Pocguide Multi-Drug Test Panel OTC is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5dimethyl-3,3-diphenylpyrrolidine, 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
Benzoylecognine (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 panels can consist of up to the above listed analytes in any combination. The tests provide only a preliminary result. A more specific alternative chemical 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.

For over-the-counter use. For in vitro diagnostic use only

Device Description

Pocguide™ Multi-Drug Test Panel and Pocguide™ Multi-Drug Test Panel OTC are immunochromatographic assays that use a lateral flow system for the qualitative detection of single drugs in human urine at or above the cut-off levels as indicated. The products are single use in vitro diagnostic devices.

This device is a dipcard format in which the test strips are integrated into the plastic dipcard. After removing the cap of the dipcard, the absorbent end of the test strips is exposed and can be in direct contact with the urine sample. The device is in a ready-to-use format and no longer requires assembly before use.

AI/ML Overview

The provided document describes the Pocguide Multi-Drug Test Panel and Pocguide Multi-Drug Test Panel OTC, which are in vitro diagnostic devices for qualitative and simultaneous detection of various drugs in human urine.

Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of qualitative diagnostic device are typically related to its analytical performance, specifically precision (reproducibility) around the cutoff concentration, and its ability to correctly identify positive and negative samples when compared to a confirmed method (method comparison).

Acceptance Criteria (Implied based on study design and regulatory context for qualitative drug tests):

Precision/Reproducibility: A high percentage of agreement (e.g., typically >80%) for samples near the cutoff (e.g., +/- 25% cutoff, cutoff itself) over multiple lots and runs, and 100% agreement for samples far from the cutoff (e.g., +/- 100% cutoff).
Method Comparison: High overall agreement (sensitivity and specificity) with a gold standard confirmatory method (LC/MS or GC/MS) for clinical samples, especially for true positive and true negative samples. Acceptable performance for samples near the cutoff where some discordance is expected due to the nature of qualitative assays.
Analytical Specificity (Cross-Reactivity): No significant cross-reactivity with common substances or structurally similar compounds to avoid false positives.
Interference: No interference from common physiological substances found in urine.
Lay-User Study (for OTC devices): High agreement with trained professionals and ease of use for the intended lay user.

Reported Device Performance (from "Precision/Reproducibility" and "Method Comparison" sections):

Test Characteristic	Drug (Cutoff) Examples	Reported Device Performance
Precision/Reproducibility	AMP 500 ng/mL, BUP 10 ng/mL, etc.	+100%, +75%, +50%, +25% Cutoff: 100.0% Positive (Across all tested drugs and cutoffs) -100%, -75%, -50%, -25% Cutoff: 100.0% Negative (Across all tested drugs and cutoffs) Cutoff: * AMP 500: 82.0% Positive, 18.0% Negative * BUP 10: 84.0% Positive, 16.0% Negative * BAR 300: 82.7% Positive, 17.3% Negative * And similar ranges for other drugs listed in Table 2. Each drug showed similar performance around the cutoff.
Method Comparison	AMP 1000 ng/mL, AMP 500 ng/mL, BAR 300 ng/mL, etc.	Excellent agreement for Drug-Free, Low Negative, and High Positive Samples: Typically 100% correct classification by the device for these categories (e.g., "Viewer A Positive" for High Positive by LC/MS and "Viewer A Negative" for Drug-Free by LC/MS are 100% for almost all drugs). Expected Discordance Near Cutoff: As anticipated for qualitative tests, some samples near the cutoff (especially -25% and +25%) show mixed results (discordance) between the device and LC/MS, as detailed in Table 5 and Table 6 (Discordant results). These are typically within acceptable ranges for qualitative tests, acknowledging the inherent variation around a precise cutoff.
Analytical Specificity	AMP, BUP, BAR, etc.	Tested numerous substances. Most showed no cross-reactivity or very low percentages at very high concentrations, indicating good specificity. Specific cross-reactivity percentages are provided in Table 3.
Interference	N/A - broadly tested	No interference observed for a wide range of common substances and physiological conditions (urine specific gravity 1.000-1.035, pH 4-9) as listed in Tables 4.
Lay-User Study	All Configuration 1 & 2 Drugs	Agreement (%): * -100%, -75%, -50% Cutoff: 100% negative calls. * +25%, +50%, +75% Cutoff: Mostly 100% positive calls, some 95% for +25% cutoff. * -25% Cutoff: 95% negative calls for most drugs. * Raw numbers show 19/20 or 20/20 correct calls for most categories. Ease of Use: All participants indicated instructions were easy to understand and follow (Flesch-Kincaid Grade Level 7).

2. Sample Sizes and Data Provenance

Test Set Sample Sizes:
- Precision/Reproducibility: For each drug and each cutoff, 50 samples were tested at each concentration level (-100%, -75%, -50%, -25%, Cutoff, +25%, +50%, +75%, +100%). This was done across 3 lots, so $50 \text{ samples/level} \times 9 \text{ levels} \times 3 \text{ lots} = 1350$ tests per drug. (For AMP alone, this would be $1350 \times 2 \text{ cutoffs} = 2700$ tests).
- Method Comparison: 100 unaltered clinical samples were used for each target drug (40 negative, 40 positive, and an additional 20 samples around the cutoff as seen in the breakdown of results). So, for 13 drug analytes, this would be $13 \times 100 = 1300$ clinical samples.
- Cross-Reactivity / Interference: Specific numbers for each substance are not given, but samples were spiked at various concentrations and tested using three lots of each device.
- Lay-User Study: For Configuration 1, 140 participants (58 male, 82 female). For Configuration 2, 140 participants (56 male, 84 female). Each participant tested 1 blind-labeled sample. For each drug within each configuration, 20 samples were prepared per concentration level (-100%, -75%, -50%, -25%, +25%, +50%, +75%).
Data Provenance: The document does not explicitly state the country of origin for the data. The consulting firm is in Shanghai, China, and the applicant's address is Irvine, CA, USA. Given the FDA 510(k) submission, it's implied that the data is intended to be representative and valid for the US market. The studies are described as retrospective as they involve samples prepared at specific concentrations or existing clinical samples compared to a gold standard.

