Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup

K260355 · WEBEST Biotech,, LLC · NFT · Mar 9, 2026 · Clinical Toxicology

Device Facts

Record IDK260355
Device NameWebest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup
ApplicantWEBEST Biotech,, LLC
Product CodeNFT · Clinical Toxicology
Decision DateMar 9, 2026
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 862.3100
Device ClassClass 2

Intended Use

The WEBEST Multi-Drug Urine Cup is a rapid lateral flow immunoassays for the qualitative detection of D-Amphetamine, Butalbital, Buprenorphine, Oxazepam, Benzoylecgonine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Fentanyl, Methylenedioxymethamphetamine, D-Methamphetamine, Methadone, 6-Monoacetylmorphine, Norfentanyl, Morphine, Oxycodone, Phencyclidine, D-Propoxyphene, Nortriptyline, 11-nor-Δ9-THC-COOH and Tramadol in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: [Table omitted]. The single or multi-test cup can consist of up to nineteen (19) 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 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 Webest Home Multi-Drug Urine Cup is lateral flow immunoassays for rapid detection of multiple commonly abused drugs in human urine. The detectable drugs and their cutoff concentrations are listed below: [Table omitted]. This is not a screening device to monitor prescription medication. The single or multi-test cup can include any combination of the analytes listed above, with and without onboard adulteration tests. However, only one cut-off concentration can be included per analyte per device. This device provides only a preliminary test result. A more specific alternate method shall be used in order to obtain a confirmed analytical test result. GC/MS or LC/MS is the preferred confirmatory method.

Device Story

Lateral flow immunochromatographic assay; detects drugs of abuse in human urine; competitive binding principle; antigen-antibody reaction. Device format: multi-test cup; ready-to-use; includes desiccant. User: lay person (home use) or professional. Operation: urine sample absorbed into test strip via capillary action; mixes with drug monoclonal antibody conjugate; flows across pre-coated membrane. Negative result: colored test line appears (drug below detection level). Preliminary positive result: no colored test line (drug at/above detection level). Control line confirms proper performance. Output: visual qualitative result. Clinical decision-making: preliminary screen only; requires confirmation via GC-MS or LC-MS. Benefit: rapid, point-of-care drug screening.

Clinical Evidence

Bench testing only. Precision/reproducibility studies (25 days, 3 lots, 3 operators) confirmed performance at cutoff concentrations. Analytical specificity/interference testing evaluated cross-reactivity with numerous compounds. Method comparison study (80 clinical samples per drug) compared device results to LC-MS/MS. Lay person study (280 participants) evaluated usability and performance across various concentrations; all participants found instructions easy to follow (Flesch-Kincaid Grade Level 7).

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding; mouse monoclonal antibody conjugates; pre-coated membrane. Cup format; sealed with desiccant. Stability: 36 months at 4-30°C. No electronic components or software.

Indications for Use

Indicated for qualitative detection of drugs of abuse (AMP, BAR, BUP, BZO, COC, EDDP, FYL, MDMA, MET, MTD, 6-MAM, NFYL, MOP/OPI, OXY, PCP, PPX, TCA, THC, TML) in human urine. For OTC and professional use. Not for monitoring prescription medication.

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

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION March 9, 2026 WEBEST Biotech, LLC % Jenny Xia LSI International Inc 504 East Diamond Ave., Suite H Gaithersburg, Maryland 20877 Re: K260355 Trade/Device Name: Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT PTH NGL NFY NFV PTG NGG NGM QBF QAW NFW Dated: February 3, 2026 Received: February 3, 2026 Dear Jenny Xia: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K260355- Jenny Shia Page 2 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. 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-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: 2026.03.09 14:31:09 -04'00' Joseph Kotarek, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health {2} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. # Indications for Use Submission Number (if known) K260355 Device Name Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup Indications for Use (Describe) The WEBEST Multi-Drug Urine Cup is a rapid lateral flow immunoassays for the qualitative detection of D-Amphetamine, Butalbital, Buprenorphine, Oxazepam, Benzoylecgonine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Fentanyl, Methylenedioxymethamphetamine, D-Methamphetamine, Methadone, 6-Monoacetylmorphine, Norfentanyl, Morphine, Oxycodone, Phencyclidine, D-Propoxyphene, Nortriptyline, 11-nor-Δ9-THC-COOH and Tramadol 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) | | --- | --- | --- | | AMP | D-Amphetamine | 1000 or 500 | | BAR | Butalbital | 300 | | BUP | Buprenorphine | 10 | | BZO | Oxazepam | 300 | | COC | Benzoylecgonine | 300 or 150 | | EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 | | FYL | Fentanyl | 1 | | MDMA | Methylenedioxymethamphetamine | 500 | | MET | D-Methamphetamine | 1000 or 500 | | MTD | Methadone | 300 | | 6-MAM | 6-Monoacetylmorphine | 10 | | NFYL | Norfentanyl | 5 | | MOP/OPI | Morphine | 2000 or 300 | | OXY | Oxycodone | 100 | | PCP | Phencyclidine | 25 | | PPX | D-Propoxyphene | 300 | | TCA | Nortriptyline | 1000 | | THC | 11-nor-Δ9-THC-COOH | 50 | | TML | Tramadol | 100 | The single or multi-test cup can consist of up to nineteen (19) 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 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 Webest Home Multi-Drug Urine Cup is lateral flow immunoassays for rapid detection of multiple commonly abused drugs in human urine. The detectable drugs and their cutoff concentrations are listed below: | CODE | SUBSTANCE | CUT-OFF (ng/mL) | | --- | --- | --- | | AMP | D-Amphetamine | 1000 or 500 | | BAR | Butalbital | 300 | {3} | BUP | Buprenorphine | 10 | | --- | --- | --- | | BZO | Oxazepam | 300 | | COC | Benzoylecgonine | 300 or 150 | | EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 | | FYL | Fentanyl | 1 | | MDMA | Methylenedioxymethamphetamine | 500 | | MET | D-Methamphetamine | 1000 or 500 | | MTD | Methadone | 300 | | 6-MAM | 6-Monoacetylmorphine | 10 | | NFYL | Norfentanyl | 5 | | MOP/OPI | Morphine | 2000 or 300 | | OXY | Oxycodone | 100 | | PCP | Phencyclidine | 25 | | PPX | D-Propoxyphene | 300 | | TCA | Nortriptyline | 1000 | | THC | 11-nor-Δ9-THC-COOH | 50 | | TML | Tramadol | 100 | This is not a screening device to monitor prescription medication. The single or multi-test cup can include any combination of the analytes listed above, with and without onboard adulteration tests. However, only one cut-off concentration can be included per analyte per device. This device provides only a preliminary test result. A more specific alternate method shall be used in order to obtain a confirmed analytical test result. GC/MS or LC/MS is the preferred confirmatory method. 