PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup

K242077 · Aicheck Biotech, Inc. · NFT · Aug 14, 2024 · Clinical Toxicology

Device Facts

• Record ID: K242077
• Device Name: PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup
• Applicant: Aicheck Biotech, Inc.
• Product Code: NFT · Clinical Toxicology
• Decision Date: Aug 14, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

Pocguide™ Multi-Drug Test Cup OTC is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3diphenylpyrrolidine, Methamphetamine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: [Table of drugs and cutoffs]. The single or multi-test cups can consist of up to the above listed analytes in any combination. For over-the-counter use. The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. Pocguide™ Multi-Drug Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: [Table of drugs and cutoffs]. The single or multi-test cups can consist of up to the above listed analytes in any combination. The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

Device Story

Pocguide™ Multi-Drug Test Cup is a lateral flow immunochromatographic assay for qualitative detection of drugs of abuse in human urine. Device consists of a cup format containing test strips; user immerses the absorbent end into a urine sample. Principle of operation: competitive binding; drug in sample competes with drug-protein conjugate for limited antibody-dye binding sites. If drug is present at or above cutoff, it binds to antibody-dye, preventing binding to the test region (T), resulting in no colored line (positive). If drug is absent or below cutoff, antibody-dye binds to the test region, producing a colored line (negative). A control line (C) confirms proper wicking. Used in OTC or clinical settings; operated by lay users or professionals. Results are visual; preliminary only. Confirmatory testing (GC-MS/LC-MS) required for positive results. Benefits include rapid, simultaneous screening for multiple analytes to assist in identifying potential drug presence.

Clinical Evidence

Bench testing only. Performance validated via precision/reproducibility studies (25 days, 3 lots), analytical specificity/cross-reactivity, and interference testing (pH 4-9, specific gravity 1.000-1.035). Method comparison study performed with 80 clinical samples per drug against LC-MS/MS. Lay-person study (n=280) conducted at three sites confirmed ease of use and performance across diverse demographics.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Form factor: test cup. Materials: membrane pre-coated with drug-protein, antibody-dye conjugate. Connectivity: none (standalone). Sterilization: not stated. Software: none.

Indications for Use

Indicated for qualitative, simultaneous detection of Amphetamine, Buprenorphine, Butalbital, Oxazepam, Cocaine, EDDP, Methamphetamine, MDMA, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, and Marijuana in human urine. Intended for OTC and professional use as a preliminary screening tool. 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of the HHS logo is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

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

Re: K242077

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

Dear Jenny Xia:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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

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

Sincerely,

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

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

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# Indications for Use

Submission Number (if known)

#### K242077 Device Name

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

Indications for Use (Describe)

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

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

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

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

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

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

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

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

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

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

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

| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|
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# 510(k) SUMMARY K242077

| 1. | Date: | July 11, 2024 |
|----|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Submitter: | Aicheck Biotech, Inc.<br>17701 Cowan, Ste 230<br>Irvine, CA 92614 |
| 3. | Contact person: | Jenny Xia<br>LSI International Inc.<br>504 East Diamond Ave., Suite H<br>Gaithersburg, MD 20877<br>Telephone: [phone]<br>Email: [e-mail] |
| 4. | Device Name: | PocguideTM Multi-Drug Test Cup OTC<br>PocguideTM Multi-Drug Test Cup |
| 5. | Classification: | Class II |

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

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

#### Predicate Devices: 6.

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

#### 7. Intended Use

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

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

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

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

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

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

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

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

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

#### Device Description 8.

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

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

| Item | Proposed Device | Predicate<br>(K182701) | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|
| 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, Nortriptyline and Marijuana in human urine. | Same (but the number of drugs detected is different) | |
| 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 and<br>Cut Off Values | Target Drug | Cutoff (ng/mL) | Same (but the number of drugs detected is different) |
| | Amphetamine (AMP) | 1000 or 500 | |
| | Buprenorphine (BUP) | 10 | |
| | Secobarbital (BAR) | 300 | |
| | Oxazepam (BZO) | 300 | |
| | Cocaine (COC) | 300 or 150 | |
| | 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine (EDDP) | 300 | |
| | Methamphetamine (MET) | 1000 or 500 | |
| | Methylenedioxymethamphetamine<br>(MDMA) | 500 | |
| | Morphine (MOP 300/OPI 2000) | 2000 or 300 | |
| | Methadone (MTD) | 300 | |
| | Oxycodone (OXY) | 100 | |
| | Phencyclidine (PCP) | 25 | |
| | Nortriptyline (TCA) | 1000 | |
| | Marijuana (THC 50) | 50 | |
| Configurations | Test cup | Same | |
| Intended Use | For over-the-counter use | Same | |

#### Substantial Equivalence Information 9.

## 10. Standard/Guidance Document Reference (if applicable)

None referenced.