3. Number of Experts and their Qualifications

For Precision/Reproducibility, Cross-Reactivity, Interference, and Method Comparison: The document does not explicitly state the number of "experts" used to establish ground truth or interpret results. These are quantitative/analytical laboratory tests where the ground truth (concentration by LC/MS or GC/MS) is established by analytical instrumentation. The "Viewers" (A, B, C) mentioned in the Method Comparison section appear to be individuals performing the visual interpretation of the device results, not necessarily independent experts establishing ground truth. Their qualifications are not specified but are implied to be trained laboratory personnel.
For Lay-User Study: No "experts" were used to establish ground truth for the lay-user study. The ground truth for the samples used in this study was established by LC-MS/MS confirming the spiked drug concentrations.

4. Adjudication Method for the Test Set

For Precision/Reproducibility, Cross-Reactivity, Interference: No adjudication method is described. The results are reported as counts of positive/negative readings against a known (spiked) concentration.
For Method Comparison: No explicit "adjudication" among multiple readers is described. Results for the candidate device were observed by "Viewer A, B, C." The comparison is directly between the "Candidate Device Result" (presumably individual Viewer results, though aggregated in Table 5) and the LC/MS reference method. The discordant results in Table 6 specify which viewers made the discordant call (e.g., "Viewer A, B," "Viewer C"). This suggests independent readings by three viewers, but no formal adjudication process to resolve disagreements among them is mentioned; the individual viewer calls are presented relative to the ground truth.
For Lay-User Study: No adjudication method is mentioned. The tables report the number of positive/negative results per concentration.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The study design is an analytical performance study and a comparison study against a laboratory reference method, along with a lay-user study for OTC claims. It assesses device performance in a standalone or simulated user setting, not direct human reader improvement with AI assistance. The device is a lateral flow immunoassay, not an AI-powered diagnostic.

6. Standalone (Algorithm Only) Performance

This question is not applicable as the device is a lateral flow immunochromatographic assay, not an algorithm or software-based diagnostic. Its performance is inherent to the chemical reactions on the test strip and visual interpretation, not an algorithm.

7. Type of Ground Truth Used

The primary ground truth used for performance evaluation (Precision/Reproducibility, Method Comparison, Lay-User Study) is analytical confirmation by Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions (LC-MS/MS), which are stated as the "preferred confirmatory methods." This is a highly accurate and quantitative method for determining drug concentrations.

8. Sample Size for the Training Set

This question is not applicable. The device is a qualitative diagnostic test based on immunoassay principles, not a machine learning or AI-based device that requires a "training set" in the computational sense. The development of the immunoassay itself relies on antigen-antibody binding characteristics and optimization, not a deep learning model.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons as #8. The "ground truth" for developing the test and optimizing its performance would be established through standard immunoassay R&D processes, involving controlled experiments with known concentrations of analytes and cross-reactants, guided by established analytical chemistry principles.

Summary

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Aicheck Biotech, Inc. % Dylan Wu IVD Senior Consultant Shanghai Sungo Management Consulting Co., Ltd. 14th Floor, 1500# Century Avenue Shanghai, 200122, China

Re: K242498

Trade/Device Name: Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, NGL, PTH, NFV, NFY, PTG, NGG, NGM, QAW, NFW Dated: August 22, 2024 Received: August 22, 2024 Dear Dylan Wu:

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 (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/cdrb/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.

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).

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).

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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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 medical devices and radiation-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. Digitally signed by Joseph A. Joseph A. Kotarek -S Kotarek -S Date: 2024.10.0 10:15:07 -04'00' Joseph Kotarek Branch Chief for Toxicology Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K242498

Device Name

Pocguide Multi-Drug Test Panel OTC Pocguide Multi-Drug Test Panel

Indications for Use (Describe)

Pocquide Multi-Drug Test Panel OTC is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5dimethyl-3,3-diphenylpyrrolidine, 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
Benzoylecognine (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

For over-the-counter use. For in vitro diagnostic use only

Pocguide Multi-Drug Test Panel is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, 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
Benzoylecognine (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

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Phencyclidine (PCP)	25 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL
The single or multi-test panels 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.
For in vitro diagnostic use only

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) Summary

K242498

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement by 21 CFR 807.92

Date prepared: 15th, Aug 2024

1 Submitter's Information

Name: Aicheck Biotech, Inc. Address: 17701 Cowan Ste 230, Irvine, CA, USA, 92614 Contact Person: Lisa Liu Title: Manager of the quality department Tel: +86-571-89055299 Email: ra.rep@aichek.com

2 Official Contact Person Information

Primary contact: Mr. Dylan Wu Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-18616797137 Email: haiyang.wu@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: zxfda@sungoglobal.com

3 Subject Device

3.1 Trade Name and Regulatory Information

Pocguide™ Multi-Drug Test Panel Pocguide™ Multi-Drug Test Panel OTC

3.2 Regulatory Information

Drug (Identifier)	Code (s)	Classification	Regulation Section	Panel
Amphetamine (AMP)	NFT	Class II	21 CFR § 862.3100Amphetamine Test System	ClinicalToxicology
Buprenorphine (BUP)	NGL	Class II	21 CFR § 862.3650Opiate Test System	ClinicalToxicology
Secobarbital (BAR)	PTH	Class II	21 CFR § 862.3150Barbiturate test system	ClinicalToxicology
Oxazepam (BZO)	NFV	Class II	21 CFR § 862.3170Benzodiazepine test system	ClinicalToxicology
Benzoylecognine (COC)	NFY	Class II	21 CFR § 862.3250Cocaine and Cocaine Metabolites Test System	ClinicalToxicology
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	PTG	Class II	21CFR § 862.3620Methadone Test System	ClinicalToxicology
Methamphetamine (MET)	NGG	Class II	21 CFR § 862.3610Methamphetamine Test System	ClinicalToxicology

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Drug (Identifier)	Code (s)	Classification	Regulation Section	Panel
Methylenedioxymethamphetamine (MDMA)	NGG	Class II	21 CFR § 862.3610Methamphetamine Test System	ClinicalToxicology
Morphine (OPI/MOP)	NGL	Class II	21 CFR § 862.3650Opiate Test System	ClinicalToxicology
Methadone (MTD)	PTG	Class II	21CFR § 862.3620Methadone Test System	ClinicalToxicology
Oxycodone (OXY)	NGL	Class II	21 CFR § 862.3650Opiate Test System	ClinicalToxicology
Phencyclidine (PCP)	NGM	Unclassified
Nortriptyline (TCA)	QAW	Class II	21 CFR § 862.3910Tricyclic antidepressant drugs test system	ClinicalToxicology
Marijuana (THC)	NFW	Class II	21 CFR § 862.3870Cannabinoid test system	ClinicalToxicology

CA IICA 92614

4 Predicate device

K202567

Wondfo T-Dip® Multi-Drug Urine Test Panel Wondfo T-Dip® Multi-Drug Urine Test Panel Rx

5 Indications for use/Intended use

Pocguide™ Multi-Drug Test Panel is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5dimethyl-3,3-diphenylpyrrolidine, Methylenedioxy-methamphetamine, Morphine, Mothadone, 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
Benzoylecognine (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 panels 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.

