Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup
Device Facts
| Record ID | K250803 |
|---|---|
| Device Name | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup |
| Applicant | Anhui Deepblue Medical Technological Co., Ltd. |
| Product Code | NGL · Clinical Toxicology |
| Decision Date | Apr 15, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
Intended Use
The Deepblue Multi-Drug Urine Test Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, fentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: [Table omitted for brevity]. The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT). The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. The Deepblue Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of one or more of the following drugs. [Table omitted for brevity]. This drug test cup may contain any combination of the drug tests listed in the table above. This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
Device Story
Device is a rapid lateral flow immunochromatographic cup for qualitative detection of drugs of abuse in human urine. User collects urine in cup; device uses competitive binding principle where drug in sample competes with drug-protein conjugate for limited antibody binding sites. Absence of colored test line indicates preliminary positive result; presence of line indicates negative result. Control line confirms proper performance. Used in clinical or home settings by professionals or lay users. Provides preliminary screening results; requires confirmation by GC-MS or LC-MS. Benefits include rapid, on-site detection of drug presence to guide further clinical or diagnostic decision-making.
Clinical Evidence
Bench testing only. Includes precision/reproducibility studies (25 days, 3 lots), analytical specificity/interference testing, and method comparison against LC-MS/MS (80 samples per drug). Lay-user study conducted with 280 participants across 3 sites, confirming ease of use and performance across various concentrations. No clinical prospective/retrospective trials performed.
Technological Characteristics
Lateral flow immunochromatographic assay. Competitive binding principle using monoclonal antibody conjugates. Form factor: urine test cup. Storage: 2-30°C. No electronic components or software algorithms. Qualitative readout via visual color bands.
Indications for Use
Indicated for qualitative detection of drugs of abuse in human urine. Intended for prescription or over-the-counter (OTC) use. Patient population includes individuals requiring drug screening; no specific age or gender restrictions.
Regulatory Classification
Identification
An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An opiate 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
- K252867 — VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup · Advin Biotech, Inc. · Oct 9, 2025
- K244043 — AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup · Hangzhou AllTest Biotech Co., Ltd. · Feb 27, 2025
- K191841 — Accurate Multi Panel Drug Urine Test Cup · Healstone Biotech, Inc. · Aug 7, 2019
- K162395 — MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup · Mp Biomedicals, LLC · Jun 2, 2017
- K250067 — Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro · Guangzhou Decheng Biotechnology Co., Ltd. · Feb 20, 2025
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
April 15, 2025
ANHUI Deepblue Medical Technological Co., Ltd.
% Jenny Xia
Director
LSI International, Inc.
504 East Diamond Ave, Suite H
Gaithersburg, Maryland 20877
Re: K250803
Trade/Device Name: Deepblue Multi-Drug Urine Test Cup; Deepblue Home Multi-Drug Urine Test Cup
Regulation Number: 21 CFR 862.3650
Regulation Name: Opiate test system
Regulatory Class: Class II
Product Code: NGL, PTH, NFT, NFV, NFY, PTG, NGG, NGM, QBF, QAW, NFW
Dated: March 16, 2025
Received: March 17, 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
K250803 - Jenny Xia
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 (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-
{2}
K250803 - Jenny Xia
Page 3
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: 2025.04.15
15:16:37 -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
{3}
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)
K250803
Device Name
Deepblue Multi-Drug Urine Test Cup;
Deepblue Home Multi-Drug Urine Test Cup
Indications for Use (Describe)
The Deepblue Multi-Drug Urine Test Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, fentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Test | Calibrator | Cut-off(ng/mL) |
| --- | --- | --- |
| 6-MAM | 6-Monoacetylmorphine | 10 |
| AMP | d-Amphetamine | 500 or 1000 |
| BAR | Secobarbital | 300 |
| BUP | Buprenorphine | 10 |
| BZO | Oxazepam | 300 |
| COC | Benzoylecgonine | 150 or 300 |
| EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 |
| FYL | Fentanyl | 1 |
| MDMA | Methylenedioxymethamphetamine | 500 |
| MET | d-Methamphetamine | 500 or 1000 |
| MTD | d/l-Methadone | 300 |
| MOP/OPI | Morphine | 300 or 2000 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | d-Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | 11-nor-Δ9-THC-COOH | 50 |
The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT).
The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
The Deepblue Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay.
The device provides preliminary results for the detection of one or more of the following drugs.
| Code | Substance | Cut-off(ng/mL) |
| --- | --- | --- |
| AMP | Amphetamine | 1000 or 500 |
| BUP | Buprenorphine | 10 |
| BAR | Secobarbital | 300 |
| BZO | Oxazepam | 300 |
| COC | Cocaine | 300 or 150 |
| EDDP | EDDP | 300 |
FORM FDA 3881 (8/23)
Page 1 of 2
PSC Publishing Services (301) 443-6740
{4}
| FYL | Fentanyl | 1 |
| --- | --- | --- |
| MET | Methamphetamine | 1000 or 500 |
| MDMA | Ecstasy | 500 |
| OPI | Morphine | 2000 or 300 |
| MTD | Methadone | 300 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | Marijuana | 50 |
| 6-MAM | 6-Monoacetylmorphine | 10 |
This drug test cup may contain any combination of the drug tests listed in the table above.
This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23)
Page 2 of 2
PSC Publishing Services (301) 443-6740
{5}
1
# 510(k) SUMMARY K250803
1. Date: March 9, 2025
2. Submitter: ANHUI Deepblue Medical Technological Co., Ltd.
Pearl Industrial Park, 106 Innovation Ave.
Hefei, Anhui 230088
China
3. Contact person: Jenny Xia
LSI International Inc.
504 East Diamond Ave., Suite H
Gaithersburg, MD 20877
Telephone: 301-525-6856
Email: jxia@lsi-consulting.org
4. Device Name: Deepblue Multi-Drug Urine Test Cup
Deepblue Home Muti-Drug Urine Test Cup
5. Classification: Class II
| Product Code
Target Drug | Regulation Section | Panel |
| --- | --- | --- |
| NFT
Amphetamine (AMP) | 862.3100, Amphetamine Test System | Toxicology |
| PTH
Secobarbital (BAR) | 862.3150, Barbiturate Test System | Toxicology |
| NGL
Buprenorphine (BUP)
Morphine (OPI)
Oxycodone (OXY)
6-Monoacetylmorphine(6-MAM)
Fentanyl (FEN) | 862.3650, Opiate Test System | Toxicology |
| NFV
Oxazepam (BZO) | 862.3170, Benzodiazepine Test System | Toxicology |
| NFY
Cocaine (COC) | 862.3250, Cocaine and cocaine metabolite test system | Toxicology |
| PTG
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)
Methadone (MTD) | 862.3620, Methadone Test System | Toxicology |
| NGG
Methylenedioxymethamphetamine (MDMA)
Methamphetamine (MET) | 862.3610, Methamphetamine Test System | Toxicology |
| NGM | Unclassified | Toxicology |
{6}
| Phencyclidine (PCP) | | |
| --- | --- | --- |
| QBF Propoxyphene(PPX) | 862.3700 Propoxyphene test system. | Toxicology |
| QAW Nortriptyline (TCA) | 862.3910 Tricyclic antidepressant drugs test system | Toxicology |
| NFW Cannabinoids (THC 50) | 862.3870, Cannabinoids Test System | Toxicology |
# 6. Predicate Devices:
Healgen Accurate Urine Drug Screen Dip Card (K240686)
# 7. Intended Use
The Deepblue Multi-Drug Urine Test Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, fentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Test | Calibrator | Cut-off (ng/mL) |
| --- | --- | --- |
| 6-MAM | 6-Monoacetylmorphine | 10 |
| AMP | d-Amphetamine | 500 / 1000 |
| BAR | Secobarbital | 300 |
| BUP | Buprenorphine | 10 |
| BZO | Oxazepam | 300 |
| COC | Benzoylecgonine | 150 / 300 |
| EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 |
| FYL | Fentanyl | 1 |
| MDMA | Methylenedioxymethamphetamine | 500 |
| MET | d-Methamphetamine | 500 / 1000 |
| MTD | d/l-Methadone | 300 |
| OPI | Morphine | 300 / 2000 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | d-Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | 11-nor-Δ9-THC-COOH | 50 |
The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT).
