Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a lateral flow immunochromatographic assay, which is a traditional biochemical test method. There is no mention of AI or ML in the description, intended use, or performance evaluation sections.

Therapeutic

No.
The device is a rapid drug screening test designed to detect the presence of drugs and drug metabolites in human urine, which is a diagnostic function, not a therapeutic one.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "The tests are intended for in vitro diagnostics use." The device also "qualitatively detect the presence of drugs and drug metabolites in human urine," which is a diagnostic function.

SaMD (Software as a Medical Device)

No

The device is described as a "Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard," which are physical, in vitro diagnostic devices designed to detect drugs in human urine. The description details the physical format (Test Cup and Test Dipcard) and the chemical formulation of the test strips, indicating it is a hardware-based device. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

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

The intended use statement explicitly states: "The tests are intended for in vitro diagnostics use."

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 is a rapid drug screening test 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
Methylenedioxymethamphetamine (MDMA)	3,4-Methylenedioxymethamphetamine	500 ng/mL
Methadone (MTD)	Methadone	300 ng/mL
Oxycodone (OXY)	Oxycodone	100 ng/mL
Phencyclidine (PCP)	Phencyclidine	25 ng/mL
Buprenorphine(BUP)	Buprenorphine	10ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine(EDDP)	2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine	300 ng/mL
Morphine(MOP300)	Morphine	300 ng/mL
Propoxyphene(PPX)	Propoxyphene	300 ng/mL
Tri-cyclic Antidepressants (TCA)	Nortriptyline	1000 ng/mL

The tests contain two formats:1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests in any combination of the drug analytes listed in the table above up to a maximum of 15 analytes. Only one cutoff concentration will be included per analyte per device. The 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 vield preliminary positive results when prescription drugs Barbiturates. Benzodiazenine, Methadone, Propoxyphene or Tricyclic Antidepressants are ingested, even at or above there are no unformly recognized drug levels for Barbiturates, Buprenorphine, Benzodiazepine, Propoxyphene and Tricyclic Antidepressants in urine.

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

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

DJG, DKZ, LFG, DIO, LDJ, DNK, LAF, LCM, JXM, DIS, DJC, DJR, JXN

Device Description

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Buprenorphine, Benzodiazepines, Cocaines, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Methamphetamine, Morphine300, Morphine2000, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Tri-cyclic Antidepressants, Marijuana and their metabolites ( specifically THC ) at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument. Test Cup and Test Dipcard use identical test strips made with 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 including point of care sites and over-the-counter use.

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

Not Found

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

Performance Data:

Cross-reactivity with structurally similar compounds: Two lots of test Dipcard and one lot of test Cup were used to test with drug metabolites and structurally similar compounds in urine. Compounds 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 positive, compounds were serially diluted and retested until the highest concentration yielding a negative result was identified. The cross-reacting substances with the lowest concentration that produced a positive result were identified and listed in tables for each drug (Amphetamine, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, EDDP, MDMA, Methamphetamine, Morphine300, Morphine2000, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Tri-cyclic Antidepressants, Cannabinoids (THC)), showing concentration and cross-reactivity percentage.
Interference: Clinical urine samples potentially containing interfering substances were spiked with drugs (AMP, BAR, BUP, BZO, COC, EDDP, MDMA, MET, MOP, MTD, OXY, PCP, PPX, TCA or THC) at concentrations 50% below and 50% above the cutoff. Potential interfering substances were added at a concentration of 100 μg/mL (confirmed by GC/MS, LC/MS, HPLC). The urine specimens were tested with two lots of the corresponding Rapid Single/Multi-drug Test Cup and Test Dipcard. None of the listed compounds (Acetaminophen, Acetophenetidin, Amoxicillin, etc.) were shown to interfere.
Effect of urinary pH: Negative urine pool pH was adjusted from 3 to 9 in 1 pH unit increments and spiked with each drug at 50% below and 50% above cutoff levels (concentrations confirmed by GC/MS, LC/MS, HPLC). Each sample was tested by two lots of the corresponding Rapid Single/Multi-drug Test Cup and Test Dipcard. Results demonstrated that varying pH ranges do not interfere with performance.
Effect of Urinary specific gravity: Specific gravity studies were conducted on drug-free urine specimens (1.002, 1.010, 1.020, 1.030, 1.040) containing drugs (AMP, BAR, BUP, BZO, COC, EDDP, MDMA, MET, MOP, MTD, OXY, PCP, PPX, TCA or THC) at 50% below and 50% above cutoff level (concentrations confirmed by GC/MS, LC/MS, HPLC). Each sample was tested by two lots of the corresponding Rapid Single/Multi-drug Test Cup and Test Dipcard. Results demonstrated that varying ranges of urinary specific gravity do not affect the test result.
Precision: Precision studies were performed using multi-drug test formats. Drug-free specimens were spiked with analytes at 0, ±75% cutoff, ±50% cutoff, and +100% cutoff (concentrations confirmed by GC/MS, LC/MS, HPLC). Aliquots were blindly labeled, assigned, and randomized. Study conducted by 6 operators at 3 Point-of-Care sites, with 2 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 used the test dipcard format, the other the test cup format. There were 1620 observations by 3 sites at 9 concentrations. Results tables are provided for both Multi-drug Test Cup and Multi-drug Test Dipcard, showing positive and negative results for each concentration and lot.
Accuracy:
- Multi-drug Test Cup: 80 clinical urine specimens for each drug were analyzed by GC/MS or HPLC and by one lot of the Rapid Multi-drug Test Cup. Samples categorized into drug free, less than half cutoff, near cutoff negative, near cutoff positive, and high positive. Results summarized in tables showing Co-Innovation Result (+/-) versus GC/MS analysis categories for each drug. Discordant results were analyzed (e.g., BUP: 10 ng/mL cutoff, negative result at 11.7 ng/mL by LC/MS).
- Multi-drug Test Dipcard: Same methodology as the Cup, 80 clinical urine specimens per drug analyzed by GC/MS or HPLC and by one lot of the Rapid Multi-drug Test Dipcard, with similar categorization and summary tables for results and discordant results.
Lay User Study: 1720 lay users (18-65 years) participated. Urine samples prepared at 0, +/- 50% cutoff, +/- 25% cutoff, and +100% cutoff by spiking (concentrations confirmed by GC/MS, LC/MS, HPLC). Each sample contained different drugs and concentrations. Participants performed 1 test with one device format (Dipcard or Cup) using the English package insert. They completed an English questionnaire. Results tables for both Multi-drug Test Cup and Multi-drug Test Dipcard show lay user results (positive/negative) for different concentrations and lots, and the agreement percentage. The overall results indicate that the test is easy to use and the instructions are clear.
Interference study (repeated): This section appears to be a re-listing/restatement of the "Interference" study from 8.2, using different phrasing and additional detail on replicates (3 lots, 15 determinations per lot per concentration over 5 non-consecutive days by 6 operators at 3 POC sites, total 180 observations at 4 concentrations for each drug). The results consistently showed 100% positive for samples at +50% and +100% cutoff and 100% negative for samples at 0 and -50% cutoff for all analytes across all lots.