For in vitro diagnostic use only.

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Pocguide™ Multi-Drug Test Panel OTC is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencycline 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
Benzoylecognine (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 panels can consist of up to the above listed analytes in any combination.

The tests provide only a preliminary result. A more specific alternative chemical 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.

For over-the-counter (OTC) use. For in vitro diagnostic use only.

б Device Description

7 Principle of Operation

Pocguide™ Multi-Drug Test Panel 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

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dye conjugate, and flows across the pre-coated membrane.

When sample drug levels are at or above the target cutoff (the detection sensitivity of 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 precoated 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.

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Substantial Equivalence Information 8

8.1 Technological characteristics

	Table 1 Comparison of Technological characteristics

Device	Proposed Device	Predicate Device
510K number	K242498	K202567
Device name	Pocguide™ Multi-Drug Test PanelPocguide™ Multi-Drug Test Panel OTC	Wondfo T-Dip® Multi-Drug Urine Test PanelWondfo T-Dip® Multi-Drug Urine Test Panel Rx
Indication (s) for use	For the qualitative determination of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine.	Same
Methodology	Competitive binding, lateral flow immunochromatographic assay based on antigen-antibody reaction	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Target Drugand CutoffValue	Target Drug	Cutoff (ng/mL)
	Amphetamine (AMP)	1000 or 500
	Buprenorphine (BUP)	10
	Secobarbital (BAR)	300
	Oxazepam (BZO)	300
	Benzoylecognine (COC)	300 or 150
	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300
	Methamphetamine (MET)	1000 or 500
	Methylenedioxymethamphetamine (MDMA)	500
	Morphine (OPI2000/MOP300)	2000 or 300
	Methadone (MTD)	300
	Oxycodone (OXY)	100
	Phencyclidine (PCP)	25
	Nortriptyline (TCA)	1000
Marijuana (THC)	50	The number of drugs detected are different, the predicate device also includes Propoxyphene (PPX) 300 ng/mL
Configurations	Test Panel	Same

{9}------------------------------------------------

д Summary of Non-Clinical Testing

9.1 Analytical performance

Precision / Reproducibility a

Precision studies were carried out for samples with contract, - 75% atoff, -25% cutoff, -25% cutoff, -15% cutoff, +50% cutoff +15% cutoff +15% cutoff and +100% cutoff. Samples with concentration of -100% cutoff were prepared by spiking target drug in drug-free urines samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were tested in a blinded fashion, tests were performed in 2 runs per day for 25 days using 3 lots of test panels. The results obtained are summarized in Table 2.

Drug testedClaimed Cutoff	%cutoff	Lot 1		Lot 2		Lot 3		Total Result		%Positive	%Negative
		+	-	+	-	+	-	+	-
AMP500	+100% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+75% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+50% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+25% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
AMP500	cutoff	41	9	42	8	40	10	123	27	82.0%	18.0%
AMP500	-25% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
	-50% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
	-75% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
	-100% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
AMP1000	+100% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+75% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+50% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+25% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
AMP1000	cutoff	42	8	43	7	43	7	128	22	85.3%	14.7%
AMP1000	-25% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
	-50% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
	-75% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
	-100% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
BUP10	+100% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+75% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+50% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+25% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
BUP10	cutoff	43	7	41	9	42	8	126	24	84.0%	16.0%
BUP10	-25% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
	-50% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
	-75% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
	Negative	0	50	0	50	0	50	0	150	0	0.0%	100.0%
BAR300	+100% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+75% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+50% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+25% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
BAR300	cutoff	42	8	41	9	41	9	124	26	82.7%	17.3%
BAR300	-25% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
	-50% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
	-75% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
	-100% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
BZO300	+100% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+75% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+50% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+25% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
BZO300	cutoff	43	7	41	9	42	8	126	24	84.0%	16.0%
BZO300	-25% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
	-50% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
	-75% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
	-100% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
COC300	+100% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+75% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+50% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+25% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
COC300	cutoff	43	7	42	8	41	9	126	24	84.0%	16.0%
COC300	-25% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
	-50% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
	-75% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%
	-100% cutoff	0	50	0	50	0	50	0	150	0	0.0%	100.0%

			Table 2 Precision / Reproducibility results of Pocquide™ Multi-Drug Test Panel
--	--	--	--------------------------------------------------------------------------------

{10}------------------------------------------------

Aicheck Biotech, Inc. 17701 Cowan Ste 230, Irvine, CA, USA, 92614

Drug tested	Lot 1Lot 2Lot 3		Total Result		%Positive	%Negative
Claimed Cutoff	%cutoff	+	-	+	-	+	-	+
	+100% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+75% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+50% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+25% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
COC	cutoff	41	9	41	9	42	8	124	26	82.7%	17.3%
150	-25% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-50% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-75% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-100% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	+100% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+75% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+50% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+25% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
EDDP	cutoff	42	8	43	7	43	7	128	22	85.3%	14.7%
300	-25% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
			50		50	0	50	0
	-50% cutoff	0		0					150	0.0%	100.0%
	-75% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-100% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	+100% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+75% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+50% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
MET	+25% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
1000	cutoff	40	10	41	9	41	9	122	28	81.3%	18.7%
	-25% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-50% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-75% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-100% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	+100% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+75% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+50% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+25% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
MET	cutoff	43	7	41	9	42	8	126	24	84.0%	16.0%
500	-25% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-50% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-75% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	Negative	0	50	0	50	0	50	0	150	0.0%	100.0%
	+100% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+75% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+50% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+25% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
MDMA	cutoff	41	9	43	7	42	8	126	24	84.0%	16.0%
500	-25% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-50% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-75% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-100% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	+100% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+75% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+50% cutoff	50	0	50	0	50	0	150	0
										100.0%	0.0%
OPI	+25% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
2000	cutoff	41	9	43	7	42	8	126	24	84.0%	16.0%
	-25% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-50% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-75% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-100% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	+100% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
MOP300	+75% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+50% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+25% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	cutoff	42	8	42	8	40	10	124	26	82.7%	17.3%
	-25% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-50% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-75% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%

