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

K242498 · Aicheck Biotech, Inc. · NFT · Oct 1, 2024 · Clinical Toxicology

Device Facts

• Record ID: K242498
• Device Name: Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC
• Applicant: Aicheck Biotech, Inc.
• Product Code: NFT · Clinical Toxicology
• Decision Date: Oct 1, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

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: [Table of analytes and cutoffs]. 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. 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: [Table of analytes and cutoffs]. 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.

Device Story

Lateral flow immunochromatographic dipcard assay; detects drugs of abuse in human urine. Principle: competitive binding; drug in sample competes with drug-protein conjugate for limited antibody-dye binding sites. Sample wicks via capillary action; absence of colored test line indicates positive result (drug concentration at/above cutoff); presence of colored line indicates negative result. Control line confirms proper wicking. Used in clinical/OTC settings; operator immerses absorbent end of dipcard into urine. Results read visually by user/clinician. Preliminary positive results require confirmation via GC-MS or LC-MS. Benefits: rapid, qualitative screening for multiple drugs simultaneously.

Clinical Evidence

Bench testing only. Analytical performance: precision/reproducibility (3 lots, 25 days), cross-reactivity, and interference studies. Method comparison: 100 clinical samples per drug compared to LC-MS/MS. Lay-user study: 162 participants (Configuration 1) and 140 participants (Configuration 2) demonstrated ease of use and performance across various concentrations.

Technological Characteristics

Lateral flow immunochromatographic assay; dipcard format with integrated test strips. Qualitative detection. Materials: plastic dipcard, absorbent test strips, antibody-dye conjugates. No external energy source. Standalone device. Shelf life: 24 months at 4-30°C.

Indications for Use

Indicated for qualitative, simultaneous detection of drugs of abuse (Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, EDDP, Methamphetamine, MDMA, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana) in human urine. Intended for both professional (Rx) and over-the-counter (OTC) use. Provides preliminary results; requires confirmatory testing (GC-MS/LC-MS). Not intended to distinguish between prescription use and abuse.

Regulatory Classification

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.

Special Controls

*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).

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The logo is simple and professional, reflecting the agency's role in protecting public health.

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 ([e-mail]) or phone [phone] 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 |

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

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: [phone] Email: [e-mail]

#### 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: [phone] Email: [e-mail] Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail]

#### 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 § 862.3100<br>Amphetamine Test System | Clinical<br>Toxicology |
| Buprenorphine (BUP) | NGL | Class II | 21 CFR § 862.3650<br>Opiate Test System | Clinical<br>Toxicology |
| Secobarbital (BAR) | PTH | Class II | 21 CFR § 862.3150<br>Barbiturate test system | Clinical<br>Toxicology |
| Oxazepam (BZO) | NFV | Class II | 21 CFR § 862.3170<br>Benzodiazepine test system | Clinical<br>Toxicology |
| Benzoylecognine (COC) | NFY | Class II | 21 CFR § 862.3250<br>Cocaine and Cocaine Metabolites Test System | Clinical<br>Toxicology |
| 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine (EDDP) | PTG | Class II | 21CFR § 862.3620<br>Methadone Test System | Clinical<br>Toxicology |
| Methamphetamine (MET) | NGG | Class II | 21 CFR § 862.3610<br>Methamphetamine Test System | Clinical<br>Toxicology |

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

# 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

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.

#### 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 Panel<br>Pocguide™ Multi-Drug Test Panel OTC | Wondfo T-Dip® Multi-Drug Urine Test Panel<br>Wondfo 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 Drug<br>and Cutoff<br>Value | 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 |

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#### 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 tested<br>Claimed Cutoff | %cutoff | Lot 1 | | Lot 2 | | Lot 3 | | Total Result | | %Positive | %Negative | |
|-------------------------------|--------------|-------|----|-------|----|-------|----|--------------|-----|-----------|-----------|--------|
| | | + | - | + | - | + | - | + | - | | | |
| AMP<br>500 | +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% | |
| AMP<br>500 | cutoff | 41 | 9 | 42 | 8 | 40 | 10 | 123 | 27 | 82.0% | 18.0% | |
| AMP<br>500 | -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% |
| AMP<br>1000 | +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% | |
| AMP<br>1000 | cutoff | 42 | 8 | 43 | 7 | 43 | 7 | 128 | 22 | 85.3% | 14.7% | |
| AMP<br>1000 | -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% |
| BUP<br>10 | +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% | |
| BUP<br>10 | cutoff | 43 | 7 | 41 | 9 | 42 | 8 | 126 | 24 | 84.0% | 16.0% | |
| BUP<br>10 | -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% |
| BAR<br>300 | +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% | |
| BAR<br>300 | cutoff | 42 | 8 | 41 | 9 | 41 | 9 | 124 | 26 | 82.7% | 17.3% | |
| BAR<br>300 | -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% |
| BZO<br>300 | +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% | |
| BZO<br>300 | cutoff | 43 | 7 | 41 | 9 | 42 | 8 | 126 | 24 | 84.0% | 16.0% | |
| BZO<br>300 | -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% |
| COC<br>300 | +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<br>300 | cutoff | 43 | 7 | 42 | 8 | 41 | 9 | 126 | 24 | 84.0% | 16.0% | |
| COC<br>300 | -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 1<br>Lot 2<br>Lot 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% |
| MOP<br>300 | +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% |
| MTD<br>300 | +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% |
| OXY<br>100 | +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% |
| PCP<br>25 | +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% |
| TCA<br>1000 | +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% |
| THC<br>50 | +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 required<br>to 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 required<br>to 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% | | |…