AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup

K243996 · Assure Tech., LLC · NFT · Feb 7, 2025 · Clinical Toxicology

Device Facts

• Record ID: K243996
• Device Name: AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup
• Applicant: Assure Tech., LLC
• Product Code: NFT · Clinical Toxicology
• Decision Date: Feb 7, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The AssureTech Panel Dip Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Methamphetamine, Fentanyl, Norfentanyl, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of: [Table of cutoffs]. The single or multi-test panels can consist of up to seventeen (17) of the above listed analytes in any combination. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. For in vitro diagnostic use only. The AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Methamphetamine, Fentanyl, Norfentanyl, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of: [Table of cutoffs]. The single or multi-test panels can consist of up to seventeen (17) of the above listed analytes in any combination. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. For in vitro diagnostic use only. The AssureTech Multi-drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana, Methamphetamine, Morphine, Fentanyl, Norfentanyl, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene and adulterants in human urine at the cutoff concentrations of: [Table of cutoffs]. The single or multi-test panel can consist of up to seventeen (17) of the above listed analytes in any combination. It is for in vitro diagnostic use only. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The AssureTech Multi-drug Urine Test Cup are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Fentanyl, Norfentanyl, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene and adulterants in human urine at the cutoff concentrations of: [Table of cutoffs]. The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination. It is for in vitro diagnostic use only. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Device Story

Lateral flow immunochromatographic assay for qualitative drug detection in human urine; competitive binding principle. Urine sample migrates via capillary action; target drugs below cutoff do not saturate monoclonal antibody binding sites, allowing formation of visible colored test line; drug levels above cutoff saturate binding sites, preventing test line formation. Control line indicates proper test performance. Used in point-of-care or home settings; operated by lay users or clinicians. Provides preliminary results; requires confirmatory testing (GC/MS or LC/MS) for clinical decision-making. Benefits include rapid, simultaneous screening for multiple substances.

Clinical Evidence

Bench testing only. Precision studies (25 days, 2 runs/day) and method comparison studies (80 clinical samples per drug) performed against LC/MS. Lay-user study (n=280 per device format) evaluated performance across various concentrations (-100% to +75% of cutoff) and confirmed ease of use. No clinical prospective/retrospective studies performed.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle; monoclonal mouse antibodies; aluminum pouch packaging with desiccant; single-use; qualitative output; no electronic components; no software.

Indications for Use

Indicated for qualitative, simultaneous detection of drugs of abuse (Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Fentanyl, Norfentanyl, Oxycodone, Secobarbital, Buprenorphine, MDMA, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene) and adulterants in human urine. Intended for OTC and prescription use.

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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 7, 2025

Assure Tech LLC % Jenny Xia Director LSI International Inc 504E Diamond Ave., Suite H Gaithersburg, Maryland 20877

Re: K243996

Trade/Device Name: AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multidrug Urine Test Panel; AssureTech Multi-drug Urine Test Cup Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, PTH, NGL, NFV, NFY, PTG, NGG, NGM, QAW, NFW, QBF Dated: December 22, 2024 Received: December 26, 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.

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Page 2

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).

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 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-regulatory

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assistance/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. Kotarek Digitally signed by Joseph A. Kotarek -S -5 Date: 2025.02.07 09:19:07 -05'00' Joseph Kotarek, Ph.D. 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

Enclosure

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## Indications for Use

510(k) Number (if known) K243996

#### Device Name

AssureTech Panel Dip Tests; AssureTech Quick Cup Tests:

AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup

#### Indications for Use (Describe)

The AssureTech Panel Dip Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Methamphetamine, Fentanyl, Norfentany], Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

| Drug (Identifier) | Cut-off level |
|-----------------------------|---------------|
| Amphetamine (AMP) | 500 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL |
| Methadone metabolite (EDDP) | 300 ng/mL |
| Fentanyl (FYL) | 1 ng/mL |
| Ecstasy (MDMA) | 500 ng/mL |
| Methamphetamine (MET) | 500 ng/mL |
| Morphine (MOR) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Norfentanyl (NFYL) | 5 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |

The single or multi-test panels can consist of up to seventeen (17) of the above listed analytes in any combination. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

The AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Methamphetamine, Fentanyl, Norfentany], Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

| Drug (Identifier) | Cut-off level |
|-----------------------------|---------------|
| Amphetamine (AMP) | 500 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL |
| Methadone metabolite (EDDP) | 300 ng/mL |

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| Fentanyl (FYL) | 1 ng/mL |
|-----------------------|------------|
| Ecstasy (MDMA) | 500 ng/mL |
| Methamphetamine (MET) | 500 ng/mL |
| Morphine (MOR) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Norfentanyl (NFYL) | 5 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |

The single or multi-test panels can consist of up to seventeen (17) of the above listed analytes in any combination. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

The AssureTech Multi-drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana, Methamphetamine, Morphine, Fentanyl, Norfentanyl, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene and adulterants in human urine at the cutoff concentrations of:

| Drug (Identifier) | Cut-off level |
|-----------------------------|---------------|
| Amphetamine (AMP) | 500 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL |
| Methadone metabolite (EDDP) | 300 ng/mL |
| Fentanyl (FYL) | 1 ng/mL |
| Ecstasy (MDMA) | 500 ng/mL |
| Methamphetamine (MET) | 500 ng/mL |
| Morphine (MOR) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Norfentanyl (NFYL) | 5 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |

The single or multi-test panel can consist of up to seventeen (17) of the above listed analytes in any combination. It is for in vitro diagnostic use only.

The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The AssureTech Multi-drug Urine Test Cup are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Fentanyl, Norfentanyl, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene and adulterants in human urine at the cutoff concentrations of:

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| Drug (Identifier) | Cut-off level |
|-----------------------------|---------------|
| Amphetamine (AMP) | 500 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL |
| Methadone metabolite (EDDP) | 300 ng/mL |
| Fentanyl (FYL) | 1 ng/mL |
| Ecstasy (MDMA) | 500 ng/mL |
| Methamphetamine (MET) | 500 ng/mL |
| Morphine (MOR) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Norfentanyl (NFYL) | 5 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |

The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination. It is for in vitro diagnostic use only.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

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 K243996

Assure Tech. LLC.

- 1. Date: December 22, 2024
- 2. Submitter:
- 1521 Concord Pike, Suite 201 Wilmington, DE 19803
- 3. Contact person: Jenny Xia LSI International Inc. 504E Diamond Ave., Suite H Gaithersburg, MD 20877 Telephone: [phone] Email: [e-mail]
- 4. Device Name: AssureTech Panel Dip Tests AssureTech Multi-drug Urine Test Panel AssureTech Quick Cup Tests AssureTech Multi-drug Urine Test Cup

| Classification: | Class 2 | | |
|-------------------------------------------|----------------|-------------------------------------------------------------------|-----------------|
| Product Code | Classification | Regulation Section | Panel |
| NFT<br>Amphetamine | II | 21 CFR § 862.3100, Amphetamine<br>Test System | Toxicology (91) |
| NFW<br>Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids<br>Test System | Toxicology (91) |
| NFY<br>Cocaine | II | 21 CFR § 862.3250, Cocaine and<br>Cocaine Metabolites Test System | Toxicology (91) |
| NGG<br>Methamphetamine | II | 21 CFR § 862.3610,<br>Methamphetamine Test System | Toxicology (91) |
| NGL<br>Morphine | II | 21 CFR § 862.3650, Opiate Test<br>System | Toxicology (91) |
| NFV<br>Oxazepam | II | 21 CFR § 862.3170,<br>Benzodiazepine Test System | Toxicology (91) |
| NGL<br>Oxycodone | II | 21 CFR § 862.3650, Opiate Test<br>System | Toxicology (91) |
| PTH<br>Secobarbital | II | 21 CFR § 862.3150, Barbiturate<br>Test System | Toxicology (91) |
| NGL<br>Buprenorphine | II | 21 CFR § 862.3650,<br>Opiate Test System | Toxicology (91) |
| NGL<br>Fentanyl<br>Norfentanyl | II | 21 CFR § 862.3650,<br>Opiate Test System | Toxicology (91) |
| NGG<br>Methylenedioxy-<br>methamphetamine | II | 21 CFR § 862.3610,<br>Methamphetamine Test System | Toxicology (91) |
| NGM<br>Phencyclidine | unclassified | Enzyme Immunoassay<br>Phencyclidine | Toxicology (91) |
| PTG<br>Methadone | II | 21 CFR § 862.3620, Methadone<br>Test System | Toxicology (91) |

