Predicate Devices

Wondfo T-Cup® Multi-Drug Urine Test Cup (K182701)

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a standard immunochromatographic assay (lateral flow test) which relies on chemical reactions and visual interpretation of lines, not AI/ML for analysis or interpretation.

Therapeutic

No
This device is a diagnostic tool used to detect the presence of certain drugs in urine, not to provide treatment or therapy.

Diagnostic

Yes

The device qualitatively and simultaneously detects various drugs in human urine at specified cutoff concentrations, which is a form of diagnostic testing to identify the presence of substances.

SaMD (Software as a Medical Device)

No

The device is described as an "immunochromatographic assay that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine." This description clearly indicates a physical test cup that utilizes chemical reactions and a lateral flow system, which are hardware components, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the PocguideTM Multi-Drug Test Cup OTC is indeed an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The device is intended for the qualitative and simultaneous detection of various drugs in human urine. This is a biological specimen collected from the human body.
Diagnostic Purpose: While it provides a "preliminary result," the purpose is to detect the presence of specific substances (drugs) in the urine, which is a form of diagnostic testing. The fact that it requires confirmation by a more specific method doesn't negate its initial diagnostic screening function.
In Vitro: The testing is performed outside of the living body, using a sample (urine) collected from the individual.
Regulatory Context: The mention of "For over-the-counter use (21 CFR 801 Subpart C)" indicates that this device is subject to FDA regulations for medical devices, specifically those intended for use by lay persons. IVDs are a category of medical devices.
Device Description: It is described as an "immunochromatographic assay that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine." This is a common format for IVD tests.
Performance Studies: The document details performance studies using clinical samples and a lay user study, which are typical requirements for demonstrating the performance of an IVD.
Predicate Device: The mention of a predicate device (K182701; Wondfo T-Cup® Multi-Drug Urine Test Cup) which is also a multi-drug urine test cup, further supports its classification as an IVD.

In summary, the PocguideTM Multi-Drug Test Cup OTC meets the definition of an In Vitro Diagnostic device because it is used to examine a specimen (urine) obtained from the human body to provide information for diagnostic purposes (detecting the presence of drugs).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

PocguideTM Multi-Drug Test Cup OTC is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dipheny|pyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier) Amphetamine (AMP) Buprenorphine (BUP) Secobarbital (BAR) Oxazepam (BZO) Benzoylecgonine (COC) 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) Methamphetamine (MET) Methylenedioxymethamphetamine (MDMA) Morphine (OPI2000/MOP300) Methadone (MTD) Oxycodone (OXY) Phencyclidine (PCP) Nortriptyline (TCA) Marijuana (THC)
Cut-off level 1000 ng/mL or 500 ng/mL 10 ng/mL 300 ng/mL 300 ng/mL 300 ng/mL or 150 ng/mL 300 ng/mL 1000 ng/mL or 500 ng/mL 500 ng/mL 2000 ng/mL or 300 ng/mL 300 ng/mL 100 ng/mL 25 ng/mL 1000 ng/mL 50 ng/mL

The single or multi-test cups can consist of up to the above listed analytes in any combination. For over-the-counter use.

The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

PocguideTM Multi-Drug Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-dipheny|pyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Benzoylecgonine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (OPI2000/MOP300)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

The single or multi-test cups can consist of up to the above listed analytes in any combination.

The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

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

NFT, PTH, NGL, NFV, NFY, PTG, NGG, NGM, QAW, NFW

Device Description

Pocguide™ Multi-Drug Test Cup OTC and Pocguide™ Multi-Drug Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

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

For over-the-counter use.
A lay user study was performed at three intended user sites with 280 lay persons.

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

Method comparison studies: 80 unaltered urine clinical samples for each drug were tested by three operators. Samples were blind labeled and compared to LC-MS/MS results.
Lay user study: 280 lay persons (114 males, 166 females, ages 18 to >50) tested the device. Urine samples were prepared at -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug-free pooled urine specimens. Concentrations were confirmed by LC-MS/MS. Each participant received 1 blind-labeled sample and a device.

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

Analytical performance:
- Precision/Reproducibility: Samples at +100% cutoff, +75% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cutoff, and -100% cutoff were tested. Drug-free urine for -100% cutoff. Other samples were spiked into drug-free urine. Each concentration confirmed by LC-MS/MS. Tests performed two runs per day for 25 days using three lots of test cups.
- Linearity/assay reportable range: Not applicable, qualitative use only.
- Stability: Stable at 4-30℃ for 24 months based on accelerated stability study.
- Analytical specificity/Interference: Drug metabolites and other compounds spiked into drug-free urine and tested with three lots. Percent cross-reactivity calculated as cutoff concentration divided by minimum concentration for positive result, multiplied by 100. Non-structurally related compounds (100ug/mL) were tested for interference in drug-free urine and in urine samples with target drugs at 25% below and 25% above cutoff. No interference found for listed compounds. pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 did not affect results.
Method comparison study: 80 unaltered urine clinical samples (40 negative, 40 positive) for each drug were tested by three operators. Samples were blind labeled and compared to LC-MS/MS results. Detailed tables of agreement and discordant results are provided.
Lay person study: 280 lay persons tested the device. Urine samples were prepared at -100%, +/-75%, +/-50%, +/-25% of the cutoff and confirmed by LC-MS/MS. Each participant was provided the package insert, a blind-labeled sample, and a device.
- Key Results for Lay Person Study (Agreement %):
  - AMP 500: 100%, 100%, 100%, 95.00%, 95.00%, 100%, 100% (for -100% to +75% cutoff concentrations respectively)
  - BAR 300: 100%, 100%, 100%, 100%, 90.00%, 100%, 100%
  - BZO 300: 100%, 100%, 100%, 100%, 95.00%, 100%, 100%
  - BUP 10: 100%, 100%, 100%, 95.00%, 95.00%, 100%, 100%
  - COC 150: 100%, 100%, 100%, 100%, 95.00%, 100%, 100%
  - EDDP 300: 100%, 100%, 100%, 95.00%, 95.00%, 100%, 100%
  - MDMA 500: 100%, 100%, 100%, 100%, 95.00%, 100%, 100%
  - MET 500: 100%, 100%, 100%, 95.00%, 95.00%, 100%, 100%
  - MOP 300: 100%, 100%, 100%, 95.00%, 100%, 100%, 100%
  - MTD 300: 100%, 100%, 100%, 95.00%, 100%, 100%, 100%
  - OXY 100: 100%, 100%, 100%, 100%, 95.00%, 100%, 100%
  - PCP 25: 100%, 100%, 100%, 95.00%, 95.00%, 100%, 100%
  - TCA 1000: 100%, 100%, 100%, 95.00%, 95.00%, 100%, 100%
  - THC 50: 100%, 100%, 100%, 100%, 95.00%, 100%, 100%
  - AMP 1000: 100%, 100%, 100%, 95.00%, 100%, 100%, 100%
  - OPI 2000: 100%, 100%, 100%, 100%, 90.00%, 100%, 100%
- All participants indicated the device instruction is easy to understand and follow, with a Flesch-Kincaid Grade Level of 7.
Clinical Studies: Not applicable.

