AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup
Device Facts
| Record ID | K252259 |
|---|---|
| Device Name | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup |
| Applicant | Assure Tech., LLC |
| Product Code | NFT · Clinical Toxicology |
| Decision Date | Aug 15, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Intended Use
The AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana in human urine at the cutoff concentrations of: [Table of cut-offs]. Configuration of the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs above when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be 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 Cup are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana in human urine at the cutoff concentrations of: [Table of cut-offs]. Configuration of the AssureTech Multi-drug Urine Test Cup can consist of any combination of the above listed drug analytes. 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.
Device Story
Single-use lateral flow immunochromatographic urine test cups; detect drugs of abuse via competitive binding. Urine sample migrates via capillary action; target drugs below cut-off allow antibody-coated particles to bind to immobilized drug-conjugate, forming a visible test line. If drug concentration exceeds cut-off, binding sites are saturated, preventing test line formation. Control line confirms proper flow. Used in OTC settings by lay users. Results are preliminary; positive results require confirmation via GC/MS or LC/MS. Provides rapid, qualitative screening to assist in clinical decision-making regarding potential drug presence.
Clinical Evidence
Bench testing only. Precision studies (25 days, 2 runs/day), interference testing, specificity/cross-reactivity, and method comparison against LC/MS. Lay-user study (n=280) conducted at three sites confirmed ease of use and performance across various drug concentrations. No clinical trials performed.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle using monoclonal mouse antibodies. Single-use cup format. Storage: 2-30°C. No electronic components or software algorithms.
Indications for Use
Indicated for qualitative, simultaneous detection of drugs of abuse (Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol, Marijuana) in human urine. Intended for OTC use. Not for distinguishing between prescription use and abuse.
Regulatory Classification
Identification
An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Related Devices
- K182530 — BIOEASY Multi-Drug Test Cup · Shenzhen Bioeasy Biotechnology Co., Ltd. · Nov 9, 2018
- K181790 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup · Hangzhou Clongene Biotech Co., Ltd. · Jul 26, 2018
- K230238 — BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx · Shenzhen Bioeasy Biotechnology Co., Ltd. · Mar 31, 2023
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
August 15, 2025
Assure Tech LLC
% Jenny Xia
Director
LSI International Inc
504E Diamond Ave., Suite H
Gaithersburg, Maryland 20877
Re: K252259
Trade/Device Name: AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup
Regulation Number: 21 CFR 862.3100
Regulation Name: Amphetamine test system
Regulatory Class: Class II
Product Code: NFT, NFW, NGL, NFY, NFV, PTH, NGG, NGM, PTG, QAW, QBF
Dated: July 18, 2025
Received: July 21, 2025
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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K252259 - Jenny Xia
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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 (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-safety-reporting-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K252259 - Jenny Xia
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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 - S
Digitally signed by JOSEPH A. KOTAREK - S
Date: 2025.08.15 08:03:32
-04'00"
Joseph Kotarek
Branch Chief for Toxicology
Division of Chemistry and
Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K252259
Device Name
Assure Tech Quick Cup Tests;
Assure Tech Multi-drug Urine Test Cup
Indications for Use (Describe)
The AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
| --- | --- |
| Amphetamine (AMP) | 500 ng/mL or 300 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL |
| EDDP | 300ng/ml |
| Fentanyl (FYL) | 1 ng/mL |