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

Key metrics are presented through the performance data tables, displaying raw counts of positive/negative results and agreement percentages at various concentrations (e.g., -25% cutoff, +25% cutoff) for precision and lay user studies. Specific calculated metrics like sensitivity, specificity, PPV, NPV are not explicitly provided in a separate summary section, but can be inferred from the accuracy study data. For example, in the Multi-drug Test Cup accuracy data for AMP:

GCC/MS Analysis	Co-Innovation Result +	Co-Innovation Result -	Total
Positive (>cutoff)	6 + 34 = 40	0	40
Negative (

Regulation Number and Section

§ 862.3650 Opiate test system.

(a)
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.(b)
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).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an image of three human profiles facing to the right, stacked on top of each other, forming a stylized wing shape.

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

April 26, 2016

CO-INNOVATION BIOTECH Co., LTD HONG FENG PRODUCT MANAGER NO. 13, YANYUAN ROAD, TIANHE DISTRICT, GUANGZHOU 510507, CHINA

Re: K153050

Trade/Device Name: Rapid Single/multi-drug Test Cup, Rapid Single/multi-drug Test Dipcard Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG, DKZ, LFG, DIO, LDJ, DNK, LAF, LCM, JXM, DIS, DJC, DJR, JXN Dated: March 28, 2016 Received: March 28, 2016

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 (OS) 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,

Courtney H. Lias -S

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)

K153050

Device Name

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

Indications for Use (Describe)

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard is a rapid drug screening test 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
Methylenedioxymethamphetamine (MDMA)	3,4-Methylenedioxymethamphetamine	500 ng/mL
Methadone (MTD)	Methadone	300 ng/mL
Oxycodone (OXY)	Oxycodone	100 ng/mL
Phencyclidine (PCP)	Phencyclidine	25 ng/mL
Buprenorphine(BUP)	Buprenorphine	10ng/mL
2-ethylidene-1, 5-dimethyl-3,	2-ethylidene-1, 5-dimethyl-3,	300 ng/mL
3-diphenylpyrrolidine(EDDP)	3-diphenylpyrrolidine
Morphine(MOP300)	Morphine	300 ng/mL
Propoxyphene(PPX)	Propoxyphene	300 ng/mL
Tri-cyclic Antidepressants (TCA)	Nortriptyline	1000 ng/mL

The tests contain two formats:1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests in any combination of the drug analytes listed in the table above up to a maximum of 15 analytes. Only one cutoff concentration will be included per analyte per device. The 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 vield preliminary positive results when prescription drugs Barbiturates. Benzodiazenine, Methadone, Propoxyphene or Tricyclic Antidepressants are ingested, even at or above there are no unformly recognized drug levels for Barbiturates, Buprenorphine, Benzodiazepine, Propoxyphene and Tricyclic Antidepressants in urine.

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

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

X Prescription Use (Part 21 CFR 801 Subpart D)

|× Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Section 5 - 510(k) Summary

Date of Summary Preparation: 26/4/2016

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

Recommended classification regulation:

21 CFR 862.3100 Amphetamine test system 21 CFR 862.3150 Barbiturate test system 21 CFR 862.3650 Opiate test system 21 CFR 862.3170 Benzodiazepine test system 21 CFR 862.3250 Cocaine test system 21 CFR 862.3620 Methadone test system 21 CFR 862.3610 Methamphetamine test system 21 CFR 862.3640 Morphine test system Unclassified, Enzyme immunoassay, phencyclidine test system 21 CFR 862.3700 Propoxyphene test system 21 CFR 862.3910 Tri-cyclic Antidepressants drug test system 21 CFR 862.3870 Cannabinoid test system

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

Amphetamine (AMP) Test System Barbiturates (BAR) Test System Buprenorphine(BUP) Test System

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Benzodiazepines (BZO) Test System Cocaine (COC) Test System 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine(EDDP) Test System Methylenedioxymethamphetamine (MDMA) Test System Methamphetamine (MET) Test System Morphine (MOP300) Test System Morphine(MOP2000) Test System Methadone (MTD) Test System Oxycodone (OXY) Test System Phencyclidine (PCP) Test System Propoxyphene(PPX) Test System Tri-cyclic Antidepressants (TCA)Test System Cannabinoid (THC) Test System

Proprietary names:

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

4. The Predicate Devices

K140748	One Step Single/Multi-drug Test Cup
	One Step Single/Multi-drug Test Dipcard
K142800	Rapid Single/Multi-drug Test Cup
	Rapid Single/Multi-drug Test Dipcard

5. Device Description

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Buprenorphine, Benzodiazepines, Cocaines, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Methamphetamine, Morphine300, Morphine2000, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Tri-cyclic Antidepressants, Marijuana and their metabolites ( specifically THC ) at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument. Test Cup and Test Dipcard use identical test strips made with same chemical formulation and manufacturing procedures.

6. Intended Use of Device

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard is a rapid drug screening test for the qualitatively detection of drugs and drug metabolites in human urine. Drug test cut-off concentrations are listed below:

6

Test	Calibrator	Cut-off level
Amphetamine (AMP)	D-Amphetamine	1000 ng/mL
Barbiturates (BAR)	Secobarbital	300 ng/mL
Buprenorphine(BUP)	Buprenorphine	10ng/mL
Benzodiazepines (BZO)	Oxazepam	300 ng/mL
Cocaine (COC)	Benzoylecgonine	300 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine(EDDP)	2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine	300 ng/mL
Methylenedioxymethamphetamine (MDMA)	3,4-Methylenedioxymethamphetamine	500 ng/mL
Methamphetamine (MET)	D-Methamphetamine	1000 ng/mL
Morphine300(MOP300)	Morphine	300 ng/mL
Morphine2000(MOP2000)	Morphine	2000 ng/mL
Methadone (MTD)	Methadone	300 ng/mL
Oxycodone (OXY)	Oxycodone	100 ng/mL
Phencyclidine (PCP)	Phencyclidine	25 ng/mL
Propoxyphene(PPX)	Propoxyphene	300 ng/mL
Tri-cyclic Antidepressants (TCA)	Nortriptyline	1000 ng/mL
Marijuana (THC)	Delta-9-THC-COOH	50 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 up to a maximum of 15 analytes. Only one cutoff concentration will be included per analyte per device. The 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, Buprenorphine, Benzodiazepine, Methadone, Propoxyphene or Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturates, Buprenorphine, Benzodiazepine, Propoxyphene and Tricyclic Antidepressants in urine.

