Specimens with specific gravity of 1.002, 1.010, 1.020, 1.030, 1.040, containing drugs at 50% below and 50% above cutoff level. Each sample tested by two lots of the corresponding Rapid Single/Multi-drug Test Cup and Test Dipcard.
Key Results: Varying ranges of urinary specific gravity do not affect the test result.

5. Precision:
Study Type: Multi-site, multi-operator study for both single and multi-drug test formats (Cup and Dipcard).
Sample Size: 1620 observations by 3 sites at 9 concentrations for each drug.
Key Results: Detailed tables for each drug (AMP, COC, MET, MOP, THC, BAR, BZO, MDMA, MTD, OXY, PCP) for both single and multi-drug test cups and dipcards, showing the number of positive and negative results at various concentrations relative to the cutoff across three different lots. The results demonstrate the consistency of the device around the cutoff concentrations.

6. Accuracy:
Study Type: Clinical urine specimen analysis compared to GC/MS.
Sample Size: 80 clinical urine specimens for each drug.
Key Results: Tables provided for Single drug Test Cup, Multi-drug Test Cup, Single drug Test Dipcard, and Multi-drug Test Dipcard formats. For each drug, results are broken down by GC/MS confirmed concentration categories (drug free, less than half cutoff, near cutoff negative, near cutoff positive, high positive) and compared to the device's positive/negative results. Tables show some discordant results where device results did not match GC/MS, particularly for concentrations near the cutoff. For example, for THC, some negative device results were observed for concentrations slightly above the 50 ng/mL cutoff (e.g., 61 ng/mL). Conversely, some positive device results were observed for concentrations slightly below the cutoff (e.g., MET at 867 ng/mL for a 1000 ng/mL cutoff).

7. Home Use Consumer Study:
Study Type: Lay user study evaluating ease of use and understanding of instructions.
Sample Size: 360 lay users (age 18 to 65 years).
Key Results: Detailed tables for each drug (AMP, COC, MET, MOP2000, THC, BAR, BZO, MDMA, MTD, OXY, PCP) for both single and multi-drug test cups and dipcards, showing the agreement percentage of lay users' results at various concentrations relative to the cutoff. Agreement percentages for drug-free, -50% cutoff, +50% cutoff, and +100% cutoff were consistently 100%. For -25% cutoff and +25% cutoff concentrations, agreement percentages ranged from 83% to 97%, indicating variability around the cutoff. The questionnaires indicated that 100% of users felt the test was easy to use and instructions were easy to understand. The readability of the package insert was assessed to be at a 6th-grade reading level.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not explicitly stated as Sensitivity, Specificity, PPV, NPV in the summary, but raw agreement data is provided in the Accuracy tables.
For instance, in the Single drug Test Cup Accuracy table, for AMP:

True Negative (Drug free, Less than half cutoff, Near Cutoff Negative): 33 + 2 + 5 = 40 (device negative)
True Positive (Near Cutoff Positive, High Positive): 6 + 34 = 40 (device positive)
False Positive: 0
False Negative: Some discordant results are shown (e.g., for THC, 1 sample at 61 ng/mL (above cutoff) was negative).

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K122809

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
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.(b)
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).

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

CO-INNOVATION BIOTECH CO., LTD. HONG FENG PRODUCT MANAGER NO. 13, YANYUAN ROAD, TIANHE DISTRICT GUANGZHOU, P.R. CHINA

December 11, 2014

Re: K142800 Trade/Device Name: Rapid Single/Multi-drug Test Cup Rapid Single/Multi-drug Test Dipcard Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: DKZ, DJC, DIS, DIO, JXM, LDJ, DJR, DJG, LCM, DNK Dated: September 26, 2014 Received: September 29, 2014

Dear Hong Feng:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -S

For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K142800

Device Name

Rapid Single/Multi-drug test Cup Rapid Single/Multi-drug test Dipcard

Indications for Use (Describe)

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

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

The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use including point of care sites and over-the-counter use. The tests will yield preliminary positive results when prescription drugs Barbiturates, Benzodiazepine, and Methadone are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturates and Benzodiazepine in urine.

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

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

3

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Section 5 - 510(k) Summary

Date of Summary Preparation: 12/05/2014

1. Submitter's Identifications

Submitter: Co-Innovation Biotech Co.,Ltd. Address: No.13, Yanyuan Road, Tianhe District, Guangzhou, P.R. China Contact Person: Hong Feng Contact Email Address: fenghongfda@126.com Telephone: + 86 -20-62867285 Fax: + 86 -20-62867285

2. Correspondent's Identifications

Correspondent's Name: Co-Innovation Biotech Co.,Ltd. Address: No.13, Yanyuan Road, Tianhe District, Guangzhou, P.R. China Contact Person: Hong Feng Contact Email Address: fenghongfda@126.com Telephone: + 86 -20-62867285 Fax: + 86 -20-62867285

3. Name of the Device

Proprietary names:

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

Recommended classification regulation:

21 CFR 862.3100 Amphetamine test system 21 CFR 862.3610 Methamphetamine test system 21 CFR 862.3250 Cocaine test system 21 CFR 862.3640 Morphine test system 21 CFR 862.3870 Cannabinoid test system 21 CFR 862.3150 Barbiturate test system 21 CFR 862.3170 Benzodiazepine test system 21 CFR 862.3620 Methadone test system 21 CFR 862.3650 Opiate test system Unclassified, Enzyme immunoassay, phencyclidine test system

Device class: Class II Panel: Toxicology (91) Product code: DKZ,DJC,DIO,LDJ,DNK,DIS,JXM,DJR,DJG,LCM

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4. The Predicate Devices

K122809	Advin Multi-Drug Screen Test Dip Card
	Advin Multi-Drug Screen Test Cup
	Advin Multi-Drug Screen Test Cassette

5. Device Description

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Methamphetamine, Barbiturates, Benzodiazepines, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine and their metabolites ( specifically THC ) at or above the cut-off levels as indicated. The tests are performed without the use of an instrument.

The test cup and test dipcard formats use identical test strips made with the same chemical formulation and manufacturing procedures.

6. Indications for Use

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

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

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

6

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

The tests will yield preliminary positive results when prescription drugs Barbiturates, Benzodiazepine, and Methadone are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturates and Benzodiazepine in urine.

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

7. Comparison to Predicate Devices:

A summary comparison of features of the Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard and the predicate devices is provided in the following Table:

| Item | Device Predicate |
|--------------------|----------------------- | Indication for use | Qualitative detection of ( but the number of |
| | drugs-of-abuse in urine | | ( Cocaine ,Morphine, | | Methamphetamine, Amphetamine, | | Marijuana, Barbiturates, | | Benzodiazepines, | | Methylenedioxymethamphetamine, | | Methadone, Oxycodone, | Intended Users | Over the Counter (OTC) Use and | | Prescription Use | Specimen | Urine | Cutoff | Cocaine:300 ng/mL | | Methamphetamine:1000 ng/mL | | Amphetamine:1000 ng/mL | | Morphine:2000 ng/mL | | Marijuana:50 ng/mL | | Barbiturates:300 ng/mL | | Benzodiazepines:300 ng/mL | | Methylenedioxymethamphetamine:500 | | ng/mL | | Methadone:300 ng/mL | | Oxycodone:100 ng/mL | | Phencyclidine:25 ng/mL | Read time | 5 minutes | (K122809)
---------------|------------------------------|
| Same
| drugs detected different) |
| |
| |
| |
| |
| |
Phencyclidine) | |
| Same |
| |
| Same |
| Cocaine:150 ng/mL |
| Methamphetamine:500 ng/mL |
| Amphetamine:500 ng/mL |
| Morphine:300 ng/mL |
| Marijuana:50 ng/mL |
| Barbiturates:300 ng/mL |
| Benzodiazepines:300 ng/mL |
| Methylenedioxymethamphetamin |
| e:500 ng/mL |
| Methadone:300 ng/mL |
| Oxycodone:100 ng/mL |
| Phencyclidine:25 ng/mL |
| Same |

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Results	Qualitative	Same
Methodology	Competitive binding, Lateral flow
immunochromatographic assay based
on the principle of antigen antibody
immunochemistry	Same
Configuration	Dipcard and Cup	Cassette,Dip Card and Cup

8. Performance Data:

8.1 Cross-reactivity with structurally similar compounds

To test the cross reactivity of the test, 2 lots of test Dipcard and one lot of test Cup was used to test with drug metabolites and drug structurally similar compounds in urine. All the components were added to drug-free normal human urine. Each sample was tested in 5 replicates using 3 lots of Test Cup and Test Dipcard. If any positive result was observed, the compounds were further diluted with known drug-free urine specimen sequentially to different concentrations and tested in quintuplicate, until the highest concentration that generates a negative result was identified. The cross reacting substances with the lowest concentration that produced a positive result was identified and is listed in the table below.