| Ecstasy (MDMA) | 500 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Morphine (MOR) | 2000 ng/mL or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Norfentanyl (NFYL) | 5 ng/mL |
| Methamphetamine (MET) | 500 ng/mL or 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| 6-Monoacetylmorphine (6-MAM) | 10 ng/mL |
| Tramadol (TML) | 100 ng/mL |
| Marijuana (THC) | 50 ng/mL or 20 ng/mL |
Configuration of the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs above when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be 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 Cup are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana in human urine at the cutoff concentrations of:
| Drug (Identifier) | Calibrator | Cut-off level |
| --- | --- | --- |
| Amphetamine (AMP) | d-Amphetamine | 500 ng/mL or 300 ng/mL |
| Secobarbital (BAR) | Secobarbital | 300 ng/mL |
| Buprenorphine (BUP) | BUP-3-D-Glucuronide | 10 ng/mL |
FORM FDA 3881 (8/23)
Page 1 of 2
PSC Publishing Services (301) 443-6740
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Oxazepam (BZO) Oxazepam 300 ng/mL
Cocaine (COC) Benzoylecgonine 150 ng/mL
EDDP 2-Ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/ml
Fentanyl (FYL) Fentanyl 1 ng/mL
Ecstasy (MDMA) 3,4-Methylenedioxy-MET 500 ng/mL
Propoxyphene (PPX) D-Propoxyphene 300 ng/mL
Morphine (MOR) Morphine 2000 ng/mL or 300 ng/mL
Methadone (MTD) Methadone 300 ng/mL
Phencyclidine (PCP) Phencyclidine 25 ng/mL
Oxycodone (OXY) Oxycodone 100 ng/mL
Norfentanyl (NFYL) Norfentanyl 5 ng/mL
Methamphetamine (MET) Methamphetamine 500 ng/mL or 300 ng/mL
Nortriptyline (TCA) Nortriptyline 1000 ng/mL
6-Monoacetylmorphine (6-MAM) 6-Monoacetylmorphine 10 ng/mL
Tramadol (TML) Cis-Tramadol 100 ng/mL
Marijuana (THC) 11-nor-9-THC-9-COOH 50 ng/mL or 20 ng/mL
Configuration of the AssureTech Multi-drug Urine Test Cup can consist of any combination of the above listed drug analytes. 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.
Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (8/23)
Page 2 of 2
PSC Publishing Services (301) 443-6740
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510(k) SUMMARY K252259
1. Date: August 6, 2025
2. Submitter: Assure Tech. LLC.
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: 301-525-6856
Email: jxia@lsi-consulting.org
4. Device Name: 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) |
| NFV Oxazepam | II | 21 CFR § 862.3170, Benzodiazepine Test System | Toxicology (91) |
| PTH Secobarbital | II | 21 CFR § 862.3150, Barbiturate Test System | Toxicology (91) |
| NGL 6-Monoacetylmorphine Buprenorphine Fentanyl Morphine Norfentanyl Oxycodone Tramadol | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) |
| NGG Methamphetamine Methylenedioxy-methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91) |
| NGM Phencyclidine | unclassified | Enzyme Immunoassay Phencyclidine | Toxicology (91) |
| PTG 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) Methadone | II | 21 CFR § 862.3620, Methadone Test System | Toxicology (91) |
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| 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) |
5. Predicate Devices: K243996
AssureTech Panel Dip Tests and AssureTech Quick Cup Tests
6. Indications for Use
The AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
| --- | --- |
| Amphetamine(AMP) | 500 ng/mL or 300 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Buprenorphine(BUP) | 10 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine(COC) | 150 ng/mL |
| EDDP | 300 ng/mL |
| Fentanyl (FYL) | 1 ng/mL |
| Ecstasy (MDMA) | 500 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Morphine (MOR) | 2000 ng/mL or 300 ng/mL |
| Methadone(MTD) | 300 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Norfentanyl (NFYL) | 5 ng/mL |
| Methamphetamine(MET) | 500 ng/mL or 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| 6-Monoacetylmorphine (6-MAM) | 10 ng/mL |
| Tramadol (TML) | 100 ng/mL |
| Marijuana (THC) | 50 ng/mL or 20 ng/mL |
Configuration of the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs above when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be 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
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analytical result. GC/MS or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only.