{7}------------------------------------------------

| PTG<br>2-ethylidene-1, 5-<br>dimethyl-3, 3-<br>diphenylpyrrolidine<br>(EDDP) | II | 21 CFR § 862.3620, Methadone<br>Test System | Toxicology (91) |
|------------------------------------------------------------------------------|----|----------------------------------------------------------------|-----------------|
| QAW<br>Nortriptyline | II | 21 CFR, 862.3910 Tricyclic<br>Antidepressant Drugs Test System | Toxicology (91) |
| QBF<br>Propoxyphene | II | 21 CFR, 862.3700 Propoxyphene<br>Test System | Toxicology (91) |

- 5. Predicate Devices: K181768
AssureTech Panel Dip Tests and AssureTech Quick Cup Tests

- 6. Indications for Use
The AssureTech Panel Dip Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Fentanyl, Norfentanyl, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

| Drug (Identifier) | Cut-off level |
|-----------------------------|---------------|
| Amphetamine (AMP) | 500 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL |
| Methadone metabolite (EDDP) | 300 ng/mL |
| Fentanyl (FYL) | 1 ng/mL |
| Ecstasy (MDMA) | 500 ng/mL |
| Methamphetamine (MET) | 500 ng/mL |
| Morphine (MOR) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Norfentanyl (NFYL) | 5 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |

The single or multi-test panels can consist of up to seventeen (17) of the above listed analytes in any combination.

Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

The AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Fentanyl, Norfentanyl, Morphine, Oxycodone, Secobarbital,

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| Drug (Identifier) | Cut-off level |
|-----------------------------|---------------|
| Amphetamine (AMP) | 500 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL |
| Methadone metabolite (EDDP) | 300 ng/mL |
| Fentanyl (FYL) | 1 ng/mL |
| Ecstasy (MDMA) | 500 ng/mL |
| Methamphetamine (MET) | 500 ng/mL |
| Morphine (MOR) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Norfentanyl (NFYL) | 5 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |

Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination.

Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

The AssureTech Multi-drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Fentanyl, Norfentanyl, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene and adulterants in human urine at the cutoff concentrations of:

| Drug (Identifier) | Cut-off level |
|-----------------------------|---------------|
| Amphetamine (AMP) | 500 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL |
| Methadone metabolite (EDDP) | 300 ng/mL |
| Fentanyl (FYL) | 1 ng/mL |
| Ecstasy (MDMA) | 500 ng/mL |
| Methamphetamine (MET) | 500 ng/mL |
| Morphine (MOR) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Norfentanyl (NFYL) | 5 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |

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

| Phencyclidine(PCP) | 25 ng/mL |
|---------------------|------------|
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana(THC) | 50 ng/mL |

The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination. It is for in vitro diagnostic use only.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The AssureTech Multi-drug Urine Test Cup are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Fentanyl, Norfentanyl, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene and adulterants in human urine at the cutoff concentrations of:

| Drug (Identifier) | Cut-off level |
|-----------------------------|---------------|
| Amphetamine (AMP) | 500 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL |
| Methadone metabolite (EDDP) | 300 ng/mL |
| Fentanyl (FYL) | 1 ng/mL |
| Ecstasy (MDMA) | 500 ng/mL |
| Methamphetamine (MET) | 500 ng/mL |
| Morphine (MOR) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Norfentanyl (NFYL) | 5 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |

The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination. It is for in vitro diagnostic use only.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result. particularly when the preliminary result is positive.

### 7. Device Description

The AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Fentanyl, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP. Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single

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

use in vitro diagnostic devices, which come in the formats of Panel Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

- 8. Substantial Equivalence Information
A summary comparison of features of the AssureTech Panel Dip Tests and AssureTech Quick Cup Tests and the predicate devices is provided in following tables.