| Amphetamine (AMP) | Lowest
Concentrat
ion
(ng/mL) | % Cross-react
ivity | Benzodiazepines (BZO) | Lowest
Concentrat
ion
(ng/mL) | % Cross-react
ivity |
|---------------------------------------------|----------------------------------------|------------------------|--------------------------------------|----------------------------------------|------------------------|
| d-Amphetamine | 1,000 | 100% | Oxazepam | 300 | 100% |
| d,l-Amphetamine | 2,500 | 40% | Alprazolam | 200 | 150% |
| 1-Amphetamine | 50,000 | 2% | α-Hydroxyalprazolam | 1100 | 27.3% |
| 3,4-Methylenedioxyamphetamine
(MDA) | 2,000 | 50% | Bromazepam | 1000 | 30% |
| d-methamphetamine | >100,000 | Not
detected | Chlordiazepoxide | 2000 | 15% |
| l-methamphetamine | >100,000 | Not
detected | Clobazam | 100 | 300% |
| 3,4-Methylenedioxumethamphetamine
(MDMA) | >100,000 | Not
detected | Clonazepam | 800 | 37.5% |
| Methylenedioxyethylamphetamine
(MDEA) | >100,000 | Not
detected | Clorazepate | 200 | 150% |
| Cannabinoids (THC) | | | Delorazepam | 1600 | 18.8% |
| 11-nor-Δ9-THC-9-COOH | 50 | 100% | Desalkylflurazepam | 400 | 75% |
| 11-nor-Δ8-THC-9-COOH | 50 | 100% | Diazepam | 200 | 150% |
| Δ8- Tetrahydrocannabinol | 10,000 | 0.5% | Estazolam | 1000 | 30% |
| Δ9- Tetrahydrocannabinol | 15,000 | 0.3% | Flunitrazepam | 350 | 85.7% |
| Cannabinol | 20,000 | 0.3% | Lorazepam | 1200 | 25% |
| Cannabidiol | >100,000 | Not
detected | Midazolam | 2500 | 12% |
| Cocaine (COC) | | | Nitrazepam | 100 | 300% |
| Benzoylecgonine | 300 | 100% | Nordiazepam | 400 | 75% |
| Cocaine | 800 | 37.5% | Temazepam | 120 | 250% |
| Cocaethylene | 12,500 | 2.4% | Triazolam | 1000 | 30% |
| Ecgonine HCl | 35,000 | 0.9% | Methylenedioxymethamphetamine (MDMA) | | |
| Methamphetamine (MET) | | | D-Amphetamine | >100000 | Not |

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					detected
D(+)-Methamphetamine	1,000	100%	(+/-)3,4-Methylenedioxymet
hamphetamine (MDMA)	500	60%
L(-)-Methamphetamine	8,000	12.5%	3,4-Methylenedioxyampheta
mine (MDA)	2200	13.6%
(+/-)3,4-Methylenedioxumethampheta
mine(MDMA)	2,000	50%	3,4-Methylenedioxyethylam
phetamine (MDEA)	240	125%
p-hydroxymethamphetamine	30,000	3.3%	D-methamphetamine(MAM
P)	100000	0.3%
3,4-
Methylenedioxyethylamphetamine(M
DEA)	50,000	2%	L-Amphetamine	>100000	Not
detected
d-Amphetamine	>100,000	Not
detected	L-Methamphetamine	>100000	Not
detected
1-Amphetamine	>100,000	Not
detected	Methadone (MTD)
3,4-methylenedioxyamphetamine
(MDA)	>100,000	Not
detected	Methadone	300	100%
Morphine 2000 (MOP)			(±)2-Ethyl-1,5-dimethyl-3,
3-diphenylpyrrolinium	50000	0.6%
Morphine	2,000	100%	Doxylamine	50000	0.6%
Codeine	2,000	100%	Oxycodone (OXY)
Hydrocodone	15,000	13.3%	Oxycodone	100	100%
Hydromorphine	10,000	20%	Naloxone	50000	0.2%
6-Monoacetylmorphine	5,000	40%	Naltrexone	50000	0.2%
Morphine 3-b-D-glucuronide	2,000	100%	Morphine
3-β-D-glucuronide	50000	0.2%
Oxycodone	>100000	2%	Hydrocodone	3000	3.3%
Hydromorphone	10,000	20%	Hydromorphone	75000	0.1%
Barbiturates (BAR)			Oxymorphone	1000	10%
Secobarbital	300	100%	Phencyclidine (PCP)
Amobarbital	500	60%	Phencyclidine	25	100%
Alphenol	150	200%	4-Hydroxyphencyclidine	15000	0.2%
Aprobarbital	200	150%
Butabarbital	75	400%
Butalbital	1,500	20%
Butethal	100	300%
Cyclopentobarbital	600	50%
Pentobarbital	700	42.9%
Phenobarbital	300	100%

8.2 Interference

Clinical urine samples may contain substances that could potentially interfere with the test. The following compounds were added to drug-free urine or drug positive urine containing AMP, THC, COC, MET, MOP, BAR, BZO, MDMA, MTD, OXY, or PCP with the concentration 50% below the cutoff and the concentration 50% above the cutoff, respectively. All potential interfering substances were added at a concentration of 100µg/mL (All concentrations of the drugs were confirmed with GC/MS). The urine specimens were tested with two lots of the corresponding Rapid Single/Multi-drug Test Cup and Test Dipcard. None of the compounds listed below were shown to interfere.

Acetaminophen	Estrone-3-sulfate	d,l-Octopamine
Acetophenetidin	Ethyl-p-aminobenzoate	Oxalic acid

9

Amoxicillin	Erythromycin	Oxolinic acid
Ampicillin	Fenoprofen	Oxymetazoline
Aspirin	Flucloxacillin	Oxytetracycline
Atenolol	Fluoxetine	Papaverine
Atorvastatin	Furosemide	Penicillin-G
Azlocillin	Gentisic acid	Pentazocine
Benzilic acid	Hemoglobin	Perphenazine
Benzylpenicillin	Hydralazine	Phenelzine
Benzoic acid	Hydrochlorothiazide	Prednisolone
Bilirubin	Hydrocortisone	Prednisone
Benzydamine	o-Hydroxyhippuric acid	d,l-Propanolol
Caffeine	p-Hydroxytyramine	d-Pseudoephedrine
Carbamazepine	Ibuprofen	Quinacrine
Cephalexin	Indomethacin	Quinine
Chloralhydrate	Iproniazid	Quindine
Chloramphenicol	d,l-Isoproterenol	Ranitidine
Chlorothiazide	Isoxsuprine	Salicylic acid
Chlorpheniramine	Ketamine	Serotonin
d,1-Chlorpromazine	Ketoprofen	Sulfamethazine
Cholesterol	Labetalol	Sulindac
Clonidine	Lisinopril	Tetracycline
Cimetidine	Loperamide	Tetrahydrozoline
Citalopram	Meperidine	Thiamine
Cortisone	Meprobamate	Thioridazine
Creatinine	Methoxyphenamine	d, 1-Thyroxine
Deoxycorticosterone	Methylphenidate	Tolbutamine
Dexamethasone	Nadolol	Tolbutamide
Dextromethorphan	Nalidixic acid	Trifluoperazine
Diclofenac	Naproxen	Tryptamine
Diflunisal	Niacinamide	Uric acid
Digoxin	Nicotine	Verapamil
Diphenhydramine	Nifedipine	Zomepirac
Ephedrine	Norethindrone
ß-Estradiol	Noscapine

8.3 Effect of urinary pH

The pH of an aliquot negative urine pool is adjusted to a pH range of 3 to 9 in 1 pH unit increments and spiked with each drug at 50% below and 50% above cutoff levels (All concentrations were confirmed with GC/MS). Each sample was tested by two lots of the corresponding Rapid Single/Multi-drug Test Cup and Test Dipcard. The results demonstrate that varying ranges of pH do not interfere with the performance of the test.

10

8.4 Effect of Urinary specific gravity

The specific gravity studies were conducted on different specific gravity including 1.002,1.010, 1.020, 1.030, 1.040 specimens with drug free urine containing AMP, THC, COC, MET, MOP, BAR, BZO, MDMA, MTD, OXY, or PCP at 50% below and 50% above cutoff level (All concentrations were confirmed with GC/MS). Each sample was tested by two lots of the corresponding Rapid Single/Multi-drug Test Cup and Test Dipcard. The results demonstrate that varying ranges of urinary specific gravity do not affect the test result.