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." {4} 1 # 510(k) SUMMARY K260355 1. Date: March 6, 2026 2. Submitter: WEBEST Biotech, LLC. 535 Irwindale Ave. Irwindale, CA 91706 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: Webest Multi-Drug Urine Cup 5. Classification: Webest Home Multi-Drug Urine Cup Class II | Product Code Target Drug | Regulation Section | Panel | | --- | --- | --- | | NFT Amphetamine (AMP) | 862.3100, Amphetamine Test System | Toxicology | | PTH Butalbital (BAR) | 862.3150, Barbiturate Test System | Toxicology | | NGL Buprenorphine (BUP) Fentanyl (FYL) Morphine (MOP/OPI) Oxycodone (OXY) 6-Monoacetylmorphine(6-MAM) Norfentanyl (NFYL) Tramadol (TML) | 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 | | QBF | 862.3700 Propoxyphene test system. | Toxicology | {5} 2 | Propoxyphene(PPX) | | | | --- | --- | --- | | NGM Phencyclidine (PCP) | Unclassified | Toxicology | | QAW Nortriptyline (TCA) | 862.3910 Tricyclic antidepressant drugs test system | Toxicology | | NFW Cannabinoids (THC) | 862.3870, Cannabinoids Test System | Toxicology | ## 6. Predicate Devices: AllTest Multi-Drug Rapid Test Cup (K244043) ## 7. Intended Use The Webest Home Multi-Drug Urine Cup is lateral flow immunoassays for rapid detection of multiple commonly abused drugs in human urine. The detectable drugs and their cutoff concentrations are listed below: | CODE | SUBSTANCE | CUT-OFF (ng/mL) | | --- | --- | --- | | AMP | D-Amphetamine | 1000 or 500 | | BAR | Butalbital | 300 | | BUP | Buprenorphine | 10 | | BZO | Oxazepam | 300 | | COC | Benzoylecgonine | 300 or 150 | | EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 | | FYL | Fentanyl | 1 | | MDMA | Methylenedioxymethamphetamine | 500 | | MET | D-Methamphetamine | 1000 or 500 | | MTD | Methadone | 300 | | 6-MAM | 6-Monoacetylmorphine | 10 | | NFYL | Norfentanyl | 5 | | MOP/OPI | Morphine | 2000 or 300 | | OXY | Oxycodone | 100 | | PCP | Phencyclidine | 25 | | PPX | D-Propoxyphene | 300 | | TCA | Nortriptyline | 1000 | | THC | 11-nor-Δ9-THC-COOH | 50 | | TML | Tramadol | 100 | This is not a screening device to monitor prescription medication. The single or multi-test cup can include any combination of the analytes listed above, with and without on-board adulteration tests. However, only one cut-off concentration can be included per analyte per device. This device provides only a preliminary test result. A more specific alternate method shall be used in order to obtain a confirmed analytical test result. GC/MS or LC/MS is the preferred confirmatory method. {6} The WEBEST Multi-Drug Urine Cup is a rapid lateral flow immunoassays for the qualitative detection of D-Amphetamine, Butalbital, Buprenorphine, Oxazepam, Benzoylecgonine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Fentanyl, Methylenedioxymethamphetamine, D-Methamphetamine, Methadone, 6-Monoacetylmorphine, Norfentanyl, Morphine, Oxycodone, Phencyclidine, D-Propoxyphene, Nortriptyline, 11-nor-Δ9-THC-COOH and Tramadol 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) | | --- | --- | --- | | AMP | D-Amphetamine | 1000 or 500 | | BAR | Butalbital | 300 | | BUP | Buprenorphine | 10 | | BZO | Oxazepam | 300 | | COC | Benzoylecgonine | 300 or 150 | | EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 | | FYL | Fentanyl | 1 | | MDMA | Methylenedioxymethamphetamine | 500 | | MET | D-Methamphetamine | 1000 or 500 | | MTD | Methadone | 300 | | 6-MAM | 6-Monoacetylmorphine | 10 | | NFYL | Norfentanyl | 5 | | MOP/OPI | Morphine | 2000 or 300 | | OXY | Oxycodone | 100 | | PCP | Phencyclidine | 25 | | PPX | D-Propoxyphene | 300 | | TCA | Nortriptyline | 1000 | | THC | 11-nor-Δ9-THC-COOH | 50 | | TML | Tramadol | 100 | The single or multi-test cup can consist of up to nineteen (19) 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 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 Webest Multi-Drug Urine Cup and Webest Home Multi-Drug Urine Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use. ## 9. Substantial Equivalence Information | Similarities | | | | --- | --- | --- | | Item | Device | Predicate (K244043) | {7} | Intended use | Qualitative detection of drugs of abuse in urine. For 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 that no Norfentanyl | | Amphetamine(AMP) | 1000 or 500 | | Butalbital (BAR) | 300 | | Buprenorphine (BUP) | 10 | | Oxazepam (BZO) | 300 | | Cocaine (COC) | 150 or 300 | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 | | Methylenedioxymethamphetamine (MDMA) | 500 | | Methamphetamine (MET) | 1000 or 500 | | Morphine (MOP300/OPI2000) | 300 or 2000 | | Methadone (MTD) | 300 | | Oxycodone (OXY) | 100 | | Phencyclidine (PCP) | 25 | | Propoxyphene(PPX) | 300 | | Nortriptyline (TCA) | 1000 | | Cannabinoids (THC) | 50 | | 6-Monoacetylmorphine(6-AM) | 10 | | Fentanyl (FYL) | 1 | | Norfentanyl (NFYL) | 5 | | Tramadol (TML) | 100 | | Configurations | Test cup | Same | ## 10. Standard/Guidance Document Reference (if applicable) None referenced. ## 11. Test Principle The Webest Multi-Drug Urine Cup or The Webest Home Multi-Drug Urine 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 (mouse) conjugate binding sites. {8} 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. Samples with concentration of -100% cutoff were drug-free urines samples. 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 with one operator per lot. 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 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 6AM 10 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27+/23- | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 26+/24- | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24+/26- | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | AMP 500 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27+/23- | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26+/24- | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25+/25- | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | BAR 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 27+/23- | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27+/23- | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26+/24- | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ | | BUP 10 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26+/24- | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26+/24- | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 27+/23- | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ | | BZO 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27+/23- | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25+/25- | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | {9} | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26+/24- | 50-/0+ | 50-/0+ | 50-/0+ | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | COC 150 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25+/25- | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 27+/23- | 49-/1+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26+/24- | 49-/1+ | 50-/0+ | 50-/0+ | | EDDP 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 27+/23- | 49-/1+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24+/26- | 49-/1+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 25+/25- | 49-/1+ | 50-/0+ | 50-/0+ | | FYL 1 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26+/24- | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 25+/25- | 48-/2+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 25+/25- | 48-/2+ | 50-/0+ | 50-/0+ | | NFYL 5 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24+/26- | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25+/25- | 