| Item | Device | Predicate - K181768 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of drugs of<br>abuse in human urine. | Same (but the number of<br>drugs detected is different) |
| Calibrator and<br>Cut-Off Values | Amphetamine (AMP): 500 ng/ml<br>Oxazepam (BZO):300 ng/ml<br>Cocaine(COC): 150 ng/ml<br>Marijuana (THC):50 ng/ml<br>Methamphetamine (MET): 500 ng/ml<br>Morphine (MOR): 300ng/mL<br>Oxycodone(OXY) : 100 ng/ml<br>Secobarbital (BAR): 300 ng/ml<br>Buprenorphine (BUP): 10 ng/ml<br>Methylenedioxy-methamphetamine(MDMA):<br>500 ng/ml<br>Phencyclidine (PCP): 25 ng/ml<br>Methadone (MTD): 300 ng/ml<br>2-ethylidene-1, 5-dimethyl-3, 3-<br>diphenylpyrrolidine (EDDP): 300 ng/ml<br>Nortriptyline (TCA): 1000 ng/ml<br>Propoxyphene (PPX): 300 ng/ml<br>Fentanyl (FYL): 1ng/ml<br>Norfentanyl (NFYL): 5ng/ml | Same except<br>that no FYL<br>and NFYL |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on the<br>principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For over-the-counter | Same |
| Configurations | Dip Card and Cup | Same |

Table 1: Features Comparison of AssureTech Panel Dip Tests/AssureTech Quick Cup Tests and the Predicate Devices

9. Test Principle

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

The AssureTech Panel Dip Tests, and AssureTech Quick Cup Tests are rapid tests for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Fentanyl, Norfentanyl, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and Propoxyphene in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoffconcentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.

### 10. Performance Characteristics

- 1. Analytical Performance
- Precision a.

Precision studies were carried out for samples with concentrations of -100% cut off. -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables for Fentanyl and Norfentanyl. Data supporting precision for the remaining analytes was reported in K181768.

| Panel Dip | | | | | | | | | |
|------------|---------------|--------------|--------------|-------------|---------|--------------|--------------|--------------|---------------|
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 28+/22- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 29+/23- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28+/22- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

#### Fentanyl

Donal D

Quick Cup

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
|------------|---------------|--------------|--------------|-------------|--------------|--------------|--------------|---------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 29+/21- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27+/23- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 29+/21- | 50+/0- | 50+/0- | 50+/0- |

### Norfentanyl

Panel Dip

| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 27+/23- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 28+/22- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 28+/22- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Quick Cup

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

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
|------------|---------------|--------------|--------------|-------------|---------|--------------|--------------|--------------|---------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 29+/21- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 27+/23- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28+/22- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

### c. Stability

The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 °C and real time stability determination at both 4 °C and 30 °C.

#### d. Interference

Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 50% below and 50% above Cut-Off levels. These urine samples were tested using three lots of each device. Compounds that showed no interference at a concentration of 100ug/mL or specified concentrations are summarized in the following table. There were no differences observed for different devices.