8.5 Precision

Precision studies were performed using the single drug and multi-drug test formats. Drug free specimens were spiked with analytes at 0, ±75% cutoff, ±25% cutoff, ±25% cutoff and +100% cutoff of drug. The concentrations of the target drugs were confirmed with GC/MS. In both the single drug test and multi-drug test precision studies each concentration of the urine specimen was divided into aliquots. Each aliquot was blindly labeled by a nonparticipant. Separate sets of blinded coded samples were assigned and randomized prior to testing. The study was conducted by 6 operators at 3 Point-of-Care sites. Two operators per location tested 3 aliquots at each concentration for each lot per day (3 runs/day) for 10 non-consecutive days using one device lot per location. One operator tested the test dipcard format and the second operator tested the test cup format. There were 1620 observations by 3 sites at 9 concentrations.

| Drug

test	Approximate		Number of	Result
	concentration
of sample	% of cutoff	determinations per lot	Lot 1		Lot 2		Lot 3
AMP	0ng/ml	Negative	60	0	60	0	60	0	60
	250ng/ml	-75%cutoff	60	0	60	0	60	0	60
	500ng/ml	-50% cutoff	60	0	60	0	60	0	60
	750ng/ml	-25%cutoff	60	6	54	8	52	8	52
	1000ng/ml	cutoff	60	34	26	36	24	32	28
	1250ng/ml	+25%cutoff	60	52	8	52	8	54	6
	1500ng/ml	+50%cutoff	60	60	0	60	0	60	0
	1750ng/ml	+75%cutoff	60	60	0	60	0	60	0
	2000ng/ml	+100%cutoff	60	60	0	60	0	60	0
COC	0ng/ml	Negative	60	0	60	0	60	0	60
	75ng/ml	-75%cutoff	60	0	60	0	60	0	60
	150ng/ml	-50%cutoff	60	0	60	0	60	0	60
	225ng/ml	-25% cutoff	60	8	52	6	54	4	56
	300ng/ml	cutoff	60	36	24	34	26	38	22
	375ng/ml	+25%cutoff	60	56	4	54	6	52	8

	450ng/ml	+50% cutoff	60	60	0	60	0	60	0
	525ng/ml	+75% cutoff	60	60	0	60	0	60	0
	600ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	250ng/ml	-75% cutoff	60	0	60	0	60	0	60
	500ng/ml	-50% cutoff	60	0	60	0	60	0	60
	750ng/ml	-25% cutoff	60	4	56	8	52	6	54
MET	1000ng/ml	cutoff	60	34	26	36	24	38	22
	1250ng/ml	+25% cutoff	60	54	6	56	4	58	2
	1500ng/ml	+50% cutoff	60	60	0	60	0	60	0
	1750ng/ml	+75% cutoff	60	60	0	60	0	60	0
	2000ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	500ng/ml	-75% cutoff	60	0	60	0	60	0	60
	1000ng/ml	-50% cutoff	60	0	60	0	60	0	60
	1500ng/ml	-25% cutoff	60	8	52	10	50	8	52
MOP	2000ng/ml	cutoff	60	42	18	44	16	44	16
	2500ng/ml	+25% cutoff	60	54	6	56	4	56	4
	3000ng/ml	+50% cutoff	60	60	0	60	0	60	0
	3500ng/ml	+75% cutoff	60	60	0	60	0	60	0
	4000ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	12.5ng/ml	-75% cutoff	60	0	60	0	60	0	60
	25ng/ml	-50% cutoff	60	0	60	0	60	0	60
	37.5ng/ml	-25% cutoff	60	8	52	6	54	6	54
THC	50ng/ml	cutoff	60	36	24	38	22	36	24
	62.5ng/ml	+25% cutoff	60	52	8	56	4	54	6
	75ng/ml	+50% cutoff	60	60	0	60	0	60	0
	87.5ng/ml	+75%cutoff	60	60	0	60	0	60	0
	100ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	75ng/ml	-75% cutoff	60	0	60	0	60	0	60
	150ng/ml	-50% cutoff	60	0	60	0	60	0	60
	225ng/ml	-25% cutoff	60	4	56	6	54	4	56
BAR	300ng/ml	cutoff	60	38	22	38	22	36	24
	375ng/ml	+25% cutoff	60	54	6	56	4	58	2
	450ng/ml	+50% cutoff	60	60	0	60	0	60	0
	525ng/ml	+75%cutoff	60	60	0	60	0	60	0
	600ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	75ng/ml	-75% cutoff	60	0	60	0	60	0	60
	150ng/ml	-50% cutoff	60	0	60	0	60	0	60
	225ng/ml	-25% cutoff	60	6	54	4	56	6	54
BZO	75ng/ml	-75% cutoff	60	0	60	0	60	0	60
	150ng/ml	-50% cutoff	60	0	60	0	60	0	60
	225ng/ml	25% cutoff	60	6	54	4	56	6	54
	300ng/ml	cutoff	60	38	22	36	24	34	26
	375ng/ml	+25% cutoff	60	56	4	54	6	52	8
	450ng/ml	+50% cutoff	60	60	0	60	0	60	0
	525ng/ml	+75%cutoff	60	60	0	60	0	60	0
	600ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	125ng/ml	-75% cutoff	60	0	60	0	60	0	60
	250ng/ml	-50% cutoff	60	0	60	0	60	0	60
	375ng/ml	-25% cutoff	60	8	52	6	54	6	54
MDMA	500ng/ml	cutoff	60	36	24	34	26	36	24
	625ng/ml	+25% cutoff	60	52	8	54	6	56	4
	750ng/ml	+50% cutoff	60	60	0	60	0	60	0
	875ng/ml	+75% cutoff	60	60	0	60	0	60	0
	1000ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	75ng/ml	-75% cutoff	60	0	60	0	60	0	60
	150ng/ml	-50% cutoff	60	0	60	0	60	0	60
	225ng/ml	-25% cutoff	60	6	54	4	56	4	56
MTD	300ng/ml	cutoff	60	34	26	38	22	36	24
	375ng/ml	+25% cutoff	60	54	6	58	2	56	4
	450ng/ml	+50% cutoff	60	60	0	60	0	60	0
	525ng/ml	+75% cutoff	60	60	0	60	0	60	0
	600ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	25ng/ml	-75% cutoff	60	0	60	0	60	0	60
	50ng/ml	-50% cutoff	60	0	60	0	60	0	60
	75ng/ml	-25% cutoff	60	6	54	4	56	8	52
OXY	100ng/ml	cutoff	60	36	24	38	22	34	26
	125ng/ml	+25% cutoff	60	56	4	56	4	58	2
	150ng/ml	+50% cutoff	60	60	0	60	0	60	0
	175ng/ml	+75%cutoff	60	60	0	60	0	60	0
	200ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	6.3ng/ml	-75% cutoff	60	0	60	0	60	0	60
	12.5ng/ml	-50% cutoff	60	0	60	0	60	0	60
	18.8ng/ml	-25% cutoff	60	4	56	4	56	6	54
PCP	25ng/ml	cutoff	60	36	24	38	22	34	26
	31.3ng/ml	+25% cutoff	60	54	6	56	4	56	4
	37.5ng/ml	+50% cutoff	60	60	0	60	0	60	0
	43.8ng/ml	+75% cutoff	60	60	0	60	0	60	0
	50ng/ml	+100% cutoff	60	60	0	60	0	60	0
Drug test	Approximate
concentration
of sample	% of cutoff	Number of
determinations
per lot	Lot 1		Lot 2		Lot 3
				Positive	Negative	Positive	Negative	Positive	Negative
AMP	0ng/ml	Negative	60	0	60	0	60	0	60
	250ng/ml	-75% cutoff	60	0	60	0	60	0	60
	500ng/ml	-50% cutoff	60	0	60	0	60	0	60
	750ng/ml	-25% cutoff	60	6	54	6	54	8	52
	1000ng/ml	cutoff	60	34	26	38	22	36	24
	1250ng/ml	+25% cutoff	60	54	6	58	2	56	4
	1500ng/ml	+50% cutoff	60	60	0	60	0	60	0
	1750ng/ml	+75% cutoff	60	60	0	60	0	60	0
	2000ng/ml	+100% cutoff	60	60	0	60	0	60	0
COC	0ng/ml	Negative	60	0	60	0	60	0	60
	75ng/ml	-75% cutoff	60	0	60	0	60	0	60
	150ng/ml	-50% cutoff	60	0	60	0	60	0	60
	225ng/ml	-25% cutoff	60	6	54	4	56	6	54
	300ng/ml	cutoff	60	34	26	36	24	34	26
	375ng/ml	+25% cutoff	60	54	6	56	4	56	4
	450ng/ml	+50% cutoff	60	60	0	60	0	60	0
	525ng/ml	+75%cutoff	60	60	0	60	0	60	0
	600ng/ml	+100% cutoff	60	60	0	60	0	60	0
MET	0ng/ml	Negative	60	0	60	0	60	0	60
	250ng/ml	-75% cutoff	60	0	60	0	60	0	60
	500ng/ml	-50% cutoff	60	0	60	0	60	0	60
	750ng/ml	-25% cutoff	60	4	56	6	54	6	54
	1000ng/ml	cutoff	60	34	26	38	22	36	24
	1250ng/ml	+25% cutoff	60	56	4	58	2	58	2
	1500ng/ml	+50% cutoff	60	60	0	60	0	60	0
	1750ng/ml	+75% cutoff	60	60	0	60	0	60	0
	2000ng/ml	+100% cutoff	60	60	0	60	0	60	0
MOP	0ng/ml	Negative	60	0	60	0	60	0	60
	500ng/ml	-75% cutoff	60	0	60	0	60	0	60
	1000ng/ml	-50% cutoff	60	0	60	0	60	0	60
	1500ng/ml	-25% cutoff	60	6	54	8	52	10	50
	2000ng/ml	cutoff	60	40	20	44	16	42	18
	2500ng/ml	+25% cutoff	60	56	4	54	6	54	6
	3000ng/ml	+50% cutoff	60	60	0	60	0	60	0
	3500ng/ml	+75%cutoff	60	60	0	60	0	60	0
	4000ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	12.5ng/ml	-75% cutoff	60	0	60	0	60	0	60
	25ng/ml	-50% cutoff	60	0	60	0	60	0	60
	37.5ng/ml	-25% cutoff	60	6	54	8	52	4	56
THC	50ng/ml	cutoff	60	38	22	36	24	36	24
	62.5ng/ml	+25% cutoff	60	52	8	56	4	54	6
	75ng/ml	+50% cutoff	60	60	0	60	0	60	0
	87.5ng/ml	+75% cutoff	60	60	0	60	0	60	0
	100ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	75ng/ml	-75% cutoff	60	0	60	0	60	0	60
	150ng/ml	-50% cutoff	60	0	60	0	60	0	60
	225ng/ml	-25% cutoff	60	6	54	2	58	4	56
BAR	300ng/ml	cutoff	60	38	22	36	24	34	26
	375ng/ml	+25% cutoff	60	58	2	54	6	56	4
	450ng/ml	+50% cutoff	60	60	0	60	0	60	0
	525ng/ml	+75%cutoff	60	60	0	60	0	60	0
	600ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	75ng/ml	-75% cutoff	60	0	60	0	60	0	60
	150ng/ml	-50% cutoff	60	0	60	0	60	0	60
	225ng/ml	-25% cutoff	60	8	52	4	56	6	54
BZO	300ng/ml	cutoff	60	36	24	36	24	38	22
	375ng/ml	+25% cutoff	60	52	8	54	6	56	4
	450ng/ml	+50% cutoff	60	60	0	60	0	60	0
	525ng/ml	+75% cutoff	60	60	0	60	0	60	0
	600ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	125ng/ml	-75% cutoff	60	0	60	0	60	0	60
	250ng/ml	-50% cutoff	60	0	60	0	60	0	60
	375ng/ml	-25% cutoff	60	8	52	10	50	6	54
MDMA	500ng/ml	cutoff	60	32	28	34	26	36	24
	625ng/ml	+25% cutoff	60	56	4	54	6	52	8
	750ng/ml	+50% cutoff	60	60	0	60	0	60	0
	875ng/ml	+75% cutoff	60	60	0	60	0	60	0
	1000ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	75ng/ml	-75% cutoff	60	0	60	0	60	0	60
	150ng/ml	-50% cutoff	60	0	60	0	60	0	60
	225ng/ml	-25% cutoff	60	2	58	4	56	4	56
MTD	300ng/ml	cutoff	60	38	22	34	26	36	24
	375ng/ml	+25% cutoff	60	58	2	54	6	56	4
	450ng/ml	+50% cutoff	60	60	0	60	0	60	0
	525ng/ml	+75% cutoff	60	60	0	60	0	60	0
	600ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	25ng/ml	-75% cutoff	60	0	60	0	60	0	60
OXY	50ng/ml	-50% cutoff	60	0	60	0	60	0	60
	75ng/ml	-25%cutoff	60	6	54	8	52	4	56
	100ng/ml	cutoff	60	34	26	36	24	38	22
	125ng/ml	+25% cutoff	60	54	6	58	2	56	4
	150ng/ml	+50% cutoff	60	60	0	60	0	60	0
	175ng/ml	+75%cutoff	60	60	0	60	0	60	0
	200ng/ml	+100% cutoff	60	60	0	60	0	60	0
		0ng/ml	Negative	60	0	60	0	60	0
	6.3ng/ml	-75%cutoff	60	0	60	0	60	0	60
	12.5ng/ml	-50% cutoff	60	0	60	0	60	0	60
	18.8ng/ml	-25%cutoff	60	4	56	4	56	6	54
PCP	25ng/ml	cutoff	60	38	22	36	24	34	26
	31.3ng/ml	+25%cutoff	60	56	4	54	6	52	8
	37.5ng/ml	+50%cutoff	60	60	0	60	0	60	0
	43.8ng/ml	+75%cutoff	60	60	0	60	0	60	0
	50ng/ml	+100%cutoff	60	60	0	60	0	60	0