48-/2+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27+/23- | 48-/2+ | 50-/0+ | 50-/0+ | | MDMA 500 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24+/26- | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 27+/23- | 49-/1+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23+/27- | 49-/1+ | 50-/0+ | 50-/0+ | | MET 500 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27+/23- | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26+/24- | 49-/1+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26+/24- | 48-/2+ | 50-/0+ | 50-/0+ | | MOR 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27+23- | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26+/24- | 49-/1+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24+/26- | 50-/0+ | 50-/0+ | 50-/0+ | | MTD 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25+/25- | 49-/1+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27+/23- | 49-/1+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 24+/26- | 50-/0+ | 50-/0+ | 50-/0+ | | OXY 100 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26+/24- | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26+/24- | 48-/2+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 25+/25- | 49-/1+ | 50-/0+ | 50-/0+ | | PCP 25 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25+/25- | 49-/1+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26+/24- | 49-/1+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 27+/23- | 49-/1+ | 50-/0+ | 50-/0+ | | PPX 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26+/24- | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25+/25- | 49-/1+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 26+/24- | 48-/2+ | 50-/0+ | 50-/0+ | | TCA 1000 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27+/23- | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26+/24- | 48-/2+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27+/23- | 49-/1+ | 50-/0+ | 50-/0+ | | THC 50 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25+/25- | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26+/24- | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26+/24- | 49-/1+ | 50-/0+ | 50-/0+ | {10} 7 | TML 100 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26+/24- | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24+/26- | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | AMP 1000 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26+/24- | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26+/24- | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 26+/24- | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | COC 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 27+/23- | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23+/27- | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25+/25- | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ | | MET 1000 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25+/25- | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26+/24- | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 27+/23- | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | OPI 2000 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27+/23- | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23+/27- | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26+/24- | 50-/0+ | 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 4-30°C for 36 months based on accelerated stability study. ## d. Analytical specificity/Interference: To test the specificity, drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine. These urine samples were tested using three lots of the device. The results obtained are summarized in the following table. 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. | 6-MAM (6-Acetylmorphine) (6-Acetylmorphine, Cutoff=10ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | Heroin | 60 | 16.7% | | Morphine | 70,000 | 0.014% | | Normorphine | 100,000(Negative) | Not detected | | NalorphineHCl | 100,000(Negative) | Not detected | | Hydrocodone | 100,000(Negative) | Not detected | | Hydromorphone | 100,000(Negative) | Not detected | | Chlordiazepoxide | 100,000(Negative) | Not detected | | Clobazam | 100,000(Negative) | Not detected | | D-Amphetamine | 100,000(Negative) | Not detected | | (±)-Amphetamine | 100,000(Negative) | Not detected | | Levorphanoltartrate | 100,000(Negative) | Not detected | | Codeine | 100,000(Negative) | Not detected | {11} | Ethylmorphine | 100,000(Negative) | Not detected | | --- | --- | --- | | Morphine3-β-D-glucuronide | 100,000(Negative) | Not detected | | Norcodeine | 100,000(Negative) | Not detected | | Oxycodone | 100,000(Negative) | Not detected | | Oxymorphone | 100,000(Negative) | Not detected | | Procainehydrochloride | 100,000(Negative) | Not detected | | Thebaine | 100,000(Negative) | Not detected | | 6-Acetylcodeine | 100,000(Negative) | Not detected | | Buprenorphine | 100,000(Negative) | Not detected | | Dihydrocodeine | 100,000(Negative) | Not detected | | Dextromethorphan | 100,000(Negative) | Not detected | | Imipraminehydrochloride | 100,000(Negative) | Not detected | | Meperidine | 100,000(Negative) | Not detected | | (±)-Methadone | 100,000(Negative) | Not detected | | Mitragynine(kratom) | 100,000(Negative) | Not detected | | Morphine-6-β-D-glucuronide | 100,000(Negative) | Not detected | | Naloxonehydrochloride | 100,000(Negative) | Not detected | | Naltrexonehydrochloride | 100,000(Negative) | Not detected | | Naproxen | 100,000(Negative) | Not detected | | Norbuprenorphine | 100,000(Negative) | Not detected | | Norbuprenorphine-3-D-Glucuronide | 100,000(Negative) | Not detected | | Noroxycodone HCL | 100,000(Negative) | Not detected | | Noroxymorphone HCL | 100,000(Negative) | Not detected | | (+)-Norpropoxyphenemaleate | 100,000(Negative) | Not detected | | Oxymorphone-3β-D-glucuronide | 100,000(Negative) | Not detected | | TapentadolHCl | 100,000(Negative) | Not detected | | Tramadol | 100,000(Negative) | Not detected | | AMP(Amphetamine) (Amphetamine, Cutoff=500ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | Hydroxyamphetamine | 4,000 | 12.5% | | (+/-)-Methylenedioxyamphetamine(MDA) | 200 | 250% | | D,L-Amphetamine | 500 | 100% | | Diethylstilbestrol | 2,500 | 20% | | L-Amphetamine | 60,000 | 0.8% | | Phentermine | 4,000 | 12.5% | | β-Phenylethylamine | 50,000 | 1% | | Tyramine | 5,000 | 10% | | p-Hydroxynorephedrine | 50,000 | 1% | | D,L-Norephedrine | 50,000 | 1% | | (+/-)3,4-Methylenedioxy-n- | 100,000 | 0.5% | | d-Methamphetamine | 100,000(Negative) | Not detected | | d-Methamphetamine-3,4-D-glucuronide | 100,000(Negative) | Not detected | | D,L-Amphetamine | 100,000(Negative) | Not detected | | D,L-Norephedrine | 100,000(Negative) | Not detected | {12} | 1-Methamphetamine | 100,000(Negative) | Not detected | | --- | --- | --- | | (+/-)3,4-Methylenedioxymethamphetamine (MDMA) | 100,000(Negative) | Not detected | | Ephedrine hydrochloride | 100,000(Negative) | Not detected | | Phenylpropanolamine | 100,000(Negative) | Not detected | | Benzphetamine | 100,000(Negative) | Not detected | | L-Ephedrine | 100,000(Negative) | Not detected | | L-Epinephrine | 100,000(Negative) | Not detected | | D,L-Epinephrine | 100,000(Negative) | Not detected | | AMP(Amphetamine) (Amphetamine, Cutoff=1000ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | Hydroxyamphetamine | 8,000 | 13% | | (+/-)-Methylenedioxyamphetamine(MDA) | 