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

7. Comparison to Predicate Devices:

7

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard are a modified product format derived from the previously FDA-cleared Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard, One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard. 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
(K140748, K142800) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Indication for use | Qualitative detection of drugs-of-abuse in
urine (Amphetamine, Barbiturates,
Benzodiazepines, Buprenorphine, Cocaine,
2-ethylidene-1, 5-dimethyl-3,
3-diphenylpyrrolidine,
Methylenedioxymethamphetamine,
Methamphetamine, Morphine300,
Morphine2000, Methadone, Oxycodone,
Phencyclidine, Propoxyphene,
Tri-cyclic Antidepressants, Marijuana) | Same (but the number of
drugs detected different) |
| Intended Users | Over the Counter (OTC) Use and
Prescription Use | Same |
| Specimen | Urine | Same |
| Cutoff | Amphetamine:1000 ng/mL
Barbiturates:300 ng/mL
Buprenorphine:10 ng/mL
Benzodiazepines:300 ng/mL
Cocaine:300 ng/mL
EDDP:300 ng/mL
Methylenedioxymethamphetamine:500
ng/mL
Methamphetamine:1000 ng/mL
Morphine:300 ng/mL
Morphine:2000 ng/mL
Methadone:300 ng/mL
Oxycodone:100 ng/mL
Phencyclidine:25 ng/mL
Propoxyphene:300 ng/mL
Tri-cyclic Antidepressants:1000 ng/mL
Marijuana:50 ng/mL | Same |
| Read time | 5 minutes | Same |
| Storage | 4 ~ 30 °C | Same |
| Results | Qualitative | Same |
| Methodology | Competitive binding, Lateral flow | Same |
| | immunochromatographic assay based on | |
| | the principle of antigen antibody | |
| | immunochemistry | |
| Configuration | Dipcard and Cup | Same |

8

Remark:

1、The subject devices have all features of the predicate device except the number of drugs detected. These differences do not affect the performance characteristics of the subject devices.

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
Concentration
(ng/mL) | % Cross-
reactivity | Methamphetamine (MET) | Lowest
Concentratio
n (ng/mL) | % Cross-
reactivity |
|---------------------------------------------------------------|------------------------------------|------------------------|-----------------------------------------------------|-------------------------------------|------------------------|
| d-Amphetamine | 1,000 | 100% | 3,4- Methylenedioxyethyl
amphetamine(MDEA) | 50,000 | 2% |
| d.l-Amphetamine | 2,500 | 40% | d-Amphetamine | > 100,000 | Not
detected |
| 1-Amphetamine | 50,000 | 2% | l-Amphetamine | > 100,000 | Not
detected |
| 3,4-Methylenedioxyamphetamine
(MDA) | 2,000 | 50% | 3,4-methylenedioxyampheta
mine (MDA) | > 100,000 | Not
detected |
| d-methamphetamine | > 100,000 | Not
detected | Morphine300(MOP300) | | |
| l-methamphetamine | > 100,000 | Not
detected | Morphine | 300 | 100% |
| 3,4-Methylenedioxumethamphetamin
e(MDMA) | > 100,000 | Not
detected | Codeine | 300 | 100% |
| Methylenedioxyethylamphetamine
(MDEA) | > 100,000 | Not
detected | Hydrocodone | 2000 | 15% |
| Barbiturates (BAR) | | | Hydromorphone | 1500 | 20% |
| Secobarbital | 300 | 100% | 6-Monoacetylmorphine
(6-MAM ) | 750 | 40% |
| Amobarbital | 500 | 60% | Morphine 3-b-D-glucuronide | 300 | 100% |
| Alphenal | 150 | 200% | Ethylmorphine | 3500 | 8.6% |
| Aprobarbital | 200 | 150% | Levorphanol | 5000 | 6% |
| Butabarbital | 75 | 400% | Heroin | 300 | 100% |
| Butalbital | 1,500 | 20% | Norcodeine | 7500 | 4% |
| Butethal | 100 | 300% | Oxycodone | 100000 | 0.3% |
| Cyclopentobarbital | 600 | 50% | Thebain | 8000 | 3.8% |
| Pentobarbital | 700 | 42.9% | Morphine2000(MOP2000) | | |
| Phenobarbital | 300 | 100% | Morphine | 2,000 | 100% |
| Buprenorphine(BUP) | | | Codeine | 2,000 | 100% |
| Buprenorphine | 10 | 100% | Hydrocodone | 15,000 | 13.3% |
| Norbuprenorphine | 20 | 50% | Hydromorphone | 10,000 | 20% |
| Buprenorphine 3-D-glucuronide | 15 | 66.7% | 6-Monoacetylmorphine | 5,000 | 40% |
| Norbuprenorphine 3-D-glucuronide | 200 | 5% | Morphine 3-b-D-glucuronide | 2,000 | 100% |
| Benzodiazepines (BZO) | | | Oxycodone | >100000 | 2% |
| Oxazepam | 300 | 100% | Methadone (MTD) | | |
| Alprazolam | 200 | 150% | Methadone | 300 | 100% |
| α-Hydroxyalprazolam | 1100 | 27.3% | (±)2-Ethy1-1,5-dimethy1-3,3-
diphenylpyrrolinium | 50000 | 0.6% |
| Bromazepam | 1000 | 30% | Doxylamine | 50000 | 0.6% |
| Chlordiazepoxide | 2000 | 15% | Oxycodone (OXY) | | |
| Clobazam | 100 | 300% | Oxycodone | 100 | 100% |
| Clonazepam | 800 | 37.5% | Naloxone | 50000 | 0.2% |
| Clorazepate | 200 | 150% | Naltrexone | 50000 | 0.2% |
| Delorazepam | 1600 | 18.8% | Morphine 3-β-D-glucuronide | 50000 | 0.2% |
| Desalkylflurazepam | 400 | 75% | Hydrocodone | 3000 | 3.3% |
| Diazepam | 200 | 150% | Hydromorphone | 75000 | 0.1% |
| Estazolam | 1000 | 30% | Oxymorphone | 1000 | 10% |
| Flunitrazepam | 350 | 85.7% | Phencyclidine (PCP) | | |
| Lorazepam | 1200 | 25% | Phencyclidine | 25 | 100% |
| Midazolam | 2500 | 12% | 4-Hydroxyphencyclidine | 15000 | 0.2% |
| Nitrazepam | 100 | 300% | Propoxyphene (PPX) | | |
| Nordiazepam | 400 | 75% | d-Propoxyphene | 300 | 100% |
| Temazepam | 120 | 250% | d-Norpropoxyphene | 300 | 100% |
| Triazolam | 1000 | 30% | Tri-cyclic Antidepressants
(TCA) | | |
| Cocaine (COC) | | | Nortriptyline | 1000 | 100% |
| Benzoylecgonine | 300 | 100% | Nordoxepin | 1000 | 100% |
| Cocaine | 800 | 37.5% | Trimipramine | 5000 | 20% |
| Cocaethylene | 12,500 | 2.4% | Promazine | 3000 | 33.3% |
| Ecgonine HCI | 35,000 | 0.9% | Desipramine | 1000 | 100% |
| 2-ethylidene-1, 5-dimethyl-3,3-
diphenylpyrrolidine (EDDP) | | | Imipramine | 1000 | 100% |
| EDDP | 300 | 100% | Clomipramine | 12500 | 8% |
| Methylenedioxymethamphetamine
(MDMA) | | | Doxepin | 2000 | 50% |
| (+/-)3,4-Methylenedioxymeth
amphetamine (MDMA) | 500 | 100% | Maprotiline | 2000 | 50% |
| 3,4-Methylenedioxyamphetamine
(MDA) | 2200 | 22.7% | Amitriptyline | 1000 | 100% |
| 3,4-Methylenedioxyethyl
amphetamine (MDEA) | 240 | 208% | Promethazine | 25000 | 4% |
| D-methamphetamine(MAMP) | 100000 | 0.5% | Cannabinoids (THC) | | |
| D-Amphetamine | >100000 | Not
detected | 11-nor-Δ9-THC-9-COOH | 50 | 100% |
| L-Amphetamine | >100000 | Not
detected | 11-nor-Δ8-THC-9-COOH | 50 | 100% |
| L-Methamphetamine | >100000 | Not
detected | Δ8- Tetrahydrocannabinol | 10,000 | 0.5% |
| Methamphetamine (MET) | | | Δ9- Tetrahydrocannabinol | 15,000 | 0.3% |
| 3,4- Methylenedioxyethyl
amphetamine(MDEA) | 50,000 | 2% | Cannabinol | 20,000 | 0.3% |
| L(-)-Methamphetamine | 8,000 | 12.5% | Cannabidiol | > 100,000 | Not
detected |
| (+/-)3,4-Methylenedioxumeth
amphetamine(MDMA) | 2,000 | 50% | | | |
| p-hydroxymethamphetamine | 30,000 | 3.3% | | | |