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## 11. Test Principle

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

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

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

## 12. Performance Characteristics

### A. Analytical performance

#### a. Precision/Reproducibility:

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

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

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

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

## b. Linearity/assay reportable range:

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

### c. Stability:

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

### d. Analytical specificity/Interference:

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

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

| Drug/Cutoff | Compound | Minimum<br>concentration<br>required to obtain<br>a positive result<br>(ng/mL) | % Cross-<br>Reactivity |
|-------------|-------------------------------------------------------|--------------------------------------------------------------------------------|------------------------|
| | d-Amphetamine | 500 | 100% |
| | l-Amphetamine | 15000 | 3.3% |
| | dl- Amphetamine | 1500 | 33.3% |
| | (+/-) 3,4-<br>Methylenedioxyamphetamine<br>(MDA) | 5000 | 10% |
| AMP 500 | Phentermine | 1500 | 33.3% |
| | Hydroxyamphetamine | 8000 | 6.25% |
| | d-Methamphetamine | >100000 | - |
| | l-Methamphetamine | >100000 | - |
| | (+/-) 3,4-<br>Methylenedioxyethylamphetamine<br>(MDE) | >100000 | - |
| | (+/-)3,4-<br>Methylenedioxymethamphetamine<br>(MDMA) | | |
| | β-Phenylethylamine | 100000 | 0.5% |
| | Tyramine | 100000 | 0.5% |
| | p-Hydroxynorephedrine | 100000 | 0.5% |
| | Phenylpropanolamine | >100000 | - |
| | (±)Phenylpropanolamine | >100000 | - |
| | p-Hydroxyamphetamine | 100000 | 0.5% |
| | d/l-Norephedrine | 100000 | 0.5% |
| | Benzphetamine | >100000 | - |
| | 1-Ephedrine | >100000 | - |
| | l-Epinephrine | >100000 | - |
| | d/l-Epinephrine | >100000 | - |
| | d-Amphetamine | 1000 | 100% |
| | l-Amphetamine | 30000 | 3.3% |
| | dl- Amphetamine | 3000 | 33.3% |
| | (+/-)3,4-<br>Methylenedioxyamphetamine (MD<br>A) | 5000 | 20% |
| | Phentermine | 3000 | 33.3% |
| | Hydroxyamphetamine | 8000 | 12.5% |
| | d-Methamphetamine | >100000 | - |
| | l-Methamphetamine | >100000 | - |
| AMP 1000 | (+/-)3,4-<br>Methylenedioxyethylamphetamine<br>(MDEA) | >100000 | - |
| | (+/-)3,4-<br>Methylenedioxymethamphetamine<br>(MDMA) | >100000 | - |
| | β-Phenylethylamine | 100000 | 1% |
| | Tyramine | 100000 | 1% |
| | p-Hydroxynorephedrine | 100000 | 1% |
| | Phenylpropanolamine | >100000 | - |
| | (±)Phenylpropanolamine | >100000 | -- |
| | p-Hydroxyamphetamine | 100000 | 1% |
| | d/l-Norephedrine | 100000 | 1% |
| | Benzphetamine | >100000 | - |