1300 | 77% | | D,L-Amphetamine | 1,000 | 100% | | Diethylstilbestrol | 5,000 | 20% | | L-Amphetamine | 100,000 | 1% | | Phentermine | 100,000 | 1% | | β-Phenylethylamine | 100,000 | 1% | | Tyramine | 10,000 | 10% | | p-Hydroxynorephedrine | 100,000 | 1% | | D,L-Norephedrine | 100,000 | 1% | | p-Hydroxyamphetamine | 100,000(Negative) | Not detected | | D-Methamphetamine | 100,000(Negative) | Not detected | | L-Methamphetamine | 100,000(Negative) | Not detected | | Ephedrine hydrochloride | 100,000(Negative) | Not detected | | (+/-)3,4- Methylenedioxymethamphetamine | 100,000(Negative) | Not detected | | Phenylpropanolamine | 100,000(Negative) | Not detected | | Benzphetamine | 100,000(Negative) | Not detected | | L-Ephedrine | 100,000(Negative) | Not detected | | L-Epinephrine | 100,000(Negative) | Not detected | | D,L-Epinephrine | 100,000(Negative) | Not detected | | (+/-)3,4-Methylenedioxyethylamphetamine (MDEA) | 100,000(Negative) | Not detected | | BAR(Butalbital) (Butalbital, Cutoff=300ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | Alphenal | 250 | 120% | | Amobarbital | 3000 | 10% | | Aprobarbital | 200 | 150% | | Butabarbital | 1,000 | 30% | 9 {13} | Butethal | 500 | 60% | | --- | --- | --- | | Cyclopentobarbital | 300 | 100% | | Pentobarbital | 1300 | 23% | | Phenobarbital | 1900 | 16% | | Secobarbital | 300 | 100% | | Barbital | | | | BUP(Buprenorphine) (Buprenorphine, Cutoff=10ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | Buprenorphine -3-D-Glucuronide | 15 | 66.67% | | Norbuprenorphine | 40 | 25% | | Norbuprenorphine-3-D-Glucuronide | 500 | 2% | | Morphine | 100,000(Negative) | Not detected | | Oxymorphone | 100,000(Negative) | Not detected | | Hydromorphone | 100,000(Negative) | Not detected | | BZO(Oxazepam) (Oxazepam, Cutoff=300ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | a-Hydroxyalprazolam | 2,500 | 12% | | Alprazolam | 120 | 250% | | Bromazepam | 1,500 | 20% | | Chlordiazepoxide | 1,500 | 20% | | Clobazam | 60 | 500% | | Clonazepam | 10,000 | 3% | | ClorazepateDipotassium | 200 | 150% | | Desalkylflurazepam | 1,500 | 20% | | Diazepam | 100 | 300% | | Estazolam | 150 | 200% | | Flunitrazepam | 160 | 187.5% | | D,L-Lorazepam | 1,560 | 19.23% | | Midazolam | 6,000 | 5.00% | | Nitrazepam | 300 | 100% | | Norchlordiazepoxide | 250 | 120% | | Nordiazepam | 400 | 75% | | Oxazepamglucuronide | 500 | 60% | | R,S-Lorazepamglucuronide | 160 | 187.5% | | Temazepam | 100 | 300% | | Triazolam | 2,500 | 12% | | Demoxepam | 2,000 | 15% | | Flurazepam | 500 | 60% | | Delorazepam | 100,000(Negative) | Not detected | 10 {14} | COC(Benzoylecgonine) (Benzoylecgonine, Cutoff=150ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | Cocaethylene | 100,000 (Negative) | Not detected | | Cocaine hydrochloride | 3,000 | 5% | | Ecgonine | 100,000 (Negative) | Not detected | | Norcocaine | 100,000 (Negative) | Not detected | | Ecgonine methyl Ester | 100,000 (Negative) | Not detected | | COC(Benzoylecgonine) (Benzoylecgonine, Cutoff=300ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | Cocaethylene | 100,000 (negative) | Not detected | | Cocaine hydrochloride | 5,000 | 6% | | Ecgonine | 100,000 (negative) | Not detected | | Norcocaine | 100,000 | 0.3% | | Ecgonine methyl ester | 100,000 (negative) | Not detected | | EDDP (EDDP, Cutoff=300ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | Methadone | 100,000 (negative) | Not detected | | EMDP | 100,000 (negative) | Not detected | | Doxylamine | 100,000 (negative) | Not detected | | Disopyramide | 100,000 (negative) | Not detected | | LAAM (Levo-alpha-acetylmethadol) | 100,000 (negative) | Not detected | | Alpha Methadol | 100,000 (negative) | Not detected | | FYL(Fentanyl) (Fentanyl, Cutoff=1ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | Norfentanyl | 300 | 0.33% | | Acetyl fentanyl | 5 | 20% | | Acetyl Norfentanyl | 100,000 | 0.001% | | (±)-β-Hydroxythiofentanyl HCl | 5 | 20% | | Acryl Fentanyl | 5 | 20% | | Butyryl Fentanyl | 30 | 3.33% | | Cis-d, I 3-Methylfentanyl | 25,000 | 0.004% | | Furanyl Fentanyl | 10 | 10% | | Para-fluorobutyl Fentanyl (P-FBF) | 25 | 4% | | Para-fluoroFentanyl | 25 | 4% | | 9-HydroxyRisperidone | 10,000 | 0.01% | | Alfentanil | 100,000(Negative) | Not detected | | Isobutyryl Fentanyl | 5 | 20% | 11 {15} | 4-Fluoro-isobutyryl Fentanyl | 50 | 2% | | --- | --- | --- | | Norcarfentail Oxalate | 100,000(Negative) | Not detected | | Remifentanil | 100,000(Negative) | Not detected | | Valeryl Fentanyl | 5 | 20% | | ThienylFentnaryl | 100 | 1% | | Trans-d, I 3-Methylfentanyl | 100 | 1% | | Despropionylfentanyl (4-ANPP) | 50,000 | 0.002% | | MT-45 | 100,000(Negative) | Not detected | | Ocfentanil | 100 | 1% | | Risperidone | 50,000 | 0.002% | | Sufentanil | 50,000 | 0.002% | | Carfentanil Oxalate | 100,000(Negative) | Not detected | | LabetalolHydrochloride | 100,000(Negative) | Not detected | | Trazodone | 50,000 | 0.002% | | U-47700 | 100,000(Negative) | Not detected | | ω-1-Hydroxyfentanyl | 50,000 | 0.002% | | 6-Acetylmorphine | 100,000(Negative) | Not detected | | Amphetamine | 100,000(Negative) | Not detected | | Buprenorphine | 100,000(Negative) | Not detected | | Buprenorphine -3-D-Glucuronide | 100,000(Negative) | Not detected | | Codeine | 100,000(Negative) | Not detected | | Dextromethorphan | 100,000(Negative) | Not detected | | Dihydrocodeine | 100,000(Negative) | Not detected | | EDDP | 100,000(Negative) | Not detected | | EMDP | 100,000(Negative) | Not detected | | Fluoxetine | 100,000(Negative) | Not detected | | Heroin | 100,000(Negative) | Not detected | | Hydrocodone | 100,000(Negative) | Not detected | | Hydromorphone | 100,000(Negative) | Not detected | | Ketamine | 100,000(Negative) | Not detected | | Levorphanol tartrate | 100,000(Negative) | Not detected | | Meperidine | 100,000(Negative) | Not detected | | Methadone | 100,000(Negative) | Not detected | | Morphine | 100,000(Negative) | Not detected | | Morphine-3-β-D-glucuronide | 100,000(Negative) | Not detected | | Naloxone hydrochloride | 100,000(Negative) | Not detected | | Naltrexonehydrochloride | 100,000(Negative) | Not detected | | Norbuprenorphine | 100,000(Negative) | Not detected | | Norcodeine | 100,000(Negative) | Not detected | | Norketamine | 100,000(Negative) | Not detected | | Normeperidine | 100,000(Negative) | Not detected | | Normorphine | 100,000(Negative) | Not detected | | Noroxycodone | 100,000(Negative) | Not detected | 12 {16} | Oxycodone | 100,000(Negative) | Not detected | | --- | --- | --- | | Oxymorphone | 100,000(Negative) | Not detected | | Pentazocine (Talwin) | 100,000(Negative) | Not detected | | Pipamperone | 100,000(Negative) | Not detected | | Tapentadolhydrochloride | 100,000(Negative) | Not detected | | Thioridazine | 100,000(Negative) | Not detected | | Tilidine | 100,000(Negative) | Not detected | | Tramadol | 100,000(Negative) | Not detected | | Tramadol-O-Desmethyl | 100,000(Negative) | Not detected | | Tramadol-N-Desmethyl | 100,000(Negative) | Not detected | | NFYL(Norfentanyl) (Norfentanyl, Cutoff=5ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | Norfentanyl | 5 | 100% | | Fentanyl | 1,000 | 0.5% | | Acetyl fentanyl | 500 | 1% | | Acetyl Norfentanyl | 50 | 10% | | (±)-β-Hydroxythiofentanyl HCl | 100 | 5% | | Acryl Fentanyl | 100 | 5% | | Butyryl Fentanyl | 500 | 1% | | Cis-d, I 3-Methylfentanyl | 300 | 1.67% | | Furanyl Fentanyl | 1,000 | 0.5% | | Para-fluorobutyl Fentanyl (P-FBF) | 100 | 5% | | Para-fluoroFentanyl | 100 | 5% | | 9-HydroxyRisperidone | 10,000 | 0.05% | | Alfentanil | 100,000(Negative) | Not detected | | Isobutyryl Fentanyl | 80 | 6.25% | | 4-Fluoro-isobutyryl Fentanyl | 200 | 2.5% | | Norcarfentail Oxalate | 10,000 | 0.05% | | Remifentanil | 10,000 | 0.05% | | Valeryl Fentanyl | 500 | 1% | | ThienylFentanyl | 100 | 5% | | Trans-d, I 3-Methylfentanyl | 200 | 2.50% | | Despropionylfentanyl (4-ANPP) | 60,000 | 0.008% | | MT-45 | 8,000 | 0.06% | | Ocfentanil | 5,000 | 0.1% | | Risperidone | 600 | 0.83% | | Sufentanil | 10,000 | 0.05% | | Carfentanil Oxalate | 10,000 | 0.05% | | LabetalolHydrochloride | 100,000(Negative) | Not detected | | Trazodone | 60,000 | 0.008% | | U-47700 | 100,000(Negative) | Not detected | | U-47701 | 100,000(Negative) | Not detected | {17} | ω-1-Hydroxyfentanyl | 60,000 | 0.008% | | --- | --- | --- | | 6-Acetylmorphine | 100,000(Negative) | Not detected | | Amphetamine | 100,000(Negative) | Not detected | | Buprenorphine | 100,000(Negative) | Not detected | | Buprenorphine -3-D-Glucuronide | 100,000(Negative) | Not detected | | Codeine | 100,000(Negative) | Not detected | | Dextromethorphan | 100,000(Negative) | Not detected | | Dihydrocodeine | 100,000(Negative) | Not detected | | EDDP | 100,000(Negative) | Not detected | | EMDP | 100,000(Negative) | Not detected | | Fluoxetine | 100,000(Negative) | Not detected | | Heroin | 100,000(Negative) | Not detected | | Hydrocodone | 100,000(Negative) | Not detected | | Hydromorphone | 100,000(Negative) | Not detected | | Ketamine | 100,000(Negative) | Not detected | | Levorphanol tartrate | 100,000(Negative) | Not detected | | Meperidine | 100,000(Negative) | Not detected | | Methadone | 100,000(Negative) | Not detected | | Morphine | 100,000(Negative) | Not detected | | Morphine-3-β-D-glucuronide | 100,000(Negative) | Not detected | | Naloxone hydrochloride | 100,000(Negative) | Not detected | | Naltrexonehydrochloride | 100,000(Negative) | Not detected | | Norbuprenorphine | 100,000(Negative) | Not detected | | Norcodeine | 100,000(Negative) | Not detected | | Norketamine | 100,000(Negative) | Not detected | | Normeperidine | 100,000(Negative) | Not detected | | Normorphine | 100,000(Negative) | Not detected | | Noroxycodone | 100,000(Negative) | Not detected | | Oxycodone | 100,000(Negative) | Not detected | | Oxymorphone | 100,000(Negative) | Not detected | | Pentazocine (Talwin) | 100,000(Negative) | Not detected | | Pipamperone | 100,000(Negative) | Not detected | | Tapentadolhydrochloride | 100,000(Negative) | Not detected | | Thioridazine | 100,000(Negative) | Not detected | | Tilidine | 100,000(Negative) | Not detected | | Tramadol | 100,000(Negative) | Not detected | | Tramadol-O-Desmethyl | 100,000(Negative) | Not detected | | Tramadol-N-Desmethyl | 100,000(Negative) | Not detected | | MDMA(Ecstasy) (Ecstasy, Cutoff=500ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | 14 {18} | (+/-)3,4-Methylenedioxy-n-ethylamphetamine(MDEA) | 1,000 | 167% | | --- | --- | --- | | (+/-)-Methylenedioxyamphetamine(MDA) | 8,000 | 6.25% | | L-Methamphetamine | 100,000 (Negative) | Not detected | | 7-Aminoclonazepam | 100,000 | 0.5% | | D-Methamphetamine | 100,000 (Negative) | Not detected | | D-Amphetamine | 100,000 (Negative) | Not detected | | L-amphetamine | 100,000 (Negative) | Not detected | | MET(Methamphetamine) (Methamphetamine, Cutoff=500ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | (+/-)3,4-Methylenedioxy-n-ethylamphetamine (MDEA) | 20,000 | 2.5% | | (±)-MDMA | 2,000 | 25% | | L-Methamphetamine | 5,000 | 10% | | Fenfluramine | 40,000 | 1.25% | | p-Hydroxymethamphetamine | 16,000 | 10% | | D,L-Methamphetamine | 500 | 100% | | β-Phenylethylamine | 25,000 | 2% | | Mephetermine | 25,000 | 2% | | Methoxyphenamine hydrochloride | 25,000 | 2% | | L-Amphetamine | 60,000 | 0.8% | | Ephedrine hydrochloride | 100,000 (Negative) | Not detected | | (1R,2S)-(-)-Ephedrine | 100,000 | 0.5% | | D-Amphetamine | 100,000 (Negative) | Not detected | | Chloroquine | 100,000 (Negative) | Not detected | | (+/-)3,4- Methylenedioxyamphetamine(MDA) | 100,000 (Negative) | Not detected | | L-Phenylephrine | 100,000 (Negative) | Not detected | | Trimethobenzamide | 100,000 (Negative) | Not detected | | Procainehydrochloride | 100,000 (Negative) | Not detected | | d/l-Amphetamine | 100,000 (Negative) | Not detected | | MET(Methamphetamine) (Methamphetamine, Cutoff=1000ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | (+/-)3,4-Methylenedioxy-n- | 40,000 | 2.5% | | (+/-)3,4-Methylenedioxymethamphetamine (MDMA) | 8,000 | 12.5% | | L-Methamphetamine | 10,000 | 10% | | Fenfluramine | 100,000 (Negative) | Not detected | | p-Hydroxymethamphetamine | 27,000 | 3.7% | | D,L-Methamphetamine | 1,000 | 100% | 15 {19} | β-Phenylethylamine | 50,000 | 2% | | --- | --- | --- | | Mephetermine | 50,000 | 2% | | Methoxyphenamine hydrochloride | 50,000 | 2% | | L-Amphetamine | 100,000 (Negative) | Not detected | | D-Amphetamine | 100,000 (Negative) | Not detected | | D,L-Amphetamine | 100,000 (Negative) | Not detected | | Chloroquine | 100,000 (Negative) | Not detected | | Ephedrine hydrochloride | 100,000 (Negative) | Not detected | | (+/-)3,4-Methylenedioxyamphetamine (MDA) | 100,000 (Negative) | Not detected | | Trimethobenzamide | 100,000 (Negative) | Not detected | | l-phenylephrine | 100,000 (Negative) | Not detected | | (1R,2S)-(-)-Ephedrine | 100,000 (Negative) | Not detected | | Procainehydrochloride | 100,000 (Negative) | Not detected | | MOR(Morphine) (Morphine, Cutoff=300ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | Codeine | 300 | 100% | | Dihydrocodeine | 1,000 | 30% | | EthylMorphine | 200 | 150% | | Heroin | 700 | 42.86% | | Hydrocodone | 2,000 | 15% | | Hydromorphone | 4,000 | 7.5% | | Levorphanol tartrate | 12,000 | 2.5% | | Nalorphinehydrochloride | 50,000 | 0.6% | | Thebaine | 90,000 | 0.33% | | Morphine-3-β-d-glucuronide | 1,000 | 30% | | 6-Monoacetylmorphine (6-MAM) | 150 | 200% | | Codeine-6-β-D-glucuronide | 150 | 200% | | Morphine-6-β-D-glucuronide | 150 | 200% | | 6-Acetylcodeine | 900 | 33.33% | | Normorphine | 100,000 (negative) | Not detected | | Oxycodone | 100,000 (negative) | Not detected | | Oxymorphone | 100,000 (negative) | Not detected | | Norcodeine | 100,000 (negative) | Not detected | | Procaine | 100,000 (negative) | Not detected | | Norpropoxyphene | 100,000 (negative) | Not detected | | OPI(Morphine) (Morphine, Cutoff=2000ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | Codeine | 1,000 | 200% | | Dihydrocodeine | 1,500 | 133.3% | | EthylMorphine | 500 | 400% | | Heroin | 100,000 (negative) | Not detected | | Hydrocodone | 100,000 (negative) | Not detected | | Hydromorphone | 100,000 (negative) | Not detected | | Levorphanol tartrate | 100,000 (negative) | Not detected | | Nalorphinehydrochloride | 100,000 (negative) | Not detected | | Thebaine | 100,000 (negative) | Not detected | | Morphine-3-β-d-glucuronide | 1,000 | 30% | | 6-Monoacetylmorphine (6-MAM) | 150 | 200% | | Codeine-6-β-D-glucuronide | 150 | 200% | | Morphine-6-β-D-glucuronide | 150 | 200% | | 6-Acetylcodeine | 100 | 33.33% | | Normorphine | 100,000 (negative) | Not detected | | Oxycodone | 100,000 (negative) | Not detected | | Oxymorphone | 100,000 (negative) | Not detected | | Norcodeine | 100,000 (negative) | Not detected | | Procaine | 100,000 (negative) | Not detected | | Norpropoxyphene | 100,000 (negative) | Not detected | 16 {20} | Codeine-6-β-D-glucuronide | 2,500 | 80% | | --- | --- | --- | | Heroin | 5,000 | 40% | | Hydrocodone | 5,000 | 40% | | Hydromorphone | 7,000 | 28.6% | | Levorphanol tartrate | 16,000 | 12.5% | | Nalorphinehydrochloride | 5,0000 | 4% | | Norcodeine | 100,000 (Negative) | Not detected | | Normorphine | 100,000 (Negative) | Not detected | | Oxymorphone | 100,000 (Negative) | Not detected | | s-Monoacetylmorphine | 2,000 | 100% | | Morphine-6-β-D-glucuronide | 1,300 | 153.8% | | Thebaine | 100,000 (Negative) | Not detected | | Morphine 3-β-D-glucuronide | 1,300 | 153.8% | | 6-Monoacetylmorphine (6-MAM) | 1,000 | 200% | | 6-Acetylcodeine | 10,000 | 20% | | Oxycodone | 100,000 (Negative) | Not detected | | Procaine | 100,000 (Negative) | Not detected | | Norpropoxyphene | 100,000 (Negative) | Not detected | | MTD(Methadone) (Methadone, Cutoff=300ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | EDDP | 100,000 (negative) | Not detected | | EMDP | 100,000 (negative) | Not detected | | LAAM | 100,000 (negative) | Not detected | | Alpha Methadol | 100,000 (negative) | Not detected | | Doxylamine | 100,000 (negative) | Not detected | | OXY(Oxycodone) (Oxycodone, Cutoff=100ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | Ethyl Oxycodone | 75,000 | 0.13% | | Hydrocodone | 10,000 | 1% | | Hydromorphone | 100,000 (negative) | Not detected | | Levorphanol tartrate | 25,000 | 0.40% | | Naloxone hydrochloride | 10,000 | 1% | | Naltrexone hydrochloride | 50,000 | 0.2% | | Oxymorphone | 200 | 50% | | Oxymorphone-3β-D-glucuronide | 100,000 (negative) | Not detected | | Noroxycodone | 1,500 | 6.67% | | Noroxymorphone | 3,000 | 3.33% | | Dihydrocodeine | 100,000 (negative) | Not detected | | Codeine | 100,000 (negative) | Not detected | | Morphine | 100,000 (negative) | Not detected | 17 {21} | Buprenorphine | 100,000 (negative) | Not detected | | --- | --- | --- | | Ethylmorphine | 100,000 (negative) | Not detected | | Thebaine | 100,000 (negative) | Not detected | | 6-acetylmorphine | 100,000 (negative) | Not detected | | PCP(Phencyclidine) (Phencyclidine, Cutoff=25ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | 4-Hydroxyphencyclidine | 12,500 | 0.2% | | PPX(Propoxyphene) (Propoxyphene, Cutoff=300ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | Norpropoxyphene | 1,500 | 20% | | TCA(Nortriptyline) (Nortriptyline, Cutoff=1000ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | Amitriptyline | 5,000 | 20% | | Chlorpheniramine | 50,000 | 2% | | Clomipramine | 10,000 | 10% | | Cyclobenzaprine Hydrochloride | 5,000 | 20% | | Desipramine | 1,000 | 100% | | Doxepine | 2,000 | 50% | | Duloxetine | 10,000 | 10% | | Imipramine | 1,000 | 100% | | Norclomipramine | 100,000 (negative) | Not detected | | Nordoxepine | 1,000 | 100% | | Promazine | 50,000 | 2% | | Trimipramine | 10,000 | 10% | | Maprotiline | 100,000 (negative) | Not detected | | Promethazine | 100,000 (negative) | Not detected | | THC(Marijuana) (Marijuana, Cutoff=50ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | 11-nor-Δ8-THC -9-COOH | 30 | 166.67% | | (-)-11-nor-9-carboxy-Δ9-THC | 50 | 100% | | (±)-11-nor-9-Carboxy-Δ9-THC | 50 | 100% | | 11-nor-Δ9-THC -carboxyglucuronide | 100 | 50% | | 11-hydroxy-Δ9-Tetrahydrocannabinol | 15,000 | 0.33% | | Δ8- Tetrahydrocannabinol | 8,000 | 0.63% | | Δ9- Tetrahydrocannabinol | 7,000 | 0.71% | | Cannabinol | 100,000 (negative) | Not detected | | Cannabidiol | 100,000 (negative) | Not detected | 18 {22} 19 | (±)-11-Hydroxy-Δ9-THC | 100,000 (negative) | Not detected | | --- | --- | --- | | TML(Tramadol) (Tramadol, Cutoff=100ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | n-Desmethyl Tramadol | 400 | 25% | | o-Desmethyl Tramadol | 1,000 | 10% | | o-Desmethyl Venlafaxine | 100,000 (negative) | Not detected | | Venlafaxine HCl | 100,000 (negative) | Not detected | 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 100μg/mL or specified concentrations are summarized in the following table. | 11-nor-9 carboxy THC (except for THC) | Diphenylhydantoin | Norpropoxyphene (except for PPX) | | --- | --- | --- | | 3-Hydroxytyramine | Disopyramide | Norpseudoephedrine | | 4-Bromo-2,5,Dimethoxyphenethylamine | DL-Tryptophan | Nortriptyline (except for TCA) | | 7-Aminoclonazepam (except for MDMA) | DL-Tyrosine | Noscapine | | 7-Aminoflunitrazepam | Dopamine | O-Hydroxyhippuric acid | | 7-Aminonitrazepam | Doxepin (except for TCA) | Octopamine | | Acetaminophen | Doxylamine | Olanzapine | | Acetone (1000 mg/dL) | Duloxetine (except for TCA) | Omeprazole | | Acetophenetidin | Ecgonine methyl ester | Oxalic Acid (100mg/dL) | | Acetylsalicylic Acid (500 μg/mL) | Ephedrine | Oxalinic acid | | Acyclovir | Erythromycin | Oxazepam (except for BZO) | | Albumin(100 mg/dL) | Esomeprazole Magnesium | Oxolinic acid | | Albuterol | Estradiol | Oxymetazoline | | Alpha Methadol | Estrone | Paliperidone | | Aminophylline | Ethanol (1%) | Papaverine | | Aminopyrine | Fenfluramine (except for MET 500) | Penicillin-G | | Amitriptyline (except for TCA) | Fenofibrate | PenicillinV Potassium | | Amlodipine besylate | Fenoprofen | Pentazocine | | Amobarbital (except for TCA) | Fluoxetine Hydrochloride | Perphenazine | | Amoxicillin | Fluphenazine | Phencyclidine (except for PCP) | | Ampicillin | Fotemustine | Phenelzine | | Apomorphine | Furosemide | Phenobarbital (except for BAR) | | Aripiprazole | Gabapentin | Phentermine (except for AMP) | | Ascorbic Acid | Galactose | Phenylethylamine (except for AMP, 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) | | Azithromycin | Guaiacolglyceryl ether | Promethazine | | 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 | {23} | 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 | | Cannabidiol | Isoxsuprine | Ranitidine | | Captopril | Ketamine | Riboflavin | | Carbamazepine | Ketoprofen | Rifampicin | | Carfentanil (except for NFYL) | L-Epinephrine | Salicylic Acid | | Carisoprodol | L-phenylephrine | Secobarbital (except for BAR) | | Cefradine | L-thyroxine | Serotonin(5-Hydroxytyramine) | | Cephalexin | LAAM HCl | Sertraline | | Cetirizine | Labetalol | Sildenafil Citrate | | Chloral hydrate | Lamotrigine | Simvastatin | | Chloramphenicol | Levofloxacin Hydrochloride | Sodium Azide | | Chlordiazepoxide (except for BZO) | Levonorgestrel | Sufentanil Citrate (except for FYL, NFYL) | | Chloroquine | Levothyroxine Sodium | Sulfamethazine | | Chlorothiazide | Lidocaine | Sulindac | | Chlorpheniramine (except for TCA) | 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 (except for THC) | | Clofibrate | Magnesium | Theophylline | | Clomipramine (except for TCA) | Maprotiline | Thiamine | | Clonidine | Meperidine | Thioridazine | | Clozapine | Meprobamate | Trazodone Hydrochloride (except for FYL, NFYL) | | Conjugated Estrogens | Metformin | Triamterene | | Cortisone | Methapyrilene | Trifluoperazine | | Cotinine | Methaqualone | Trifluoromethylphenyl- piperazine | | Creatine Hydrate | Methoxyphenamine (except for MET) | Trimethobenzamide | | Creatinine | Methylphenidate | Trimethoprim | | Cyclobenzaprine (except for TCA) | Metoprolol | Tryptamine | | Cyclodextrin-r | Metronidazole (300 ug/mL) | Tyramine (except for AMP) | | 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 | NaCl (40000 ug/mL) | Venlafaxine | | Demoxepam (except for BZO) | Nalidixic Acid | Verapamil | | Deoxycorticosterone | Naloxone (except for OXY) | Vitamin B2 | | Desipramine (except for TCA) | Naltrexone (except for OXY) | 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 | Norethindrone | | 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** {24} 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 Cup 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%) | | --- | --- | --- | --- | --- | --- | --- | --- | | 6-MAM10 | Operator A | - | 10 | 16 | 13 | 2 | 0 | | | | + | 0 | 0 | 1 | 19 | 19 | | | Operator B | - | 10 | 16 | 13 | 1 | 0 | | | | + | 0 | 0 | 1 | 20 | 19 | | | Operator C | - | 10 | 16 | 14 | 2 | 0 | | | | + | 0 | 0 | 0 | 19 | 19 | | AMP500 | Operator A | - | 10 | 18 | 11 | 1 | 0 | | | | + | 0 | 0 | 1 | 15 | 24 | | | Operator B | - | 10 | 18 | 11 | 1 | 0 | | | | + | 0 | 0 | 1 | 15 | 24 | | | Operator C | - | 10 | 18 | 11 | 1 | 0 | | | | + | 0 | 0 | 1 | 15 | 24 | | AMP1000 | Operator A | - | 10 | 14 | 14 | 1 | 0 | | | | + | 0 | 0 | 2 | 17 | 22 | | | Operator B | - | 10 | 14 | 15 | 1 | 0 | | | | + | 0 | 0 | 1 | 17 | 22 | | | Operator C | - | 10 | 14 | 14 | 0 | 0 | | | | + | 0 | 0 | 2 | 18 | 22 | | BAR300 | Operator A | - | 10 | 16 | 14 | 2 | 0 | | | | + | 0 | 0 | 0 | 17 | 21 | | | Operator B | - | 10 | 16 | 13 | 1 | 0 | | | | + | 0 | 0 | 1 | 18 | 21 | | | Operator C | - | 10 | 16 | 14 | 2 | 0 | | | | + | 0 | 0 | 0 | 17 | 21 | | BUP10 | Operator A | - | 10 | 16 | 14 | 2 | 0 | | | | + | 0 | 0 | 0 | 14 | 24 | | | Operator B | - | 10 | 16 | 13 | 1 | 0 | | | | + | 0 | 0 | 1 | 15 | 24 | | | Operator C | - | 10 | 16 | 13 | 1 | 0 | | | | + | 0 | 0 | 1 | 15 | 24 | | BZO300 | Operator | - | 10 | 19 | 10 | 1 | 0 | {25} | | A | + | 0 | 0 | 1 | 15 | 24 | | --- | --- | --- | --- | --- | --- | --- | --- | | | Operator B | - | 10 | 19 | 10 | 1 | 0 | | | | + | 0 | 0 | 1 | 15 | 24 | | | Operator C | - | 10 | 19 | 10 | 1 | 0 | | | | + | 0 | 0 | 1 | 15 | 24 | | COC150 | Operator A | - | 10 | 15 | 14 | 2 | 0 | | | | + | 0 | 0 | 1 | 15 | 23 | | | Operator B | - | 10 | 15 | 14 | 1 | 0 | | | | + | 0 | 0 | 1 | 16 | 23 | | | Operator C | - | 10 | 15 | 14 | 1 | 0 | | | | + | 0 | 0 | 1 | 16 | 23 | | COC300 | Operator A | - | 10 | 16 | 13 | 1 | 0 | | | | + | 0 | 0 | 1 | 21 | 18 | | | Operator B | - | 10 | 16 | 13 | 2 | 0 | | | | + | 0 | 0 | 1 | 20 | 18 | | | Operator C | - | 10 | 16 | 12 | 0 | 0 | | | | + | 0 | 0 | 2 | 22 | 18 | | EDDP300 | Operator A | - | 10 | 13 | 16 | 1 | 0 | | | | + | 0 | 0 | 1 | 15 | 24 | | | Operator B | - | 10 | 13 | 16 | 1 | 0 | | | | + | 0 | 0 | 1 | 15 | 24 | | | Operator C | - | 10 | 13 | 17 | 1 | 0 | | | | + | 0 | 0 | 0 | 15 | 24 | | FYL1 | Operator A | - | 10 | 14 | 14 | 0 | 0 | | | | + | 0 | 0 | 2 | 18 | 22 | | | Operator B | - | 10 | 14 | 14 | 1 | 0 | | | | + | 0 | 0 | 2 | 17 | 22 | | | Operator C | - | 10 | 14 | 14 | 1 | 0 | | | | + | 0 | 0 | 2 | 17 | 22 | | NFYL5 | Operator A | - | 10 | 16 | 13 | 2 | 0 | | | | + | 0 | 0 | 1 | 14 | 24 | | | Operator B | - | 10 | 16 | 12 | 1 | 0 | | | | + | 0 | 0 | 2 | 15 | 24 | | | Operator C | - | 10 | 16 | 12 | 1 | 0 | | | | + | 0 | 0 | 2 | 15 | 24 | | MDMA500 | Operator A | - | 10 | 16 | 13 | 1 | 0 | | | | + | 0 | 0 | 1 | 18 | 21 | | | Operator B | - | 10 | 16 | 13 | 1 | 0 | | | | + | 0 | 0 | 1 | 18 | 21 | | | Operator C | - | 10 | 16 | 13 | 1 | 0 | | | | + | 0 | 0 | 1 | 18 | 21 | | MET500 | Operator | - | 10 | 16 | 13 | 1 | 0 | {26} | | A | + | 0 | 0 | 1 | 15 | 24 | | --- | --- | --- | --- | --- | --- | --- | --- | | | Operator B | - | 10 | 16 | 12 | 1 | 0 | | | | + | 0 | 0 | 2 | 15 | 24 | | | Operator C | - | 10 | 16 | 13 | 1 | 0 | | | | + | 0 | 0 | 1 | 15 | 24 | | MET1000 | Operator A | - | 10 | 16 | 13 | 1 | 0 | | | | + | 0 | 0 | 1 | 18 | 21 | | | Operator B | - | 10 | 16 | 13 | 2 | 0 | | | | + | 0 | 0 | 1 | 17 | 21 | | | Operator C | - | 10 | 16 | 13 | 1 | 0 | | | | + | 0 | 0 | 1 | 18 | 21 | | MTD300 | Operator A | - | 10 | 16 | 13 | 1 | 0 | | | | + | 0 | 0 | 1 | 18 | 21 | | | Operator B | - | 10 | 16 | 13 | 1 | 0 | | | | + | 0 | 0 | 1 | 18 | 21 | | | Operator C | - | 10 | 16 | 14 | 3 | 0 | | | | + | 0 | 0 | 0 | 16 | 21 | | MOP300 | Operator A | - | 10 | 13 | 17 | 1 | 0 | | | | + | 0 | 0 | 0 | 20 | 19 | | | Operator B | - | 10 | 13 | 16 | 2 | 0 | | | | + | 0 | 0 | 1 | 19 | 19 | | | Operator C | - | 10 | 13 | 16 | 0 | 0 | | | | + | 0 | 0 | 1 | 21 | 19 | | OPI2000 | Operator A | - | 10 | 16 | 11 | 0 | 0 | | | | + | 0 | 0 | 3 | 21 | 19 | | | Operator B | - | 10 | 16 | 13 | 1 | 0 | | | | + | 0 | 0 | 1 | 20 | 19 | | | Operator C | - | 10 | 16 | 13 | 1 | 0 | | | | + | 0 | 0 | 1 | 20 | 19 | | OXY100 | Operator A | - | 10 | 15 | 15 | 1 | 0 | | | | + | 0 | 0 | 0 | 17 | 22 | | | Operator B | - | 10 | 15 | 13 | 1 | 0 | | | | + | 0 | 0 | 2 | 17 | 22 | | | Operator C | - | 10 | 15 | 14 | 0 | 0 | | | | + | 0 | 0 | 1 | 18 | 22 | | PCP25 | Operator A | - | 10 | 16 | 14 | 2 | 0 | | | | + | 0 | 0 | 0 | 16 | 22 | | | Operator B | - | 10 | 16 | 14 | 1 | 0 | | | | + | 0 | 0 | 0 | 17 | 22 | | | Operator C | - | 10 | 16 | 13 | 0 | 0 | | | | + | 0 | 0 | 1 | 18 | 22 | | PPX300 | Operator | - | 10 | 17 | 13 | 2 | 0 | {27} | | A | + | 0 | 0 | 0 | 17 | 21 | | --- | --- | --- | --- | --- | --- | --- | --- | | | Operator B | - | 10 | 17 | 13 | 1 | 0 | | | | + | 0 | 0 | 0 | 18 | 21 | | | Operator C | - | 10 | 17 | 12 | 1 | 0 | | | | + | 0 | 0 | 1 | 18 | 21 | | TCA1000 | Operator A | - | 10 | 17 | 12 | 1 | 0 | | | | + | 0 | 0 | 1 | 16 | 23 | | | Operator B | - | 10 | 17 | 12 | 2 | 0 | | | | + | 0 | 0 | 1 | 15 | 23 | | | Operator C | - | 10 | 17 | 13 | 2 | 0 | | | | + | 0 | 0 | 0 | 15 | 23 | | THC50 | Operator A | - | 10 | 15 | 14 | 1 | 0 | | | | + | 0 | 0 | 1 | 20 | 19 | | | Operator B | - | 10 | 15 | 14 | 1 | 0 | | | | + | 0 | 0 | 1 | 20 | 19 | | | Operator C | - | 10 | 15 | 15 | 2 | 0 | | | | + | 0 | 0 | 0 | 19 | 19 | | TML100 | Operator A | - | 10 | 16 | 13 | 2 | 0 | | | | + | 0 | 0 | 1 | 16 | 22 | | | Operator B | - | 10 | 16 | 13 | 0 | 0 | | | | + | 0 | 0 | 1 | 18 | 22 | | | Operator C | - | 10 | 16 | 13 | 1 | 0 | | | | + | 0 | 0 | 1 | 17 | 22 | Discordant Results are summarized below. | Drug | Operator | Sample Number | LC/MS/MS Result (ng/mL) | Accurate Result | | --- | --- | --- | --- | --- | | 6AM | Operator A | 2025021225 | 11.69 | - | | | Operator C | 2024112928 | 10.03 | - | | | Operator A, C | 2025010829 | 10.37 | - | | | Operator B | 2025022819 | 10.14 | - | | | Operator A, B | 2024121928 | 9.62 | + | | AMP500 | Operator A | 2024072222 | 520.38 | - | | | Operator B | 2024092628 | 506.41 | - | | | Operator C | 2024081607 | 512.57 | - | | | Operator A | 2024120516 | 494.96 | + | | | Operator B | 2024073117 | 473.49 | + | | | Operator C | 2025011427 | 443.03 | + | | AMP1000 | Operator A | 2025022406 | 1018.68 | - | | | Operator B | 2024082723 | 1029.82 | - | | | Operator B, C | 2024082624 | 984.60 | + | | | Operator A | 2024071704 | 989.98 | + | {28} | | Operator A, C | 2025021122 | 875.36 | + | | --- | --- | --- | --- | --- | | BAR300 | Operator A | 2024071518 | 311.29 | - | | | Operator A | 2025012211 | 333.75 | - | | | Operator B | 2024092411 | 344.57 | - | | | Operator C | 2024112222 | 323.25 | - | | | Operator C | 2025012217 | 325.28 | - | | | Operator B | 2024070127 | 294.61 | + | | BUP10 | Operator A | 2024072327 | 12.38 | - | | | Operator A | 2024102420 | 10.17 | - | | | Operator B | 2025022828 | 10.15 | - | | | Operator C | 2025011721 | 10.01 | - | | | Operator B | 2024110828 | 9.85 | + | | | Operator C | 2024081216 | 9.36 | + | | BZO300 | Operator A | 2025012103 | 305.56 | - | | | Operator B | 2024110729 | 301.66 | - | | | Operator C | 2024070128 | 311.53 | - | | | Operator A, C | 2024110118 | 264.48 | + | | | Operator B | 