Drug tested	%cutoff	Lot 1		Lot 2		Lot 3		Total Result		%Positive	%Negative
Claimed Cutoff		+	-	+	-	+	-	+	-
	-100% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
MTD300	+100% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+75% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+50% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+25% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	cutoff	42	8	42	8	43	7	127	23	84.7%	15.3%
	-25% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-50% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-75% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-100% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
OXY100	+100% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+75% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+50% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+25% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	cutoff	43	7	44	6	43	7	130	20	86.7%	13.3%
	-25% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-50% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-75% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-100% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
PCP25	+100% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+75% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+50% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+25% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	cutoff	42	8	43	7	42	8	127	23	84.7%	15.3%
	-25% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-50% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-75% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-100% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
TCA1000	+100% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+75% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+50% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+25% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	cutoff	43	7	41	9	42	8	126	24	84.0%	16.0%
	-25% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-50% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-75% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-100% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
THC50	+100% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+75% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+50% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	+25% cutoff	50	0	50	0	50	0	150	0	100.0%	0.0%
	cutoff	42	8	43	7	43	7	128	22	85.3%	14.7%
	-25% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-50% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%
	-75% cutoff	0	50	0	50	0	50	0	150	0.0%	100.0%

{11}------------------------------------------------

Aicheck Biotech, Inc. 17701 Cowan Ste 230, Irvine, CA, USA, 92614

Linearity/assay reportable range b

Linearity is not applicable since this is a qualitative test.

Analytical specificity/Interference C

c.1 Cross-Reactivity

To test cross-reactivity, drug netabolites and other compounds that are likely to cross-react in urine samples were spiked into drug-free unine sample and were tested using three lots of each device. The lowed a positive result for each compound is listed below along with the corresponding % crossreactivity. The highest concentration tested is shown if no cross reactivity was observed.

Drug (Cutoff)	Substances	Minimum concentration requiredto obtain a positive result (ng/mL)	% Cross-Reactivity
AMP 500	d-Amphetamine	500	100%
	l-Amphetamine	15000	3.30%
	dl- Amphetamine	1500	33.30%
	(+/-) 3,4-Methylenedioxyamphetamine (MDA)	5000	10%

Table 3 Cross-Reactivity results of Pocguide™ Multi-Drug Test Panel

{12}------------------------------------------------

Drug (Cutoff)	Substances	Minimum concentration requiredto obtain a positive result (ng/mL)	% Cross-Reactivity
	Phentermine	1500	33.30%
	Hydroxyamphetamine	8000	6.25%
	d-Methamphetamine	>100000	--
	l-Methamphetamine	>100000	--
	(+/-) 3,4-Methylenedioxyethylamphetamine (MDE)	>100000	--
	(+/-) 3,4-Methylenedioxymethamphetamine (MDMA)	>100000	--
	Ephedrine	>100000	--
	β-Phenylethylamine	100000	0.50%
	Tyramine	100000	0.50%
	p-Hydroxynorephedrine	100000	0.50%
	Phenylpropanolamine	>100000	--
	(±) Phenylpropanolamine	>100000	--
	p-Hydroxyamphetamine	100000	0.50%
	d/l-Norephedrine	100000	0.50%
	Benzphetamine	>100000	--
	l-Ephedrine	>100000	--
	l-Epinephrine	>100000	--
	d/l-Epinephrine	>100000	--
	d-Amphetamine	1000	100%
AMP 1000	l-Amphetamine	30000	3.30%
	dl- Amphetamine	3000	33.30%
	(+/-)3,4-Methylenedioxyamphetamine (MDA)	5000	20%
	Phentermine	3000	33.30%
	Hydroxyamphetamine	8000	12.50%
	d-Methamphetamine	> 100000	--
	l-Methamphetamine	> 100000	--
	(+/-)3,4-Methylenedioxyethylamphetamine (MDEA)	> 100000	--
	(+/-)3,4-Methylenedioxymethamphetamine (MDMA)	> 100000	--
	Ephedrine	>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	--
	l-Ephedrine	> 100000	--
	l-Epinephrine	> 100000	--
	d/l-Epinephrine	> 100000	--
	BUP 10	Buprenorphine	10
Buprenorphine -3-D-Glucuronide		15	66.67%
Norbuprenorphine		20	50%
Norbuprenorphine-3-D-Glucuronide		100	10%
Morphine		> 100000	-
	Oxymorphone	> 100000	-
	Hydromorphone	> 100000	-
	Secobarbital	300	100%
	Amobarbital	5000	6%
BAR 300	Alphenol	150	200%
	Aprobarbital	200	150%
	Butabarbital	150	200%
	Butethal	50	600%
	Butalbital	2500	12%
	Cyclopentobarbital	600	50%
	Pentobarbital	2000	15%
	Phenobarbital	5000	6%
BZO 300	Oxazepam	300	100%
	Alprazolam	200	150%
	a-Hydroxyalprazolam	1000	30%
	Bromazepam	500	60%
	Chlordiazepoxide	1500	20%