9

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, BAR, BUP, BZO, COC, EDDP, MDMA, MET, MOP, MTD, OXY, PCP, PPX, TCA or THC 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, or LC/MS,HPLC). The urine specimens were tested with two lots of the corresponding Rapid Single/Multi-drug Test Cup and Test Dipcard.

10

None of the compounds listed below were shown to interfere.

Acetaminophen	Estrone-3-sulfate	d,l-Octopamine
Acetophenetidin	Ethyl-p-aminobenzoate	Oxalic acid
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-Propranolol
Caffeine	p-Hydroxytyramine	d-Pseudoephedrine
Carbamazepine	Ibuprofen	Quinacrine
Cephalexin	Indomethacin	Quinine
Chloralhydrate	Iproniazid	Quinidine
Chloramphenicol	d,l-Isoproterenol	Ranitidine
Chlorothiazide	Isoxsuprine	Salicylic acid
Chlorpheniramine	Ketamine	Serotonin
d,l-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
β-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, or LC/MS, HPLC). Each sample was tested by two lots of the corresponding Rapid Single/Multi-drug Test Cup and Test Dipcard. The results

11

demonstrate that varying ranges of pH do not interfere with the performance of the test.

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, BAR, BUP, BZO, COC, EDDP, MDMA, MET, MOP, MTD, OXY, PCP, PPX, TCA or THC at 50% below and 50% above cutoff level (All concentrations were confirmed with GC/MS, or LC/MS, HPLC). 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 multi-drug test formats. Drug free specimens were spiked with analytes at 0, ±75% cutoff, ±50% cutoff and +100% cutoff of The concentrations of the target drugs were confirmed with GC/MS, or LC/MS, drug. HPLC. Each concentration of the urine specimen was then 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	% of cutoff	Number of	Result
	concentration		determinati	Lot 1		Lot 2		Lot 3
	of sample		ons per lot	Positive	Negative	Positive	Negative	Positive	Negative
	0ng/ml	Negative	60	0	60	0	60	0	60
	250ng/ml	-75%cutoff	60	0	60	0	60	0	60
AMP	500ng/ml	-50%cutoff	60	0	60	0	60	0	60
	750ng/ml	-25%cutoff	60	8	52	8	52	10	50
	1000ng/ml	cutoff	60	34	26	34	26	32	28
	1250ng/ml	+25%cutoff	60	52	8	50	10	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
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	8	52	6	54	10	50
	300ng/ml	cutoff	60	38	22	36	24	38	22
	375ng/ml	+25%cutoff	60	56	4	56	4	54	6
	450ng/ml	+50%cutoff	60	60	0	60	0	60	0
	525ng/ml	+75%cutoff	60	60	0	60	0	60	0
	600ng/ml	+100%cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	2.5ng/ml	-75%cutoff	60	0	60	0	60	0	60
	5ng/ml	-50%cutoff	60	0	60	0	60	0	60
	7.5ng/ml	-25%cutoff	60	8	52	6	54	6	54
BUP	10ng/ml	cutoff	60	34	26	32	28	34	26
	12.5ng/ml	+25%cutoff	60	50	10	48	12	50	10
	15ng/ml	+50%cutoff	60	60	0	60	0	60	0
	17.5ng/ml	+75%cutoff	60	60	0	60	0	60	0
	20ng/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	8	52
BZO	300ng/ml	cutoff	60	36	24	34	26	34	26
	375ng/ml	+25%cutoff	60	52	8	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
	75ng/ml	-75%cutoff	60	0	60	0	60	0	60
	150ng/ml	-50%cutoff	60	0	60	0	60	0	60
	225ng/ml	-25%cutoff	60	6	54	8	52	6	54
COC	300ng/ml	cutoff	60	38	22	36	24	38	22
	375ng/ml	+25%cutoff	60	54	6	56	4	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
	75ng/ml	-75%cutoff	60	0	60	0	60	0	60
	150ng/ml	-50%cutoff	60	0	60	0	60	0	60
EDDP	225ng/ml	-25%cutoff	60	4	56	4	56	6	54
	300ng/ml	cutoff	60	36	24	36	24	38	22
	375ng/ml	+25%cutoff	60	54	6	56	4	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
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	8	52	6	54	4	56
	500ng/ml	cutoff	60	32	28	34	26	34	26
	625ng/ml	+25%cutoff	60	52	8	48	12	50	10
	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
	250ng/ml	-75%cutoff	60	0	60	0	60	0	60
	500ng/ml	-50%cutoff	60	0	60	0	60	0	60
	750ng/ml	-25%cutoff	60	8	52	10	50	8	52
MET	1000ng/ml	cutoff	60	36	24	34	26	38	22
	1250ng/ml	+25%cutoff	60	54	6	52	8	50	10
	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
	75ng/ml	-75%cutoff	60	0	60	0	60	0	60
	150ng/ml	-50%cutoff	60	0	60	0	60	0	60
	225ng/ml	-25%cutoff	60	10	50	10	50	12	48
MOP	300ng/ml	cutoff	60	38	22	40	20	38	22
300	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
	500ng/ml	-75%cutoff	60	0	60	0	60	0	60
	1000ng/ml	-50%cutoff	60	0	60	0	60	0	60
MOP	1500ng/ml	-25%cutoff	60	6	54	8	52	4	56
2000	2000ng/ml	cutoff	60	36	24	34	26	32	28
	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
MTD	75ng/ml	-75%cutoff	60	0	60	0	60	0	60
	150ng/ml	-50%cutoff	60	0	60	0	60	0	60
	225ng/ml	-25%cutoff	60	8	52	4	56	6	54
	300ng/ml	cutoff	60	38	22	36	24	36	24
	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
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	4	56	6	54	6	54
	100ng/ml	cutoff	60	36	24	38	22	36	24
	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	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	38	22	34	26	34	26
	31.3ng/ml	+25%cutoff	60	56	4	54	6	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
	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	6	54
PPX	300ng/ml	cutoff	60	34	26	32	28	32	28
	375ng/ml	+25%cutoff	60	54	6	52	8	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	8	52	6	54	4	56
TCA	1000ng/ml	cutoff	60	34	26	36	24	36	24
	1250ng/ml	+25%cutoff	60	52	8	50	10	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
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	4	56	6	54	6	54
	50ng/ml	cutoff	60	38	22	38	22	36	24
	62.5ng/ml	+25%cutoff	60	54	6	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