| | 1-Ephedrine | >100000 | - |
| | 1-Epinephrine | >100000 | - |
| | d/l-Epinephrine | >100000 | - |
| | Secobarbital | 300 | 100% |
| | Amobarbital | 5000 | 6% |
| | Alphenol | 150 | 200% |
| | Aprobarbital | 200 | 150% |
| BAR 300 | Butabarbital | 150 | 200% |
| | Butethal | 50 | 600% |
| | Butalbital | 2500 | 12% |
| | Cyclopentobarbital | 600 | 50% |
| | Pentobarbital | 2000 | 15% |
| | Phenobarbital | 5000 | 6% |
| | Buprenorphine | 10 | 100% |
| | Buprenorphine -3-D-Glucuronide | 15 | 66.67% |
| | Norbuprenorphine | 20 | 50% |
| BUP 10 | Norbuprenorphine-3-D-Glucuronide | 100 | 10% |
| | Glucuronide | | |
| | Morphine | > 100000 | - |
| | Oxymorphone | > 100000 | - |
| | Hydromorphone | > 100000 | - |
| | Oxazepam | 300 | 100% |
| | Alprazolam | 200 | 150% |
| | a-Hydroxyalprazolam | 1000 | 30% |
| BZO 300 | Bromazepam | 500 | 60% |
| | Chlordiazepoxide | 1500 | 20% |
| | Clobazam | 100 | 300% |
| | Clonazepam | 3000 | 10% |
| | Clorazepate dipotassium | 200 | 150% |
| | Delorazepam | 1500 | 20% |
| | Desalkylflurazepam | 400 | 75% |
| | Diazepam | 200 | 150% |
| | Estazolam | 500 | 60% |
| | Flunitrazepam | 1000 | 30% |
| | Midazolam | 5000 | 6% |
| | Nitrazepam | 1000 | 30% |
| | Norchlordiazepoxide | 200 | 150% |
| | Nordiazepam | 500 | 60% |
| | Temazepam | 250 | 120% |
| | Triazolam | 1200 | 25% |
| | Demoxepam | 2000 | 15% |
| | Flurazepam | 500 | 60% |
| | D,L-Lorazepam | 1500 | 20% |
| | Benzoylecgonine | 150 | 100% |
| | Cocaine | 500 | 30% |
| | Cocaethylene | 6250 | 2.4% |
| COC 150 | Ecgonine | 16000 | 0.94% |
| | Ecgonine methyl ester | >100000 | - |
| | Norcocaine | >100000 | - |
| | Benzoylecgonine | 300 | 100% |
| | Cocaine | 1000 | 30% |
| COC 300 | Cocaethylene | 15000 | 2% |
| | Ecgonine | 30000 | 1% |
| | Ecgonine methyl ester | >100000 | - |
| | Norcocaine | >100000 | - |
| | 3,4-<br>Methylenedioxymethamphetamine<br>(MDMA) | 500 | 100% |
| MDMA 500 | 3,4-Methylenedioxyamphetamine HCl (MDA) | 3000 | 16.67% |
| | 3,4-<br>Methylenedioxyethylamphetamine<br>(MDEA) | 500 | 100% |
| | d-methamphetamine | > 100000 | - |
| | d-amphetamine | > 100000 | - |
| | l-methamphetamine | 50000 | 1% |
| | l-amphetamine | > 100000 | - |
| | D(+)-Methamphetamine | 500 | 100% |
| | (+/-)3,4-Methylenedioxy-n-<br>ethylamphetamine(MDEA) | 2000 | 25%<br>5% |
| | D/L-Methamphetamine | 500 | 100% |
| | p-Hydroxymethamphetamine | 15000 | 3.33% |
| | D-Amphetamine | 50000 | 1% |
| | L-Amphetamine | 100000 | 0.5% |
| | Chloroquine | 10000 | 5% |
| | (+/-)-Ephedrine | 25000 | 2% |
| | (-)-Methamphetamine | 12500 | 4% |
| MET 500 | (+/-)3,4-<br>Methylenedioxyamphetamine<br>(MDA) | 2000 | 25% |
| | (+/-)3,4-<br>Methylenedioxymethamphetamine<br>(MDMA) | 2000 | 25% |
| | β-Phenylethylamine | 25000 | 2% |
| | Trimethobenzamide | 5000 | 10% |
| | d,l-Amphetamine | 75000 | 0.67% |
| | Mephetermine | 25000 | 2% |
| | (1R,2S)-(-)-Ephedrine | 50000 | 1% |