The AssureTech Multi-drug Urine Test Cup are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana in human urine at the cutoff concentrations of:
| Drug (Identifier) | Calibrator | Cut-off level |
| --- | --- | --- |
| Amphetamine(AMP) | d-Amphetamine | 500 ng/mL or 300 ng/mL |
| Secobarbital (BAR) | Secobarbital | 300 ng/mL |
| Buprenorphine(BUP) | BUP-3-D-Glucuronide | 10 ng/mL |
| Oxazepam (BZO) | Oxazepam | 300 ng/mL |
| Cocaine(COC) | Benzoylecgonine | 150 ng/mL |
| EDDP | 2-Ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 ng/mL |
| Fentanyl (FYL) | Fentanyl | 1 ng/mL |
| Ecstasy (MDMA) | 3,4-Methylenedioxy-MET | 500 ng/mL |
| Propoxyphene (PPX) | D-Propoxyphene | 300 ng/mL |
| Morphine (MOR) | Morphine | 2000 ng/mL or 300 ng/mL |
| Methadone(MTD) | Methadone | 300 ng/mL |
| Phencyclidine (PCP) | Phencyclidine | 25 ng/mL |
| Oxycodone (OXY) | Oxycodone | 100 ng/mL |
| Norfentanyl (NFYL) | Norfentanyl | 5 ng/mL |
| Methamphetamine(MET) | Methamphetamine | 500 ng/mL or 300 ng/mL |
| Nortriptyline (TCA) | Nortriptyline | 1000 ng/mL |
| 6-Monoacetylmorphine (6-MAM) | 6-Monoacetylmorphine | 10 ng/mL |
| Tramadol (TML) | Cis-Tramadol | 100 ng/mL |
| Marijuana (THC) | 11-nor-Δ⁹-THC-9-COOH | 50 ng/mL or 20 ng/mL |
Configuration of the AssureTech Multi-drug Urine Test Cup can consist of any combination of the above listed drug analytes. 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 Quick Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device and a package insert. Each test device is sealed with
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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.
Table 1: Features Comparison of AssureTech Quick Cup Tests and the Predicate Devices
| Item | Device | Predicate - K243996 |
| --- | --- | --- |
| 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 or 300 ng/mlOxazepam (BZO):300 ng/mlCocaine (COC): 150 ng/mlMarijuana (THC):50 ng/ml or 20 ng/mlMethamphetamine (MET): 500 ng/ml or 300 ng/mlMorphine (MOR): 2000 ng/ml or 300ng/mL Oxycodone (OXY): 100 ng/mlSecobarbital (BAR): 300 ng/mlBuprenorphine (BUP): 10 ng/mlMethylenedioxy-methamphetamine (MDMA): 500 ng/mlPhencyclidine (PCP): 25 ng/mlMethadone (MTD): 300 ng/ml2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP): 300 ng/mlNortriptyline (TCA): 1000 ng/mlPropoxyphene (PPX): 300 ng/mlFentanyl (FYL): 1ng/mlNorfentanyl (NFYL): 5ng/ml6-Monoacetylmorphine (6-MAM): 10 ng/mlTramadol (TML): 100 ng/ml | Same except that no 6-MAM and TML; No AMP 300, MET300, THC 20 and MOR2000 |
| 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 | Cup | Dip Card and Cup |
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9. Test Principle
The AssureTech Quick Cup Tests are rapid tests for the qualitative detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana 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 cutoff-concentration 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
a. 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. 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 only for Amphetamine (AMP300), Methamphetamine (MET300) and Tramadol (TML100).
Data for Fentanyl (FYL) and Norfentanyl (NFYL) was reported in K243996. Data for 6-Monoacetylmorphine (6-MAM) and Marijuana (THC20) was reported in K201630. Data for Amphetamine (AMP500), Cocaine (COC150), and Methamphetamine (MET500) was reported in K181768. Data for 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP300), Propoxyphene (PPX300), and Nortriptyline (TCA1000) was reported in K180349. Data for Oxazepam (BZO300), Methylenedioxymethamphetamine (MDMA500), and Morphine (MOR300) was reported in K170049. Data for Phencyclidine (PCP25) and Marijuana (THC50) was reported in K161044. Data for Morphine (MOR2000) was reported in K153465. Data for Buprenorphine (BUP10) and Methadone (MTD300) was reported in K152025. Data for Secobarbital (BAR300) and Oxycodone (OXY100) was reported in K151211.