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

Not Found (raw agreement data provided without summarized metrics)

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.

Wondfo T-Cup® Multi-Drug Urine Test Cup (K182701)

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

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of the HHS logo is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Aicheck Biotech, Inc. % Jenny Xia Director LSI International Inc 504E Diamond Ave., Suite H Gaithersburg, Maryland 20877

Re: K242077

Trade/Device Name: Pocguide™ Multi-Drug Test Cup OTC, Pocguide™ Multi-Drug Test Cup Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Code: NFT Dated: July 12, 2024 Received: July 16, 2024

Dear Jenny Xia:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

1

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Joseph A. Digitally signed by Kotarek -S Date: 2024.08.14
10:57:33 -04'00'

Joseph Kotarek, Ph.D. Branch Chief Division of Chemistryand Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

2

Indications for Use

Submission Number (if known)

K242077 Device Name

PocquideTM Multi-Drug Test Cup OTC; PocquideTM Multi-Drug Test Cup

Indications for Use (Describe)

PocguideTM Multi-Drug Test Cup OTC is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dipheny|pyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier) Amphetamine (AMP) Buprenorphine (BUP) Secobarbital (BAR) Oxazepam (BZO) Benzoylecgonine (COC) 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) Methamphetamine (MET) Methylenedioxymethamphetamine (MDMA) Morphine (OPI2000/MOP300) Methadone (MTD) Oxycodone (OXY) Phencyclidine (PCP) Nortriptyline (TCA) Marijuana (THC)
Cut-off level 1000 ng/mL or 500 ng/mL 10 ng/mL 300 ng/mL 300 ng/mL 300 ng/mL or 150 ng/mL 300 ng/mL 1000 ng/mL or 500 ng/mL 500 ng/mL 2000 ng/mL or 300 ng/mL 300 ng/mL 100 ng/mL 25 ng/mL 1000 ng/mL 50 ng/mL

The single or multi-test cups can consist of up to the above listed analytes in any combination. For over-the-counter use.

The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

PocquideTM Multi-Drug Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-dipheny|pyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL

3

Benzoylecgonine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (OPI2000/MOP300)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

The single or multi-test cups can consist of up to the above listed analytes in any combination.

The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

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)
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510(k) SUMMARY K242077

1.	Date:	July 11, 2024
2.	Submitter:	Aicheck Biotech, Inc.
17701 Cowan, Ste 230
Irvine, CA 92614
3.	Contact person:	Jenny Xia
LSI International Inc.
504 East Diamond Ave., Suite H
Gaithersburg, MD 20877
Telephone: 301-525-6856
Email: jxia@lsi-consulting.org
4.	Device Name:	PocguideTM Multi-Drug Test Cup OTC
PocguideTM Multi-Drug Test Cup
5.	Classification:	Class II

| Product Code

Target Drug	Regulation Section	Panel
NFT
Amphetamine (AMP)	862.3100, Amphetamine Test System	Toxicology
PTH
Secobarbital (BAR)	862.3150, Barbiturate Test System	Toxicology
NGL
Buprenorphine (BUP)
Morphine (MOP/OPI)
Oxycodone (OXY)	862.3650, Opiate Test System	Toxicology
NFV
Oxazepam (BZO)	862.3170, Benzodiazepine Test System	Toxicology
NFY
Cocaine (COC)	862.3250, Cocaine and cocaine
metabolite test system	Toxicology
PTG
Methadone (MTD)
2-ethylidene-1,5-dimethyl-3,3-
diphenylpyrrolidine (EDDP)	862.3620, Methadone Test System	Toxicology
NGG
Methylenedioxymethamphetamine
(MDMA)
Methamphetamine (MET)	862.3610,
Methamphetamine Test System	Toxicology
NGM
Phencyclidine (PCP)	Unclassified	Toxicology
QAW
Nortriptyline (TCA)	862.3910 Tricyclic antidepressant drugs
test system	Toxicology
NFW	862.3870, Cannabinoids Test System	Toxicology

5

Cannabinoids (THC)
And Comments of Children Comments of Children Comments of Children

Predicate Devices: 6.

Wondfo T-Cup® Multi-Drug Urine Test Cup (K182701)

7. Intended Use

Pocguide™ Multi-Drug Test Cup OTC is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3diphenylpyrrolidine, Methamphetamine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Benzoylecgonine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine
(EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (OPI2000/MOP300)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

The single or multi-test cups can consist of up to the above listed analytes in any combination. For over-the-counter use.

The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem massspectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

6

Pocguide™ Multi-Drug Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Benzoylecgonine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine
(EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (OPI2000/MOP300)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

The single or multi-test cups can consist of up to the above listed analytes in any combination.

The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem massspectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

Device Description 8.

Pocguide™ Multi-Drug Test Cup OTC and Pocguide™ Multi-Drug Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.

7

The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

| Item | Proposed Device ( Cut Off Values | Target Drug | | Amphetamine (AMP) | | Buprenorphine (BUP) | | Secobarbital (BAR) | | Oxazepam (BZO) | | Cocaine (COC) | | 2-ethylidene-1,5- diphenylpyrrolidine (EDDP) | | Methamphetamine (MET) | | Methylenedioxymet (MDMA) | | Morphine (MOP 300/OPI 2000) | | Methadone (MTD) | | Oxycodone (OXY) | | Phencyclidine (PCP) | | Nortriptyline (TCA) | | Marijuana (THC 50) | Configurations | Test cup | Intended Use | For over-the-counter use | Predicate
target="_blank" rel="noopener noreferrer" class="text-primary hover:underline break-words">K182701) | |
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|
qualitative determination of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine. | Same (but the number of drugs detected is different) | |
binding, lateral flow immunochromatographic assay based on antigen-antibody reaction | Same | |
| Same | |
| Same | |
| Cutoff (ng/mL) | Same (but the number of drugs detected is different) |
| 1000 or 500 | |
| 10 | |
| 300 | |
| 300 | |
| 300 or 150 | |
dimethyl-3,3-
| 300 | |
| 1000 or 500 | |
hamphetamine
| 500 | |
| 2000 or 300 | |
| 300 | |
| 100 | |
| 25 | |
| 1000 | |
| 50 | |
| Same | |
| Same | |

Substantial Equivalence Information 9.