| 11-nor-9 carboxy THC (except for<br>THC) | DL-Tyrosine | Nifedipine |
|------------------------------------------|-------------------------------|-----------------------------------|
| 3-Hydroxytyramine | Dopamine | Norethindrone |
| 4-Bromo-<br>2,5,Dimethoxyphenethylamine | Doxepin (except for TCA) | Norpropoxyphene (except for PPX) |
| 7-Aminoflunitrazepam | Ecgonine methyl ester | Norpseudoephedrine |
| 7-Aminonitrazepam | Ephedrine (except for MET) | Nortriptyline (except for TCA) |
| Acetaminophen | Erythromycin | Noscapine |
| Acetone (1000 mg/dL) | Estradiol | Octopamine |
| Acetophenetidin | Estrone | O-Hydroxyhippuric acid |
| Acetylsalicylic Acid (500 µg/mL) | Ethanol (1%) | Oxalic Acid (100mg/dL) |
| Albumin (100 mg/dL) | Fenfluramine (except for MET) | Oxazepam (except for BZO) |
| Albuterol | Fenofibrate | Oxolinic acid |
| Aminopyrine | Fenoprofen | Oxymetazoline |
| Amitriptyline (except for TCA) | Fluphenazine | Papaverine |
| Amlodipine besylate | Fotemustine | Penicillin-G |
| Amobarbital (except for BAR) | Furosemide | Pentazocine |
| Amoxicillin | Galactose | Perphenazine |
| Ampicillin | Gamma Globulin (500mg/dL) | Phencyclidine (except for PCP) |
| Apomorphine | Gemfibrozil | Phenelzine |
| Ascorbic Acid | Gentisic acid | Phenobarbital (except for BAR) |
| Aspartame | Glucose (3000 mg/dL) | Phentermine (except for AMP) |
| Aspirin | Guaiacolglyceryl ether | Phenylethylamine (except for MET) |
| Atropine | Hemoglobin | Prednisone |
| Baclofen | Hexobarbital | Promazine (except for TCA/EDDP) |
| Benzilic acid | Hydralazine | Promethazine |
| Benzocaine6 | Hydrochlorothiazide | Propoxyphene (except for PPX) |
| Benzoic Acid | Hydrocortisone | Propranolol |
| Benzoylecgonine (except for COC) | Hydroxytyramine | Pseudoephedrine |
| Benzylpiperiazine | Ibuprofen | Pyridoxine |
| Bilirubin | I-Cotinine | Pyrilamine |
| Boric Acid (1%) | I-Erythromycin | Pyrogallol |
| Bupropion | Imipramine (except for TCA) | Quinidine |
| Caffeine (500 µg/mL) | Isoproterenol | Quinine |
| Carbamazepine | Isoxsuprine | Quinolinic Acid |
| Carisoprodol | Ketamine | Ranitidine |
| Cetirizine | Ketoprofen | r-Globulin |
| Chloral hydrate | Labetalol | Riboflavin |
| Chloramphenicol | Lamotrigine | Salicylic Acid |
| Chlordiazepoxide (except for BZO) | Lidocaine | Secobarbital (except for BAR) |
| Chlorothiazide | Lisinopril | Serotonin(5-Hydroxytyramine) |
| Chlorpheniramine | Loperamide | Sodium Azide |
| Chlorpromazine | Loratidine | Sufentanil Citrate |
| Cholesterol | Lorazepam (except for BZO) | Sulfamethazine |

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

| Clofibrate | LSD | Sulindac | |
|----------------------------------|------------------------------------------|---------------------------------------|--|
| Clomipramine (except for TCA) | L-thyroxine | Tetracycline | |
| Clonidine | Maprotiline (except for TCA) | Tetrahydrocortisone 3-acetate | |
| Cortisone | Meperidine | Tetrahydrocortisone3-(B-Dglucuronide) | |
| Cotinine | Meprobamate | Tetrahydrozoline | |
| Creatine Hvdrate | Metformin | Thiamine | |
| Creatinine | Methapyrilene | Thioridazine | |
| Cyclobenzaprine (except for TCA) | Methaqualone | Triamterene | |
| Cyclodextrin-r | Methoxyphenamine (except for<br>AMP/MET) | Trifluoperazine | |
| Cyproheptadine | Methylphenidate | Trifluoromethylphenyl- piperazine | |
| d.l-Isoproterenol | Metoprolol | Trimethoprim | |
| Demoxepam | Metronidazole (300 ug/mL) | Tryptamine | |
| Deoxycorticosterone | N-Acetylprocainamide | Tyramine | |
| Desipramine (except for TCA) | NaCl (40000 ug/mL) | Urea (2000 mg/dL) | |
| Dextromethorphan | Nalidixic Acid | Uric Acid | |
| Diclofenac | Naloxone (except for OXY) | Valproic acid (250 ug/mL) | |
| Diflunisal | Naltrexone | Venlafaxine | |
| Digoxin | Naproxen | Verapamil | |
| Dimethyl-aminoantipyrine | N-desmethylapentadol | Zolpidem | |
| Diphenhydramine | Niacinamide | Zolpidem Tartrate | |
| Diphenylhydantoin | Nicotine | Zomepirac | |
| DL-Tryptophan | Nicotinic Acid | ß-Estradiol | |
| B-Hvdroxybutvric Acid | | | |

### e. Specificity

To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three lots of each device. The lowest concentration that caused a positive result for each compound are listed below for Fentanyl and Norfentanyl. Data supporting specificity for the remaining analytes was reported in K181768. There were no differences observed for different devices.