Multi-drug Test Cup:

12

13

14

15

Multi-drug Test Dipcard:

	Approximate		Number of	Result		Lot 2		Lot 3
Drug	concentration	% of cutoff	determinati	Lot 1
test	of sample		ons per lot	Positive	Negative	Positive	Negative	Positive	Negative
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	8	52	6	54	6	54
	1000ng/ml	cutoff	60	32	28	34	26	36	24
	1250ng/ml	+25%cutoff	60	50	10	52	8	50	10
	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
	250ng/ml	-75%cutoff	60	0	60	0	60	0	60
	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
BAR	225ng/ml	-25%cutoff	60	10	50	8	52	10	50
	300ng/ml	cutoff	60	36	24	38	22	36	24
	375ng/ml	+25%cutoff	60	52	8	54	6	56	4
	450ng/ml	+50%cutoff	60	60	0	60	0	60	0
	525ng/ml	+75%cutoff	60	60	0	60	0	60	0
	600ng/ml	+100%cutoff	60	60	0	60	0	60	0
	0ng/ml	Negative	60	0	60	0	60	0	60
	2.5ng/ml	-75%cutoff	60	0	60	0	60	0	60
	5ng/ml	-50%cutoff	60	0	60	0	60	0	60
	7.5ng/ml	-25%cutoff	60	4	56	8	52	6	54
BUP	10ng/ml	cutoff	60	32	28	32	28	34	26
	12.5ng/ml	+25%cutoff	60	52	8	50	10	48	12
	15ng/ml	+50%cutoff	60	60	0	60	0	60	0
	17.5ng/ml	+75%cutoff	60	60	0	60	0	60	0
	20ng/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
BZO	225ng/ml	-25%cutoff	60	6	54	8	52	4	56
	300ng/ml	cutoff	60	34	26	36	24	32	28
	375ng/ml	+25%cutoff	60	54	6	50	10	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
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	4	56	4	56	8	52
	300ng/ml	cutoff	60	36	24	38	22	34	26
	375ng/ml	+25%cutoff	60	54	6	52	8	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
EDDP	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	38	22	36	24
	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
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	6	54	4	56	8	52
	500ng/ml	cutoff	60	34	26	32	28	32	28
	625ng/ml	+25%cutoff	60	50	10	48	12	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
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	10	50	8	52	6	54
	1000ng/ml	cutoff	60	36	24	34	26	36	24
	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
MOP
300	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	12	48	10	50	8	52
	300ng/ml	cutoff	60	36	24	38	22	40	20
	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
MOP
2000	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	8	52	6	54
	2000ng/ml	cutoff	60	34	26	32	28	34	26
	2500ng/ml	+25%cutoff	60	54	6	52	8	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
	75ng/ml	-75%cutoff	60	0	60	0	60	0	60
	150ng/ml	-50%cutoff	60	0	60	0	60	0	60
MTD	225ng/ml	-25%cutoff	60	6	54	4	56	8	52
	300ng/ml	cutoff	60	36	24	34	26	38	22
	375ng/ml	+25%cutoff	60	56	4	56	4	54	6
	450ng/ml	+50%cutoff	60	60	0	60	0	60	0
	525ng/ml	+75%cutoff	60	60	0	60	0	60	0
	600ng/ml	+100%cutoff	60	60	0	60	0	60	0
	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
OXY	75ng/ml	-25%cutoff	60	6	54	4	56	4	56
	100ng/ml	cutoff	60	38	22	36	24	38	22
	125ng/ml	+25%cutoff	60	54	6	54	6	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	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	6	54	2	58
PCP	25ng/ml	cutoff	60	36	24	38	22	34	26
	31.3ng/ml	+25%cutoff	60	54	6	56	4	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
	0ng/ml	Negative	60	0	60	0	60	0	60
PPX	75ng/ml	-75%cutoff	60	0	60	0	60	0	60
	0ng/ml	Negative	60	0	60	0	60	0	60
	75ng/ml	-75%cutoff	60	0	60	0	60	0	60
	225ng/ml	-25%cutoff	60	6	54	4	56	8	52
	300ng/ml	cutoff	60	34	26	36	24	32	28
	375ng/ml	+25%cutoff	60	56	4	52	8	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	6	54	4	56	6	54
TCA	1000ng/ml	cutoff	60	32	28	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
	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
	12.5ng/ml	-75%cutoff	60	0	60	0	60	0	60
THC	25ng/ml	-50%cutoff	60	0	60	0	60	0	60
	37.5ng/ml	-25%cutoff	60	6	54	8	52	4	56
	50ng/ml	cutoff	60	34	26	36	24	38	22
	62.5ng/ml	+25%cutoff	60	52	8	54	6	56	4
	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

16

17

18

8.6 Accuracy

Multi-drug Test Cup:

80 clinical urine specimens for each drug were analyzed by GC/MS, or HPLC and by one lot of the corresponding Rapid Multi-drug Test Cup. Samples were divided by concentration into five categories: drug free, less than half the cutoff, near cutoff negative, near cutoff positive, and high positive. Results were as follows:

| 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 | |
| BAR | + | 0 | 0 | 0 | 7 | 33 | 80 |
| | - | 34 | 1 | 5 | 0 | 0 | |
| BUP | + | 0 | 0 | 0 | 6 | 33 | 80 |
| | - | 34 | 0 | 6 | 1 | 0 | |

