Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on immunochromatographic assays and does not mention any computational analysis, image processing, or algorithms that would suggest the use of AI/ML.

Therapeutic

No
The device is described as an "in vitro diagnostic device" designed for the qualitative detection of various substances in human urine. It is used for preliminary screening of drugs of abuse and does not provide any therapeutic benefit or treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" multiple times for all listed products. Additionally, the "Device Description" section identifies the products as "single use in vitro diagnostic devices."

SaMD (Software as a Medical Device)

No

The device is described as immunochromatographic assays using a lateral flow system, which are physical test strips or cups that detect substances in urine. This involves hardware components and chemical reactions, not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The intended use and device description sections repeatedly state "For in vitro diagnostic use only."
Intended Use: The device is intended for the qualitative and simultaneous detection of various substances (drugs of abuse) in human urine. This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to provide information about a person's health status or exposure to substances.
Device Description: The description details the mechanism of action (immunochromatographic assays, lateral flow system) and the sample type (human urine), which are characteristic of IVD devices.
Performance Studies: The submission includes details about analytical performance studies (precision, stability, interference, specificity, effect of urine specific gravity and pH) and comparison studies (method comparison with LC/MS, lay user study). These types of studies are required for the regulatory approval of IVD devices to demonstrate their performance characteristics.
Predicate Device: The submission lists a predicate device with a K number (K181768), which is a regulatory identifier for medical devices, including IVDs. This indicates that the device is being compared to a previously cleared device of the same type.

Based on these points, the AssureTech Panel Dip Tests, AssureTech Quick Cup Tests, AssureTech Multi-drug Urine Test Panel, and AssureTech Multi-drug Urine Test Cup are all clearly intended and described as In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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:

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, 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 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:

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.

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

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

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-The-Counter Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

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

Analytical Performance - Precision:

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.
Samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by LC/MS.
All sample aliquots were blindly labeled.
For each concentration, tests were performed two runs per day for 25 days per device in a randomized order.
Results provided for Fentanyl and Norfentanyl, with data for remaining analytes reported in K181768.

Analytical Performance - Stability:

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

Analytical Performance - 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 were summarized.
No differences observed for different devices.

Analytical Performance - Specificity:

Drug metabolites and other components likely to interfere in urine samples were tested using three lots of each device.
Lowest concentration that caused a positive result for each compound listed for Fentanyl and Norfentanyl.
Data supporting specificity for remaining analytes reported in K181768.
No differences observed for different devices.
Negative results obtained for various opioid compounds tested at 100 µg/mL, indicating no cross-reactivity.

Analytical Performance - Effect of Urine Specific Gravity and Urine pH:

Urine samples with 1.000 to 1.035 specific gravity or 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.
No differences observed for different devices.

Comparison Studies - Method Comparison:

Performed in-house with three laboratory assistants for each device.
Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug.
Samples were blind labeled and compared to LC/MS results.
Results presented for Fentanyl and Norfentanyl, with data for remaining analytes reported in K181768.

Lay-user study:

Performed at three intended user sites with 280 lay persons for each device format.
Lay users had diverse educational and professional backgrounds and ranged in age from 20 to > 50 years.
Urine samples prepared at negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug-free pooled urine specimens.
Concentrations confirmed by LC/MS. Each sample aliquoted into individual containers and blind-labeled.
Each participant provided with package insert, 1 blind labeled sample, and a device. Each device was tested.
Results summarized for AMP, FYL, NFYL, BAR, BUP, BZO, COC, EDDP, MDMA, MET, MOR, MTD, OXY, PCP, PPX, TCA, THC.
All lay users indicated that the device instructions can be easily followed.
Flesch-Kincaid reading analysis on package insert revealed a reading Grade Level of 7.

Clinical Studies:

Not applicable.

Conclusion:

Based on test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison, and lay-user studies, the devices are substantially equivalent to the predicate.