Aicheck Biotech, Inc. 17701 Cowan Ste 230, Irvine, CA, USA, 92614

{13}------------------------------------------------

Drug (Cutoff)	Substances	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
	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%
COC 300	Benzoylecgonine	300	100%
	Cocaine	1000	30%
	Cocaethylene	15000	2%
	Ecgonine	30000	1%
	Ecgonine methyl ester	>100000	--
	Norcocaine	>100000	--
COC 150	Benzoylecgonine	150	100%
	Cocaine	500	30%
	Cocaethylene	6250	2.40%
	Ecgonine	16000	0.94%
	Ecgonine methyl ester	> 100000	--
	Norcocaine	> 100000	--
EDDP 300	2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine	300	100%
	Methadone	200000	0.15%
	EMDP	300000	0.10%
	Doxylamine	> 100000	--
	Disopyramide	> 100000	--
	LAAM (Levo-alpha-acetylmethadol) HCl	> 100000	--
	Alpha Methadol	> 100000	--
	D (+)-Methamphetamine	1000	100%
	(+/-)3,4-Methylenedioxy-n-ethylamphetamine (MDEA)	2000	50%
	D/L-Methamphetamine	1000	100%
	p-Hydroxymethamphetamine	30000	3.30%
	D-Amphetamine	> 100000	--
	L-Amphetamine	100000	1%
	Chloroquine	20000	5%
	(+/-) -Ephedrine	50000	2%
MET 1000	(-) -Methamphetamine	25000	4%
	(+/-)3,4-Methylenedioxyamphetamine (MDA)	2500	40%
	(+/-)3,4-Methylenedioxymethamphetamine (MDMA)	4000	25%
	ẞ-Phenylethylamine	50000	2%
	Trimethobenzamide	10000	10%
	d,l-Amphetamine	100000	1%
	Mephetermine	50000	2%
	(1R,2S)-(-)-Ephedrine	> 100000	--
	1-phenylephrine	> 100000	--
	L-Methamphetamine	20000	5%
MET 500	D (+) -Methamphetamine	500	100%
	(+/-)3,4-Methylenedioxy-n-ethylamphetamine (MDEA)	2000	25%
	D/L-Methamphetamine	500	100%
	MET 500	p-Hydroxymethamphetamine	(+/-)3,4-Methylenedioxy-n-ethylamphetamine (MDEA)	15000	2000	3.33%	25%
	D/L-Methamphetamine	500	100%
	p-Hydroxymethamphetamine	15000	3.33%
	D-Amphetamine	50000	1%
	L-Amphetamine	100000	0.50%
	Chloroquine	10000	5%
	(+/-)-Ephedrine	25000	2%

Aicheck Biotech, Inc. 17701 Cowan Ste 230, Irvine, CA, USA, 92614

{14}------------------------------------------------

Drug (Cutoff)	Substances	Minimum concentration requiredto obtain a positive result (ng/mL)	% Cross-Reactivity
	(-)-Methamphetamine	12500	4%
	(+/-)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	0.50%
	L-Methamphetamine	10000	5%
	3,4-Methylenedioxymethamphetamine (MDMA)	500	100%
	3,4-Methylenedioxyamphetamine HCl (MDA)	3000	16.67%
	3,4-Methylenedioxyethylamphetamine (MDEA)	500	100%
MDMA 500	d-methamphetamine	> 100000	--
	d-amphetamine	> 100000	--
	l-methamphetamine	50000	1%
	l-amphetamine	> 100000	--
	Morphine	2000	100%
	Normorphine	50000	4%
	Codeine	2000	100%
	s-Monoacetylmorphine	2000	100%
	Ethyl Morphine	1500	133.30%
OPI 2000	Heroin	2000	100%
	Hydrocodone	12500	16%
	Hydromorphone	3500	57.10%
	Morphinie-3-β-d-glucuronide	2000	100%
	Oxycodone	25000	8%
	Oxymorphone	25000	8%
	Thebaine	5000	40%
	Levorphanol	75000	2.70%
	6-Monoacetylmorphine (6-MAM)	1500	133.30%
	Norcodeine	12500	16%
	Procaine	150000	1.30%
MOP 300	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%
	Morphinie-3-β-d-glucuronide	1000	30%
	Oxycodone	> 100000	--
	Oxymorphone	100000	0.30%
	Thebaine	3000	10%
	Levorphanol	5000	6%
	6-Monoacetylmorphine (6-MAM)	150	200%
	Norcodeine	6500	4.60%
	Procaine	100000	0.30%
MTD 300	Methadone	300	100%
	Doxylamine	3000	10%
	EDDP	> 100000	--
	EMDP	> 100000	--
	LAAM	> 100000	--
	Alpha Methadol	> 100000	--
OXY 100	Oxycodone	100	100%
	Dihydrocodeine	20000	0.50%
	Hydrocodone	10000	1%
	Oxymorphone	1000	10%
	Codeine	100000	0.10%
	Hydromorphone	32000	0.30%
	Morphine	>100000	--

Aicheck Biotech, Inc. 17701 Cowan Ste 230, Irvine, CA, USA, 92614

{15}------------------------------------------------

Drug (Cutoff)	Substances	Minimum concentration requiredto obtain a positive result (ng/mL)	% Cross-Reactivity
	Acetylmorphine	>100000	--
	Buprenorphine	>100000	--
	Ethylmorphine	>100000	--
	Thebaine	>100000	--
PCP 25	Phencyclidine	25	100%
	4-Hydroxyphencyclidine	12500	0.20%
	Nortriptyline	1000	100%
	Nordoxepine	1000	100%
	Trimipramine	2000	50%
	Amitriptyline	1500	66.70%
	Promazine	1500	66.70%
	Desipramine	400	250%
TCA 1000	Imipramine	400	250%
	Clomipramine	12500	8%
	Doxepin	1000	100%
	Maprotiline	2000	50%
	Promethazine	25000	4%
	Cyclobenzaprine	1500	66.70%
	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	3.80%
	Δ9- Tetrahydrocannabinol	5000	1%
	511-hydroxy-Δ9-Tetrahydrocannabinol	5000	1%