The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass
{7}
spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
The Deepblue Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay.
The device provides preliminary results for the detection of one or more of the following drugs.
| CODE | SUBSTANCE | CUT-OFF (ng/mL) |
| --- | --- | --- |
| AMP | Amphetamine | 1000 or 500 |
| BUP | Buprenorphine | 10 |
| BAR | Secobarbital | 300 |
| BZO | Oxazepam | 300 |
| COC | Cocaine | 300 or 150 |
| EDDP | EDDP | 300 |
| FYL | Fentanyl | 1 |
| MET | Methamphetamine | 1000 or 500 |
| MDMA | Ecstasy | 500 |
| OPI | Morphine | 2000 or 300 |
| MTD | Methadone | 300 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | Marijuana | 50 |
| 6-MAM | 6-Monoacetylmorphine | 10 |
This drug test cup may contain any combination of the drug tests listed in the table above. This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
## 8. Device Description
Deepblue Home Multi-Drug Urine Test Cup and Deepblue Multi-Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
The device is a cup format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
## 9. Substantial Equivalence Information
{8}
| Similarities | | | |
| --- | --- | --- | --- |
| Item | Device | | Predicate (K240686) |
| Intended use | Qualitative detection of drugs of abuse in urine. For prescription use or over-the-counter use | | Same. |
| Methodology | Competitive binding, lateral flow immunochromatographic assay based on antigen-antibody reaction | | Same |
| Type of Test | Qualitative | | Same |
| Specimen Type | Human urine | | Same |
| Target Drug and Cut Off Values | Target Drugs | Cutoff (ng/mL) | Same except no Fentanyl |
| | Amphetamine(AMP) | 1000 or 500 | |
| | Secobarbital (BAR) | 300 | |
| | Buprenorphine (BUP) | 10 | |
| | Oxazepam (BZO) | 300 | |
| | Cocaine (COC) | 300 or 150 | |
| | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 | |
| | Fentanyl | 1 | |
| | Methylenedioxymethamphetamine (MDMA) | 500 | |
| | Methamphetamine (MET) | 1000 or 500 | |
| | Morphine (MOP300/OPI2000) | 2000 or 300 | |
| | Methadone (MTD) | 300 | |
| | Oxycodone (OXY) | 100 | |
| | Phencyclidine (PCP) | 25 | |
| | Propoxyphene(PPX) | 300 | |
| | Nortriptyline (TCA) | 1000 | |
| | Cannabinoids (THC) | 50 | |
| | 6-Monoacetylmorphine(6-MAM) | 10 | |
| | Differences | | |
| Configurations | Test cup | | Test Dip Card |
{9}
5
10. Standard/Guidance Document Reference (if applicable)
None referenced.
11. Test Principle
Deepblue Home Muti-Drug Urine Test Cup or Deepblue Muti-Drug Urine Test Cup is a competitive immunoassay that is used to screen for the presence of various drugs and drug metabolites in urine. It is chromatographic absorbent device in which, drugs within a urine sample, competitively combined to a limited number of drug monoclonal antibody conjugate binding sites.
When the test is activated, the urine is absorbed into each test strip by capillary action, mixes with the respective drug monoclonal antibody conjugate, and flows across a pre-coated membrane. When drug within the urine sample is below the detection level of the test, respective drug monoclonal antibody conjugate binds to the respective drug-protein conjugate immobilized in the Test Region (T) of the test strip. This produces a colored Test line in the Test Region (T) of the strip, which, regardless of its intensity, indicates a negative test result.
When sample drug levels are at or above the detection level of the test, the free drug in the sample binds to the respective drug monoclonal antibody conjugate, preventing the respective drug monoclonal antibody conjugate from binding to the respective drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result.
To serve as a procedure control, a colored line will appear at the Control Region (C) of each strip, if the test has been performed properly.
12. Performance Characteristics
A. Analytical performance
a. Precision/Reproducibility:
Precision studies were carried out for samples with concentrations of +100% cutoff, +75% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cut off and -100% cutoff. Other samples were prepared by spiked target drug in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test cups. The results obtained are summarized in the following tables:
| Drug | Lot Number | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| AMP 1000 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 8-/42+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 4-/46+ | 11-/39+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 7-/43+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BAR 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 4--/46+ | 17-/33+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 14-/36+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 15-/35+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
{10}
| BUP 10 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 19-/31+ | 46-/4+ | 50-/0+ | 50-/0+ | 50-/0+ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 18-/32+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 18-/32+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BZO 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 15-/35+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 16-/34+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 14-/36+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| COC 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 9-/41+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 8-/42+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 12-/38+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| EDDP 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 10-/40+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 10-/40+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 10-/40+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| FYL 1 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 18-/32+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 4-/46+ | 20-/30+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 18-/32+ | 46-/4+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MDM A 500 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 12-/38+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 14-/36+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 15-/35+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MET 1000 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 10-/40+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 8-/42+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 7-/43+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MOP 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 4-/46+ | 10-/40+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 12-/38+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 13-/37+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MTD 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 17-/33+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 19-/31+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 20-/30+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| OXY 100 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 10-/40+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 9-/41+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 10-/40+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| PCP 25 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 17-/33+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 20-/30+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 18-/32+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| PPX 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 22-/28+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 24-/26+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 23-/27+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| TCA 1000 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 20-/30+ | 46-/4+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 18-/32+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 21-/29+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| THC 50 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 24-/26+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 4-/46+ | 26-/24+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
{11}
7
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 4-/46+ | 22-/28+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6-MAM 10 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 11-/39+ | 46-/4+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 14-/36+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 9-/41+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| AMP 500 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 11-/39+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 3--/47+ | 12-/38+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 11-/39+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| COC 150 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 12-/38+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 14-/36+ | 46-/4+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 10-/40+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MET 500 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 9-/41+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 4-/46+ | 10-/40+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 8-/42+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| OPI 2000 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 12-/38+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 14-/36+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 4-/46+ | 15-/35+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
## b. Linearity/assay reportable range:
Not applicable. This device is intended for qualitative use only.
## c. Stability:
The device is stable at 2-30°C for 24 months based on real time stability study.
## d. Analytical specificity/Interference:
To test the specificity, drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine. These urine samples were tested using three lots of the device.