10. Standard/Guidance Document Reference (if applicable)

None referenced.

8

11. Test Principle

Pocguide™ Multi-Drug Test Cup OTC or Pocguide™ Multi-Drug Test Cup is a competitive immunoassay that is used to screen for the presence of drugs of abuse in urine. It is chromatographic absorbent device in which drugs or drug metabolites in a sample competitively combined to a limited number of antibody-dye conjugate binding sites. When the absorbent end of the test device is immersed into the urine sample, the urine is absorbed into the device by capillary action, mixes with the antibody-dye conjugate, and flows across the precoated membrane.

When sample drug levels are at or above the target cutoff (the detection sensitivity of the test), the drug in the sample binds to the antibody-dye conjugate preventing the antibody-dye conjugate from binding to the drug-protein pre-coated in the test region (T). This prevents the development of a distinct colored band in the test region indicating a potentially positive result. When sample drug levels are zero or below the target cutoff, antibody-dye conjugate binds to the drug-protein pre-coated in the test region (T) of the device. This produces a colored test line that, regardless of its intensity, indicates a negative result.

To serve as a procedural control, a colored line will always appear at the control region (C) indicating that proper volume of specimen has been added and membrane wicking has occurred.

12. Performance Characteristics

A. Analytical performance

a. Precision/Reproducibility:

Precision studies were carried out for samples with concentrations of +100% cutoff, +75% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cut off and -100% cutoff. Samples with concentration of -100% cutoff were drug-free urine samples. Other samples were prepared by spiking target drug in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test cups. The results obtained are summarized in the following tables:

| Drug | Lot
Number | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|-------------|---------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| AMP
500 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 500 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| AMP
1000 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 1000 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BAR
300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 300 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BUP 10 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BZO | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 300 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 9-/41+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MDMA | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 500 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MET | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 8-/42+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 500 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MET | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 1000 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MOP | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 300 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| OPI | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 2000 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MTD | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 300 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| OXY | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 9-/41+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 100 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 8-/42+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| PCP 25 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| TCA | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 1000 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| THC | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 50 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 8-/42+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 9-/41+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| COC | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 16-/34+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 150 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 17-/33+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| COC | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 9-/41+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 300 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| EDDP | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 300 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |

9

10

b. Linearity/assay reportable range:

Not applicable. This device is intended for qualitative use only.

c. Stability:

The device is stable at 4-30℃ for 24 months based on accelerated stability study.

d. Analytical specificity/Interference:

To test the specificity, drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine. These urine samples were tested using three lots of the device.

Percent cross-reactivity, provided in the below table, was calculated as the cutoff concentration divided by the concentration of analyte tested that yielded a positive result, multiplied by 100.