Aicheck Biotech, Inc. 17701 Cowan Ste 230, Irvine, CA, USA, 92614

c.2 Interference Study

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

Table 4 Interfering substances

Acetaminophen	Ciprofloxacin Hydrochloride	1% Ethanol	Lidocaine Hydrochloride	Ondansetran
Acetophenetidin	Citalopram	Fenofibrate	Lisinopril	Paliperidone
Acetylsalicylic Acid	Clarithromycin	Fenoprofen	Lithium Carbonate	Pantoprazole
Acyclovir	Clonidine	Fentanyl Citrate	Liverite	Papaverine
Afrin	Clopidogrel Hydrogen Sulphate	Fluoxetine Hydrochloride	Loperamide	Paroxetine Hydrochloride
Albumin(100mg/dL)	Clozapine	Fluvoxamine	Loratadine	Penfluridol
Aminophylline	Conjugated Estrogens	Furosemide	Magnesium	PenicillinV Potassium
Aminopyrine	Cortisone	Gabapentin	Meperidine	Penicillin-G
Amiodarone Hydrochloride	Creatinine	Gentisic Acid	Meprobamate	Phenelzine
Amlodipine Mesylate	(-) Cotinine	Glibenclamide	Metoprolol Tartrate	Pioglitazone Hydrochloride
Amoxicillin	chlorpheniramine	Gliclazide	Mifepristone	Piracetam
Ampicillin	D, L-Octopamine	Glipizide	Mirtazapine	Pravastatin Sodium
Apomorphine	D, L-Propranolol	Glucose	Montelukast Sodium	Prednisone
Aripiprazole	D, L-Tyrosine	Haloperidol	Mosapride Citrate	Propylthiouracil
Aspartame	Deoxy- corticosterone	Hemoglobin	Minocycline	Quetiapine Fumarate
Atomoxetine	Dextromethorphan	Hydrochlorothiazide	Nalidixic Acid	Quinine
Atorvastatin Calcium	Diclofenac	Hydrocortisone	Naproxen	Ranitidine
Atropine	Diflunisal	3-Hydroxytyramine	Niacinamide	Rifampicin
Benzilic Acid	Digoxin	Isosorbide Dinitrate	Nifedipine	Risperidone
Benzoic Acid	Diphenhydramine	Isoxsuprine	Nikethamide	Salicylic Acid
Bilirubin	Dirithromycin	Ibuprofen	Nimodipine	Serotonin
Bupropion	Domperidone	Ketoconazole	Nitroglycerin	Sertraline Hydrochloride
Captopril	D-Pseudoephedrine	Ketoprofen	Norethindrone	Sildenafil Citrate
Carbamazepine	Duloxetine	Ketamine	N-Acetylprocain-amide	Simvastatin
Cefradine	Dicyclomine	Kratom powder	0-Hydroxyhippuric Acid	Sodium Valproate
Cephalexin	Effexor	Labetalol	Olanzapine	Spironolactone
Chloral Hydrate	Enalapril Maleate	Lamotrigine	Omeprazole	Sulfamethazine
Chloramphenicol	Erythromycin	Levofloxacin Hydrochloride	Oxalic Acid	Sulindac

{16}------------------------------------------------

Chlorothiazide	Esomeprazole Magnesium	Levonorgestrel	Oxolinic Acid	Tetracycline
Cholesterol	ß-Estradiol	Levothyroxine Sodium	Oxymetazoline	Tetrahydrocortisone 3 -acetate
Tetrahydrocortisone 3-(ß-D glucuronide)	Thioridazine	Trazodone Hydrochloride	Trimethoprim	Verapamil
Tetrahydrozoline	Topiramate	Triamterene	Uric Acid	Vitamin B2
Thiamine	Tramadol Hydrochloride	Trifluoperazine	Valproate	Vitamin C
Chloroquine	Ecgonine Methyl Ester	Doxylamine	Epinephrine Hydrochloride	Maprotiline
Promethazine

c.3 Effect of urine specific gravity and pH

To investigate the effect of urine specific gravity and urine samples, with specific gravity ranging from 1.000 to 1.035 or urine samples with pH ranging from 4 to 9 were spiked with the target drugs to concentrations at -25% Cutoff levels. These samples were tested using three lots of each device. Results vere all postive for samples at +25% Cutoff and all negative for samples demonstrated that urine specific gravity levels of 1000 to 1.035 and urine pH levels of 4 to 9 do not affect the results of the assays.

Traceability, Stability, Expected values (controls, calibrators, or methods): d

d.1 Traceability

The device is traceable to commercially available materials.

d.2 Stability

The stability data supports that the products have the shelf life of 24 months when stored at 4-30°C.

Real time Stability

A 27-month real time stability test is planned to vertify of the device as 24 morths. Three batches for each configuration in sealed foil pouch are currently stable for 21 months at 4°C and 30°C, and the real time stability study is still on-going.

Accelerated Stability

Stable at 4-30°C for 24 months based on the accelerated stability study at 55°C for 31 days and real time stability determination at both 4°C and 30°C.

e Detection limit

Not Applicable.

Assay Cut-off f

Refer to section 9.1.a.

9.2 Comparison Studies

Method comparison studies a

Method comparison studies were performed by the 100 unaltered clinical samples (40 negative and 40 positive) were run for each target drug. The samples were tested in a blinded fashion and compared to LC/MS results are presented in Table 5 below, and the discordant results are summarized in below.

Drugcutoff	Candidate Device Result	Drug-Free	Low Negative by LC/MS(less than - 50%)	Near Cutoff Negative by LC/MS(Between -50% and cutoff)	Near Cutoff Positive by LC/MS(Between cutoff and +50%)	High Positive by LC/MS(greater than +50%)
AMP 1000	Viewer A	Positive	0	0	1	14	25
		Negative	7	15	17	1	0
	Viewer B	Positive	0	0	1	15	25
		Negative	7	15	17	0	0
	Viewer C	Positive	0	0	1	14	25
		Negative	7	15	17	1	0
AMP 500	Viewer A	Positive	0	0	2	15	23
		Negative	13	7	18	2	0
	Viewer B	Positive	0	0	2	16	23
		Negative	13	7	18	1	0
	Viewer C	Positive	0	0	1	15	23
		Negative	13	7	19	2	0
BAR 300	Viewer A	Positive	0	0	1	19	19
		Negative	10	15	14	2	0
	Viewer B	Positive	0	0	1	19	19
		Negative	10	15	14	2	0
	Viewer C	Positive	0	0	1	19	19
		Negative	10	15	14	2	0
BUP 10	Viewer A	Positive	0	0	3	20	18
		Negative	10	15	12	2	0
	Viewer B	Positive	0	0	3	20	18
		Negative	10	15	10	2	0

Table 5 The Results of Method comparison with predicate device

	Viewer C	Positive	0	0	2	20	18
		Negative	10	15	13	2	0
BZO 300	Viewer A	Positive	0	0	2	18	20
		Negative	10	15	13	2	0
	Viewer B	Positive	0	0	2	18	20
		Negative	10	15	13	2	0
	Viewer C	Positive	0	0	3	18	20
		Negative	10	15	12	2	0
COC 300	Viewer A	Positive	0	0	0	18	21
		Negative	9	16	15	1	0
	Viewer B	Positive	0	0	0	17	21
		Negative	9	16	15	2	0
	Viewer C	Positive	0	0	1	19	21
		Negative	9	16	14	0	0
COC 150	Viewer A	Positive	0	0	0	21	15
		Negative	10	15	15	4	0
	Viewer B	Positive	0	0	1	23	15
		Negative	10	15	14	2	0