Single drug Test Cup:

11

12

Multi-drug Test Cup:

13

14

15

Single drug Test Dipcard:

| Drug
test | Approximate
concentration
of sample | % of cutoff | Number of
determinations
per lot | Result | | Lot 1 | | Lot 2 | | Lot 3 | |
|--------------|-------------------------------------------|-------------|----------------------------------------|----------|----------|----------|----------|----------|----------|-------|--|
| | | | | Positive | Negative | Positive | Negative | Positive | Negative | | |
| AMP | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | |
| | 250ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | |
| | 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | |
| | 750ng/ml | -25%cutoff | 60 | 8 | 52 | 6 | 54 | 10 | 50 | | |
| | 1000ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 36 | 24 | | |
| | 1250ng/ml | +25%cutoff | 60 | 50 | 10 | 52 | 8 | 54 | 6 | | |
| | 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | |

16

	1750ng/ml	+75%cutoff	60	60	0	60	0	60	0
	2000ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	75ng/ml	-75%cutoff	60	0	60	0	60	0	60
	150ng/ml	-50%cutoff	60	0	60	0	60	0	60
	225ng/ml	-25%cutoff	60	6	54	4	56	8	52
COC	300ng/ml	cutoff	60	34	26	36	24	34	26
	375ng/ml	+25%cutoff	60	54	6	56	4	56	4
	450ng/ml	+50%cutoff	60	60	0	60	0	60	0
	525ng/ml	+75%cutoff	60	60	0	60	0	60	0
	600ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	250ng/ml	-75%cutoff	60	0	60	0	60	0	60
	500ng/ml	-50%cutoff	60	0	60	0	60	0	60
	750ng/ml	-25%cutoff	60	4	56	4	56	6	54
MET	1000ng/ml	cutoff	60	36	24	34	26	34	26
	1250ng/ml	+25%cutoff	60	56	4	56	4	54	6
	1500ng/ml	+50%cutoff	60	60	0	60	0	60	0
	1750ng/ml	+75%cutoff	60	60	0	60	0	60	0
	2000ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	500ng/ml	-75%cutoff	60	0	60	0	60	0	60
	1000ng/ml	-50%cutoff	60	0	60	0	60	0	60
	1500ng/ml	-25%cutoff	60	10	50	8	52	6	54
MOP	2000ng/ml	cutoff	60	44	16	42	18	40	20
	2500ng/ml	+25%cutoff	60	56	4	54	6	54	6
	3000ng/ml	+50%cutoff	60	60	0	60	0	60	0
	3500ng/ml	+75%cutoff	60	60	0	60	0	60	0
	4000ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	12.5ng/ml	-75%cutoff	60	0	60	0	60	0	60
	25ng/ml	-50%cutoff	60	0	60	0	60	0	60
	37.5ng/ml	-25%cutoff	60	6	54	4	56	8	52
THC	50ng/ml	cutoff	60	34	26	38	22	36	24
	62.5ng/ml	+25%cutoff	60	50	10	52	8	54	6
	75ng/ml	+50%cutoff	60	60	0	60	0	60	0
	87.5ng/ml	+75%cutoff	60	60	0	60	0	60	0
	100ng/ml	+100%cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	75ng/ml	-75%cutoff	60	0	60	0	60	0	60
BAR	150ng/ml	-50%cutoff	60	0	60	0	60	0	60
	225ng/ml	-25%cutoff	60	6	54	4	56	4	56
	300ng/ml	cutoff	60	38	22	36	24	34	26
	375ng/ml	+25%cutoff	60	56	4	54	6	56	4
	450ng/ml	+50%cutoff	60	60	0	60	0	60	0
	525ng/ml	+75%cutoff	60	60	0	60	0	60	0
	600ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	75ng/ml	-75% cutoff	60	0	60	0	60	0	60
	150ng/ml	-50% cutoff	60	0	60	0	60	0	60
	225ng/ml	-25% cutoff	60	8	52	6	54	4	56
BZO	300ng/ml	cutoff	60	36	24	38	22	36	24
	375ng/ml	+25% cutoff	60	54	6	54	6	56	4
	450ng/ml	+50%cutoff	60	60	0	60	0	60	0
	525ng/ml	+75%cutoff	60	60	0	60	0	60	0
	600ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	125ng/ml	-75% cutoff	60	0	60	0	60	0	60
	250ng/ml	-50% cutoff	60	0	60	0	60	0	60
	375ng/ml	-25% cutoff	60	6	54	8	52	10	50
MDMA	500ng/ml	cutoff	60	34	26	36	24	32	28
	625ng/ml	+25% cutoff	60	54	6	56	4	52	8
	750ng/ml	+50% cutoff	60	60	0	60	0	60	0
	875ng/ml	+75%cutoff	60	60	0	60	0	60	0
	1000ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	150ng/ml	-50% cutoff	60	0	60	0	60	0	60
	75ng/ml	-75% cutoff	60	0	60	0	60	0	60
MTD	225ng/ml	-25% cutoff	60	4	56	2	58	6	54
	300ng/ml	cutoff	60	32	28	36	24	34	26
	375ng/ml	+25% cutoff	60	56	4	54	6	58	2
	450ng/ml	+50% cutoff	60	60	0	60	0	60	0
	525ng/ml	+75%cutoff	60	60	0	60	0	60	0
	600ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	75ng/ml	-75% cutoff	60	0	60	0	60	0	60
	25ng/ml	-75%cutoff	60	0	60	0	60	0	60
	50ng/ml	-50%cutoff	60	0	60	0	60	0	60
	75ng/ml	-25%cutoff	60	2	58	6	54	4	56
OXY	100ng/ml	cutoff	60	34	26	36	24	34	26
	125ng/ml	+25%cutoff	60	54	6	56	4	58	2
	150ng/ml	+50%cutoff	60	60	0	60	0	60	0
	175ng/ml	+75%cutoff	60	60	0	60	0	60	0
	200ng/ml	+100% cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	6.3ng/ml	-75%cutoff	60	0	60	0	60	0	60
	12.5ng/ml	-50%cutoff	60	0	60	0	60	0	60
PCP
18.8ng/ml	-25%cutoff	60	6	54	6	54	4	56
25ng/ml	cutoff	60	38	22	36	24	38	22
31.3ng/ml	+25%cutoff	60	56	4	56	4	58	2
37.5ng/ml	+50%cutoff	60	60	0	60	0	60	0
43.8ng/ml	+75%cutoff	60	60	0	60	0	60	0
50ng/ml	+100%cutoff	60	60	0	60	0	60	0