| Drug/Cutoff | Compound | Minimum
concentration
required to obtain
a positive result
(ng/mL) | % Cross-
Reactivity |
|-------------|-------------------------------------------------------|--------------------------------------------------------------------------------|------------------------|
| | d-Amphetamine | 500 | 100% |
| | l-Amphetamine | 15000 | 3.3% |
| | dl- Amphetamine | 1500 | 33.3% |
| | (+/-) 3,4-
Methylenedioxyamphetamine
(MDA) | 5000 | 10% |
| AMP 500 | Phentermine | 1500 | 33.3% |
| | Hydroxyamphetamine | 8000 | 6.25% |
| | d-Methamphetamine | >100000 | - |
| | l-Methamphetamine | >100000 | - |
| | (+/-) 3,4-
Methylenedioxyethylamphetamine
(MDE) | >100000 | - |
| | (+/-)3,4-
Methylenedioxymethamphetamine
(MDMA) | | |
| | β-Phenylethylamine | 100000 | 0.5% |
| | Tyramine | 100000 | 0.5% |
| | p-Hydroxynorephedrine | 100000 | 0.5% |
| | Phenylpropanolamine | >100000 | - |
| | (±)Phenylpropanolamine | >100000 | - |
| | p-Hydroxyamphetamine | 100000 | 0.5% |
| | d/l-Norephedrine | 100000 | 0.5% |
| | Benzphetamine | >100000 | - |
| | 1-Ephedrine | >100000 | - |
| | l-Epinephrine | >100000 | - |
| | d/l-Epinephrine | >100000 | - |
| | d-Amphetamine | 1000 | 100% |
| | l-Amphetamine | 30000 | 3.3% |
| | dl- Amphetamine | 3000 | 33.3% |
| | (+/-)3,4-
Methylenedioxyamphetamine (MD
A) | 5000 | 20% |
| | Phentermine | 3000 | 33.3% |
| | Hydroxyamphetamine | 8000 | 12.5% |
| | d-Methamphetamine | >100000 | - |
| | l-Methamphetamine | >100000 | - |
| AMP 1000 | (+/-)3,4-
Methylenedioxyethylamphetamine
(MDEA) | >100000 | - |
| | (+/-)3,4-
Methylenedioxymethamphetamine
(MDMA) | >100000 | - |
| | β-Phenylethylamine | 100000 | 1% |
| | Tyramine | 100000 | 1% |
| | p-Hydroxynorephedrine | 100000 | 1% |
| | Phenylpropanolamine | >100000 | - |
| | (±)Phenylpropanolamine | >100000 | -- |
| | p-Hydroxyamphetamine | 100000 | 1% |
| | d/l-Norephedrine | 100000 | 1% |
| | Benzphetamine | >100000 | - |
| | 1-Ephedrine | >100000 | - |
| | 1-Epinephrine | >100000 | - |
| | d/l-Epinephrine | >100000 | - |
| | Secobarbital | 300 | 100% |
| | Amobarbital | 5000 | 6% |
| | Alphenol | 150 | 200% |
| | Aprobarbital | 200 | 150% |
| BAR 300 | Butabarbital | 150 | 200% |
| | Butethal | 50 | 600% |
| | Butalbital | 2500 | 12% |
| | Cyclopentobarbital | 600 | 50% |
| | Pentobarbital | 2000 | 15% |
| | Phenobarbital | 5000 | 6% |
| | Buprenorphine | 10 | 100% |
| | Buprenorphine -3-D-Glucuronide | 15 | 66.67% |
| | Norbuprenorphine | 20 | 50% |
| BUP 10 | Norbuprenorphine-3-D-Glucuronide | 100 | 10% |
| | Glucuronide | | |
| | Morphine | > 100000 | - |
| | Oxymorphone | > 100000 | - |
| | Hydromorphone | > 100000 | - |
| | Oxazepam | 300 | 100% |
| | Alprazolam | 200 | 150% |
| | a-Hydroxyalprazolam | 1000 | 30% |
| BZO 300 | Bromazepam | 500 | 60% |
| | Chlordiazepoxide | 1500 | 20% |
| | Clobazam | 100 | 300% |
| | Clonazepam | 3000 | 10% |
| | Clorazepate dipotassium | 200 | 150% |
| | Delorazepam | 1500 | 20% |
| | Desalkylflurazepam | 400 | 75% |
| | Diazepam | 200 | 150% |
| | Estazolam | 500 | 60% |
| | Flunitrazepam | 1000 | 30% |
| | Midazolam | 5000 | 6% |
| | Nitrazepam | 1000 | 30% |
| | Norchlordiazepoxide | 200 | 150% |
| | Nordiazepam | 500 | 60% |
| | Temazepam | 250 | 120% |
| | Triazolam | 1200 | 25% |
| | Demoxepam | 2000 | 15% |
| | Flurazepam | 500 | 60% |
| | D,L-Lorazepam | 1500 | 20% |
| | Benzoylecgonine | 150 | 100% |
| | Cocaine | 500 | 30% |
| | Cocaethylene | 6250 | 2.4% |
| COC 150 | Ecgonine | 16000 | 0.94% |
| | Ecgonine methyl ester | >100000 | - |
| | Norcocaine | >100000 | - |
| | Benzoylecgonine | 300 | 100% |
| | Cocaine | 1000 | 30% |
| COC 300 | Cocaethylene | 15000 | 2% |
| | Ecgonine | 30000 | 1% |
| | Ecgonine methyl ester | >100000 | - |
| | Norcocaine | >100000 | - |
| | 3,4-
Methylenedioxymethamphetamine
(MDMA) | 500 | 100% |
| MDMA 500 | 3,4-Methylenedioxyamphetamine HCl (MDA) | 3000 | 16.67% |
| | 3,4-
Methylenedioxyethylamphetamine
(MDEA) | 500 | 100% |
| | d-methamphetamine | > 100000 | - |
| | d-amphetamine | > 100000 | - |
| | l-methamphetamine | 50000 | 1% |
| | l-amphetamine | > 100000 | - |
| | D(+)-Methamphetamine | 500 | 100% |
| | (+/-)3,4-Methylenedioxy-n-
ethylamphetamine(MDEA) | 2000 | 25%
5% |
| | D/L-Methamphetamine | 500 | 100% |
| | p-Hydroxymethamphetamine | 15000 | 3.33% |
| | D-Amphetamine | 50000 | 1% |
| | L-Amphetamine | 100000 | 0.5% |
| | Chloroquine | 10000 | 5% |
| | (+/-)-Ephedrine | 25000 | 2% |
| | (-)-Methamphetamine | 12500 | 4% |
| MET 500 | (+/-)3,4-
Methylenedioxyamphetamine
(MDA) | 2000 | 25% |
| | (+/-)3,4-
Methylenedioxymethamphetamine
(MDMA) | 2000 | 25% |
| | β-Phenylethylamine | 25000 | 2% |
| | Trimethobenzamide | 5000 | 10% |
| | d,l-Amphetamine | 75000 | 0.67% |
| | Mephetermine | 25000 | 2% |
| | (1R,2S)-(-)-Ephedrine | 50000 | 1% |
| | l-phenylephrine | 100000 | 0.5% |
| | L-Methamphetamine | 10000 | 5% |
| | D(+)-Methamphetamine | 1000 | 100% |
| MET 1000 | (+/-)3,4-Methylenedioxy-n-
ethylamphetamine (MDEA) | 2000 | 50% |
| | D/L-Methamphetamine | 1000 | 100% |
| | p-Hydroxymethamphetamine | 30000 | 3.3% |
| | D-Amphetamine | > 100000 | - |
| | L-Amphetamine | 100000 | 1% |
| | Chloroquine | 20000 | 5% |
| | (+/-)-Ephedrine | 50000 | 2% |
| | (-)-Methamphetamine | 25000 | 4% |
| | (+/-)3,4-
Methylenedioxyamphetamine
(MDA) | 2500 | 40% |
| | (+/-)3,4-
Methylenedioxymethamphetamine
(MDMA) | 4000 | 25% |
| | β-Phenylethylamine | 50000 | 2% |
| | Trimethobenzamide | 10000 | 10% |
| | d,l-Amphetamine | 100000 | 1% |
| | Mephetermine | 50000 | 2% |
| | (1R,2S)-(-)-Ephedrine | > 100000 | - |
| | l-phenylephrine | > 100000 | - |
| | L-Methamphetamine | 20000 | 5% |
| | Morphine | 300 | 100% |
| | Normorphine | 250 | 120% |
| | Codeine | 300 | 100% |
| | s-Monoacetylmorphine | 300 | 100% |
| | Ethyl Morphine | 100 | 300% |
| | Heroin | 300 | 100% |
| | Hydrocodone | 5000 | 6% |
| | Hydromorphone | 2000 | 15% |
| MOP 300 | Morphinie-3-β-d-glucuronide | 1000 | 30% |
| | Oxycodone | >100000 | -- |
| | Oxymorphone | 100000 | 0.3% |
| | Thebaine | 3000 | 10% |
| | Levorphanol | 5000 | 6% |
| | 6-Monoacetylmorphine (6-MAM) | 150 | 200% |
| | Norcodeine | 6500 | 4.6% |
| | Procaine | 100000 | 0.3% |
| | Morphine | 2000 | 100% |
| OPI 2000 | Normorphine | 50000 | 4% |
| | Codeine | 2000 | 100% |
| | s-Monoacetylmorphine | 2000 | 100% |
| | Ethyl Morphine | 1500 | 133.3% |
| | Heroin | 2000 | 100% |
| | Hydrocodone | 12500 | 16% |
| | Hydromorphone | 3500 | 57.1% |
| | Morphinie-3-β-d-glucuronide | 2000 | 100% |
| | Oxycodone | 25000 | 8% |
| | Oxymorphone | 25000 | 8% |
| | Thebaine | 5000 | 40% |
| | Levorphanol | 75000 | 2.7% |
| | 6-Monoacetylmorphine (6-MAM) | 1500 | 133.3% |
| | Norcodeine | 12500 | 16% |
| | Procaine | 150000 | 1.3% |
| MTD 300 | Methadone | 300 | 100% |
| | Doxylamine | 3000 | 10% |
| | EDDP | >100000 | - |
| | EMDP | >100000 | - |
| | LAAM | >100000 | - |
| | Alpha Methadol | >100000 | - |
| OXY 100 | Oxycodone | 100 | 100% |
| | Dihydrocodeine | 20000 | 0.5% |
| | Hydrocodone | 10000 | 1% |
| | Oxymorphone | 1000 | 10% |
| | Codeine | 100000 | 0.1% |
| | Hydromorphone | 32000 | 0.3% |
| | Morphine | >100000 | - |
| | Acetylmorphine | >100000 | - |
| | Buprenorphine | >100000 | - |
| | Ethylmorphine | >100000 | - |
| | Thebaine | >100000 | - |
| PCP 25 | Phencyclidine | 25 | 100% |
| | 4-Hydroxyphencyclidine | 12500 | 0.2% |
| TCA 1000 | Nortriptyline | 1000 | 100% |
| | Nordoxepine | 1000 | 100% |
| | | | |
| | Trimipramine | 2000 | 50% |
| | Amitriptyline | 1500 | 66.7% |
| | Promazine | 1500 | 66.7% |
| | Desipramine | 400 | 250% |
| | Imipramine | 400 | 250% |
| | Clomipramine | 12500 | 8% |
| | Doxepin | 1000 | 100% |
| | Maprotiline | 2000 | 50% |
| | Promethazine | 25000 | 4% |
| | Cyclobenzaprine | 1500 | 66.7% |
| | Norclomipramine | 10000 | 10% |
| THC 50 | 11-nor-Δ9-THC-9-COOH | 50 | 100% |
| | (-)-11-nor-9-carboxy-Δ9-THC | 50 | 100% |
| | 11-nor-Δ8-THC-9-COOH | 30 | 166.67% |
| | 11-nor-Δ9-THC-carboxy
glucuronide | 100 | 50% |
| | Cannabinol | 20000 | 0.25% |
| | Cannabidiol | 100000 | 0.05% |
| | Δ8- Tetrahydrocannabinol | 1300 | 3.8% |
| | Δ9- Tetrahydrocannabinol | 5000 | 1% |
| | 11-hydroxy-Δ9-
Tetrahydrocannabinol | 5000 | 1% |
| EDDP 300 | 2-ethylidene-1,5-dimethyl-3,3-
diphenylpyrrolidine | 300 | 100% |
| | Methadone | 200000 | 0.15% |
| | EMDP | 300000 | 0.1% |
| | Doxylamine | >100000 | - |
| | Disopyramide | >100000 | - |
| | LAAM (Levo-alpha-
acetylmethadol) HCl | >100000 | - |
| | Alpha Methadol | >100000 | - |