| Fentanyl (Cutoff=1ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-Reactivity |
|-----------------------------|--------------------------------------------------------------------------|--------------------|
| (±) β-hydroxythiofentanyl | 5 | 20 |
| (±)-3-cis-methyl fentanyl | 50 | 2 |
| 4-Fluoro-isobutyrylfentanyl | 50 | 2 |
| Acetyl fentanyl | 5 | 20 |
| Acryl fentanyl | 5 | 20 |
| Butyryl fentanyl | 25 | 4 |
| Fentanyl | 1 | 100 |
| Furanyl fentanyl | 10 | 10 |
| Isobutyryl fentanyl | 5 | 20 |
| Ocfentanil | 100 | 1 |
| Para-fluoro fentanyl | 25 | 4 |
| Para-fluorobutyryl fentanyl | 25 | 4 |
| Valeryl fentanyl | 50 | 2 |
| ω-1-Hydroxyfentanyl | 50000 | 0.002 |
| Acetyl norfentanyl | >100000 | <0.001 |
| Alfentanil | >100000 | <0.001 |
| Norcarfentanil | >10000 | <0.01 |
| Norfentanyl | >100000 | <0.001 |
| Remifentanil | >10000 | <0.01 |
| Sufentanil | >10000 | <0.01 |
| Carfentanil | >10000 | <0.01 |

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

| Despropionyl fentanyl (4-<br>ANPP) | >50000 | <0.002 |
|------------------------------------|--------------------------------------------------------------------------|--------------------|
| Norfentanyl<br>(Cutoff=5ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-Reactivity |
| (±)-β-Hydroxythiofentanyl | 80 | 6.25 |
| 4-Fluoro-isobutyryl<br>Fentanyl | 250 | 2 |
| 9-HydroxyRisperidone | 10000 | 0.05 |
| Acetyl Fentanyl | 500 | 1 |
| Acetyl Norfentanyl | 50 | 10 |
| Acryl Fentanyl | 100 | 5 |
| Alfentanil | 100000 | 0.005 |
| Butyryl Fentanyl | 500 | 1 |
| (±)-3-cis-methyl fentanyl | 200 | 2.5 |
| trans-d, 1-3-methylfentanyl | 200 | 2.5 |
| Fentanyl | 500 | 1 |
| Furanyl Fentanyl | 1000 | 0.5 |
| Isobutyryl Fentanyl | 75 | 6.67 |
| Labetalol Hydrochloride | 100000 | 0.005 |
| MT-45 | 8000 | 0.06 |
| Norfentanyl | 5 | 100 |
| Ocfentanil | 5000 | 0.1 |
| Para-fluorobutyryl fentanyl | 100 | 5 |
| Para-fluoro fentanyl | 100 | 5 |
| Risperidone | 800 | 0.63 |
| Thienyl Fentnayl | 100 | 5 |
| Valeryl Fentanyl | 500 | 1 |
| Carfentanil | >10000 | <0.05 |
| Despropionyl fentanyl (4-<br>ANPP) | >50000 | <0.01 |
| Norcarfentanil | >10000 | <0.05 |
| Remifentanil | >10000 | <0.05 |
| Sufentanil | >10000 | <0.05 |
| Trazodone | >10000 | <0.05 |
| U-47700 | >100000 | <0.005 |
| ω- 1-Hydroxyfentanyl | >50000 | <0.01 |

Negative results were obtained for all the following opioids compounds tested at 100 µg/mL. There is no cross-reactivity for these compounds.

| 6-Acetyl morphine | Hydromorphone | Oxycodone |
|--------------------------|------------------------|----------------------|
| Amphetamine | Levorphanol | Oxymorphone |
| Buprenorphine | Methadone | Pentazocine (Talwin) |
| Buprenorphineglucuronide | Morphine | Pipamperone |
| Codeine | Morphine-3-glucuronide | Tapentadol |
| Dihydrocodeine | Norbuprenorphine | Tilidine |
| EDDP | Norcodeine | Tramadol |
| EMDP | Norketamine | Tramadol-O-Desmethyl |

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

| Fluoxetine | Normeperidine | Tramadol-N-Desmethyl |
|-------------|---------------|----------------------|
| Heroin | Normorphine | |
| Hydrocodone | Noroxycodone | |

## f. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 50% below and 50% above Cut-Off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +50% Cut-Off and all negative for samples at and below -50% Cut-Off. There were no differences observed for different devices.