AMP300
| 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+ | 50-/0+ | 30+/20- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 32+/18- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 34+/16- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
MET300
| 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+ | 50-/0+ | 35+/15- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 33+/17- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
{10}
9
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 36+/14- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
TML100
| 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+ | 50-/0+ | 36+/14- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 34+/16- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 32+/18- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
b. Stability
The devices are stable at 2-30 °C for 36 months based on the accelerated stability study at 55 °C.
c. 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 100μg/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) | Diphenylhydantoin | Norpropoxyphene (except for PPX) |
| --- | --- | --- |
| 3-Hydroxytyramine | Disopyramide (except for EDDP) | Norpeidoephedrine |
| 4-Bromo-2,5,Dimethoxyphenethylamine | DL-Tryptophan | Nortriptyline (except for TCA) |
| 7-Aminoclonazepam | DL-Tyrosine | Noscapine |
| 7-Aminoflunitrazepam | Dopamine | O-Hydroxyhippuric acid |
| 7-Aminonitrazepam | Doxepin (except for TCA) | Octopamine |
| Acetaminophen | Doxylamine (except for MTD) | Olanzapine |
| Acetone (1000 mg/dL) | Duloxetine | Omeprazole |
| Acetophenetidin | Ecgonine methyl ester | Oxalic Acid (100mg/dL) |
| Acetylsalicylic Acid (500 μg/mL) | Ephedrine (except for MET) | Oxaluic acid |
| Acyclovir | Erythromycin | Oxazepam (except for BZO) |
| Albumin(100 mg/dL) | Esomeprazole Magnesium | Oxolinic acid |
| Albuterol | Estradiol | Oxymetazoline |
| Alpha Methadol (except for MTD) | Estrone | Paliperidone |
| Aminophylline | Ethanol (1%) | Papaverine |
| Aminopyrine | Fenfluramine (except for MET) | Penicillin-G |
| Amitriptyline (except for TCA) | Fenofibrate | PenicillinV Potassium |
| Amlodipine besylate | Fenoprofen | Pentazocine |
| Amobarbital (except for BAR) | Fluoxetine Hydrochloride | Perphenazine |
| Amoxicillin | Fluphenazine | Phencyclidine (except for PCP/TML) |
| Ampicillin | Fotemustine | Phenelzine |
| Apomorphine | Furosemide | Phenobarbital (except for BAR) |
| Aripiprazole | Gabapentin | Phentermine (except for AMP) |
| Ascorbic Acid | Galactose | Phenylethylamine (except for MET) |
| Aspartame | Gamma Globulin (500mg/dL) | Phenylpropanolamine |
| Aspirin | Gatifloxacin | Prednisone |
| Atomoxetine | Gemfibrozil | Pregablin |
| Atorvastatin Calcium | Gentisic acid | Procaine |
| Atropine | Glucose (3000 mg/dL) | Promazine (except for TCA/EDDP) |
| Azithromycin | Guaiacolglyceryl ether | Promethazine (except for BZO/EDDP/TCA) |
| Baclofen | Hemoglobin | Propoxyphene (except for PPX) |
| Benzilic acid | Hexobarbital | Propranolol |
| Benzocaine | Hydralazine | Pseudoephedrine |
| Benzoic Acid | Hydrochlorothiazide | Pyridoxine |
| Benzoylecgonine (except for COC) | Hydrocortisone | Pyrilamine |
| Benzphetamine | Hydroxytyramine | Pyrogallol |
| Benzylpiperazine | I-Cotinine | Quetiapine |
| Bilirubin | I-Erythromycin | Quinidine |
| Boric Acid (1%) | Ibuprofen | Quinine |
| Bupropion | Imipramine (except for TCA) | Quinolinic Acid |