11

12

13

14

15

16

17

To evaluate potential interference, non-structurally related compounds were added to drug-free urine and to urine samples containing the target drugs at 25% below and 25% above each corresponding cutoff.

18

Compounds that show no interference at a concentration of 100μg/mL are summarized in the following table.

following table.
(-) Cotinine	Duloxetine	Nimodipine
3-Hydroxytyramine	Effexor	Nitroglycerin
Acetaminophen	Enalapril Maleate	Norethindrone
Acetophenetidin	Erythromycin	O-Hydroxyhippuric Acid
Acetylsalicylic Acid	Esomeprazole Magnesium	Olanzapine
Acyclovir	Ethanol (1%)	Omeprazole
Afrin	Fenofibrate	Ondansetran
Albumin (100mg/dL)	Fenoprofen	Oxalic Acid
Aminophylline	Fentanyl Citrate	Oxolinic Acid
Aminopyrine	Fluoxetine Hydrochloride	Oxymetazoline
Amiodarone Hydrochloride	Fluvoxamine	Paliperidone
Amlodipine Mesylate	Furosemide	Pantoprazole
Amoxicillin	Gabapentin	Papaverine
Ampicillin	Gentisic Acid	Paroxetine Hydrochloride
Apomorphine	Glibenclamide	Penfluridol
Aripiprazole	Gliclazide	Penicillin-G
Aspartame	Glipizide	PenicillinV Potassium
Atomoxetine	Glucose	Phenelzine
Atorvastatin Calcium	Haloperidol	Pioglitazone Hydrochloride
Atropine	Hemoglobin	Piracetam
Benzilic Acid	Hydrochlorothiazide	Pravastatin Sodium
Benzoic Acid	Hydrocortisone	Prednisone
Bilirubin	Ibuprofen	Propylthiouracil
Bupropion	Isosorbide Dinitrate	Quetiapine Fumarate
Captopril	Isoxsuprine	Quinine
Carbamazepine	Ketamine	Ranitidine
Cefradine	Ketoconazole	Rifampicin
Cephalexin	Ketoprofen	Risperidone
Chloral Hydrate	Kratom powder	Salicylic Acid
Chloramphenicol	Labetalol	Serotonin
Chlorothiazide	Lamotrigine	Sertraline Hydrochloride
chlorpheniramine	Levofloxacin Hydrochloride	Sildenafil Citrate
Cholesterol	Levonorgestrel	Simvastatin
Ciprofloxacin Hydrochloride	Levothyroxine Sodium	Sodium Valproate
Citalopram	Lidocaine Hydrochloride	Spironolactone
Clarithromycin	Lisinopril	Sulfamethazine
Clonidine	Lithium Carbonate	Sulindac
Clopidogrel Hydrogen
Sulphate	Liverite	Tetracycline
Clozapine	Loperamide	Tetrahydrocortisone 3-(β-D glucuronide)
Conjugated Estrogens	Loratadine	Tetrahydrocortsone 3 -acetate
Cortisone	Magnesium	Tetrahydrozoline
Creatinine	Meperidine	Thiamine
D,L-Octopamine	Meprobamate	Thioridazine
D,L-Propranolol	Metoprolol Tartrate	Topiramate
D,L-Tyrosine	Mifepristone	Tramadol Hydrochloride
Deoxy- corticosterone	Minocycline	Trazodone Hydrochloride
Dextromethorphan	Mirtazapine	Triamterene
Diclofenac	Montelukast Sodium	Trifluoperazine
Dicyclomine	Mosapride Citrate	Trimethoprim
Diflunisal	N-Acetylprocain-amide	Uric Acid
Digoxin	Nalidixic Acid	Valproate
Diphenhydramine	Naproxen	Verapamil
Dirithromycin	Niacinamide	Vitamin B2
Domperidone	Nifedipine	Vitamin C
D-Pseudoephedrine	Nikethamide	β-Estradiol

19

Interference by pH and specific gravity were also evaluated using pooled urine specimens with concentrations at 25% below and 25% above each corresponding cutoff. The results demonstrated that pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 do not affect the results of the assays.