Percent cross-reactivity, provided in the below table, was calculated as the cutoff concentration divided by the concentration of analyte tested that yielded a positive result, multiplied by 100. If no cross-reactivity was observed, the highest concentration tested is shown.
| Drug/Cutoff | Compound | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
| --- | --- | --- | --- |
| AMP 1000 | Hydroxyamphetamine | 8000 | 12.5% |
| | (+/-)-Methylenedioxyamphetamine (MDA) | 10000 | 10% |
| | D,L-Amphetamine | 1,000 | 100% |
| | D-Amphetamine | 1,000 | 100% |
| | Diethylstilbestrol | >100000 | <1% |
{12}
| | L-Amphetamine | 50000 | 2% |
| --- | --- | --- | --- |
| | Phentermine | 10000 | 10% |
| | β-Phenylethylamine | 100000 | 1% |
| | Tyramine | 100000 | 1% |
| | p-Hydroxynorephedrine | 100000 | 1% |
| | D,L-Norephedrine | 100000 | 1% |
| | p-Hydroxyamphetamine | 100000 | 1% |
| | D-Methamphetamine | >100000 | <1% |
| | L-Methamphetamine | >100000 | <1% |
| | Ephedrine hydrochloride | >100000 | <1% |
| | (+/-)3,4-Methylenedioxymethamphetamine(MDMA) | >100000 | <1% |
| | Phenylpropanolamine | >100000 | <1% |
| | Benzphetamine | >100000 | <1% |
| | L-Ephedrine | >100000 | <1% |
| | L-Epinephrine | >100000 | <1% |
| | D,L-Epinephrine | >100000 | <1% |
| | (+/-)3,4-Methylenedioxyethylamphetamine(MDEA) | >100000 | <1% |
| BAR 300 | Alphenal | 150 | 200% |
| | Amobarbital | 300 | 100% |
| | Aprobarbital | 300 | 100% |
| | Butabarbital | 100 | 300% |
| | Butethal | 100 | 300% |
| | Cyclopentobarbital | 500 | 60% |
| | Pentobarbital | 200 | 150% |
| | Phenobarbital | 200 | 150% |
| | Secobarbital | 300 | 100% |
| | Butalbital | 2500 | 12% |
| BUP 10 | Buprenorphine | 10 | 100% |
| | Buprenorphine -3-D-Glucuronide | 10 | 100% |
| | Norbuprenorphine | 20 | 50% |
| | Norbuprenorphine-3-D-Glucuronide | 200 | 5% |
| | Morphine | >100000 | <0.01% |
{13}
| | Oxymorphone | >100000 | <0.01% |
| --- | --- | --- | --- |
| | Hydromorphone | >100000 | <0.01% |
| BZO 300 | a-Hydroxyalprazolam | 1000 | 30% |
| Alprazolam | 200 | 150% |
| Bromazepam | 1000 | 30% |
| Chlordiazepoxide | 1500 | 20% |
| Clobazam | 100 | 300% |
| Clonazepam | 2500 | 12% |
| Clorazepate Dipotassium | 200 | 150% |
| Desalkylflurazepam | 500 | 60% |
| Diazepam | 200 | 150% |
| Estazolam | 500 | 60% |
| Flunitrazepam | 400 | 75% |
| D,L-Lorazepam | 1000 | 30% |
| Midazolam | 10000 | 3% |
| Nitrazepam | 100 | 300% |
| Norchlordiazepoxide | 200 | 150% |
| Nordiazepam | 200 | 150% |
| Oxazepam | 300 | 100% |
| R,S-Lorazepam glucuronide | 200 | 150% |
| Temazepam | 100 | 300% |
| Triazolam | 2500 | 12% |
| Demoxepam | 2000 | 15% |
| Flurazepam | 500 | 60% |
| Delorazepam | 10000 | 3% |
| COC 300 | Benzoylecogonine | 300 | 100% |
| Cocaethylene | 12500 | 2.4% |
| Cocaine hydrochloride | 200 | 150% |
| Ecgonine | >100000 | <0.3% |
| Norcocaine | 100000 | 0.3% |
| Ecgonine methyl ester | >100000 | <0.3% |
| EDDP 300 | EDDP | 300 | 100% |
| Methadone | >100000 | <0.3% |
| EMDP | >100000 | <0.3% |
9
{14}
| | Doxylamine | >100000 | <0.3% |
| --- | --- | --- | --- |
| | Disopyramide | 100000 | 0.3% |
| | LAAM (Levo-alpha-acetylmethadol) hydrochloride | >100000 | <0.3% |
| | Alpha Methadol | >100000 | <0.3% |
| | Norfentanyl | >100000 | <0.001% |
| | Fentanyl | 1 | 100% |
| | Acetyl fentanyl | 1 | 100% |
| | Acetyl Norfentanyl | >100000 | <0.001% |
| | (±)-β-Hydroxythiofentanyl HCl | 1 | 100% |
| | Acryl Fentanyl | 1 | 100% |
| | Butyryl Fentanyl | 2 | 50% |
| | Cis-d, I 3-Methylfentanyl | 50 | 2% |
| | Furanyl Fentanyl | 5 | 20% |
| | Para-fluoro butyrl Fentanyl (P-FBF) | 3 | 33.3% |
| | Para-fluoro Fentanyl | 3 | 33.3% |
| | 9-Hydroxy Risperidone | 10000 | 0.01% |
| | Alfentanil | 5000 | 0.02% |
| | Isobutyryl Fentanyl | 1 | 100% |
| | 4-Fluoro-isobutyryl Fentanyl | 50 | 2% |
| | Norcarfentail Oxalate | 10000 | 0.01% |
| | Remifentanil | >100000 | <0.001% |
| | Valeryl Fentanyl | 10 | 10% |
| | Thienyl Fentanyl | 1000 | 0.1% |
| | Trans-d, I 3-Methylfentanyl | 1000 | 0.1% |
| | Despropionyl fentanyl (4-ANPP) | 2500 | 0.04% |
| | MT-45 | 10000 | 0.01% |
| | Ocfentanil | 2 | 50% |
| | Risperidone | >100000 | <0.001% |
| | Sufentanil | 10 | 10% |
| | Carfentanil Oxalate | 500 | 0.2% |
| | Labetalol Hydrochloride | >100000 | <0.001% |
| | Trazodone | >100000 | <0.001% |
| | U-47700 | >100000 | <0.001% |
FYL 1
{15}
| | ω-1-Hydroxyfentanyl | 20000 | 0.005 |
| --- | --- | --- | --- |
| | 6-Acetyl morphine | >100000 | <0.001% |
| | Amphetamine | >100000 | <0.001% |
| | Buprenorphine | >100000 | <0.001% |
| | Buprenorphineglucuronide | >100000 | <0.001% |
| | Codeine | >100000 | <0.001% |
| | Dextromethorphan | >100000 | <0.001% |
| | Dihydrocodeine | >100000 | <0.001% |