17

18

Multi-drug Test Dipcard:

| Drug
test | Approximate
concentration
of sample | % of cutoff | Number of
determinations
per lot | Result | | Lot 1 | | Lot 2 | | Lot 3 | |
|--------------|-------------------------------------------|--------------|----------------------------------------|----------|----------|-------|----|-------|----|-------|----|
| | 0ng/ml | Negative | 60 | Positive | Negative | 0 | 60 | 0 | 60 | 0 | 60 |
| AMP | 250ng/ml | -75% cutoff | 60 | | | 0 | 60 | 0 | 60 | 0 | 60 |
| | 500ng/ml | -50% cutoff | 60 | | | 0 | 60 | 0 | 60 | 0 | 60 |
| | 750ng/ml | -25% cutoff | 60 | | | 10 | 50 | 8 | 52 | 6 | 54 |
| | 1000ng/ml | cutoff | 60 | | | 36 | 24 | 32 | 28 | 34 | 26 |
| | 1250ng/ml | +25% cutoff | 60 | | | 56 | 4 | 54 | 6 | 54 | 6 |
| | 1500ng/ml | +50% cutoff | 60 | | | 60 | 0 | 60 | 0 | 60 | 0 |
| | 1750ng/ml | +75% cutoff | 60 | | | 60 | 0 | 60 | 0 | 60 | 0 |
| | 2000ng/ml | +100% cutoff | 60 | | | 60 | 0 | 60 | 0 | 60 | 0 |
| COC | 0ng/ml | Negative | 60 | | | 0 | 60 | 0 | 60 | 0 | 60 |
| | 75ng/ml | -75% cutoff | 60 | | | 0 | 60 | 0 | 60 | 0 | 60 |
| | 150ng/ml | -50% cutoff | 60 | | | 0 | 60 | 0 | 60 | 0 | 60 |
| | 225ng/ml | -25% cutoff | 60 | | | 8 | 52 | 6 | 54 | 4 | 56 |
| | 300ng/ml | cutoff | 60 | | | 34 | 26 | 36 | 24 | 32 | 28 |
| | 375ng/ml | +25% cutoff | 60 | | | 56 | 4 | 54 | 6 | 52 | 8 |
| | 450ng/ml | +50% cutoff | 60 | | | 60 | 0 | 60 | 0 | 60 | 0 |
| | 525ng/ml | +75%cutoff | 60 | | | 60 | 0 | 60 | 0 | 60 | 0 |
| | 600ng/ml | +100% cutoff | 60 | | | 60 | 0 | 60 | 0 | 60 | 0 |
| MET | 0ng/ml | Negative | 60 | | | 0 | 60 | 0 | 60 | 0 | 60 |
| | 250ng/ml | -75% cutoff | 60 | | | 0 | 60 | 0 | 60 | 0 | 60 |
| | 500ng/ml | -50% cutoff | 60 | | | 0 | 60 | 0 | 60 | 0 | 60 |
| | 750ng/ml | -25% cutoff | 60 | | | 6 | 54 | 8 | 52 | 4 | 56 |
| | 1000ng/ml | cutoff | 60 | | | 38 | 22 | 36 | 24 | 36 | 24 |
| | 1250ng/ml | +25% cutoff | 60 | | | 54 | 6 | 56 | 4 | 56 | 4 |
| | 1500ng/ml | +50% cutoff | 60 | | | 60 | 0 | 60 | 0 | 60 | 0 |
| | 1750ng/ml | +75%cutoff | 60 | | | 60 | 0 | 60 | 0 | 60 | 0 |
| | 2000ng/ml | +100% cutoff | 60 | | | 60 | 0 | 60 | 0 | 60 | 0 |

19

MOP	0ng/ml	Negative	60	0	60	0	60	0	60
	500ng/ml	-75% cutoff	60	0	60	0	60	0	60
	1000ng/ml	-50% cutoff	60	0	60	0	60	0	60
	1500ng/ml	-25% cutoff	60	8	52	10	50	8	52
	2000ng/ml	cutoff	60	42	18	40	20	44	16
	2500ng/ml	+25% cutoff	60	54	6	56	4	56	4
	3000ng/ml	+50% cutoff	60	60	0	60	0	60	0
	3500ng/ml	+75% cutoff	60	60	0	60	0	60	0
	4000ng/ml	+100% cutoff	60	60	0	60	0	60	0
THC	0ng/ml	Negative	60	0	60	0	60	0	60
	12.5ng/ml	-75% cutoff	60	0	60	0	60	0	60
	25ng/ml	-50% cutoff	60	0	60	0	60	0	60
	37.5ng/ml	-25% cutoff	60	8	52	4	56	6	54
	50ng/ml	cutoff	60	36	24	34	26	38	22
	62.5ng/ml	+25% cutoff	60	50	10	52	8	54	6
	75ng/ml	+50% cutoff	60	60	0	60	0	60	0
	87.5ng/ml	+75%cutoff	60	60	0	60	0	60	0
	100ng/ml	+100% cutoff	60	60	0	60	0	60	0
BAR	0ng/ml	Negative	60	0	60	0	60	0	60
	75ng/ml	-75% cutoff	60	0	60	0	60	0	60
	150ng/ml	-50% cutoff	60	0	60	0	60	0	60
	225ng/ml	-25% cutoff	60	4	56	6	54	8	52
	300ng/ml	cutoff	60	36	24	34	26	38	22
	375ng/ml	+25% cutoff	60	56	4	54	6	54	6
	450ng/ml	+50% cutoff	60	60	0	60	0	60	0
	525ng/ml	+75% cutoff	60	60	0	60	0	60	0
	600ng/ml	+100% cutoff	60	60	0	60	0	60	0
BZO	0ng/ml	Negative	60	0	60	0	60	0	60
	75ng/ml	-75% cutoff	60	0	60	0	60	0	60
	150ng/ml	-50% cutoff	60	0	60	0	60	0	60
	225ng/ml	-25% cutoff	60	6	54	4	56	6	54
	300ng/ml	cutoff	60	38	22	34	26	36	24
	375ng/ml	+25% cutoff	60	56	4	54	6	56	4
	450ng/ml	+50% cutoff	60	60	0	60	0	60	0
	525ng/ml	+75% cutoff	60	60	0	60	0	60	0
	600ng/ml	+100% cutoff	60	60	0	60	0	60	0
MDMA	0ng/ml	Negative	60	0	60	0	60	0	60
	125ng/ml	-75% cutoff	60	0	60	0	60	0	60
	250ng/ml	-50% cutoff	60	0	60	0	60	0	60