| Caffeine (500 μg/mL) | Isoproterenol | r-Globulin |
{11}
| Cannabidiol | Isoxsuprine | Ranitidine |
| --- | --- | --- |
| Captopril | Ketamine | Riboflavin |
| Carbamazepine | Ketoprofen | Rifampicin |
| Carfentanil (except for FYL/NFYL) | L-Epinephrine | Salicylic Acid |
| Carisoprodol | L-phenylephrine | Secobarbital (except for BAR) |
| Cefradine | L-thyroxine | Serotonin(5-Hydroxytyramine) |
| Cephalexin | LAAM HCl (except for MTD) | Sertraline |
| Cetirizine | Labetalol | Sildenafil Citrate |
| Chloral hydrate | Lamotrigine | Simvastatin |
| Chloramphenicol | Levofloxacin Hydrochloride | Sodium Azide |
| Chlordiazepoxide (except for BZO) | Levonorgestrel | Sufentanil Citrate |
| Chloroquine (except for MET) | Levothyroxine Sodium | Sulfamethazine |
| Chlorothiazide | Lidocaine | Sulindac |
| Chlorpheniramine | Lisinopril | Telmisartan |
| Chlorpromazine | Loperamide | Tetracycline |
| Cholesterol | Loratadine | Tetrahydrocortisone 3-acetate |
| Ciprofloxacin Hydrochloride | Loratidine | Tetrahydrocortisone3-(β-Dglucuronide) |
| Citalopram | Lorazepam (except for BZO) | Tetrahydrozoline |
| Clarithromycin | LSD | THC |
| Clofibrate | Magnesium | Theophylline |
| Clomipramine (except for TCA) | Maprotiline (except for TCA) | Thiamine |
| Clonidine | Meperidine | Thioridazine |
| Clozapine | Meprobamate | Trazodone Hydrochloride |
| Conjugated Estrogens | Metformin | Triamterene |
| Cortisone | Methapyrilene | Trifluoperazine |
| Cotinine | Methaqualone | Trifluoromethylphenyl- piperazine |
| Creatine Hydrate | Methoxyphenamine (except for AMP/MET) | Trimethobenzamide (except for MET) |
| Creatinine | Methylphenidate | Trimethoprim |
| Cyclobenzaprine (except for TCA) | Metoprolol | Tryptamine |
| Cyclodextrin-r | Metronidazole (300 ug/mL) | Tyramine |
| Cyproheptadine | Mifepristone | Urea (2000 mg/dL) |
| D,L-Epinephrine | N-Acetylprocainamide | Uric Acid |
| d,l-Isoproterenol | N-desmethyl Tapentadol | Valproic acid (250 ug/mL) |
| Delorazepam (except for BZO) | NaCl (40000 ug/mL) | Venlafaxine |
| Demoxepam | Nalidixic Acid | Verapamil |
| Deoxycorticosterone | Naloxone (except for OXY) | Vitamin B2 |
| Desipramine (except for TCA) | Naltrexone | Zaleplon |
| Desloratadine | Naproxen | Zolpidem |
| Dextromethorphan | Niacinamide | Zolpidem Tartrate |
| Diclofenac | Nicotine | Zomepirac |
| Diflunisal | Nicotinic Acid | β-Estradiol |
| Digoxin | Nifedipine | β-Hydroxybutyric Acid |
| Dimethyl-aminoantipyrine | Nitroglycerin | |
| Diphenhydramine (except for TLM) | Norethindrone | |
## d.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 Amphetamine (AMP300), Methamphetamine (MET300) and Tramadol (TML100). Data for Fentanyl (FYL) and Norfentanyl (NFYL) was reported in K243996. Data for 6-Monoacetylmorphine (6-MAM) and Marijuana (THC20) was reported in K201630. Data for Amphetamine (AMP500), Cocaine (COC150), and Methamphetamine (MET500) was reported in K181768. Data for 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP300), Propoxyphene (PPX300), and Nortriptyline (TCA1000) was reported in K180349. Data for Oxazepam (BZO300), Methylenedioxymethamphetamine (MDMA500), and Morphine (MOR300) was reported in K170049. Data for Phencyclidine (PCP25) and Marijuana (THC50) was reported in K161044. Data for Morphine (MOR2000) was reported in K153465. Data for Buprenorphine (BUP10) and Methadone (MTD300) was reported in K152025. Data for Secobarbital (BAR300) and Oxycodone (OXY100) was reported in K151211.