2024093005 | 278.91 | + | | COC150 | Operator A | 2024112124 | 152.97 | - | | | Operator B | 2024123126 | 151.87 | - | | | Operator A, C | 2024071513 | 150.11 | - | | | Operator A, B | 2024093011 | 149.17 | + | | | Operator C | 2025021221 | 147.39 | + | | COC300 | Operator A,B | 2024101021 | 300.47 | - | | | Operator B | 2024082311 | 304.87 | - | | | Operator C | 2025010603 | 296.21 | + | | | Operator A,B,C | 2024082222 | 299.37 | + | | EDDP300 | Operator A | 2025012323 | 303.33 | - | | | Operator B, C | 2024071623 | 308.15 | - | | | Operator A | 2025010618 | 290.68 | + | | | Operator B | 2024103023 | 298.10 | + | | FYL1 | Operator B | 2024092630 | 1.03 | - | | | Operator C | 2024111411 | 1.01 | - | | | Operator A, C | 2025010803 | 0.99 | + | | | Operator A | 2024111501 | 0.94 | + | | | Operator B, C | 2024070914 | 0.89 | + | | | Operator B | 2024080509 | 0.99 | + | | NFYL5 | Operator A | 2024082121 | 5.93 | - | | | Operator B,C | 2024090221 | 5.24 | - | | | Operator A | 2024120311 | 5.09 | - | | | Operator C | 2024071209 | 4.12 | + | | | Operator C | 2024071216 | 3.99 | + | | | Operator B | 2025022821 | 4.11 | + | {29} | | Operator A,B | 2025021826 | 4.62 | + | | --- | --- | --- | --- | --- | | MDMA500 | Operator A | 2024122504 | 512.65 | - | | | Operator B | 2024082902 | 505.45 | - | | | Operator C | 2024091212 | 501.55 | - | | | Operator A | 2025012429 | 498.12 | + | | | Operator B | 2024080521 | 488.93 | + | | | Operator C | 2024122412 | 469.24 | + | | MET500 | Operator A | 2024121328 | 516.28 | - | | | Operator B | 2024111330 | 500.12 | - | | | Operator C | 2024081506 | 506.10 | - | | | Operator A, B | 2024120413 | 496.93 | + | | | Operator B | 2025012023 | 485.93 | + | | | Operator C | 2024070214 | 463.37 | + | | MET1000 | Operator B, C | 2024072201 | 1142.94 | - | | | Operator A | 2024072421 | 1000.87 | - | | | Operator B | 2024111414 | 1014.70 | - | | | Operator C | 2024070803 | 980.34 | + | | | Operator B | 2024071613 | 998.49 | + | | | Operator A | 2024092417 | 998.48 | + | | MTD300 | Operator A | 2024070110 | 312.01 | - | | | Operator C | 2024090327 | 338.62 | - | | | Operator B, C | 2024110616 | 302.80 | - | | | Operator C | 2025010714 | 308.66 | - | | | Operator B | 2024101503 | 241.25 | + | | | Operator A | 2024121005 | 298.81 | + | | MOP300 | Operator A, B | 2024083003 | 306.99 | - | | | Operator B | 2024090405 | 359.23 | - | | | Operator C | 2024120925 | 241.77 | + | | | Operator B | 2025011722 | 298.07 | + | | OPI2000 | Operator B,C | 2024092621 | 2032.06 | - | | | Operator A | 2024081411 | 1946.49 | + | | | Operator A,C | 2025022118 | 1992.26 | + | | | Operator A,B | 2024071702 | 1890.60 | + | | OXY100 | Operator B | 2025021017 | 118.39 | - | | | Operator A | 2024112817 | 101.02 | - | | | Operator B | 2024112917 | 93.38 | + | | | Operator B,C | 2025010903 | 98.65 | + | | PCP25 | Operator A, B | 2024082203 | 25.61 | - | | | Operator A | 2024122009 | 26.88 | - | | | Operator C | 2024091909 | 24.51 | + | | PPX300 | Operator A | 2024102227 | 319.65 | - | | | Operator B,C | 2024082228 | 306.89 | - | | | Operator A | 2024103108 | 305.09 | - | {30} # C. Lay person study A lay user study was performed at three intended user sites with 280 lay persons. 158 male and 122 female tested the Webest Multi-Drug Urine Cup. They had diverse educational and professional backgrounds and their age range from 20 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 The Webest Multi-Drug Urine Cup: Configuration 1 | Drug | Cutoff (ng/mL) | Results | Concentration | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff | | AMP | 500 | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 100% | | BAR | 300 | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 100% | | BUP | 10 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | | CYP2C1 | 10 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | | CYP3A1 | 10 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | | CYP3A2 | 10 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | | CYP3A3 | 10 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | {31} | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | | BZO | 300 | Positive | 0 | 0 | 0 | 0 | 18 | 20 | | | | Negative | 20 | 20 | 20 | 20 | 2 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 100% | 90% | 100% | | COC | 150 | Positive | 0 | 0 | 0 | 2 | 19 | 20 | | | | Negative | 20 | 20 | 20 | 18 | 1 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | | EDDP | 300 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | | FYL | 1 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | | MDMA | 500 | Positive | 0 | 0 | 0 | 2 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 18 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 90% | 100% | 100% | | MET | 500 | Positive | 0 | 0 | 0 | 2 | 19 | 20 | | | | Negative | 20 | 20 | 20 | 18 | 1 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | | MTD | 300 | Positive | 0 | 0 | 0 | 2 | 19 | 20 | | | | Negative | 20 | 20 | 20 | 18 | 1 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | | 6-MAM | 10 | Positive | 0 | 0 | 0 | 2 | 19 | 20 | | | | Negative | 20 | 20 | 20 | 18 | 1 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | | NFYL | 5 | Positive | 0 | 0 | 0 | 2 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 18 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 90% | 100% | 100% | | MOP | 300 | Positive | 0 | 0 | 0 | 2 | 19 | 20 | | | | Negative | 20 | 20 | 20 | 18 | 1 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | | OXY | 100 | Positive | 0 | 0 | 0 | 2 | 19 | 20 | {32} Result of the Webest Multi-Drug Urine Cup: Configuration 2 | Drug | Cutoff (ng/mL) | Results | Concentration | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff | | | | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff | | AMP | 1000 | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% | | BAR | 300 | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% | | BUP | 10 | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% | | BZO | 300 | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% | {33} | | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | COC | 300 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% | | EDDP | 300 | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | | FYL | 1 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% | | MDMA | 500 | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% | | MET | 1000 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% | | MTD | 300 | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | | 6-MAM | 10 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% | | NFYL | 5 | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 100% | | OPI | 2000 | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 100% | | OXY | 100 | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 100% | | PCP | 25 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | {34} | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% | | PPX | 300 | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% | | TCA | 1000 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% | | THC | 50 | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | | TML | 100 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | | | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | | | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 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 ch…
Innolitics
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