# 2. Comparison Studies

Method comparison studies for the AssureTech Panel Dip Tests and the AssureTech Quick Cup Tests were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below for Fentanyl and Norfentanyl. Data supporting method comparison for the remaining analytes was reported in K181768.

### FYL

| Panel<br>Dip | | Negative | Low Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|---------------|----------|----------|-------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------|
| Operator<br>1 | Positive | 0 | 0 | 2 | 19 | 20 |
| | Negative | 1 | 19 | 18 | 1 | 0 |
| Operator<br>2 | Positive | 0 | 0 | 2 | 19 | 20 |
| | Negative | 1 | 19 | 18 | 1 | 0 |
| Operator<br>3 | Positive | 0 | 0 | 2 | 19 | 20 |
| | Negative | 1 | 19 | 18 | 1 | 0 |

### Discordant Results

| Operator | Sample ID | LC/MS Result (ng/mL) | Rapid Test Result |
|------------------|-----------|----------------------|-------------------|
| Operator 1, 2, 3 | 1484 | 0.78 | + |
| Operator 1 | 9778 | 0.95 | + |
| Operator 2, 3 | 4576 | 0.97 | + |
| Operator 1 | 5419 | 1.05 | - |
| Operator 2, 3 | 9401 | 1.00 | - |

| Quick Cup | Negative | Low Negative by LC/MS<br>(less than -50%) | Near Cutoff Negative by LC/MS<br>(Between -50% and cutoff) | Near Cutoff Positive by LC/MS<br>(Between the cutoff and +50%) | High Positive by LC/MS<br>(greater than +50%) |
|-----------|----------|-------------------------------------------|------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------|
| | | | | | |

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

| Operator | | 0 | 0 | 3 | 19 | 20 |
|----------|----------|---|----|----|----|----|
| 1 | Positive | 0 | 0 | 3 | 19 | 20 |
| | Negative | 1 | 19 | 17 | 1 | 0 |
| 2 | Positive | 0 | 0 | 2 | 19 | 20 |
| | Negative | 1 | 19 | 18 | 1 | 0 |
| 3 | Positive | 0 | 0 | 2 | 18 | 20 |
| | Negative | 1 | 19 | 18 | 2 | 0 |

## Discordant Results

| Operator | Sample ID | LC/MS Result (ng/mL) | Rapid Test Result |
|------------------|-----------|----------------------|-------------------|
| Operator 1, 2, 3 | 1484 | 0.78 | + |
| Operator 1, 3 | 9778 | 0.95 | + |
| Operator 1, 2 | 4576 | 0.97 | + |
| Operator 1, 3 | 5419 | 1.05 | - |
| Operator 2, 3 | 9401 | 1.00 | - |

# NFYL

| Panel<br>Dip | | Negative | Low<br>Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|---------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator<br>1 | Positive | 0 | 0 | 3 | 19 | 20 |
| | Negative | 2 | 18 | 18 | 1 | 0 |
| Operator<br>2 | Positive | 0 | 0 | 2 | 19 | 20 |
| | Negative | 2 | 18 | 19 | 1 | 0 |
| Operator<br>3 | Positive | 0 | 0 | 2 | 18 | 20 |
| | Negative | 2 | 18 | 19 | 2 | 0 |

### Discordant Results

| Operator | Sample ID | LC/MS Result (ng/mL) | Rapid Test Result |
|---------------|-----------|----------------------|-------------------|
| Operator 1 | 4074 | 4.39 | + |
| Operator 1 | 1311 | 4.10 | + |
| Operator 1, 2 | 0242 | 4.82 | + |
| Operator 2, 3 | 5906 | 4.68 | + |
| Operator 3 | 2066 | 4.24 | + |
| Operator 1, 3 | 0687 | 5.05 | - |
| Operator 2, 3 | 8069 | 5.15 | - |

| Quick<br>Cup | | Negative | Low<br>Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|---------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator<br>1 | Positive | 0 | 0 | 2 | 18 | 20 |
| | Negative | 2 | 18 | 18 | 2 | 0 |
| Operator<br>2 | Positive | 0 | 0 | 3 | 19 | 20 |
| | Negative | 2 | 18 | 17 | 1 | 0 |