B. Method comparison study

The method comparison studies for the device were performed with three operators. Operators ran 80 (40 negative and 40 positive) unaltered urine clinical samples for each drug. The samples were blind labeled and compared to LC-MS/MS results. The results are presented in the table below:

| Drug
test | Test Cup
Result | | Drug-
Free | Low
Negative by
LC-MS/MS
(less than -
50%) | Near Cutoff
Negative by
LC-MS/MS
(Between -
50% and the
Cutoff) | Near Cutoff
Positive by
LC-MS/MS
(Between
the cutoff
and +50%) | High Positive
by LC-
MS/MS
(greater than
+50%) |
|--------------|--------------------|---|---------------|--------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------|
| AMP
500 | Operator
A | + | 0 | 0 | 3 | 16 | 23 |
| | | - | 13 | 7 | 17 | 1 | 0 |
| | Operator
B | + | 0 | 0 | 4 | 16 | 23 |
| | | - | 13 | 7 | 16 | 1 | 0 |
| | Operator
C | + | 0 | 0 | 1 | 15 | 23 |
| | | - | 13 | 7 | 19 | 2 | 0 |
| | Operator | + | 0 | 0 | 1 | 15 | 25 |
| AMP
1000 | A | - | 7 | 15 | 17 | 0 | 0 |
| | Operator | + | 0 | 0 | 1 | 14 | 25 |
| | B | - | 7 | 15 | 17 | 1 | 0 |
| | Operator | + | 0 | 0 | 1 | 14 | 25 |
| | C | - | 7 | 15 | 17 | 1 | 0 |
| BAR | Operator | + | 0 | 0 | 1 | 18 | 19 |
| | A | - | 10 | 15 | 14 | 3 | 0 |
| | Operator | + | 0 | 0 | 0 | 18 | 19 |
| | B | - | 10 | 15 | 15 | 3 | 0 |
| | Operator | + | 0 | 0 | 2 | 19 | 19 |
| | C | - | 10 | 15 | 13 | 2 | 0 |
| BUP | Operator | + | 0 | 0 | 3 | 20 | 18 |
| | A | - | 10 | 15 | 12 | 2 | 0 |
| | Operator | + | 0 | 0 | 4 | 20 | 18 |
| | B | - | 10 | 15 | 11 | 2 | 0 |
| | Operator | + | 0 | 0 | 3 | 20 | 18 |
| | C | - | 10 | 15 | 12 | 2 | 0 |
| BZO | Operator | + | 0 | 0 | 2 | 18 | 20 |
| | A | - | 10 | 15 | 13 | 2 | 0 |
| | Operator | + | 0 | 0 | 2 | 18 | 20 |
| | B | - | 10 | 15 | 13 | 2 | 0 |
| | Operator | + | 0 | 0 | 3 | 18 | 20 |
| | C | - | 10 | 15 | 12 | 2 | 0 |
| COC
150 | Operator | + | 0 | 0 | 0 | 21 | 15 |
| | A | - | 10 | 15 | 15 | 4 | 0 |
| | Operator | + | 0 | 0 | 0 | 22 | 15 |
| | B | - | 10 | 15 | 15 | 3 | 0 |
| | Operator | + | 0 | 0 | 0 | 21 | 15 |
| | C | - | 10 | 15 | 15 | 4 | 0 |
| COC
300 | Operator | + | 0 | 0 | 0 | 18 | 21 |
| | A | - | 9 | 16 | 15 | 1 | 0 |
| | Operator | + | 0 | 0 | 0 | 17 | 21 |
| | B | - | 9 | 16 | 15 | 2 | 0 |
| | Operator | + | 0 | 0 | 0 | 17 | 21 |
| | C | - | 9 | 16 | 15 | 2 | 0 |
| MDMA | Operator | + | 0 | 0 | 0 | 20 | 18 |
| | A | - | 10 | 15 | 15 | 2 | 0 |
| | Operator | + | 0 | 0 | 2 | 21 | 18 |
| | B | - | 10 | 15 | 13 | 1 | 0 |
| | Operator | + | 0 | 0 | 0 | 19 | 18 |
| | C | - | 10 | 15 | 15 | 3 | 0 |
| | Operator | + | 0 | 0 | 0 | 20 | 16 |
| MET | A | - | 8 | 20 | 12 | 4 | 0 |
| 500 | Operator | + | 0 | 0 | 0 | 20 | 16 |
| | B | - | 8 | 20 | 12 | 4 | 0 |
| | Operator | + | 0 | 0 | 1 | 22 | 16 |
| | C | - | 8 | 20 | 11 | 2 | 0 |
| MET | Operator | + | 0 | 0 | 3 | 18 | 22 |
| 1000 | A | - | 8 | 13 | 16 | 0 | 0 |
| | Operator | + | 0 | 0 | 2 | 17 | 22 |
| | B | - | 8 | 13 | 17 | 1 | 0 |
| | Operator | + | 0 | 0 | 2 | 16 | 22 |
| | C | - | 8 | 13 | 17 | 2 | 0 |
| MOP | Operator | + | 0 | 0 | 1 | 23 | 15 |
| | A | - | 10 | 14 | 15 | 2 | 0 |
| | Operator | + | 0 | 0 | 1 | 22 | 15 |
| | B | - | 10 | 14 | 15 | 3 | 0 |
| | Operator | + | 0 | 0 | 3 | 23 | 15 |
| | C | - | 10 | 14 | 13 | 2 | 0 |
| OPI | Operator | + | 0 | 0 | 1 | 21 | 18 |
| | A | - | 10 | 15 | 14 | 1 | 0 |
| | Operator | + | 0 | 0 | 2 | 21 | 18 |
| | B | - | 10 | 15 | 13 | 1 | 0 |
| | Operator | + | 0 | 0 | 2 | 20 | 18 |
| | C | - | 10 | 15 | 13 | 2 | 0 |
| MTD | Operator | + | 0 | 0 | 1 | 14 | 24 |
| | A | - | 10 | 18 | 11 | 2 | 0 |
| | Operator | + | 0 | 0 | 0 | 14 | 24 |
| | B | - | 10 | 18 | 12 | 2 | 0 |
| | Operator | + | 0 | 0 | 1 | 14 | 24 |
| | C | - | 10 | 18 | 11 | 2 | 0 |
| OXY | Operator | + | 0 | 0 | 4 | 25 | 15 |
| | A | - | 10 | 15 | 11 | 0 | 0 |
| | Operator | + | 0 | 0 | 3 | 24 | 15 |
| | B | - | 10 | 15 | 12 | 1 | 0 |
| | Operator | + | 0 | 0 | 2 | 23 | 15 |
| | C | - | 10 | 15 | 13 | 2 | 0 |
| PCP | Operator | + | 0 | 0 | 1 | 19 | 18 |
| | A | - | 9 | 16 | 14 | 3 | 0 |
| | Operator | + | 0 | 0 | 0 | 19 | 18 |
| | B | - | 9 | 16 | 15 | 3 | 0 |
| | Operator | + | 0 | 0 | 2 | 18 | 18 |
| | C | - | 9 | 16 | 13 | 4 | 0 |
| TCA | Operator | + | 0 | 0 | 3 | 20 | 18 |
| | A | - | 10 | 15 | 12 | 2 | 0 |
| | Operator | + | 0 | 0 | 3 | 21 | 18 |
| | B | - | 10 | 15 | 12 | 1 | 0 |
| | Operator | + | 0 | 0 | 3 | 20 | 18 |
| | C | - | 10 | 15 | 12 | 2 | 0 |
| THC | Operator | + | 0 | 0 | 1 | 18 | 20 |
| | A | - | 10 | 15 | 14 | 2 | 0 |
| | Operator | + | 0 | 0 | 0 | 17 | 20 |
| | B | - | 10 | 15 | 15 | 3 | 0 |
| | Operator | + | 0 | 0 | 2 | 18 | 20 |
| | C | - | 10 | 15 | 13 | 2 | 0 |
| EDDP | Operator | + | 0 | 0 | 3 | 20 | 20 |
| | A | - | 10 | 14 | 13 | 0 | 0 |
| | Operator | + | 0 | 0 | 2 | 18 | 20 |
| | B | - | 10 | 14 | 14 | 2 | 0 |
| | Operator | + | 0 | 0 | 3 | 19 | 20 |
| | C | - | 10 | 14 | 13 | 1 | 0 |