	375ng/ml	-25%cutoff	60	10	50	6	54	8	52
	500ng/ml	cutoff	60	36	24	34	26	34	26
	625ng/ml	+25%cutoff	60	52	8	56	4	54	6
	750ng/ml	+50%cutoff	60	60	0	60	0	60	0
	875ng/ml	+75%cutoff	60	60	0	60	0	60	0
	1000ng/ml	+100%cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	75ng/ml	-75%cutoff	60	0	60	0	60	0	60
MTD	150ng/ml	-50%cutoff	60	0	60	0	60	0	60
	225ng/ml	-25%cutoff	60	6	54	4	56	2	58
	300ng/ml	cutoff	60	36	24	34	26	36	24
	375ng/ml	+25%cutoff	60	56	4	58	2	56	4
	450ng/ml	+50%cutoff	60	60	0	60	0	60	0
	525ng/ml	+75%cutoff	60	60	0	60	0	60	0
	600ng/ml	+100%cutoff	60	60	0	60	0	60	0
OXY	0ng/ml	Negative	60	0	60	0	60	0	60
	25ng/ml	-75%cutoff	60	0	60	0	60	0	60
	50ng/ml	-50%cutoff	60	0	60	0	60	0	60
	75ng/ml	-25%cutoff	60	8	52	4	56	6	54
	100ng/ml	cutoff	60	38	22	36	24	34	26
	125ng/ml	+25%cutoff	60	56	4	58	2	54	6
	150ng/ml	+50%cutoff	60	60	0	60	0	60	0
	175ng/ml	+75%cutoff	60	60	0	60	0	60	0
	200ng/ml	+100%cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	6.3ng/ml	-75%cutoff	60	0	60	0	60	0	60
	12.5ng/ml	-50%cutoff	60	0	60	0	60	0	60
	18.8ng/ml	-25%cutoff	60	2	58	4	56	6	54
PCP	25ng/ml	cutoff	60	36	24	38	22	34	26
	31.3ng/ml	+25%cutoff	60	58	2	56	4	54	6
	37.5ng/ml	+50%cutoff	60	60	0	60	0	60	0
	43.8ng/ml	+75%cutoff	60	60	0	60	0	60	0
	50ng/ml	+100%cutoff	60	60	0	60	0	60	0

20

8.6 Accuracy

80 clinical urine specimens for each drug were analyzed by GC/MS and by two lots of the corresponding Rapid Single/Multi-drug Test Cup and Test Dipcard. Samples were divided by

21

concentration into five categories: drug free, less than half the cutoff, near cutoff negative, near cutoff positive, and high positive. All samples were blindly labeled by a nonparticipant. Separate sets of the blind coded were assigned. Samples were also randomized prior to testing. The study was conducted by 4 nurses at two Point-of-Care sites. The test dipcard format was performed at one site and the test cup format at the second site. Each operator only performed one test format and different nurses tested each format. Results were as follows:

Single drug Test Cup:

| Drug
Test | Co-Innovation
Result | Drug free
by
GC/MS
analysis | Less than half the
cutoff
concentration by
GC/MS analysis | Near Cutoff
Negative (Between
50% below the
cutoff and the cutoff
concentration) | Near Cutoff Positive
(Between the cutoff
and 50% above the
cutoff concentration) | High Positive
(greater than 50%
above the cutoff
concentration) | Total |
|--------------|-------------------------|--------------------------------------|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------|
| | + | 0 | 0 | 0 | 6 | 34 | 80 |
| AMP | - | 33 | 2 | 5 | 0 | 0 | |
| | + | 0 | 0 | 0 | 5 | 35 | 80 |
| COC | - | 33 | 1 | 6 | 0 | 0 | |
| | + | 0 | 0 | 1 | 5 | 35 | 80 |
| MET | - | 30 | 3 | 6 | 0 | 0 | |
| MOP2000 | + | 0 | 0 | 1 | 6 | 34 | 80 |
| | - | 30 | 4 | 5 | 0 | 0 | |
| THC | + | 0 | 0 | 0 | 6 | 33 | 80 |
| | - | 34 | 1 | 5 | 1 | 0 | |
| | + | 0 | 0 | 0 | 6 | 34 | |
| BAR | - | 33 | 0 | 7 | 0 | 0 | 80 |
| | + | 0 | 0 | 1 | 7 | 33 | |
| BZO | - | 31 | 0 | 8 | 0 | 0 | 80 |
| | + | 0 | 0 | 0 | 5 | 34 | |
| MDMA | - | 32 | 3 | 5 | 1 | 0 | 80 |
| | + | 0 | 0 | 1 | 5 | 35 | |
| MTD | - | 32 | 2 | 5 | 0 | 0 | 80 |
| | + | 0 | 0 | 0 | 6 | 34 | |
| OXY | - | 35 | 0 | 5 | 0 | 0 | 80 |
| | + | 0 | 0 | 1 | 5 | 35 | |
| PCP | - | 35 | 0 | 4 | 0 | 0 | 80 |

Analysis of Discordant Results with Rapid Single drug Test Cup

Rapid Single drug Test Cup			GC/MS Analysis
Drug Test	Cutoff(ng/mL)	Test Result	Drug Concentration (ng/mL)	Drug in Urine
MET	1000	Positive	867	Methamphetamine
MOP2000	2000	Positive	1742	Morphine
THC	50	Negative	61	11-nor-Δ9--THC-9-COOH
BZO	300	Positive	188	Oxazepam
MDMA	500	Negative	715	3,4-Methylenedioxymethamphetamine
MTD	300	Positive	209	Methadone
PCP	25	Positive	23	Phencyclidine

22

Multi-drug Test Cup:

| Drug
Test | Co-Innovation
Result | Drug free
by
GC/MS
analysis | Less than half the
cutoff
concentration by
GC/MS analysis | Near Cutoff
Negative (Between
50% below the
cutoff and the cutoff
concentration) | Near Cutoff Positive
(Between the cutoff
and 50% above the
cutoff concentration) | High Positive
(greater than 50%
above the cutoff
concentration) | Total |
|--------------|-------------------------|--------------------------------------|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------|
| AMP | + | 0 | 0 | 0 | 6 | 34 | 80 |
| AMP | - | 33 | 2 | 5 | 0 | 0 | |
| COC | + | 0 | 0 | 0 | 5 | 35 | 80 |
| COC | - | 33 | 1 | 6 | 0 | 0 | |
| MET | + | 0 | 0 | 1 | 5 | 35 | 80 |
| MET | - | 30 | 3 | 6 | 0 | 0 | |
| MOP2000 | + | 0 | 0 | 1 | 6 | 34 | 80 |
| MOP2000 | - | 30 | 4 | 5 | 0 | 0 | |
| THC | + | 0 | 0 | 0 | 6 | 33 | 80 |
| THC | - | 34 | 1 | 5 | 1 | 0 | |
| BAR | + | 0 | 0 | 0 | 6 | 34 | 80 |
| BAR | - | 33 | 0 | 7 | 0 | 0 | |
| BZO | + | 0 | 0 | 1 | 7 | 33 | 80 |
| BZO | - | 31 | 0 | 8 | 0 | 0 | |
| MDMA | + | 0 | 0 | 0 | 5 | 34 | 80 |
| MDMA | - | 32 | 3 | 5 | 1 | 0 | |
| MTD | + | 0 | 0 | 1 | 5 | 35 | 80 |
| MTD | - | 32 | 2 | 5 | 0 | 0 | |
| OXY | + | 0 | 0 | 0 | 6 | 34 | 80 |
| OXY | - | 35 | 0 | 5 | 0 | 0 | |
| PCP | + | 0 | 0 | 1 | 5 | 35 | 80 |
| PCP | - | 35 | 0 | 4 | 0 | 0 | |

Analysis of Discordant Results with Rapid Multi-drug Test Cup

Rapid Multi-drug Test Cup			GC/MS Analysis
Drug Test	Cutoff(ng/mL)	Test Result	Drug
Concentration
(ng/mL)	Drug in Urine
MET	1000	Positive	867	Methamphetamine
MOP2000	2000	Positive	1742	Morphine
THC	50	Negative	61	11-nor-Δ9--THC-9-COOH
BZO	300	Positive	188	Oxazepam
MDMA	500	Negative	715	3,4-Methylenedioxymethamphetamine
MTD	300	Positive	209	Methadone
PCP	25	Positive	23	Phencyclidine

Single drug Test Dipcard:

| Drug
Test | Co-Innovation
Result | Drug free
by
GC/MS
analysis | Less than half the
cutoff
concentration by
GC/MS analysis | Near Cutoff
Negative (Between
50% below the
cutoff and the cutoff
concentration) | Near Cutoff Positive
(Between the cutoff
and 50% above the
cutoff concentration) | High Positive
(greater than 50%
above the cutoff
concentration) | Total |
|--------------|-------------------------|--------------------------------------|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------|
| AMP | + | 0 | 0 | 0 | 6 | 34 | 80 |
| | - | 33 | 2 | 5 | 0 | 0 | |
| COC | + | 0 | 0 | 0 | 5 | 35 | 80 |
| | - | 33 | 1 | 6 | 0 | 0 | |
| MET | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 30 | 3 | 6 | 0 | 0 | |