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

Lay user study results for percent correct results:

AMP:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 100%
- +25% Cutoff: 95%
- +50% Cutoff: 100%
- +75% Cutoff: 100%
FYL:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 95%
- +25% Cutoff: 100%
- +50% Cutoff: 100%
- +75% Cutoff: 100%
NFYL:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 95%
- +25% Cutoff: 100%
- +50% Cutoff: 100%
- +75% Cutoff: 100%
BAR:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 90%
- +25% Cutoff: 95%
- +50% Cutoff: 100%
- +75% Cutoff: 100%
BUP:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 95%
- +25% Cutoff: 95%
- +50% Cutoff: 100%
- +75% Cutoff: 100%
BZO:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 90%
- +25% Cutoff: 100%
- +50% Cutoff: 100%
- +75% Cutoff: 100%
COC:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 95%
- +25% Cutoff: 95%
- +50% Cutoff: 100%
- +75% Cutoff: 100%
EDDP:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 95%
- +25% Cutoff: 95%
- +50% Cutoff: 100%
- +75% Cutoff: 100%
MDMA:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 95%
- +25% Cutoff: 100%
- +50% Cutoff: 100%
- +75% Cutoff: 100%
MET:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 100%
- +25% Cutoff: 95%
- +50% Cutoff: 100%
- +75% Cutoff: 100%
MOR:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 95%
- +25% Cutoff: 95%
- +50% Cutoff: 100%
- +75% Cutoff: 100%
MTD:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 95%
- +25% Cutoff: 95%
- +50% Cutoff: 100%
- +75% Cutoff: 100%
OXY:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 95%
- +25% Cutoff: 95%
- +50% Cutoff: 100%
- +75% Cutoff: 100%
PCP:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 90%
- +25% Cutoff: 95%
- +50% Cutoff: 100%
- +75% Cutoff: 100%
PPX:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 95%
- +25% Cutoff: 95%
- +50% Cutoff: 100%
- +75% Cutoff: 100%
TCA:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 95%
- +25% Cutoff: 100%
- +50% Cutoff: 100%
- +75% Cutoff: 100%
THC:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 95%
- +25% Cutoff: 95%
- +50% Cutoff: 100%
- +75% Cutoff: 100%

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K181768

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

3

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

4

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:

5

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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6

510(k) SUMMARY K243996

Assure Tech. LLC.

1. Date: December 22, 2024
1. Submitter:
1521 Concord Pike, Suite 201 Wilmington, DE 19803
1. Contact person: Jenny Xia LSI International Inc. 504E Diamond Ave., Suite H Gaithersburg, MD 20877 Telephone: 301-525-6856 Email: jxia@lsi-consulting.org
1. 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
Amphetamine	II	21 CFR § 862.3100, Amphetamine
Test System	Toxicology (91)
NFW
Cannabinoids	II	21 CFR § 862.3870, Cannabinoids
Test System	Toxicology (91)
NFY
Cocaine	II	21 CFR § 862.3250, Cocaine and
Cocaine Metabolites Test System	Toxicology (91)
NGG
Methamphetamine	II	21 CFR § 862.3610,
Methamphetamine Test System	Toxicology (91)
NGL
Morphine	II	21 CFR § 862.3650, Opiate Test
System	Toxicology (91)
NFV
Oxazepam	II	21 CFR § 862.3170,
Benzodiazepine Test System	Toxicology (91)
NGL
Oxycodone	II	21 CFR § 862.3650, Opiate Test
System	Toxicology (91)
PTH
Secobarbital	II	21 CFR § 862.3150, Barbiturate
Test System	Toxicology (91)
NGL
Buprenorphine	II	21 CFR § 862.3650,
Opiate Test System	Toxicology (91)
NGL
Fentanyl
Norfentanyl	II	21 CFR § 862.3650,
Opiate Test System	Toxicology (91)
NGG
Methylenedioxy-
methamphetamine	II	21 CFR § 862.3610,
Methamphetamine Test System	Toxicology (91)
NGM
Phencyclidine	unclassified	Enzyme Immunoassay
Phencyclidine	Toxicology (91)
PTG
Methadone	II	21 CFR § 862.3620, Methadone
Test System	Toxicology (91)

7

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

1. Predicate Devices: K181768
  AssureTech Panel Dip Tests and AssureTech Quick Cup Tests
1. 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,

8

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.