20

21

22

Discordant Results are summarized below.

Drug	Operator	Sample Number	LC/MS/MS Result (ng/mL)	Discordant Result
AMP 500	Operator B	AL243	441.6	Positive
AMP 500	Operator A, B, C	AL073	443.7	Positive
AMP 500	Operator A, B	AL251	457	Positive
AMP 500	Operator B	AL022	475.7	Positive
AMP 500	Operator A	AL143	489	Positive
AMP 500	Operator C	AL036	501.2	Negative
AMP 500	Operator A, B, C	AL212	508.9	Negative
AMP 1000	Operator C	AH051	910.3	Positive
AMP 1000	Operator B	AH070	968.6	Positive
AMP 1000	Operator A	AH066	970.1	Positive
AMP 1000	Operator B, C	AH002	1101	Negative
BAR	Operator C	BR328	279.6	Positive
BAR	Operator A, C	BR311	296	Positive
BAR	Operator A, B	BR321	302.1	Negative
BAR	Operator A, B, C	BR440	307.2	Negative
BAR	Operator B	BR226	319.83	Negative
BAR	Operator A, C	BR227	323	Negative
BUP	Operator A, B, C	BP449	7.73	Positive
BUP	Operator A, B	BP306	8.02	Positive
BUP	Operator A, B, C	BP329	9.21	Positive
BUP	Operator B, C	BP330	9.42	Positive
	Operator A, B, C	BP277	10.5	Negative
	Operator A, B, C	BP450	11.3	Negative
BZO	Operator A, B, C	BZ201	282	Positive
	Operator A, B, C	BZ213	291.2	Positive
	Operator C	BZ257	298	Positive
	Operator B	BZ204	301	Negative
	Operator C	BZ197	305	Negative
	Operator A, B	BZ356	317.6	Negative
	Operator A, C	BZ200	346	Negative
COC 150	Operator A, B	CL534	154	Negative
	Operator A, B, C	CL530	156.5	Negative
	Operator C	CL537	160.1	Negative
	Operator C	CL573	161.4	Negative
	Operator A	CL565	163.5	Negative
	Operator A, B, C	CL575	166.9	Negative
COC 300	Operator A, B, C	CH513	338.5	Negative
	Operator B	CH572	346.4	Negative
	Operator C	CH553	356.8	Negative
MDMA	Operator B	MM238	476.1	Positive
	Operator B	MM305	482.34	Positive
	Operator A, C	MM303	502	Negative
	Operator A	MM278	527.89	Negative
	Operator C	MM284	536.21	Negative
	Operator B	MM263	543.6	Negative
	Operator C	MM266	605	Negative
MET 500	Operator C	ML648	456.2	Positive
	Operator B	ML665	506	Negative
	Operator A, B, C	ML652	511	Negative
	Operator B	ML657	512	Negative
	Operator A, B, C	ML671	534	Negative
	Operator A	ML662	543	Negative
	Operator A	ML668	564.2	Negative
MET 1000	Operator A, C	MH623	962.6	Positive
	Operator A, B, C	MH667	981.1	Positive
	Operator A, B	MH651	995.8	Positive
	Operator C	MH767	1009.7	Negative
	Operator B, C	MH625	1083.2	Negative
MOP	Operator C	MO484	246	Positive
	Operator C	MO488	272.3	Positive
	Operator A, B, C	MO431	298	Positive
	Operator A, B, C	MO420	301	Negative
	Operator A, B, C	MO374	301.6	Negative
	Operator B	MO424	313.3	Negative