{12}
| Methamphetamine (Cutoff=300ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| d-Methamphetamine | 300 | 100 |
| Chloroquine | 7,500 | 4 |
| (-)-Ephedrine | 2,000 | 15 |
| Fenfluramine | 12,500 | 2.4 |
| l-Methamphetamine | 1,000 | 30 |
| Mephentermine hemisulfate salt | 31,250 | 0.96 |
| MDEA | 50,000 | 0.6 |
| MDMA | 313 | 95.85 |
| PMMA | 625 | 48 |
| d,l-Methamphetamine | 1250 | 24 |
| p-Hydroxymethamphetamine | 4000 | 7.5 |
| (+/-)-Ephedrine | 2000 | 15 |
| Methamphetamine (Cutoff=300ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
| d-Methamphetamine | 300 | 100 |
| Chloroquine | 7,500 | 4 |
| (-)-Ephedrine | 2,000 | 15 |
| Fenfluramine | 12,500 | 2.4 |
| l-Methamphetamine | 1,000 | 30 |
| Mephentermine hemisulfate salt | 31,250 | 0.96 |
| MDEA | 50,000 | 0.6 |
| MDMA | 313 | 95.85 |
| PMMA | 625 | 48 |
| d,l-Methamphetamine | 1250 | 24 |
{13}
| d-Amphetamine | >100000 | <0.3 |
| --- | --- | --- |
| d,l-Amphetamine | >100000 | <0.3 |
| l-Amphetamine | >100000 | <0.3 |
| Phenylephrine | >100000 | <0.3 |
| Phenylethylamine | >100000 | <0.3 |
| Pseudoephedrine | >100000 | <0.3 |
| d,l-(MDA) | >100000 | <0.3 |
| Phentermine | >100000 | <0.3 |
| Methoxyphenamine hydrochloride | 2500 | 12 |
| Trimethobenzamide | >100000 | <0.3 |
| Procaine hydrochloride | >100000 | <0.3 |
| Tramadol (Cutoff=100ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Tramadol | 100 | 100 |
| (+/-)Chlorpheniramine | 50000 | 0.2 |
| Dimenhydrinate | 50000 | 0.2 |
| Diphenhydramine | 50000 | 0.2 |
| Phencyclidine | 50000 | 0.2 |
| (+)-Chlorpheniramine | >100000 | <0.1 |
| Tramadol-N-Desmethyl | 300 | 33.33 |
| Tramadol-O-Desmethyl | 5,000 | 2 |
| Venlafaxine | >100000 | <0.1 |
| o-Desmethyl Venlafaxine | >100000 | <0.1 |
# e. 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 Amphetamine (AMP300), Methamphetamine (MET300) and Tramadol (TML100) 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. Data for Fentanyl (FYL) and Norfentanyl (NFYL) was reported in K243996. Data for 6-Monoacetylmorphine (6-MAM) and Marijuana (THC20) was reported in K201630. Data for Amphetamine (AMP500), Cocaine (COC150), and Methamphetamine (MET500) was reported in K181768. Data for 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP300), Propoxyphene (PPX300), and Nortriptyline (TCA1000) was reported in K180349. Data for Oxazepam (BZO300), Methylenedioxy-methamphetamine (MDMA500), and Morphine (MOR300) was reported in K170049. Data for Phencyclidine (PCP25) and Marijuana (THC50) was reported in K161044. Data for Morphine (MOR2000) was reported in K153465. Data for Buprenorphine (BUP10) and Methadone (MTD300) was reported in K152025. Data for Secobarbital (BAR300) and Oxycodone (OXY100) was reported in K151211.
# 2. Comparison Studies
Method comparison studies for the AssureTech Quick Cup Tests were performed in-house with three laboratory assistants for the device. Operators ran 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 Amphetamine (AMP300), Methamphetamine (MET300) and Tramadol
{14}
(TML100). Data for Fentanyl (FYL) and Norfentanyl (NFYL) was reported in K243996. Data for 6-Monoacetylmorphine (6-MAM) and Marijuana (THC20) was reported in K201630. Data for Amphetamine (AMP500), Cocaine (COC150), and Methamphetamine (MET500) was reported in K181768. Data for 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP300), Propoxyphene (PPX300), and Nortriptyline (TCA1000) was reported in K180349. Data for Oxazepam (BZO300), Methylenedioxy-methamphetamine (MDMA500), and Morphine (MOR300) was reported in K170049. Data for Phencyclidine (PCP25) and Marijuana (THC50) was reported in K161044. Data for Morphine (MOR2000) was reported in K153465. Data for Buprenorphine (BUP10) and Methadone (MTD300) was reported in K152025. Data for Secobarbital (BAR300) and Oxycodone (OXY100) was reported in K151211.