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

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
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+ | 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

THC)	DL-Tyrosine	Nifedipine
3-Hydroxytyramine	Dopamine	Norethindrone
4-Bromo-
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
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
required to obtain a
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 | 100000 | 10000 | 100000 | 10000 | 10000 | 10000 | 50000 | 10000 | 50000 | 10000 | 10000 | 10000 | 10000 | 100000 | 50000 | 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
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 | 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
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 | 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
LC/MS(ng/mL) | No. of
Positive | No. of
Negative | of correct
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
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 | 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
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|-------------|----------------------|------------------------------------------|--------------------|----|---------------------------------------------|
| | | -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
LC/MS(ng/mL) | No. of
Positive | No. of
Negative | of correct results
(%) |
|--------------|---------|----------------------------------|--------------------|--------------------|---------------------------|
| -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 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 223.3 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 262.1 | 20 | 0 | 100 |

The results summary for EDDP:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|----------------------|------------------------------------------|--------------------|----|---------------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 75.8 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 150.7 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 225.7 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 375.7 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 450.3 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 525.5 | 20 | 0 | 100 |

The results summary for MDMA:

| % 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 | 126.1 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 250.6 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 361.4 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 632.2 | 20 | 0 | 100 |
| +50% Cutoff | 20 | 748.0 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 869.1 | 20 | 0 | 100 |

The results summary for MET:

| % 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 | 122.6 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 248.9 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 376.2 | 0 | 20 | 100 |
| +25% Cutoff | 20 | 628.4 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 753.3 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 871.7 | 20 | 0 | 100 |

The results summary for MOR:

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

20

| | samples | Concentration by
LC/MS(ng/mL) | No. of
Positive | No. of
Negative | of correct results
(%) |
|--------------|---------|----------------------------------|--------------------|--------------------|---------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 76.8 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 150.1 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 225.8 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 376.5 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 449.1 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 526.3 | 20 | 0 | 100 |

The results summary for MTD:

| % 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 | 75.4 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 157.6 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 225.6 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 374.5 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 451.6 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 524.2 | 20 | 0 | 100 |

The results summary for OXY:

| % of Cutoff | Number of samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results
No. of
Positive | Lay person Results
No. of
Negative | The percentage
of correct results
(%) |
|--------------|-------------------|------------------------------------------|------------------------------------------|------------------------------------------|---------------------------------------------|
| -100% Cutoff | 20 | 0 | 20 | 0 | 100 |
| -75% Cutoff | 20 | 26.2 | 20 | 0 | 100 |
| -50% Cutoff | 20 | 50.7 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 75.9 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 125.8 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 146.7 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 173.7 | 20 | 0 | 100 |

The results summary for PCP:

| % of Cutoff | Number of samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|-------------------|------------------------------------------|------------------------|------------------------|---------------------------------------------|
| -100% Cutoff | 20 | 0 | No. of
Positive: 0 | No. of
Negative: 20 | 100 |
| -75% Cutoff | 20 | 6.42 | No. of
Positive: 0 | No. of
Negative: 20 | 100 |
| -50% Cutoff | 20 | 12.47 | No. of
Positive: 0 | No. of
Negative: 20 | 100 |
| -25% Cutoff | 20 | 19.18 | No. of
Positive: 2 | No. of
Negative: 18 | 90 |
| +25% Cutoff | 20 | 31.63 | No. of
Positive: 19 | No. of
Negative: 1 | 95 |
| +50% Cutoff | 20 | 37.73 | No. of
Positive: 20 | No. of
Negative: 0 | 100 |
| +75% Cutoff | 20 | 43.60 | No. of
Positive: 20 | No. of
Negative: 0 | 100 |

The results summary for PPX:

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

21

| | samples | Concentration by
LC/MS(ng/mL) | No. of
Positive | No. of
Negative | of correct results
(%) |
|--------------|---------|----------------------------------|--------------------|--------------------|---------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 75.0 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 143.7 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 220.6 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 375.2 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 452.5 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 525.3 | 20 | 0 | 100 |

The results summary for TCA:

| % 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 | 236.9 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 491.6 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 751.3 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 1254.2 | 20 | 0 | 100 |
| +50% Cutoff | 20 | 1493.4 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1750.5 | 20 | 0 | 100 |

The results summary for THC:

| % 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 | 12.3 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 24.1 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 38.3 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 63.3 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 76.1 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 87.4 | 20 | 0 | 100 |

Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

Clinical Studies

Not applicable.

11. Conclusion

Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison, and lay-user studies of the devices, it's concluded that the AssureTech Panel Dip Tests, AssureTech Quick Cup Tests, AssureTech Multi-drug Urine Test Panel and AssureTech Multi-drug Urine Test Cup are substantially equivalent to the predicate.