OPI	Operator A, B, C	OP384	1869.3	Positive
	Operator B, C	OP379	1984	Positive
	Operator C	OP472	2028	Negative
	Operator A, B, C	OP373	2080	Negative
MTD	Operator A, C	MT753	278.8	Positive
	Operator A, B, C	MT709	326.5	Negative
	Operator A, B, C	MT872	329.8	Negative
OXY	Operator A	OX286	77	Positive
	Operator A, B	OX296	92.3	Positive
	Operator A, B, C	OX272	95	Positive
	Operator A, B, C	OX253	96	Positive
	Operator C	OX267	100	Negative
	Operator B	OX277	102	Negative
	Operator C	OX263	103	Negative
PCP	Operator A, C	PC380	22.257	Positive
	Operator C	PC341	23.97	Positive
	Operator A, B, C	PC371	25.39	Negative
	Operator A, B, C	PC425	26.4	Negative
	Operator A, B, C	PC340	27.2	Negative
	Operator C	PC376	27.5	Negative
TCA	Operator A, C	TA419	817	Positive
	Operator B	TA407	849	Positive
	Operator A, B, C	TA431	892	Positive
	Operator A, B, C	TA379	934	Positive
	Operator A, B	TA429	1025	Negative
	Operator C	TA422	1069	Negative
	Operator A, C	TA391	1117	Negative
THC	Operator A, C	TH360	47.7	Positive
	Operator C	TH374	48.8	Positive
	Operator B	TH373	50.35	Negative
	Operator A, B, C	TH338	53.46	Negative
	Operator A, B, C	TH332	57.1	Negative
EDDP	Operator A, B, C	ED725	280.8	Positive
	Operator A, B, C	ED709	281	Positive
	Operator A, C	ED694	281.4	Positive
	Operator B	ED690	325	Negative
	Operator C	ED724	335	Negative
	Operator B	ED717	335.7	Negative

23

24

C. Lay person study

A lay user study was performed at three intended user sites with 280 lay persons. 114 males and 166 females tested Pocguide™ Multi-Drug Test Cup. They had diverse educational and professional backgrounds and their ages ranged from 18 to > 50. The 280 lay persons were split

25

into two groups of 140 whereby group 1 tested configuration 1 of the cup and group 2 tested configuration 2 of the cup. Urine samples were prepared at the following concentrations: -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC-MS/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample, and a device. The results are summarized below.

	Cutoff	Results	Concentration
Drug	(ng/mL)		-100%	-75%	-50%	-25%	+25%	+50%	+75%
			cutoff	cutoff	cutoff	cutoff	cutoff	cutoff	cutoff
AMP	500	Negative	20	20	20	19	1	0	0
		Positive	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95.00%	95.00%	100%	100%
		Negative	20	20	20	20	2	0	0
		Positive	0	0	0	0	18	20	20
BAR	300	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	100%	90.00%	100%	100%
		Negative	20	20	20	20	1	0	0
BZO		Positive	0	0	0	0	19	20	20
	300	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	100%	95.00%	100%	100%
	10	Negative	20	20	20	19	1	0	0
		Positive	0	0	0	1	19	20	20
BUP		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95.00%	95.00%	100%	100%
	150	Negative	20	20	20	20	1	0	0
		Positive	0	0	0	0	19	20	20
COC		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	100%	95.00%	100%	100%
	300	Negative	20	20	20	19	1	0	0
EDDP		Positive	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95.00%	95.00%	100%	100%
		Negative	20	20	20	20	1	0	0
MDMA	500	Positive	0	0	0	0	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	100%	95.00%	100%	100%
		Negative	20	20	20	19	1	0	0
MET	500	Positive	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95.00%	95.00%	100%	100%
MOP	300	Negative	20	20	20	19	0	0	0
		Positive	0	0	0	1	20	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95.00%	100%	100%	100%
MTD	300	Negative	20	20	20	20	1	0	0
		Positive	0	0	0	0	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95.00%	100%	100%	100%
OXY	100	Negative	20	20	20	19	1	0	0
		Positive	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	100%	95.00%	100%	100%
PCP	25	Negative	20	20	20	19	0	0	0
		Positive	0	0	0	1	20	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95.00%	95.00%	100%	100%
TCA	1000	Negative	20	20	20	19	1	0	0
		Positive	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95.00%	95.00%	100%	100%
THC	50	Negative	20	20	20	20	1	0	0
		Positive	0	0	0	0	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	100%	95.00%	100%	100%

Results of Pocguide™ Multi-Drug Test Cup: Sample Group 1 for Configuration 1 Cup:

26

Sample Group 2 for Configuration 2 Cup:

| Drug | Cutoff
(ng/mL) | Results | Concentration | | | | | | |
|------|-------------------|---------------|---------------|--------|--------|--------|--------|--------|--------|
| | | | -100% | -75% | -50% | -25% | +25% | +50% | +75% |
| | | | cutoff | cutoff | cutoff | cutoff | cutoff | cutoff | cutoff |
| AMP | 1000 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.00% | 100% | 100% | 100% |
| BAR | 300 | Negative | 20 | 20 | 20 | 20 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 90.00% | 100% | 100% |
| BZO | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.00% | 95.00% | 100% | 100% |
| BUP | 10 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95.00% | 100% | 100% |
| COC | 300 | Negative | 20 | 20 | 20 | 20 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 90.00% | 100% | 100% |
| EDDP | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.00% | 95.00% | 100% | 100% |
| MDMA | 500 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95.00% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| MET | 1000 | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95.00% | 100% | 100% |
| OPI | 2000 | Negative | 20 | 20 | 20 | 20 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 90.00% | 100% | 100% |
| | 300 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| MTD | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95.00% | 100% | 100% |
| OXY | 100 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.00% | 95.00% | 100% | 100% |
| PCP | 25 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.00% | 100% | 100% | 100% |
| TCA | 1000 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.00% | 95.00% | 100% | 100% |
| THC | 50 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.00% | 95.00% | 100% | 100% |

27

28

Participants were given surveys on the ease of understanding the instruction for use. All participants indicated that the device instruction is easy to understand and follow. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

Clinical Studies: Not applicable.

13. Conclusion

Based on the test principle and performance characteristics of the device including precision, cutoff, interference, specificity, method comparison and lay-user studies of the devices, it's concluded that Pocguide™ Multi-Drug Test Cup OTC and Pocguide™ Multi-Drug Test Cup are substantially equivalent to the predicate device.