| | EDDP | >100000 | <0.001% |
| | EMDP | >100000 | <0.001% |
| | Fluoxetine | >100000 | <0.001% |
| | Heroin | >100000 | <0.001% |
| | Hydrocodone | >100000 | <0.001% |
| | Hydromorphone | >100000 | <0.001% |
| | Ketamine | >100000 | <0.001% |
| | Levorphanol | >100000 | <0.001% |
| | Meperidine | >100000 | <0.001% |
| | Methadone | >100000 | <0.001% |
| | Morphine | >100000 | <0.001% |
| | Morphine-3-glucuronide | >100000 | <0.001% |
| | Naloxone | >100000 | <0.001% |
| | Naltrexone | >100000 | <0.001% |
| | Norbuprenorphine | >100000 | <0.001% |
| | Norcodeine | >100000 | <0.001% |
| | Norketamine | >100000 | <0.001% |
| | Normeperidine | >100000 | <0.001% |
| | Normorphine | >100000 | <0.001% |
| | Noroxycodone | >100000 | <0.001% |
| | Oxycodone | >100000 | <0.001% |
| | Oxymorphone | >100000 | <0.001% |
| | Pentazocine (Talwin) | >100000 | <0.001% |
| | Pipamperone | >100000 | <0.001% |
| | Tapentadol | >100000 | <0.001% |
| | Thioridazine | >100000 | <0.001% |
{16}
| | Tilidine | >100000 | <0.001% |
| --- | --- | --- | --- |
| | Tramadol | >100000 | <0.001% |
| | Tramadol-O-Desmethyl | >100000 | <0.001% |
| | Tramadol-N-Desmethyl | >100000 | <0.001% |
| MDMA 500 | (+/-)3,4-Methylenedioxy-n-Ethylamphetamine (MDEA) | >100000 | <0.5% |
| | (+/-)-Methylenedioxyamphetamine(MDA) | 5000 | 10% |
| | (±)-MDMA | 500 | 100% |
| | L-Methamphetamine | 100000 | 0.5% |
| | d-methamphetamine | 100000 | 0.5% |
| | d-amphetamine | >100000 | <0.5% |
| | l-amphetamine | >100000 | <0.5% |
| MET 1000 | (+/-)3,4-Methylenedioxy-n-Ethylamphetamine (MDEA) | >100000 | <1% |
| | (±)-MDMA | 2000 | 50% |
| | D-Methamphetamine | 1000 | 100% |
| | L-Methamphetamine | 25000 | 4% |
| | Fenfluramine | 50000 | 2% |
| | p-Hydroxymethamphetamine | 10000 | 10% |
| | D,L-Methamphetamine | 1000 | 100% |
| | β-Phenylethylamine | 50000 | 2% |
| | Mephetermine | 50000 | 2% |
| | Methoxyphenamine hydrochloride | 10000 | 1% |
| | L-Amphetamine | 75000 | 1.3% |
| | D-Amphetamine | >100000 | <1% |
| | D,L-Amphetamine | >100000 | <1% |
| | Chloroquine | 100000 | 1% |
| | Ephedrine hydrochloride | 50000 | 2% |
| | (+/-)3,4-Methylenedioxyamphetamine (MDA) | 100000 | 1% |
| | Trimethobenzamide | 100000 | 1% |
| | l-phenylephrine | 50000 | 2% |
| | (1R,2S)-(-)-Ephedrine | 100000 | 1% |
| | Procaine hydrochloride | >100000 | <1% |
{17}
| MOP 300 | 6-acetylmorphine | 100 | 300% |
| --- | --- | --- | --- |
| | Codeine | 300 | 100% |
| | Dihydrocodeine | 1000 | 30% |
| | EthylMorphine | 300 | 100% |
| | Heroin | 500 | 60% |
| | Hydrocodone | 1000 | 30% |
| | Hydromorphone | 10000 | 3% |
| | Levorphanol tartrate | 1500 | 20% |
| | Morphine | 300 | 100% |
| | Nalorphine hydrochloride | 300 | 100% |
| | Thebaine | 10000 | 3% |
| | s-Monoacetylmorphine | 300 | 100% |
| | Morphine-3-β-d-glucuronide | 300 | 100% |
| | 6-Monoacetylmorphine | 300 | 100% |
| | Codeine-6-β-D-glucuronide | 25000 | 1.2% |
| | Morphine-6-β-D-glucuronide | 1000 | 30% |
| | 6-Acetylcodeine | 25000 | 1.2% |
| | Normorphine | 50000 | 0.6% |
| | Oxycodone | >100000 | <0.3% |
| | Oxymorphone | >100000 | <0.3% |
| | Norcodeine | 25000 | 1.2% |
| | Procaine hydrochloride | >100000 | <0.3% |
| | Norpropoxyphene | >100000 | <0.3% |
| MTD 300 | (±)-Methadone | 300 | 100% |
| | EDDP | >100000 | <0.3% |
| | EMDP | >100000 | <0.3% |
| | LAAM | >100000 | <0.3% |
| | Alpha Methadol | >100000 | <0.3% |
| | Doxylamine | >100000 | <0.3% |
| OXY 100 | Ethyl Oxycodone | 50000 | 0.2% |
| | Hydrocodone | 5000 | 2% |
| | Hydromorphone | 100000 | 0.1% |
| | Levorphanol tartrate | 50000 | 0.2% |
| | Naloxone hydrochloride | 50000 | 0.2% |
13
{18}
| | Naltrexone hydrochloride | 50000 | 0.2% |
| --- | --- | --- | --- |
| | Oxycodone | 100 | 100% |
| | Oxymorphone | 200 | 50% |
| | Oxymorphone-3β-D-glucuronide | 500 | 20% |
| | Noroxycodone | 1000 | 10% |
| | Noroxymorphone | 2500 | 4% |
| | Dihydrocodeine | 20000 | 0.5% |
| | Codeine | 100000 | 0.1% |
| | Morphine | >100000 | <0.1% |
| | Buprenorphine | >100000 | <0.1% |
| | Ethylmorphine | >100000 | <0.1% |
| | Thebaine | >100000 | <0.1% |
| | 6-acetylmorphine | >100000 | <0.1% |
| PCP 25 | Phencyclidine | 25 | 100% |
| | 4-Hydroxy Phencyclidine | 12,500 | 0.2% |
| PPX 300 | d-Propoxyphene | 300 | 100% |
| | d-Norpropoxyphene | 300 | 100% |
| TCA 1000 | Amitriptyline | 1000 | 100% |
| | Chlorpheniramine | 50000 | 2% |
| | Clomipramine | 1000 | 100% |
| | Cyclobenzaprine Hydrochloride | 1000 | 100% |
| | Desipramine | 300 | 333% |
| | Doxepine | 1000 | 100% |
| | Duloxetine | >100000 | <1% |
| | Imipramine | 500 | 200% |
| | Norclomipramine | 500 | 200% |
| | Nordoxepine | 10000 | 10% |
| | Nortriptyline | 1000 | 100% |