| | l-phenylephrine | 100000 | 0.5% |
| | L-Methamphetamine | 10000 | 5% |
| | D(+)-Methamphetamine | 1000 | 100% |
| MET 1000 | (+/-)3,4-Methylenedioxy-n-<br>ethylamphetamine (MDEA) | 2000 | 50% |
| | D/L-Methamphetamine | 1000 | 100% |
| | p-Hydroxymethamphetamine | 30000 | 3.3% |
| | D-Amphetamine | > 100000 | - |
| | L-Amphetamine | 100000 | 1% |
| | Chloroquine | 20000 | 5% |
| | (+/-)-Ephedrine | 50000 | 2% |
| | (-)-Methamphetamine | 25000 | 4% |
| | (+/-)3,4-<br>Methylenedioxyamphetamine<br>(MDA) | 2500 | 40% |
| | (+/-)3,4-<br>Methylenedioxymethamphetamine<br>(MDMA) | 4000 | 25% |
| | β-Phenylethylamine | 50000 | 2% |
| | Trimethobenzamide | 10000 | 10% |
| | d,l-Amphetamine | 100000 | 1% |
| | Mephetermine | 50000 | 2% |
| | (1R,2S)-(-)-Ephedrine | > 100000 | - |
| | l-phenylephrine | > 100000 | - |
| | L-Methamphetamine | 20000 | 5% |
| | Morphine | 300 | 100% |
| | Normorphine | 250 | 120% |
| | Codeine | 300 | 100% |
| | s-Monoacetylmorphine | 300 | 100% |
| | Ethyl Morphine | 100 | 300% |
| | Heroin | 300 | 100% |
| | Hydrocodone | 5000 | 6% |
| | Hydromorphone | 2000 | 15% |
| MOP 300 | Morphinie-3-β-d-glucuronide | 1000 | 30% |
| | Oxycodone | >100000 | -- |
| | Oxymorphone | 100000 | 0.3% |
| | Thebaine | 3000 | 10% |
| | Levorphanol | 5000 | 6% |
| | 6-Monoacetylmorphine (6-MAM) | 150 | 200% |
| | Norcodeine | 6500 | 4.6% |
| | Procaine | 100000 | 0.3% |
| | Morphine | 2000 | 100% |
| OPI 2000 | Normorphine | 50000 | 4% |
| | Codeine | 2000 | 100% |
| | s-Monoacetylmorphine | 2000 | 100% |
| | Ethyl Morphine | 1500 | 133.3% |
| | Heroin | 2000 | 100% |
| | Hydrocodone | 12500 | 16% |
| | Hydromorphone | 3500 | 57.1% |
| | Morphinie-3-β-d-glucuronide | 2000 | 100% |
| | Oxycodone | 25000 | 8% |
| | Oxymorphone | 25000 | 8% |
| | Thebaine | 5000 | 40% |
| | Levorphanol | 75000 | 2.7% |
| | 6-Monoacetylmorphine (6-MAM) | 1500 | 133.3% |
| | Norcodeine | 12500 | 16% |
| | Procaine | 150000 | 1.3% |
| MTD 300 | Methadone | 300 | 100% |
| | Doxylamine | 3000 | 10% |
| | EDDP | >100000 | - |
| | EMDP | >100000 | - |
| | LAAM | >100000 | - |
| | Alpha Methadol | >100000 | - |
| OXY 100 | Oxycodone | 100 | 100% |
| | Dihydrocodeine | 20000 | 0.5% |
| | Hydrocodone | 10000 | 1% |
| | Oxymorphone | 1000 | 10% |
| | Codeine | 100000 | 0.1% |
| | Hydromorphone | 32000 | 0.3% |
| | Morphine | >100000 | - |
| | Acetylmorphine | >100000 | - |
| | Buprenorphine | >100000 | - |
| | Ethylmorphine | >100000 | - |
| | Thebaine | >100000 | - |
| PCP 25 | Phencyclidine | 25 | 100% |
| | 4-Hydroxyphencyclidine | 12500 | 0.2% |
| TCA 1000 | Nortriptyline | 1000 | 100% |
| | Nordoxepine | 1000 | 100% |
| | | | |
| | Trimipramine | 2000 | 50% |
| | Amitriptyline | 1500 | 66.7% |
| | Promazine | 1500 | 66.7% |
| | Desipramine | 400 | 250% |
| | Imipramine | 400 | 250% |
| | Clomipramine | 12500 | 8% |
| | Doxepin | 1000…