าก

Negative

Docitive

{17}------------------------------------------------

Aicheck Biotech, Inc. 17701 Cowan Ste 230, Irvine, CA, USA, 92614

Drug cutoff	Candidate Device Result	Drug-Free	Low Negative by LC/MS (less than - 50%)	Near Cutoff Negative by LC/MS (Between -50% and cutoff)	Near Cutoff Positive by LC/MS (Between cutoff and +50%)	High Positive by LC/MS (greater than +50%)
EDDP 300	Viewer A Positive	0	0	0	21	15
	Viewer A Negative	10	14	15	4	0
	Viewer A Positive	0	0	2	19	20
	Viewer A Negative	10	14	14	1	0
	Viewer B Positive	0	0	3	19	20
	Viewer B Negative	10	14	13	1	0
	Viewer C Positive	0	0	2	20	20
	Viewer C Negative	10	14	14	0	0
MET 1000	Viewer A Positive	0	0	1	16	22
	Viewer A Negative	8	13	18	2	0
	Viewer B Positive	0	0	2	17	22
	Viewer B Negative	8	13	17	1	0
	Viewer C Positive	0	0	2	17	22
	Viewer C Negative	8	13	17	1	0
MET 500	Viewer A Positive	0	0	1	21	16
	Viewer A Negative	8	20	11	3	0
	Viewer B Positive	0	0	2	23	16
	Viewer B Negative	8	20	10	1	0
	Viewer C Positive	0	0	0	21	16
	Viewer C Negative	8	20	12	3	0
OPI 2000	Viewer A Positive	0	0	1	22	18
	Viewer A Negative	10	15	14	0	0
	Viewer B Positive	0	0	1	20	18
	Viewer B Negative	10	15	14	2	0
	Viewer C Positive	0	0	2	20	18
	Viewer C Negative	10	15	13	2	0
MOP 300	Viewer A Positive	0	0	1	23	15
	Viewer A Negative	10	14	15	2	0
	Viewer B Positive	0	0	2	23	15
	Viewer B Negative	10	14	14	2	0
	Viewer C Positive	0	0	1	23	15
	Viewer C Negative	10	14	15	2	0
MTD 300	Viewer A Positive	0	0	1	14	24
	Viewer A Negative	10	18	11	2	0
	Viewer B Positive	0	0	1	15	24
	Viewer B Negative	10	18	11	1	0
	Viewer C Positive	0	0	0	14	24
	Viewer C Negative	10	18	12	2	0
OXY 100	Viewer A Positive	0	0	2	23	15
	Viewer A Negative	10	15	13	2	0
	Viewer B Positive	0	0	2	23	15
	Viewer B Negative	10	15	13	2	0
	Viewer C Positive	0	0	1	22	15
	Viewer C Negative	10	15	14	3	0
PCP 25	Viewer A Positive	0	0	1	20	18
	Viewer A Negative	9	16	14	2	0
	Viewer B Positive	0	0	1	20	18
	Viewer B Negative	9	16	14	2	0
	Viewer C Positive	0	0	0	20	18
	Viewer C Negative	9	16	15	2	0
TCA 1000	Viewer A Positive	0	0	2	20	18
	Viewer A Negative	10	15	13	2	0
	Viewer B Positive	0	0	1	19	18
	Viewer B Negative	10	15	14	3	0
	Viewer C Positive	0	0	2	20	18
	Viewer C Negative	10	15	13	2	0
THC 50	Viewer A Positive	0	0	1	18	20
	Viewer A Negative	10	15	14	2	0
	Viewer B Positive	0	0	2	19	20
	Viewer B Negative	10	15	13	1	0
	Viewer C Positive	0	0	1	17	20
	Viewer C Negative	10	15	14	3	0
		Viewer A Positive	Viewer A	0	Positive	0	0	1	0	20	1	18	18	20
		Negative	10	15	14	2	0
THC 50	Viewer B	Positive	0	0	2	19	20
		Negative	10	15	13	1	0
	Viewer C	Positive	0	0	1	17	20
		Negative	10	15	14	3	0
	Viewer A	Positive	0	0	1	20	18
		Negative	10	15	14	2	0


Viewer B	Positive	0	0	1	21	18
	Negative	10	15	14	1	0
Viewer C	Positive	0	0	1	20	18
	Negative	10	15	14	2	0