| | Promazine | 2000 | 50% |
| | Trimipramine | 3000 | 33.3% |
| | Maprotiline | >100000 | <1% |
| | Promethazine hydrochloride | 50000 | 2% |
| THC 50 | 11-nor-Δ8-THC -9-COOH | 30 | 166% |
| | (-)-11-nor-9-carboxy-Δ9-THC | 50 | 100% |
14
{19}
| | (±)-11-nor-9-Carboxy-Δ9-THC | 50 | 100% |
| --- | --- | --- | --- |
| | 11-nor-Δ9-THC -carboxy glucuronide | 50 | 100% |
| | 11-hydroxy-Δ9-Tetrahydrocannabinol | 5000 | 1% |
| | Δ8- Tetrahydrocannabinol | 5000 | 1% |
| | Δ9- Tetrahydrocannabinol | 10000 | 0.5% |
| | Cannabinol | 10000 | 0.5% |
| | Cannabidiol | >100000 | <0.05% |
| | (±)-11-Hydroxy-Δ9-THC | >100000 | <0.05% |
| 6-MAM 10 | 6-acetylmorphine | 10 | 100% |
| | Heroin | 50 | 20% |
| | Morphine | 10000 | 0.1% |
| | Normorphine | 100000 | 0.01% |
| | Nalorphine HCl | 100000 | 0.01% |
| | Hydrocodone | 100000 | 0.01% |
| | Hydromorphone | 100000 | 0.01% |
| | Chlordiazepoxide | 100000 | 0.01% |
| | Clobazam | 100000 | 0.01% |
| | D-Amphetamine | >100000 | <0.01% |
| | (±)-Amphetamine | >100000 | <0.01% |
| | Levorphanol tartrate | 100000 | 0.01% |
| | Codeine | >100000 | <0.01% |
| | Ethylmorphine | >100000 | <0.01% |
| | Morphine3-β-D-glucuronide | 100000 | 0.01% |
| | Norcodeine | 100000 | 0.01% |
| | Oxycodone | >100000 | <0.01% |
| | Oxymorphone | >100000 | <0.01% |
| | Procaine hydrochloride | >100000 | <0.01% |
| | Thebaine | >100000 | <0.01% |
| | 6-Acetylcodeine | 100000 | 0.01% |
| | Buprenorphine | >100000 | <0.01% |
| | Dihydrocodeine | >100000 | <0.01% |
| | Dextromethorphan | >100000 | <0.01% |
| | Imipramine hydrochloride | >100000 | <0.01% |
15
{20}
| | Meperidine | >100000 | <0.01% |
| --- | --- | --- | --- |
| | (±)-Methadone | >100000 | <0.01% |
| | Mitragynine(kratom) | 100000 | 0.01% |
| | Morphine-6-β-D-glucuronide | 100000 | 0.01% |
| | Naloxone hydrochloride | >100000 | <0.01% |
| | Naltrexone hydrochloride | >100000 | <0.01% |
| | Naproxen | >100000 | <0.01% |
| | Norbuprenorphine | >100000 | <0.01% |
| | Norbuprenorphine-3-D-Glucuronide | 100000 | 0.01% |
| | Noroxycodone HCL | >100000 | <0.01% |
| | Noroxymorphone HCL | >100000 | <0.01% |
| | Norpropoxyphene | >100000 | <0.01% |
| | Oxymorphone-3β-D-glucuronide | >100000 | <0.01% |
| | Tapentadol hydrochloride | >100000 | <0.01% |
| | Tramadol hydrochloride | >100000 | <0.01% |
| AMP 500 | Hydroxyamphetamine | 4000 | 12.5% |
| | (+/-)-Methylenedioxyamphetamine(MDA) | 200 | 250% |
| | D,L-Amphetamine | 500 | 100% |
| | D-Amphetamine | 500 | 100% |
| | Diethylstilbestrol | >100000 | <0.5% |
| | L-Amphetamine | 10000 | 5% |
| | Phentermine | 4000 | 12.5% |
| | β-Phenylethylamine | 50000 | 1% |
| | Tyramine | 10000 | 5% |
| | p-Hydroxynorephedrine | 50000 | 1% |
| | p-Hydroxyamphetamine | 50000 | 1% |
| | D,L-Norephedrine | 50000 | 1% |
| | (+/-)3,4-Methylenedioxy-n-ethylamphetamine(MDEA) | >100000 | <0.5% |
| | d-Methamphetamine | >100000 | <0.5% |
| | l-Methamphetamine | >100000 | <0.5% |
| | (+/-)3,4-Methylenedioxymethamphetamine(MDMA) | >10000 | <5% |
| | Ephedrine hydrochloride | >100000 | <0.5% |
{21}
| | Phenylpropanolamine | >100000 | <0.5% |
| --- | --- | --- | --- |
| | Benzphetamine | >100000 | <0.5% |
| | L-Ephedrine | >100000 | <0.5% |
| | L-Epinephrine | >100000 | <0.5% |
| | D,L-Epinephrine | >100000 | <0.5% |
| COC 150 | Benzoylecogonine | 150 | 100% |
| | Cocaethylene | 150 | 100% |
| | Cocaine hydrochloride | 100 | 150% |
| | Ecgonine | >100000 | <0.15% |
| | Norcocaine | >100000 | <0.15% |
| | Ecgonine methyl Ester | >100000 | <0.15% |
| MET 500 | (+/-)3,4-Methylenedioxy-n-ethylamphetamine (MDEA) | >100000 | <0.5% |
| | (±)-MDMA | 1000 | 50% |
| | D-Methamphetamine | 500 | 100% |
| | L-Methamphetamine | 10000 | 5% |
| | Fenfluramine | 25000 | 2% |
| | p-Hydroxymethamphetamine | 5000 | 10% |
| | D,L-Methamphetamine | 500 | 100% |
| | β-Phenylethylamine | 10000 | 5% |
| | Mephetermine | 25000 | 2% |
| | Methoxyphenamine hydrochloride | 50000 | 1% |
| | L-Amphetamine | 100000 | 0.5% |
| | Ephedrine hydrochloride | 100000 | 0.5% |
| | (1R,2S)-(-)-Ephedrine | >100000 | <0.5% |
| | D-Amphetamine | >100000 | <0.5% |
| | Chloroquine | 100000 | 0.5% |
| | (+/-)3,4-Methylenedioxyamphetamine(MDA) | >100000 | <0.5% |
| | L-Phenylephrine | 100000 | 0.5% |
| | Trimethobenzamide | 100000 | 0.1% |
| | Procaine hydrochloride | >100000 | <0.5% |
| | d/l-Amphetamine | 100000 | 0.5% |
17
{22}
To evaluate potential interference, non-structurally related compounds were added to drug-free urine and to urine samples containing the target drugs at $50\%$ below and $50\%$ above each corresponding cutoff.
Compounds that show no interference at a concentration of $100\mu \mathrm{g / mL}$ are summarized in the following table.