| AMP300 | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Positive | 0 | 0 | 1 | 24 | 16 |
| | Negative | 5 | 15 | 19 | 0 | 0 |
| Operator 2 | Positive | 0 | 0 | 2 | 24 | 16 |
| | Negative | 5 | 15 | 18 | 0 | 0 |
| Operator 3 | Positive | 0 | 0 | 1 | 23 | 16 |
| | Negative | 5 | 15 | 19 | 1 | 0 |
Discordant Results
| Operator | Sample ID | LC/MS Result (ng/mL) | Rapid Test Result |
| --- | --- | --- | --- |
| Operator 1, 2 | 226 | 287.658 | + |
| Operator 2, 3 | 173 | 292.420 | + |
| Operator 3 | 054 | 300.145 | - |
| MET300 | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Positive | 0 | 0 | 0 | 20 | 20 |
| | Negative | 4 | 13 | 23 | 0 | 0 |
| Operator 2 | Positive | 0 | 0 | 2 | 18 | 20 |
| | Negative | 4 | 13 | 21 | 2 | 0 |
| Operator 3 | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 4 | 13 | 22 | 1 | 0 |
Discordant Results
| Operator | Sample ID | LC/MS Result (ng/mL) | Rapid Test Result |
| --- | --- | --- | --- |
| Operator 2 | 084 | 263.912 | + |
| Operator 2, 3 | 233 | 290.852 | + |
{15}
14
| Operator 2, 3 | 072 | 300.124 | - |
| --- | --- | --- | --- |
| Operator 2 | 139 | 306.361 | - |
| TML100 | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Positive | 0 | 0 | 2 | 19 | 20 |
| | Negative | 2 | 18 | 18 | 1 | 0 |
| Operator 2 | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 2 | 18 | 19 | 1 | 0 |
| Operator 3 | Positive | 0 | 0 | 0 | 19 | 20 |
| | Negative | 2 | 18 | 20 | 1 | 0 |
**Discordant Results**
| Operator | Sample ID | LC/MS Result (ng/mL) | Rapid Test Result |
| --- | --- | --- | --- |
| Operator 1 | 006 | 94.451 | + |
| Operator 1, 2 | 109 | 98.345 | + |
| Operator 1, 3 | 218 | 102.172 | - |
| Operator 2 | 265 | 106.333 | - |
## Lay-user study
A lay user study was performed at three intended user sites with 280 lay persons. 66 male and 74 female tested AssureTech Quick Cup Tests configuration 1; 87 male and 53 female tested AssureTech Quick Cup Tests configuration 2. They 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. The results are summarized below.
The results summary for Configuration 1:
| Drug | Cutoff (ng/mL) | Results | Concentration | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff |
| AMP | 500 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| BAR | 300 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| BUP | 10 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
{16}
| | | Agreement (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| BZO | 300 | Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 100% | 100% | 100% |
| COC | 150 | Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 100% | 100% | 100% |
| EDDP | 300 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| FYL | 1 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| MDMA | 500 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| PPX | 300 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| MOP | 2000 | Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 100% | 100% | 100% |
| MTD | 300 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| PCP | 25 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| OXY | 100 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| NFYL | 5 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| MET | 500 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| TCA | 1000 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| 6-MAM | 10 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
{17}
The results summary for Configuration 2:
| Drug | Cutoff (ng/mL) | Results | Concentration | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff |
| AMP | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| BAR | 300 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| BUP | 10 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| BZO | 300 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| COC | 150 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| EDDP | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| FYL | 1 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| MDMA | 500 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| PPX | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
{18}
| MOP | 300 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| MTD | 300 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| PCP | 25 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| OXY | 100 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| NFYL | 5 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| MET | 300 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| TCA | 1000 | Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 100% | 100% | 100% |
| 6-MAM | 10 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| TML | 100 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| THC | 20 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 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.
# 3. 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 device, it's concluded that the AssureTech Quick Cup Tests and AssureTech Multi-drug Urine Test Cup are substantially equivalent to the predicate.