19

BZO	+	0	0	1	6	34	80
	-	31	2	6	0	0
COC	+	0	0	0	5	35	80
	-	33	1	6	0	0
EDDP	+	0	0	0	5	35	80
	-	35	0	5	0	0
MDMA	+	0	0	0	7	33	80
	-	35	0	5	0	0
MET	+	0	0	1	5	35	80
	-	30	3	6	0	0
MOP300	+	0	0	0	5	34	80
	-	33	2	5	1	0
MOP2000	+	0	0	1	6	34	80
	-	30	4	5	0	0
MTD	+	0	0	0	7	32	80
	-	35	0	5	1	0
OXY	+	0	0	0	5	34	80
	-	33	2	5	1	0
PCP	+	0	0	0	5	35	80
	-	34	0	6	0	0
PPX	+	0	0	1	5	35	80
	-	33	0	6	0	0
TCA	+	0	0	1	5	35	80
	-	33	1	5	0	0
THC	+	0	0	0	6	33	80
	-	34	1	5	1	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
BUP**	10	Negative	11.7	Buprenorphine
BZO	300	Positive	286	Oxazepam
MET	1000	Positive	867	Methamphetamine
MOP300	300	Negative	356	Morphine
MOP2000	2000	Positive	1742	Morphine
MTD	300	Negative	328	Methadone
OXY	100	Negative	122	Oxycodone
PPX	300	Positive	248	Propoxyphene
TCA*	1000	Positive	861	Nortriptyline
THC	50	Negative	61	11-nor-A9--THC-9-COOH

(TCA*:TCA was based on HPLC data.BUP**:BUP was based on LC/MS data.)

Multi-drug Test Dipcard

20

80 clinical urine specimens for each drug were analyzed by GC/MS, or HPLC and by one lot of the corresponding Rapid Multi-drug Test Dipcard. Samples were divided by concentration into five categories: drug free,less than half the cutoff, near cutoff negative, near cutoff positive, and high positive. Results were as follows:

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
BAR	+	0	0	0	7	33	80
	-	34	1	5	0	0
BUP	+	0	0	0	6	33	80
	-	34	0	6	1	0
BZO	+	0	0	1	6	34	80
	-	31	2	6	0	0
COC	+	0	0	0	5	35	80
	-	33	1	6	0	0
EDDP	+	0	0	0	5	35	80
	-	35	0	5	0	0
MDMA	+	0	0	0	7	33	80
	-	35	0	5	0	0
MET	+	0	0	1	5	35	80
	-	30	3	6	0	0
MOP300	+	0	0	0	5	34	80
	-	33	2	5	1	0
MOP2000	+	0	0	1	6	34	80
	-	30	4	5	0	0
MTD	+	0	0	0	7	32	80
	-	35	0	5	1	0
OXY	+	0	0	0	5	34	80
	-	33	2	5	1	0
PCP	+	0	0	0	5	35	80
	-	34	0	6	0	0
PPX	+	0	0	1	5	35	80
	-	33	0	6	0	0
TCA	+	0	0	1	5	35	80
	-	33	1	5	0	0
THC	+	0	0	0	6	33	80

Analysis of Discordant Results with Rapid Multi-drug Test Dipcard

Rapid Multi-drug Test Dipcard			GC/MS Analysis
Drug Test	Cutoff(ng/mL)	Test Result	Drug Concentration (ng/mL)	Drug in Urine
BUP**	10	Negative	11.7	Buprenorphine
BZO	300	Positive	286	Oxazepam
MET	1000	Positive	867	Methamphetamine

21

MOP300	300	Negative	356	Morphine
MOP2000	2000	Positive	1742	Morphine
MTD	300	Negative	328	Methadone
OXY	100	Negative	122	Oxycodone
PPX	300	Positive	248	Propoxyphene
TCA*	1000	Positive	861	Nortriptyline
THC	50	Negative	61	11-nor-Δ9--THC-9-COOH

(TCA*:TCA was based on HPLC data.BUP**:BUP was based on LC/MS data.)

8.7 Lay User Study

1720 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. Each sample contain different drugs and the different concentrations. The concentrations of target drugs were confirmed with GC/MS, or LC/MS, HPLC. Each participant performed only 1 test on provided specimen with one format of Rapid Multi- drug 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:

Multi-drug Test Cup:

| Drug test | Approximate
concentration of
sample | % of cutoff | Number of
determinations
per lot | Layer user Results | (%) | | |
|-----------|--------- | | | AMP | 0ng/ml | | 500ng/ml | | 750ng/ml | | 1250ng/ml | | 1500ng/ml | | 2000ng/ml | BAR | 0ng/ml | | 150ng/ml | | 225ng/ml | | 375ng/ml | | 450ng/ml | | 600ng/ml | BUP | 0ng/ml | | 5ng/ml | | 7.5ng/ml | | 12.5ng/ml | | 15ng/ml | | 20ng/ml | BZO | 0ng/ml | | 150ng/ml | | 225ng/ml | | 375ng/ml | | 450ng/ml | | 600ng/ml | | 0ng/ml | | 150ng/ml | | 225ng/ml | COC | 375ng/ml | | 450ng/ml | | 600ng/ml | | 0ng/ml | | 150ng/ml | EDDP | 225ng/ml | | 375ng/ml | | 450ng/ml | | 600ng/ml | | 0ng/ml | | 250ng/ml | MDM | 375ng/ml | A | 625ng/ml | | 750ng/ml | | 1000ng/ml | MET | 0ng/ml | | 500ng/ml | | 750ng/ml | | 1250ng/ml | | 1500ng/ml | | 2000ng/ml | | 0ng/ml | | 150ng/ml | MOP | 225ng/ml | 300 | 375ng/ml | | 450ng/ml | | 600ng/ml | | 0ng/ml | | 1000ng/ml | MOP | 1500ng/ml | 2000 | 2500ng/ml | | 3000ng/ml | | 4000ng/ml | | 0ng/ml | MTD | 150ng/ml | | 225ng/ml | | 375ng/ml | | 450ng/ml | | 600ng/ml | | 0ng/ml | | 50ng/ml | | 75ng/ml | OXY | 125ng/ml | | 150ng/ml | | 200ng/ml | | 0ng/ml | | 12.5ng/ml | | 18.8ng/ml | PCP | 31.3ng/ml | | 37.5ng/ml | | 50ng/ml | | 0ng/ml | | 150ng/ml | | 225ng/ml | PPX | 375ng/ml | | 450ng/ml | | 600ng/ml | | 0ng/ml | | 500ng/ml | | 750ng/ml | TCA | 1250ng/ml | | 1500ng/ml | | 2000ng/ml | | 0ng/ml | | 25ng/ml | | 37.5ng/ml | THC | 62.5ng/ml | | 75ng/ml | | 100ng/ml | Agreement
----------------------------------|-------------|----------------------------------------|--------------------|------|------------------|-----|------|
| | | Lot1 | Lot2 | | | |
| Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| -25%cutoff | 10 | 1 | 9 | 2 | 8 | 85% |
| +25%cutoff | 10 | 8 | 2 | 9 | 1 | 85% |
| +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| -25%cutoff | 10 | 1 | 9 | 1 | 9 | 90% |
| +25%cutoff | 10 | 10 | 0 | 9 | 1 | 95% |
| +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| -25%cutoff | 10 | 1 | 9 | 2 | 8 | 85% |
| +25%cutoff | 10 | 9 | 1 | 9 | 1 | 90% |
| +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| -25%cutoff | 10 | 0 | 10 | 1 | 9 | 95% |
| +25%cutoff | 10 | 9 | 1 | 9 | 1 | 90% |
| +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| -25%cutoff | 10 | 0 | 10 | 1 | 9 | 95% |
| +25%cutoff | 10 | 10 | 0 | 8 | 2 | 90% |
| +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| -25%cutoff | 10 | 1 | 9 | 0 | 10 | 95% |
| +25%cutoff | 10 | 8 | 2 | 9 | 1 | 85% |
| +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| -25%cutoff | 10 | 1 | 9 | 1 | 9 | 90% |
| +25%cutoff | 10 | 8 | 2 | 9 | 1 | 85% |
| +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| -25%cutoff | 10 | 2 | 8 | 1 | 9 | 85% |
| +25%cutoff | 10 | 8 | 2 | 10 | 0 | 90% |
| +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| Negative | 310 | 0 | 310 | | | 100% |
| -50%cutoff | 10 | 0 | 10 | | | 100% |
| -25%cutoff | 60 | 1 | 9 | | | 90% |
| +25%cutoff | 60 | 9 | 1 | | | 90% |
| +50%cutoff | 30 | 30 | 0 | | | 100% |
| +100%cutoff | 10 | 10 | 0 | | | 100% |
| Negative | 310 | | | 0 | 310 | 100% |
| -50%cutoff | 10 | | | 0 | 10 | 100% |
| -25%cutoff | 60 | | | 1 | 9 | 90% |
| +25%cutoff | 60 | | | 9 | 1 | 90% |
| +50%cutoff | 30 | | | 30 | 0 | 100% |
| +100%cutoff | 10 | | | 10 | 0 | 100% |
| Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| -25%cutoff | 10 | 1 | 9 | 2 | 8 | 85% |
| +25%cutoff | 10 | 8 | 2 | 9 | 1 | 85% |
| +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| -25%cutoff | 10 | 1 | 9 | 1 | 9 | 90% |
| +25%cutoff | 10 | 8 | 2 | 10 | 0 | 90% |
| +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| -25%cutoff | 10 | 2 | 8 | 1 | 9 | 85% |
| +25%cutoff | 10 | 9 | 1 | 9 | 1 | 90% |
| +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| -25%cutoff | 10 | 1 | 9 | 0 | 10 | 95% |
| +25%cutoff | 10 | 9 | 1 | 9 | 1 | 90% |
| +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| -25%cutoff | 10 | 0 | 10 | 2 | 8 | 90% |
| +25%cutoff | 10 | 8 | 2 | 10 | 0 | 90% |
| +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| -25%cutoff | 10 | 1 | 9 | 2 | 8 | 85% |
| +25%cutoff | 10 | 8 | 2 | 10 | 0 | 90% |
| +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |

22

23

Multi-drug Test Dipcard:

| Drug test | Approximate
concentration
of sample | % of cutoff | Number of
determinations
per lot | Layer user Results | | | | Agreement(%) |
|-----------|-------------------------------------------|-------------|----------------------------------------|--------------------|----------|----------|----------|--------------|
| | | | | Lot1 | | Lot2 | | |
| | | | | Positive | Negative | Positive | Negative | |
| AMP | 0ng/ml | Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| AMP | 500ng/ml | -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| | 750ng/ml | -25%cutoff | 10 | 1 | 9 | 1 | 9 | 90% |
| | 1250ng/ml | +25%cutoff | 10 | 9 | 1 | 10 | 0 | 95% |
| | 1500ng/ml | +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| | 2000ng/ml | +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| | 0ng/ml | Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| | 150ng/ml | -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| | 225ng/ml | -25%cutoff | 10 | 0 | 10 | 1 | 9 | 95% |
| BAR | 375ng/ml | +25%cutoff | 10 | 9 | 1 | 9 | 1 | 90% |
| | 450ng/ml | +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| | 600ng/ml | +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| | 0ng/ml | Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| | 5ng/ml | -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| BUP | 7.5ng/ml | -25%cutoff | 10 | 1 | 9 | 2 | 8 | 85% |
| | 12.5ng/ml | +25%cutoff | 10 | 10 | 0 | 9 | 1 | 95% |
| | 15ng/ml | +50%cutoff | 30 | 10 | 0 | 9 | 0 | 100% |
| | 20ng/ml | +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| | 0ng/ml | Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| | 150ng/ml | -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| BZO | 225ng/ml | -25%cutoff | 10 | 1 | 9 | 1 | 9 | 90% |
| | 375ng/ml | +25%cutoff | 10 | 8 | 2 | 10 | 0 | 90% |
| | 450ng/ml | +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| | 600ng/ml | +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| | 0ng/ml | Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| | 150ng/ml | -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| COC | 225ng/ml | -25%cutoff | 10 | 1 | 9 | 1 | 9 | 90% |
| | 375ng/ml | +25%cutoff | 10 | 9 | 1 | 9 | 1 | 90% |
| | 450ng/ml | +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| | 600ng/ml | +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| | 0ng/ml | Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| | 150ng/ml | -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| EDDP | 225ng/ml | -25%cutoff | 10 | 2 | 8 | 1 | 9 | 85% |
| | 375ng/ml | +25%cutoff | 10 | 9 | 1 | 9 | 1 | 90% |
| | 450ng/ml | +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| | 600ng/ml | +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| | 0ng/ml | Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| | 250ng/ml | -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| | 375ng/ml | -25%cutoff | 10 | 1 | 9 | 2 | 8 | 85% |
| MDMA | 625ng/ml | +25%cutoff | 10 | 10 | 0 | 9 | 1 | 95% |
| | 750ng/ml | +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| | 1000ng/ml | +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| | 0ng/ml | Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| MET | 500ng/ml | -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| | 750ng/ml | -25%cutoff | 10 | 1 | 9 | 0 | 10 | 95% |
| | 1250ng/ml | +25%cutoff | 10 | 10 | 0 | 9 | 1 | 95% |
| | 1500ng/ml | +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| | 2000ng/ml | +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| | 0ng/ml | Negative | 310 | 0 | 310 | | | 100% |
| | 150ng/ml | -50%cutoff | 10 | 0 | 10 | | | 100% |
| | 225ng/ml | -25%cutoff | 60 | 0 | 10 | | | 100% |
| MOP300 | 375ng/ml | +25%cutoff | 60 | 9 | 1 | | | 90% |
| | 450ng/ml | +50%cutoff | 30 | 30 | 0 | | | 100% |
| | 600ng/ml | +100%cutoff | 10 | 10 | 0 | | | 100% |
| | 0ng/ml | Negative | 310 | 0 | | 0 | 310 | 100% |
| | 1000ng/ml | -50%cutoff | 10 | 0 | | 0 | 10 | 100% |
| | 1500ng/ml | -25%cutoff | 60 | | | 1 | 9 | 90% |
| MOP2000 | 2500ng/ml | +25%cutoff | 60 | | | 9 | 1 | 90% |
| | 3000ng/ml | +50%cutoff | 30 | | | 30 | 0 | 100% |
| | 4000ng/ml | +100%cutoff | 10 | | | 10 | 0 | 100% |
| | 0ng/ml | Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| | 150ng/ml | -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| | 225ng/ml | -25%cutoff | 10 | 2 | 8 | 0 | 10 | 90% |
| MTD | 375ng/ml | +25%cutoff | 10 | 10 | 0 | 8 | 2 | 90% |
| | 450ng/ml | +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| | 600ng/ml | +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| | 0ng/ml | Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| | 50ng/ml | -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| | 75ng/ml | -25%cutoff | 10 | 2 | 8 | 1 | 9 | 85% |
| OXY | 125ng/ml | +25%cutoff | 10 | 9 | 1 | 9 | 1 | 90% |
| | 150ng/ml | +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| | 200ng/ml | +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| | 0ng/ml | Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| | 12.5ng/ml | -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| | 18.8ng/ml | -25%cutoff | 10 | 0 | 10 | 2 | 8 | 90% |
| PCP | 31.3ng/ml | +25%cutoff | 10 | 8 | 2 | 9 | 1 | 85% |
| | 37.5ng/ml | +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| | 50ng/ml | +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| | 0ng/ml | Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| | 150ng/ml | -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| | 225ng/ml | -25%cutoff | 10 | 1 | 9 | 2 | 8 | 85% |
| PPX | 375ng/ml | +25%cutoff | 10 | 8 | 2 | 9 | 1 | 85% |
| | 450ng/ml | +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| | 600ng/ml | +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| | 0ng/ml | Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| | 500ng/ml | -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| TCA | 750ng/ml | -25%cutoff | 10 | 2 | 8 | 1 | 9 | 85% |
| | 1250ng/ml | +25%cutoff | 10 | 9 | 1 | 9 | 1 | 90% |
| | 1500ng/ml | +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| | 2000ng/ml | +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |
| THC | 0ng/ml | Negative | 360 | 0 | 360 | 0 | 360 | 100% |
| | 25ng/ml | -50%cutoff | 10 | 0 | 10 | 0 | 10 | 100% |
| | 37.5ng/ml | -25%cutoff | 10 | 0 | 10 | 2 | 8 | 90% |
| | 62.5ng/ml | +25%cutoff | 10 | 9 | 1 | 8 | 2 | 85% |
| | 75ng/ml | +50%cutoff | 30 | 30 | 0 | 30 | 0 | 100% |
| | 100ng/ml | +100%cutoff | 10 | 10 | 0 | 10 | 0 | 100% |