| (-) Cotinine | Diflunisal | Norethindrone |
| --- | --- | --- |
| 3-Hydroxytyramine(except AMP test) | Digoxin | Norpropoxyphene |
| 7-Aminoflunitrazepam(except MDMA test) | Dimethyl-aminoantipyrine | Norpseudoephedrine |
| 7-Aminonitrazepam | Diphenhydramine HCl | Nortriptyline(except TCA test) |
| Acetaminophen | Diphenylhydantoin | Noscapine |
| Acetone (1000 mg/dL) | Disopyramide | Octopamine |
| Diphenhydramine HCl | Diphenylhydantoin | Nortriptyline |
| Diphenhydramine (1000 mg/dL) | Diphenylhydantoin | Noscapine |
| Diphenhydramine (2000 mg/dL) | Diphenylhydantoin | Noscapine |
| Diphenhydramine (3000 mg/dL) | Diphenylhydantoin | Noscapine |
| Diphenhydramine (4000 mg/dL) | Diphenylhydantoin | Noscapine |
| Diphenhydramine (5000 mg/dL) | Diphenylhydantoin | Noscapine |
| Diphenhydramine (6000 mg/dL) | Diphenylhydantoin | Noscapine |
| Diphenhydramine (7000 mg/dL) | Diphenylhydantoin | Noscapine |
| Diphenhydramine (8000 mg/dL) | Diphenylhydantoin | Noscapine |
{23}
| Acetophenetidin | Dopamine HCl (except AMP TCA test) | O-Hydroxyhippuric acid |
| --- | --- | --- |
| Acetylsalicylic acid | Doxepine(except TCA test) | Olanzapine |
| Acyclovir | Doxylamine | Omeprazole |
| Albumin(100mg/dL) | D-Pseudoephedrine | Oxalic acid |
| Albuterol | Duloxetine | Oxazepam (except BZO test) |
| Albuterol sulfate(Proair HFA) | Ecgonine methyl ester | Oxolinic acid |
| Alpha Methadol | EMDP | Oxymetazoline |
| Aminophylline | Ephedrine hydrochloride(except MET test) | Paliperidone |
| Aminopyrine | Erythromycin | Papaverine |
| Amitriptyline(except TCA test) | Esomeprazole Magnesium | Penicillin-G |
| Amlodipine besylate | Estradiol | PenicillinV Potassium |
| Amobarbital(except BAR test) | Estrone | Perphenazine(except TCA test) |
| Amoxicillin | Ethanol(1%) | Phenacetin |
| Ampicillin | Fenfluramine(except MET test) | Phencyclidine(except PCP test) |
| Apomorphine | Fenofibrate | Phenelzine |
| Aripiprazole | Fenoprofen | Phenethylamine(except AMP MDMA test) |
| Ascorbic acid | Fluoxetine Hydrochloride | Phenobarbital(except BAR test) |
| Aspartame | Fluphenazine | Phentermine(except AMP test) |
| Aspirin | Fotemustine | Phenylpropanolamine |
| Atomoxetine | Furosemide | Prednisone |
| Atorvastatin Calcium | Gabapentin | Pregablin |
| Atropine | Galactose | Procaine |
| Azithromycin | Gatifloxacin | Promazine(except TCA test) |
| Baclofen | Gemfibrozil | Promethazine |
| Benzilic acid | Gentisic acid | Propoxyphene(except PPX test) |
| Benzocaine | Glucose | Propranolol |
| Benzoic acid | Guaiacolglycerylether | Pseudoephedrine |
| Benzoylecogonine(except COC test) | Hemoglobin | Pyridoxine |
| Benzphetamine | Hexobarbital | Pyrilamine |
| Benzylpiperazine | Hydralazine | Pyrogallol |
| Bilirubin | Hydrochlorothiazide | Quetiapine |
| Boric Acid (1%) | Hydrocortisone | Quinidine |
| Bromo-2,5,Dimethoxyphenethylamine | Hydroxybutyric Acid | Quinine |
| Bupropion | Ibuprofen | Quinolinic Acid |
| Caffeine | Imipramine(except TCA test) | Ranitidine |
| Cannabidiol | Isoproterenol | Rifampicin |
| Captopril | Isoxsuprine | Salicylic acid |
| Carbamazepine | Ketamine | Secobarbital(except BAR test) |
| Carfentanil | Ketoprofen | Serotonin(except AMP test) |
19
{24}
| Carisoprodol | LAAM HCl | Serotonin (5-Hydroxytyramine)(except AMP test) |
| --- | --- | --- |
| Cefradine | Labetalol | Sertraline |
| Cephalexin | Lamotrigine | Sildenafil Citrate |
| Cetirizine | L-Ephedrine | Simvastatin |
| Chloralhydrate | L-Epinephrine | Sodium Azide |
| Chloramphenicol | Levofloxacin Hydrochloride(except AMP test) | Sulfamethazine(except 6-MAM test) |
| Chlordiazepoxide(except BZO test) | Levonorgestrel | Sulindac(except BZO test) |
| Chloroquine | Levothyroxine Sodium | Telmisartan |
| Chlorothiazide | Lidocaine Hydrochloride | Tetracycline |
| Chlorpheniramine(except TCA test) | Lisinopril | Tetrahydrocortisone 3-(β-Dglucuronide) |
| Chlorpromazine(except TCA test) | Loperamide | Tetrahydrocortisone, 3-acetate |
| Cholesterol | Loratadine | Tetrahydrozoline |
| Ciprofloxacin Hydrochloride(except AMP test) | L-phenylephrine | THC (except THC test) |
| Citalopram(except TCA test) | LSD | Theophylline |
| Clarithromycin | L-thyroxine | Thiamine |
| Clofibrate | Magnesium | Thioridazine(except TCA test) |
| Clomipramine(except TCA test) | Maprotiline | Trazodone Hydrochloride |
| Clonidine | Meperidine | Triamteren |
| Clozapine | Meprobamate | Trifluoperazine |
| Conjugated Estrogens | Metformin | Trifluoromethylphenyl-piperazine |
| Cortisone | Methapyrilene | Trimethobenzamide(except AMP MET test) |
| Creatine Hydrate | Methaqualone | Trimethoprime |
| Creatinine | Methoxyphenamine (except MET test) | Tryptamine |
| Cyclobenzaprine(except TCA test) | Methylphenidate | Tyramine (except AMP test) |
| Cyproheptadine | Metoprolol Tartrate | Urea (2000 mg/dL) |
| D,L-Epinephrine | Metronidazole | Uric acid |
| D,L-Isoproterenol | Mifepristone | Valproic acid (250 μg/mL) |
| D,L-Lorazepam (except BZO test) | N-Acetylprocainamide | Venlafaxine HCl |
| D,L-Octopamine | Nacl (4000 mg/dL) | Verapamil |
| D,L-Propranolol | Nalidixic acid | Vitamin B2 |
| D,L-Tryptophan | Naloxone hydrochloride(except OXY test) | Vitamin C |
| D,L-Tyrosine | Naltrexone hydrochloride(except OXY test) | Zaleplon |
| Delorazepam | Naproxen | Zolpidem |
| Demoxepam(except BZO test) | N-desmethyl Tapentadol | Zomepirac |
{25}
21
| Deoxycorticosterone | Niacinamide | β-Estradiol |
| --- | --- | --- |
| Desloratadine(except TCA test) | Nicotine | γ-Cyclodextrin |
| Dextromethorphan | Nicotinic Acid | γ-Globulin (500mg/dL) |
| Diclofenac | Nifedipine | |
| Diclofenac sodium | Nitroglycerin | |
Interference by pH and specific gravity were also evaluated using pooled urine specimens with concentrations of 0 (drug-free), at 50% below and 50% above each corresponding cutoff. The results demonstrated that pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 do not affect the results of the assays.