{18}------------------------------------------------

Table 6 Discordant results
Drug cutoff	Operator	Sample ID	LC/MS Results(ng/mL)	Test Result	Drug cutoff	Operator	Sample ID	LC/MS Results(ng/mL)	Test Result
AMP 1000	Viewer C	AH621	968.6	Positive	MET 500	Viewer B	ML217	457.3	Positive
	Viewer A, B	AH618	970.1	Positive		Viewer A, B	ML177	491	Positive
	Viewer A, C	AH562	1101	Negative		Viewer A, C	ML224	506	Negative
	Viewer B	AL554	472.6	Positive		Viewer B, C	ML216	512	Negative
	Viewer A	AL486	475.7	Positive		Viewer A, C	ML168	518	Negative
AMP 500	Viewer A, B, C	AL546	489	Positive		Viewer A	ML233	523	Negative
	Viewer A, C	AL491	501.2	Negative		Viewer A, C	OP094	1869.3	Positive
	Viewer B, C	AL551	508.9	Negative	OPI 2000	Viewer B, C	OP084	1983	Positive
	Viewer A	AL483	536.2	Negative		Viewer B, C	OP149	2045	Negative
	Viewer A, B, C	BA436	296	Positive		Viewer B, C	OP087	2080	Negative
BAR 300	Viewer A, C	BA445	302.1	Negative		Viewer B	M0033	287.5	Positive
	Viewer A, B, C	BA474	307.2	Negative		Viewer A, B, C	M0039	298	Positive
	Viewer B	BA403	319.83	Negative	MOP 300	Viewer A, B, C	M0028	301	Negative
	Viewer A, B	BU001	8.36	Positive		Viewer A, C	MO009	301.6	Negative
	Viewer A, B, C	BU052	9.21	Positive		Viewer B	M0071	319.5	Negative
BUP 10	Viewer A, B, C	BU053	9.42	Positive		Viewer C	OX236	87	Positive
	Viewer A, B, C	BU007	10.2	Negative		Viewer B	OX228	92.3	Positive
	Viewer A, B, C	BU003	10.5	Negative		Viewer A, B	OX204	95	Positive
	Viewer B, C	BZ100	282	Positive	OXY 100	Viewer A	OX185	96	Positive
	Viewer A, C	BZ112	291.2	Positive			Viewer A, B, C	OX199	100
	Viewer A, B, C	BZ149	298	Positive			Viewer A, C	OX209	102
BZO 300	Viewer C	BZ103	301	Negative		Viewer B, C	OX195	103	Negative
	Viewer A, B, C	BZ096	305	Negative		Viewer A	PC252	23.16	Positive
	Viewer B	BZ108	309	Negative		Viewer B	PC260	23.97	Positive
	Viewer A	BZ155	317.6	Negative	PCP 25	Viewer A, B, C	PC286	25.39	Negative
	Viewer C	CH945	294.8	Positive			Viewer A, B, C	PC297	25.9
COC 300	Viewer A, B	CH948	328.5	Negative		Viewer C	TA752	849	Positive
	Viewer B	CH893	338.5	Negative		Viewer A, C	TA776	892	Positive
	Viewer B	CL801	145	Positive		Viewer A, B	TA724	934	Positive
	Viewer B	CL827	154	Negative	TCA 1000	Viewer A	TA774	1025	Negative
	Viewer A, C	CL806	156	Negative			Viewer B, C	TA761	1058
COC 150	Viewer A, B, C	CL839	159	Negative		Viewer B, C	TA767	1069	Negative
	Viewer A, C	CL830	160.1	Negative		Viewer A, B	TA799	1079	Negative
	Viewer A, C	CL858	163.5	Negative		Viewer B, C	TH334	48	Positive
	Viewer B	ED366	280.8	Positive		Viewer A, B	TH375	48.8	Positive
	Viewer A, B, C	ED350	281	Positive	THC 50	Viewer A, C	TH374	50.35	Negative
EDDP 300	Viewer A, B, C	ED335	284.1	Positive			Viewer A, C	TH339	53.46
	Viewer A	ED331	325	Negative		Viewer B, C	TH398	54.45	Negative
	Viewer B	ED358	335.7	Negative		Viewer B	MD642	476.1	Positive
	Viewer A, B, C	MH307	981.1	Positive	MDMA 500	Viewer A, C	MD708	482.34	Positive
MET 1000	Viewer B, C	MH291	995.8	Positive			Viewer A, C	MD706	502
	Viewer A, B	MH246	1039.7	Negative		Viewer B, C	MD681	527.89	Negative
	Viewer A, C	MH302	1098	Negative		Viewer A	MD710	532	Negative
	Viewer A, B	MT464	278.8	Positive
MTD 300	Viewer A, B, C	MT424	326.5	Negative
	Viewer A, C	MT475	329.8	Negative

b Matrix comparison

Not applicable. This device is for testing with human urine only.

10 Clinical studies

Clinical Sensitivity a

Not applicable

Clinical specificity b

Not applicable

Other clinical supportive data (when a. and b. are not applicable) C

c.1 Lay-User Study

The lay-user study was performed at three intensed by and 82 female tested Porguite™ Multi-Drug Test Panel Configuration 1 (including AMP 500, MET 500, NET 500, NET 500, NET MOP 300, COC 150); 56 male and 84 female tested Poguide™ Multi-Drug Test Panel Configuration 2 (including AMP 1000, MET 1000). Ney had

direrse educational and occupational backgrounds and the > 50. Urine samples were prepared at the following concentrations: -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug free-pooled urine specimens. The concentrations of the sample were confirmed by LC-MS/MS Each sample was aliquoted into individual containers and blind-label. Each participant was provided with the package insert, 1 blind label sample and a device. The results are summarized in below.

Drug	Cutoff(ng/mL)	Results	Concentration
AMP	500	Negative	20	20	20	19	1	0	0
AMP		Positive	0	0	0	1	19	20	20
AMP		Total	20	20	20	20	20	20	20
AMP		Agreement (%)	100%	100%	100%	95.00%	95.00%	100%	100%
BAR	300	Negative	20	20	20	20	1	0	0
BAR		Positive	0	0	0	0	19	20	20

Table 7 Result of Pocquide™ Multi-Drug Test Panel Configuration 1 (including AMP 500, MET 500, MOP 300, COC 150)

{19}------------------------------------------------

	Cutoff					Concentration
Drug	(ng/mL)	Results	-100% cutoff	-75% cutoff	-50% cutoff	-25% cutoff	+25% cutoff	+50% cutoff	+75% cutoff
BZO	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%
BUP	10	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%
COC	150	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%
EDDP	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%
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%
MET	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%
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%	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	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%
THC	50	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%

Agreement (%)	100%	100%	100%	95.00%	100%	100%	100%
---------------	------	------	------	--------	------	------	------

Drug	Cutoff(ng/mL)	Results	Concentration
			-100% cutoff	-75% cutoff	-50% cutoff	-25% cutoff	+25% cutoff	+50% cutoff	+75% 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%	100.00%	100%	100%
BAR	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%
Drug	Cutoff(ng/mL)	Results	Concentration
			-100% cutoff	-75% cutoff	-50% cutoff	-25% cutoff	+25% cutoff	+50% cutoff	+75% cutoff
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%	100.00%	95.00%	100%	100%
COC	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%	100.00%	95.00%	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%
MET	1000	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%	100.00%	95.00%	100%	100%
OPI	2000	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%
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%	100%	95.00%	100%	100%
OXY	100	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%	100.00%	95.00%	100%	100%
PCP	25	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%	100.00%	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	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%

Table 8 Result of Pocguide™ Multi-Drug Test Panel Configuration 2 (including AMP 1000, MET 1000, MOP 2000 (OPI), COC 300)

{20}------------------------------------------------

Participants were given surveys on the ease of under on to 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 Cut-off d

Not applicable

11 Conclusion

Based on the test principle and performance charactive including precision, cut-off, interference, specificity, method comparison and lay-user studies of the devices, it's concluded that Pocguide™ Multi-Drug Test Panel OTC are substantially equivalent to the predicate devices. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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).