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

| Operator | | 0 | 0 | 2 | 19 | 20 |
|----------|----------|---|----|----|----|----|
| 3 | Positive | 0 | 0 | 2 | 19 | 20 |
| 3 | Negative | 2 | 18 | 18 | 1 | 0 |

| Discordant Results | | | |
|--------------------|-----------|----------------------|-------------------|
| Operator | Sample ID | LC/MS Result (ng/mL) | Rapid Test Result |
| Operator 1, 2 | 4074 | 4.39 | + |
| Operator 1, 3 | 0242 | 4.82 | + |
| Operator 2, 3 | 2066 | 4.24 | + |
| Operator 2 | 5906 | 4.68 | + |
| Operator 1, 2, 3 | 0687 | 5.05 | - |
| Operator 1 | 8069 | 5.15 | - |

Lay-user study

A lay user study was performed at three intended user sites with 280 lay persons for each device format. The lay users had diverse educational and professional backgrounds and ranged in age from 20 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device was tested. Typical results are shown below.

The results summary for AMP:

| % of Cutoff | Number of<br>samples | Drug<br>Concentration by<br>LC/MS(ng/mL) | Lay person Results | | The percentage<br>of correct<br>results (%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of<br>Positive | No. of<br>Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 124.4 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 246.6 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 377.7 | 0 | 20 | 100 |
| +25% Cutoff | 20 | 621.2 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 756.6 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 870.5 | 20 | 0 | 100 |

The results summary for FYL:

| % of Cutoff | Number of<br>samples | Drug<br>Concentration by<br>LC/MS(ng/mL) | Lay person Results | | The percentage<br>of correct<br>results (%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of<br>Positive | No. of<br>Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 0.24 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 0.51 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 0.77 | 0 | 19 | 95 |
| +25% Cutoff | 20 | 1.26 | 20 | 0 | 100 |
| +50% Cutoff | 20 | 1.47 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1.76 | 20 | 0 | 100 |

The results summary for NFYL:

| % of Cutoff | Number of | Drug | Lay person Results | The percentage |
|-------------|-----------|------|--------------------|----------------|
|-------------|-----------|------|--------------------|----------------|

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

| | samples | Concentration by<br>LC/MS(ng/mL) | No. of<br>Positive | No. of<br>Negative | of correct<br>results (%) |
|--------------|---------|----------------------------------|--------------------|--------------------|---------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 1.25 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 2.65 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 3.73 | 0 | 19 | 95 |
| +25% Cutoff | 20 | 6.09 | 20 | 0 | 100 |
| +50% Cutoff | 20 | 7.14 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 8.77 | 20 | 0 | 100 |

The results summary for BAR:

| % of Cutoff | Number of<br>samples | Drug<br>Concentration by<br>LC/MS(ng/mL) | Lay person Results | | The percentage<br>of correct<br>results (%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of<br>Positive | No. of<br>Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 76.4 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 158.2 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 224.2 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 372.5 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 440.2 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 537.9 | 20 | 0 | 100 |

The results summary for BUP:

| % of Cutoff | Number of<br>samples | Drug<br>Concentration by<br>LC/MS(ng/mL) | Lay person Results | | The percentage<br>of correct results<br>(%) |
|-------------|----------------------|------------------------------------------|--------------------|----|---------------------------------------------|
| | | -100% Cutoff | 20 | 0 | 0 |
| -75% Cutoff | 20 | 2.46 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 4.99 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 7.49 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 12.51 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 14.88 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 17.53 | 20 | 0 | 100 |

The results summary for BZO:

| % of Cutoff | Number of samples | Drug Concentration by LC/MS(ng/mL) | Lay person Results | | The percentage of correct results (%) |
|--------------|-------------------|------------------------------------|--------------------|-----------------|---------------------------------------|
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 71.6 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 146.1 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 224.1 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 373.8 | 20 | 0 | 100 |
| +50% Cutoff | 20 | 459.7 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 514.0 | 20 | 0 | 100 |

The results summary for COC:

| % of Cutoff | Number of | Drug | Lay person Results | The percentage |
|-------------|-----------|------|--------------------|----------------|
|-------------|-----------|------|--------------------|----------------|

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

| | samples | Concentration by<br>LC/MS(ng/mL) | No. of<br>Positive | No. of<br>Negative | of correct results<br>(%) |
|--------------|---------|----------------------------------|--------------------|--------------------|---------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 39.1 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 75.6 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 113.0 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 188.6…