24

25

26

1720 questionnaires were distributed collected. The results show that the test is easy to be used and the instruction insert is clear.

Evaluation of the readability of the labeling

The entire package insert readability was assessed. We choose 30 chain sentences from Instructions Insert at OTC user read. According to SMOG Conversion Table of Appendix B the SMOG Readability Formula of "Labeling of Home-Use In Vitro Testing Products: Approved Guideline: GP-14A5", the reading level belong to 7th degree.

8.7 Interference study

Interference studies were performed using the multi-drug test formats. Drug free specimens were spiked with single drug at 0, ±50% cutoff and +100% cutoff of drug. The concentrations of the target drugs were confirmed with GC/MS, or LC/MS, HPLC. Each concentration of the urine divided into aliquots. Each aliquot was specimen was blindly labeled by a nonparticipant. Separate sets of blinded coded samples were assigned and randomized prior to The study was conducted by 6 operators at 3 Point-of-Care sites. Operators tested 3 testing. aliquots at each concentration for each lot per day (3runs/day ) and lasted for 5 non-consecutive days. A total of 15 determinations were made by each site at each concentration. There were 180 observations by 3 sites at 4 concentrations.

| Drug test | Approximate
concentration of
sample | % of cutoff | Number of
determinations per lot | Result | | Lot2 | | Lot3 | |
|-----------|-------------------------------------------|-------------|-------------------------------------|--------|----------|----------|----------|----------|----------|
| | | | | | Lot1 | | | | |
| | | | | | Positive | Negative | Positive | Negative | Positive |
| AMP | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 500ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 1500ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 2000ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| BAR | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 150ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 450ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 600ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| BUP | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 5ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | | | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| BZO | 15ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 20ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 150ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 450ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 600ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| COC | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 150ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 450ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 600ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| EDDP | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 150ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 450ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 600ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| MDMA | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 250ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 750ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 1000ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| MET | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 500ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 1500ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 2000ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| MOP300 | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 150ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 450ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 600ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| MOP2000 | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 1000ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 3000ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 4000ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| MTD | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 150ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 450ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 600ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| OXY | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 50ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 150ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 200ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| PCP | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 12.5ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 37.5ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 50ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| PPX | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 150ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 450ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 600ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| TCA | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 500ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 1500ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 2000ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| THC | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 25ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 75ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 100ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |

Multi-drug Test Cup:

27

28

Multi-drug Test Dipcard:

| Drug test | Approximate
concentration of
sample | % of cutoff | Number of
determinations per lot | Lot1 | | Lot2 | | Lot3 | |
|-----------|-------------------------------------------|-------------|-------------------------------------|----------|----------|----------|----------|----------|----------|
| | | | | Positive | Negative | Positive | Negative | Positive | Negative |
| AMP | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 500ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 1500ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 2000ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| BAR | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 150ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 450ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 600ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| BUP | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 5ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 15ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 20ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| BZO | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 150ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 450ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 600ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| COC | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 150ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 450ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 600ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| EDDP | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 150ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 450ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 600ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| MD | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| MA | 250ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 750ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 1000ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| MET | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 500ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 1500ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 2000ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| MOP | 150ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| 300 | 450ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 600ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| MOP | 1000ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| 2000 | 3000ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 4000ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| MTD | 150ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 450ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 600ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| OXY | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 50ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 150ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 200ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| PCP | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 12.5ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 37.5ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 50ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| PPX | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 150ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 450ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 600ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| TCA | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 500ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 1500ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 2000ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| THC | 0ng/ml | Negative | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 25ng/ml | -50%cutoff | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
| | 75ng/ml | +50%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| | 100ng/ml | +100%cutoff | 15 | 15 | 0 | 15 | 0 | 15 | 0 |

29

9. Conclusion:

30

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 ---