## B. Method comparison study
The method comparison studies for the device were performed in-house with three operators. Operators ran 80 (40 negative and 40 positive) unaltered urine clinical samples for each drug. The samples were blind labeled and compared to LC-MS/MS results. The results are presented in the table below:
| Drug test | Test Result | | Drug-Free | Low Negative by LC-MS/MS (less than -50%) | Near Cutoff Negative by LC-MS/MS (Between -50% and the Cutoff) | Near Cutoff Positive by LC-MS/MS (Between the cutoff and +50%) | High Positive by LC-MS/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| AMP (1000) | Operator A | + | 0 | 0 | 0 | 15 | 22 |
| | | - | 10 | 14 | 16 | 3 | 0 |
| | Operator B | + | 0 | 0 | 1 | 17 | 22 |
| | | - | 10 | 14 | 15 | 1 | 0 |
| | Operator C | + | 0 | 0 | 1 | 17 | 22 |
| | | - | 10 | 14 | 15 | 1 | 0 |
| AMP (500) | Operator A | + | 0 | 0 | 0 | 16 | 22 |
| | | - | 10 | 14 | 16 | 2 | 0 |
| | Operator B | + | 0 | 0 | 0 | 16 | 22 |
| | | - | 10 | 14 | 16 | 2 | 0 |
| | Operator C | + | 0 | 0 | 1 | 18 | 22 |
| | | - | 10 | 14 | 15 | 0 | 0 |
| BAR | Operator A | + | 0 | 0 | 1 | 16 | 22 |
| | | - | 10 | 14 | 15 | 2 | 0 |
| | Operator B | + | 0 | 0 | 1 | 17 | 22 |
| | | - | 10 | 14 | 15 | 1 | 0 |
| | Operator C | + | 0 | 0 | 2 | 17 | 22 |
| | | - | 10 | 14 | 14 | 1 | 0 |
| BUP | Operator | + | 0 | 0 | 0 | 16 | 22 |
{26}
| | A | - | 10 | 14 | 16 | 2 | 0 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Operator B | + | 0 | 0 | 1 | 16 | 22 |
| | | - | 10 | 14 | 15 | 2 | 0 |
| | Operator C | + | 0 | 0 | 1 | 17 | 22 |
| | | - | 10 | 14 | 15 | 1 | 0 |
| BZO | Operator A | + | 0 | 0 | 0 | 15 | 22 |
| | | - | 10 | 14 | 16 | 3 | 0 |
| | Operator B | + | 0 | 0 | 1 | 17 | 22 |
| | | - | 10 | 14 | 15 | 1 | 0 |
| | Operator C | + | 0 | 0 | 2 | 18 | 22 |
| | | - | 10 | 14 | 14 | 0 | 0 |
| COC (300) | Operator A | + | 0 | 0 | 1 | 15 | 22 |
| | | - | 10 | 14 | 15 | 3 | 0 |
| | Operator B | + | 0 | 0 | 1 | 15 | 22 |
| | | - | 10 | 14 | 15 | 3 | 0 |
| | Operator C | + | 0 | 0 | 1 | 17 | 22 |
| | | - | 10 | 14 | 15 | 1 | 0 |
| COC (150) | Operator A | + | 0 | 0 | 2 | 18 | 22 |
| | | - | 10 | 14 | 14 | 0 | 0 |
| | Operator B | + | 0 | 0 | 2 | 18 | 22 |
| | | - | 10 | 14 | 14 | 0 | 0 |
| | Operator C | + | 0 | 0 | 3 | 18 | 22 |
| | | - | 10 | 14 | 13 | 0 | 0 |
| EDDP | Operator A | + | 0 | 0 | 2 | 17 | 22 |
| | | - | 10 | 14 | 14 | 1 | 0 |
| | Operator B | + | 0 | 0 | 2 | 18 | 22 |
| | | - | 10 | 14 | 14 | 0 | 0 |
| | Operator C | + | 0 | 0 | 3 | 18 | 22 |
| | | - | 10 | 14 | 13 | 0 | 0 |
| FYL | Operator A | + | 0 | 0 | 2 | 16 | 22 |
| | | - | 10 | 14 | 14 | 2 | 0 |
| | Operator B | + | 0 | 0 | 2 | 16 | 22 |
| | | - | 10 | 14 | 14 | 2 | 0 |
| | Operator C | + | 0 | 0 | 3 | 16 | 22 |
| | | - | 10 | 14 | 13 | 2 | 0 |
| MDMA | Operator A | + | 0 | 0 | 2 | 17 | 22 |
| | | - | 10 | 14 | 14 | 1 | 0 |
| | Operator B | + | 0 | 0 | 1 | 16 | 22 |
| | | - | 10 | 14 | 15 | 2 | 0 |
| | Operator C | + | 0 | 0 | 2 | 17 | 22 |
| | | - | 10 | 14 | 14 | 1 | 0 |
| MET | Operator | + | 0 | 0 | 1 | 17 | 22 |
{27}
| (1000) | A | - | 10 | 14 | 15 | 1 | 0 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Operator B | + | 0 | 0 | 0 | 17 | 22 |
| | | - | 10 | 14 | 16 | 1 | 0 |
| | Operator C | + | 0 | 0 | 2 | 18 | 22 |
| | | - | 10 | 14 | 14 | 0 | 0 |
| MET (500) | Operator A | + | 0 | 0 | 0 | 16 | 22 |
| | | - | 10 | 14 | 16 | 2 | 0 |
| | Operator B | + | 0 | 0 | 1 | 17 | 22 |
| | | - | 10 | 14 | 15 | 1 | 0 |
| | Operator C | + | 0 | 0 | 2 | 17 | 22 |
| | | - | 10 | 14 | 14 | 1 | 0 |
| MOP (300) | Operator A | + | 0 | 0 | 0 | 16 | 22 |
| | | - | 10 | 14 | 16 | 2 | 19 |
| | Operator B | + | 0 | 0 | 0 | 15 | 22 |
| | | - | 10 | 14 | 16 | 3 | 0 |
| | Operator C | + | 0 | 0 | 1 | 17 | 22 |
| | | - | 10 | 14 | 15 | 1 | 0 |
| OPI (2000) | Operator A | + | 0 | 0 | 1 | 17 | 22 |
| | | - | 10 | 14 | 15 | 1 | 0 |
| | Operator B | + | 0 | 0 | 1 | 17 | 22 |
| | | - | 10 | 14 | 15 | 1 | 0 |
| | Operator C | + | 0 | 0 | 2 | 17 | 22 |
| | | - | 10 | 14 | 14 | 1 | 0 |
| MTD | Operator A | + | 0 | 0 | 0 | 15 | 22 |
| | | - | 10 | 14 | 16 | 3 | 0 |
| | Operator B | + | 0 | 0 | 0 | 15 | 22 |
| | | - | 10 | 14 | 16 | 3 | 0 |
| | Operator C | + | 0 | 0 | 1 | 17 | 22 |
| | | - | 10 | 14 | 15 | 1 | 0 |
| OXY | Operator A | + | 0 | 0 | 0 | 16 | 22 |
| | | - | 10 | 14 | 16 | 2 | 0 |
| | Operator B | + | 0 | 0 | 0 | 16 | 22 |
| | | - | 10 | 14 | 16 | 2 | 0 |
| | Operator C | + | 0 | 0 | 1 | 16 | 22 |
| | | - | 10 | 14 | 15 | 2 | 0 |
| PCP | Operator A | + | 0 | 0 | 0 | 16 | 22 |
| | | - | 10 | 14 | 16 | 2 | 0 |
| | Operator B | + | 0 | 0 | 1 | 17 | 22 |
| | | - | 10 | 14 | 15 | 1 | 0 |
| | Operator C | + | 0 | 0 | 1 | 17 | 22 |
| | | - | 10 | 14 | 15 | 1 | 0 |
| PPX | Operator | + | 0 | 0 | 0 | 16 | 22 |
{28}
| | A | - | 10 | 14 | 16 | 2 | 0 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Operator B | + | 0 | 0 | 0 | 16 | 22 |
| | | - | 10 | 14 | 16 | 2 | 0 |
| | Operator C | + | 0 | 0 | 0 | 17 | 22 |
| | | - | 10 | 14 | 16 | 1 | 0 |
| TCA | Operator A | + | 0 | 0 | 0 | 16 | 22 |
| | | - | 10 | 14 | 16 | 2 | 0 |
| | Operator B | + | 0 | 0 | 0 | 16 | 22 |
| | | - | 10 | 14 | 16 | 2 | 0 |
| | Operator C | + | 0 | 0 | 1 | 17 | 22 |
| | | - | 10 | 14 | 15 | 1 | 0 |
| THC | Operator A | + | 0 | 0 | 0 | 16 | 22 |
| | | - | 10 | 14 | 16 | 2 | 0 |
| | Operator B | + | 0 | 0 | 0 | 16 | 22 |
| | | - | 10 | 14 | 16 | 2 | 0 |
| | Operator C | + | 0 | 0 | 1 | 18 | 22 |
| | | - | 10 | 14 | 15 | 0 | 0 |
| 6-MAM | Operator A | + | 0 | 0 | 1 | 16 | 22 |
| | | - | 10 | 14 | 15 | 2 | 0 |
| | Operator B | + | 0 | 0 | 1 | 16 | 22 |
| | | - | 10 | 14 | 15 | 2 | 0 |
| | Operator C | + | 0 | 0 | 2 | 18 | 22 |
| | | - | 10 | 14 | 14 | 0 | 0 |
Discordant Results are summarized below.