23

MOP2000	+	0	0	1	6	34	80
MOP2000	-	30	4	5	0	0
THC	+	0	0	0	6	33
THC	-	34	1	5	1	0	80
BAR	+	0	0	0	6	34	80
BAR	-	33	0	7	0	0
BZO	+	0	0	1	7	33
BZO	-	31	0	8	0	0	80
MDMA	+	0	0	0	5	34	80
MDMA	-	32	3	5	1	0
MTD	+	0	0	1	5	35
MTD	-	32	2	5	0	0	80
OXY	+	0	0	0	6	34
OXY	-	35	0	5	0	0	80
PCP	+	0	0	1	5	35
PCP	-	35	0	4	0	0	80

Analysis of Discordant Results with Rapid Single drug Test Dipcard

Rapid Single drug Test Dipcard			GC/MS Analysis
Drug Test	Cutoff(ng/mL)	Test Result	Drug Concentration (ng/mL)	Drug in Urine
MET	1000	Positive	867	Methamphetamine
MOP2000	2000	Positive	1742	Morphine
THC	50	Negative	61	11-nor-Δ9--THC-9-COOH
BZO	300	Positive	188	Oxazepam
MDMA	500	Negative	715	3,4-Methylenedioxymethamphetamine
MTD	300	Positive	209	Methadone
PCP	25	Positive	23	Phencyclidine

Multi-drug Test Dipcard:

| Drug
Test | Co-Innovation
Result | Drug free
by
GC/MS
analysis | Less than half the
cutoff
concentration by
GC/MS analysis | Near Cutoff
Negative (Between
50% below the
cutoff and the cutoff
concentration) | Near Cutoff Positive
(Between the cutoff
and 50% above the
cutoff concentration) | High Positive
greater than 50%
above the cutoff
concentration) | Total |
|--------------|-------------------------|--------------------------------------|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------|
| | + | 0 | 0 | 0 | б | 34 | 80 |
| AMP | - | 33 | 2 | 5 | 0 | 0 | |
| COC | + | 0 | 0 | 0 | 5 | રેર | 80 |
| | - | 33 | 1 | б | 0 | 0 | |
| | + | 0 | 0 | l | 5 | રેરે | 80 |
| MET | - | 30 | 3 | б | 0 | 0 | |
| MOP2000 | + | 0 | 0 | l | б | 34 | 80 |
| | - | 30 | 4 | 5 | 0 | 0 | |
| THC | + | 0 | 0 | 0 | б | 33 | 80 |
| | - | 34 | 1 | 5 | 1 | 0 | |
| | + | 0 | 0 | 0 | б | 34 | |
| BAR | - | 33 | 0 | 7 | 0 | 0 | 80 |
| | + | 0 | 0 | 1 | 7 | 33 | |
| BZO | - | 31 | 0 | 8 | 0 | 0 | 80 |
| | + | 0 | 0 | 0 | 5 | 34 | |
| MDMA | - | 32 | 3 | 5 | l | 0 | 80 |
| MTD | + | 0 | 0 | 1 | 5 | રેર | |
| | - | 32 | 2 | 5 | 0 | 0 | 80 |
| | + | 0 | 0 | 0 | б | 34 | |
| OXY | - | રેરે | 0 | 5 | 0 | 0 | 80 |

24

PCP	+	0	0	1	5	35	80
	-	35	0	4	0	0

	Rapid Multi-drug Test Dipcard			GC/MS Analysis
Drug Test	Cutoff(ng/mL)	Test Result	Drug Concentration (ng/mL)	Drug in Urine
MET	1000	Positive	867	Methamphetamine
MOP2000	2000	Positive	1742	Morphine
THC	50	Negative	61	11-nor-Δ9--THC-9-COOH
BZO	300	Positive	188	Oxazepam
MDMA	500	Negative	715	3,4-Methylenedioxymethamphetamine
MTD	300	Positive	209	Methadone
PCP	25	Positive	23	Phencyclidine

Analysis of Discordant Results with Rapid Multi-drug Test Dipcard

8.7 Home Use Consumer Study

360 lay users from age 18 to 65 years participated in the study. Urine samples were prepared at the following concentrations: 0, +/- 50% cutoff,+/- 25% cutoff and +100% cutoff by spiking drug into drug free urine specimens. The concentrations of target drugs were confirmed with GC/MS. Each participant performed only 1 test on provided specimen with one format of Rapid Single/Multidrug Test (Dipcard, Cup) using the English package insert as guide to perform the test. They were asked to fill out an English questionnaire after finishing the test. Results were as follows:

Single drug Test Cup:

| Drug test | Approximate
concentration
of sample | % of cutoff | Number of
determinations | Layer user Results | | Agreement
(%) |
|-----------|-------------------------------------------|--------------|-----------------------------|--------------------|----------|------------------|
| | | | | Positive | Negative | |
| AMP | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 500ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 750ng/ml | -25% cutoff | 60 | 7 | 53 | 88% |
| | 1250ng/ml | +25% cutoff | 60 | 50 | 10 | 83% |
| | 1500ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 2000ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| COC | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 150ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 225ng/ml | -25% cutoff | 60 | 6 | 54 | 90% |
| | 375ng/ml | +25% cutoff | 60 | 56 | 4 | 93% |
| | 450ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 600ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| MET | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 500ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 750ng/ml | -25% cutoff | 60 | 4 | 56 | 93% |
| | 1250ng/ml | +25% cutoff | 60 | 55 | 5 | 92% |
| | 1500ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 2000ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 1000ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 1500ng/ml | -25% cutoff | 60 | 8 | 52 | 87% |
| MOP2000 | 2500ng/ml | +25% cutoff | 60 | 58 | 2 | 97% |
| | 3000ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 4000ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | | | | | | |
| | 25ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| THC | 37.5ng/ml | -25% cutoff | 60 | 6 | 54 | 90% |
| | 62.5ng/ml | +25% cutoff | 60 | 52 | 8 | 87% |
| | 75ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 100ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 150ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 225ng/ml | -25% cutoff | 60 | 6 | 54 | 90% |
| BAR | 375ng/ml | +25% cutoff | 60 | 56 | 4 | 93% |
| | 450ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 600ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 150ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| BZO | 225ng/ml | -25% cutoff | 60 | 8 | 52 | 87% |
| | 375ng/ml | +25% cutoff | 60 | 55 | 5 | 92% |
| | 450ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 600ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| MDMA | 250ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 375ng/ml | -25% cutoff | 60 | 5 | 55 | 92% |
| | 625ng/ml | +25% cutoff | 60 | 56 | 4 | 93% |
| | 750ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 1000ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| MTD | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 150ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 225ng/ml | -25% cutoff | 60 | 6 | 54 | 90% |
| | 375ng/ml | +25% cutoff | 60 | 57 | 3 | 95% |
| | 450ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 600ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 50ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 75ng/ml | -25% cutoff | 60 | 5 | 55 | 92% |
| OXY | 125ng/ml | +25% cutoff | 60 | 56 | 4 | 93% |
| | 150ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 200ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| PCP | 12.5ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 18.8ng/ml | -25% cutoff | 60 | 4 | 56 | 93% |
| | 31.3ng/ml | +25% cutoff | 60 | 56 | 4 | 93% |
| | 37.5ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 50ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |

25

26

Multi-drug Test Cup:

| Drug test | Approximate
concentration
of sample | % of cutoff | Number of
determinations | Layer user Results | | Agreement
(%) |
|-----------|-------------------------------------------|--------------|-----------------------------|--------------------|----------|------------------|
| | | | | Positive | Negative | |
| AMP | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 500ng/ml | -50%cutoff | 60 | 0 | 60 | 100% |
| | 750ng/ml | -25%cutoff | 60 | 9 | 51 | 85% |
| | 1250ng/ml | +25%cutoff | 60 | 54 | 6 | 90% |
| | 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 100% |
| | 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 100% |
| COC | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 100% |
| | 225ng/ml | -25%cutoff | 60 | 6 | 54 | 90% |
| | 375ng/ml | +25%cutoff | 60 | 56 | 4 | 93% |
| | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 100% |
| | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 100% |
| MET | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 500ng/ml | -50%cutoff | 60 | 0 | 60 | 100% |
| | 750ng/ml | -25% cutoff | 60 | 4 | 56 | 93% |
| | 1250ng/ml | +25% cutoff | 60 | 58 | 2 | 97% |
| | 1500ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 2000ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 1000ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 1500ng/ml | -25% cutoff | 60 | 6 | 54 | 90% |
| MOP2000 | 2500ng/ml | +25% cutoff | 60 | 55 | 5 | 92% |
| | 3000ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 4000ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 25ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 37.5ng/ml | -25% cutoff | 60 | 4 | 56 | 93% |
| | 62.5ng/ml | +25% cutoff | 60 | 54 | 6 | 90% |
| | 75ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 100ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| THC | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 150ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 225ng/ml | -25% cutoff | 60 | 5 | 55 | 92% |
| | 375ng/ml | +25% cutoff | 60 | 54 | 6 | 90% |
| | 450ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 600ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 150ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| BAR | 225ng/ml | -25% cutoff | 60 | 5 | 55 | 92% |
| | 375ng/ml | +25% cutoff | 60 | 54 | 6 | 90% |
| | 450ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 600ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 150ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 225ng/ml | -25% cutoff | 60 | 5 | 55 | 92% |
| BZO | 375ng/ml | +25% cutoff | 60 | 56 | 4 | 93% |
| | 450ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 600ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 250ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 375ng/ml | -25% cutoff | 60 | 6 | 54 | 90% |
| | 625ng/ml | +25% cutoff | 60 | 54 | 6 | 90% |
| MDMA | 750ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 1000ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 250ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 375ng/ml | -25% cutoff | 60 | 6 | 54 | 90% |
| MTD | 625ng/ml | +25% cutoff | 60 | 54 | 6 | 90% |
| | 750ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 1000ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| MTD | 150ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 225ng/ml | -25% cutoff | 60 | 5 | 55 | 92% |
| | 375ng/ml | +25% cutoff | 60 | 54 | 6 | 90% |
| | 450ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 600ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 50ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 75ng/ml | -25% cutoff | 60 | 4 | 56 | 93% |
| OXY | 125ng/ml | +25% cutoff | 60 | 56 | 4 | 93% |
| | 150ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 200ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| PCP | 12.5ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 18.8ng/ml | -25% cutoff | 60 | 5 | 55 | 92% |
| | 31.3ng/ml | +25% cutoff | 60 | 54 | 6 | 90% |
| | 37.5ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 50ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |

27

28

Single drug Test Dipcard:

| Drug test | Approximate
concentration
of sample | % of cutoff | Number of
determinations | Layer user Results | | Agreement
(%) |
|-----------|-------------------------------------------|--------------|-----------------------------|--------------------|----------|------------------|
| | | | | Positive | Negative | |
| AMP | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 500ng/ml | -50%cutoff | 60 | 0 | 60 | 100% |
| | 750ng/ml | -25%cutoff | 60 | 8 | 52 | 87% |
| | 1250ng/ml | +25%cutoff | 60 | 51 | 9 | 85% |
| | 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 100% |
| | 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 100% |
| COC | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 100% |
| | 225ng/ml | -25%cutoff | 60 | 5 | 55 | 92% |
| | 375ng/ml | +25%cutoff | 60 | 54 | 6 | 90% |
| | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 100% |
| | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 100% |
| MET | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 500ng/ml | -50%cutoff | 60 | 0 | 60 | 100% |
| | 750ng/ml | -25%cutoff | 60 | 6 | 54 | 90% |
| | 1250ng/ml | +25%cutoff | 60 | 53 | 7 | 88% |
| | 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 100% |
| | 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 1000ng/ml | -50%cutoff | 60 | 0 | 60 | 100% |
| | 1500ng/ml | -25%cutoff | 60 | 9 | 51 | 85% |
| MOP2000 | 2500ng/ml | +25%cutoff | 60 | 56 | 4 | 93% |
| | 3000ng/ml | +50%cutoff | 60 | 60 | 0 | 100% |
| | 4000ng/ml | +100%cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 25ng/ml | -50%cutoff | 60 | 0 | 60 | 100% |
| | | | | | | |
| THC | 37.5ng/ml | -25%cutoff | 60 | 7 | 53 | 88% |
| | 62.5ng/ml | +25%cutoff | 60 | 50 | 10 | 83% |
| | 75ng/ml | +50%cutoff | 60 | 60 | 0 | 100% |
| | 100ng/ml | +100%cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 100% |
| BAR | 225ng/ml | -25%cutoff | 60 | 5 | 55 | 92% |
| | 375ng/ml | +25%cutoff | 60 | 54 | 6 | 90% |
| | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 100% |
| | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 100% |
| | 225ng/ml | -25%cutoff | 60 | 7 | 53 | 88% |
| BZO | 375ng/ml | +25%cutoff | 60 | 56 | 4 | 93% |
| | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 100% |
| | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 250ng/ml | -50%cutoff | 60 | 0 | 60 | 100% |
| MDMA | 375ng/ml | -25%cutoff | 60 | 6 | 54 | 90% |
| | 625ng/ml | +25%cutoff | 60 | 53 | 7 | 88% |
| | 750ng/ml | +50%cutoff | 60 | 60 | 0 | 100% |
| | 1000ng/ml | +100%cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 100% |
| | 225ng/ml | -25%cutoff | 60 | 4 | 56 | 93% |
| MTD | 375ng/ml | +25%cutoff | 60 | 54 | 6 | 90% |
| | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 100% |
| | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 100% |
| OXY | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 50ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 75ng/ml | -25% cutoff | 60 | 4 | 56 | 93% |
| | 125ng/ml | +25% cutoff | 60 | 57 | 3 | 95% |
| | 150ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 200ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| PCP | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 12.5ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 18.8ng/ml | -25% cutoff | 60 | 3 | 57 | 95% |
| | 31.3ng/ml | +25% cutoff | 60 | 54 | 6 | 90% |
| | 37.5ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 50ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |

29

30

Multi-drug Test Dipcard:

| Drug test | Approximate
concentration
of sample | % of cutoff | Number of
determinations | Layer user Results | | Agreement
(%) |
|-----------|-------------------------------------------|--------------|-----------------------------|--------------------|------|------------------|
| AMP | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 500ng/ml | -50%cutoff | 60 | 0 | 60 | 100% |
| | 750ng/ml | -25%cutoff | 60 | 6 | 54 | 90% |
| | 1250ng/ml | +25%cutoff | 60 | 53 | 7 | 88% |
| | 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 100% |
| | 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 100% |
| COC | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 100% |
| | 225ng/ml | -25%cutoff | 60 | 4 | 56 | 93% |
| | 375ng/ml | +25%cutoff | 60 | 53 | 7 | 88% |
| | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 100% |
| | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 100% |
| MET | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 500ng/ml | -50%cutoff | 60 | 0 | 60 | 100% |
| | 750ng/ml | -25%cutoff | 60 | 5 | 55 | 92% |
| | 1250ng/ml | +25%cutoff | 60 | 54 | 6 | 90% |
| | 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 100% |
| | 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 100% |
| MOP2000 | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| 1000ng/ml | -50% cutoff | 60 | 0 | 60 | 100% | |
| 1500ng/ml | -25% cutoff | 60 | 7 | 53 | 88% | |
| 2500ng/ml | +25% cutoff | 60 | 57 | 3 | 95% | |
| 3000ng/ml | +50% cutoff | 60 | 60 | 0 | 100% | |
| 4000ng/ml | +100% cutoff | 60 | 60 | 0 | 100% | |
| 0ng/ml | Negative | 60 | 0 | 60 | 100% | |
| 25ng/ml | -50% cutoff | 60 | 0 | 60 | 100% | |
| 37.5ng/ml | -25% cutoff | 60 | 8 | 52 | 87% | |
| THC | 62.5ng/ml | +25% cutoff | 60 | 53 | 7 | 88% |
| | 75ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 100ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 150ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| BAR | 225ng/ml | -25% cutoff | 60 | 4 | 56 | 93% |
| | 375ng/ml | +25% cutoff | 60 | 57 | 3 | 95% |
| | 450ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 600ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| BZO | 150ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 225ng/ml | -25% cutoff | 60 | 6 | 54 | 90% |
| | 375ng/ml | +25% cutoff | 60 | 54 | 6 | 90% |
| | 450ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 600ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| MDMA | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 250ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 375ng/ml | -25% cutoff | 60 | 4 | 56 | 93% |
| | 625ng/ml | +25% cutoff | 60 | 55 | 5 | 92% |
| | 750ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| 1000ng/ml | +100% cutoff | 60 | 60 | 0 | 100% | |
| MTD | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 150ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 225ng/ml | -25% cutoff | 60 | 3 | 57 | 95% |
| | 375ng/ml | +25% cutoff | 60 | 56 | 4 | 93% |
| | 450ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| 600ng/ml | +100% cutoff | 60 | 60 | 0 | 100% | |
| OXY | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 50ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 75ng/ml | -25% cutoff | 60 | 6 | 54 | 90% |
| | 125ng/ml | +25% cutoff | 60 | 55 | 5 | 92% |
| | 150ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 200ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |
| PCP | 0ng/ml | Negative | 60 | 0 | 60 | 100% |
| | 12.5ng/ml | -50% cutoff | 60 | 0 | 60 | 100% |
| | 18.8ng/ml | -25% cutoff | 60 | 6 | 54 | 90% |
| | 31.3ng/ml | +25% cutoff | 60 | 57 | 3 | 95% |
| | 37.5ng/ml | +50% cutoff | 60 | 60 | 0 | 100% |
| | 50ng/ml | +100% cutoff | 60 | 60 | 0 | 100% |

31

32

720 questionnaires were distributed and collected. Results from the questionnaires indicated that 100% of users felt the test is easy to use and the test instructions are easy to understand.

Evaluation of the readability of the labeling

The entire package insert readability was assessed. The numbers of polysyllabic words are 12 words. The numbers of total sentences are 156. According to Appendix B the SMOG Readability Formula of "Labeling of Home-Use In Vitro Testing Products: Approved Guideline: GP-14A5", the reading level belong to 6 degree.

9. Conclusion:

The data collected in the performance and accuracy studies demonstrate that the Rapid Single/Multi Drug test cup and dipcard are substantially equivalent to the predicate device.

--- End of this section ---