| Drug | Operator | Sample Number | LC/MS/MS Result (ng/mL) | Accurate Result |
| --- | --- | --- | --- | --- |
| 6-MAM 10 | Operator A、C | DBMC1307 | 8.77 | Positive |
| | Operator B、C | DBMC0177 | 9.16 | Positive |
| | Operator A、B | DBMC0604 | 10.82 | Negative |
| | Operator A、B | DBMC0685 | 11.01 | Negative |
| AMP 1000 | Operator B、C | DBMC0242 | 998.95 | Positive |
| | Operator A、B、C | DBMC1670 | 1017.86 | Negative |
| | Operator A | DBMC1538 | 1033.17 | Negative |
| | Operator A | DBMC0629 | 1039.9 | Negative |
| BAR 300 | Operator A、B、C | DBMC0762 | 298.98 | Positive |
| | Operator C | DBMC0612 | 288.79 | Positive |
| | Operator A、B、C | DBMC0103 | 314.09 | Negative |
| | Operator A | DBMC0278 | 319.32 | Negative |
| BUP 10 | Operator B | DBMC0867 | 9.95 | Positive |
| | Operator C | DBMC0498 | 9.97 | Positive |
| | Operator A、B、C | DBMC0182 | 10.44 | Negative |
{29}
| | Operator A、B | DBMC0496 | 10.69 | Negative |
| --- | --- | --- | --- | --- |
| BZO 300 | Operator C | DBMC1305 | 278.05 | Positive |
| | Operator B、C | DBMC0603 | 285.73 | Positive |
| | Operator A | DBMC1300 | 310.58 | Negative |
| | Operator A、B | DBMC1022 | 305.35 | Negative |
| | Operator A | DBMC0514 | 309.44 | Negative |
| COC 300 | Operator A、B、C | DBMC0058 | 295.45 | Positive |
| | Operator A、B | DBMC1107 | 305.07 | Negative |
| | Operator A、B、C | DBMC0277 | 301.06 | Negative |
| | Operator B | DBMC0815 | 311.63 | Negative |
| | Operator A | DBMC0550 | 312.18 | Negative |
| EDDP 300 | Operator C | DBMC0495 | 268.37 | Positive |
| | Operator A、B、C | DBMC0728 | 284.94 | Positive |
| | Operator A、B、C | DBMC1634 | 288.76 | Positive |
| | Operator A | DBMC0961 | 301.82 | Negative |
| FYL | Operator C | DBMC1630 | 0.94 | Positive |
| | Operator A、B、C | DBMC0260 | 0.97 | Positive |
| | Operator A、B、C | DBMC0313 | 0.99 | Positive |
| | Operator A、B、C | DBMC0622 | 1.03 | Negative |
| | Operator A | DBMC1198 | 1.06 | Negative |
| | Operator C | DBMC1514 | 1.1 | Negative |
| | Operator B | DBMC1336 | 1.06 | Negative |
| MDMA 500 | Operator A、C | DBMC0425 | 472.58 | Positive |
| | Operator A、B、C | DBMC0522 | 471.3 | Positive |
| | Operator A、B、C | DBMC0804 | 527.24 | Negative |
| | Operator B | DBMC0464 | 540.66 | Negative |
| MET 1000 | Operator A、C | DBMC0780 | 981.48 | Positive |
| | Operator C | DBMC1290 | 978.54 | Positive |
| | Operator A、B | DBMC0723 | 1019.75 | Negative |
| MOP 300 | Operator C | DBMC0162 | 290.78 | Positive |
| | Operator A、B、C | DBMC0424 | 301.43 | Negative |
| | Operator A、B | DBMC1121 | 303.18 | Negative |
| | Operator B | DBMC0343 | 304.93 | Negative |
| MTD 300 | Operator C | DBMC0452 | 286.81 | Positive |
| | Operator A、B、C | DBMC0668 | 310.22 | Negative |
| | Operator A、B | DBMC0750 | 316.65 | Negative |
| | Operator A、B | DBMC0553 | 327.95 | Negative |
| OXY 100 | Operator C | DBMC0525 | 92.84 | Positive |
| | Operator A、B、C | DBMC0838 | 102.37 | Negative |
| | Operator A、B、C | DBMC1006 | 101.84 | Negative |
| PCP 25 | Operator B、C | DBMC1636 | 24.98 | Positive |
| | Operator A、B | DBMC1007 | 25.72 | Negative |
| | Operator A、C | DBMC0548 | 25.82 | Negative |
{30}
# C. Lay person study
A lay user study was performed at three intended user sites with 280 lay persons. 176 male and 104 female participated the study. They had diverse educational and professional backgrounds and their age range from 21 to $>50$ . Urine samples were prepared at the following concentrations; $-100\%$ , $+/-75\%$ , $+/-50\%$ , $+/-25\%$ of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC-MS/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.
Result of Deepblue Muti-Drug Urine Test Cup Configuration 1:
| Drug | Cutoff (ng/mL) | Results | Concentration | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff |
| AMP | 500 | Negative | 20 | 20 | 20 | 19 | 1 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% |
| BAR | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 |
| DAM | 200 | Negative | 20 | 20 | 20 | 19 | 1 | 0 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 |
| DAM + DAP | 100 | Negative | 20 | 20 | 20 | 19 | 1 | 0 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 |
| DAM + DAP + DAP + DAP + DAP + DAP + DAP + DAP + DAP + DAP + DAP + DAP + DAP + DAP + DAP + DAP + DAP + D | 100 | Negative | 20 | 20 | 20 | 19 | 1 | 0 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 |
{31}
| | | Positive | 0 | 0 | 0 | 1 | 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 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| BZO | 300 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 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 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| FTY | 1 | 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% |
| 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% |
| MET | 500 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| 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% | 95% | 95% | 100% | 100% |
| MTD | 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% |
| OXY | 100 | 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% |
{32}
Result of Deepblue Muti-Drug Urine Test Cup Configuration 2:
| Drug | Cutoff (ng/mL) | Results | Concentration | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff |
| | | | Negative | 20 | 20 | 20 | 19 | 1 | 0 |
| | | | Positive | 0 | 0 | 0 | 1 | 19 | 20 |
| AMP | 1000 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| BAR | 300 | 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% |
| BUP | 10 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 100% |
{33}
| | | 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% | 95% | 100% | 100% |
| FTY | 1 | 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% |
| MDMA | 500 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| MET | 1000 | 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% | 90% | 95% | 100% | 100% |
| MOP | 2000 | 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% |
| MTD | 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% |
| OXY | 100 | 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% |
| PCP | 25 | 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% |
| PPX | 300 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 100% |
| TCA | 1000 | 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% |
{34}
| THC | 50 | 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% |
| 6-MAM | 10 | 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% |
Participants were given surveys on the ease of understanding the instruction for use. All participants indicated that the device instruction is easy to understand and follow. 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.
## 13. Conclusion
Based on the test principle and performance characteristics of the device including precision, cut-off, interference, specificity, method comparison and lay-user studies of the devices, it's concluded that Deepblue Home Muti-Drug Urine Test Cup and Deepblue Muti-Drug Urine Test Cup are substantially equivalent to the predicate devices.
