AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
Device Facts
| Record ID | K180349 |
|---|---|
| Device Name | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests |
| Applicant | Assure Tech. (Hangzhou) Co, Ltd. |
| Product Code | NFT · Clinical Toxicology |
| Decision Date | Apr 5, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Intended Use
AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamine, Phencyclidine. Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of: [Table of cut-offs]. Configuration of the AssureTech Panel Dip Tests and the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
Device Story
AssureTech Panel Dip Tests and Quick Cup Tests are lateral flow immunochromatographic assays for qualitative detection of drugs of abuse in human urine. Device formats include dip cards or cups. Principle: competitive binding; target drugs below cutoff allow antibody-coated particles to bind to immobilized drug-conjugate, forming a visible test line; drugs above cutoff saturate binding sites, preventing line formation. Control line forms regardless of drug presence. Used in point-of-care or home settings by lay users or professionals. Output is visual (presence/absence of lines). Results are preliminary; positive results require confirmation via GC/MS or LC/MS. Benefits include rapid, simultaneous screening for multiple substances to assist in clinical decision-making.
Clinical Evidence
Bench testing only. Performance validated via precision studies (25 days, two runs/day), interference testing with physiological/pathological substances, specificity/cross-reactivity analysis, and method comparison against LC/MS. Lay-user study (n=310 per format) confirmed ease of use and accuracy across diverse demographics. No clinical studies performed.
Technological Characteristics
Lateral flow immunochromatographic assay. Competitive binding principle using monoclonal mouse antibodies. Form factors: Panel Dip Cards or Cups. Single-use. Stable at 4-30°C for 24 months. No electronic components; no software.
Indications for Use
Indicated for qualitative, simultaneous detection of drugs of abuse (Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, MDMA, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene) in human urine. Intended for OTC and prescription use. Not for distinguishing between prescription use and abuse.
Regulatory Classification
Identification
An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Predicate Devices
- CO-INNOVATION BIOTECH Rapid Multi-Drug Test Dip Card and Rapid Multi-Drug Test Cup (K153050)
Related Devices
- K181768 — AssureTech Panel Dip Tests, AssureTech Quick Cup Tests · Assure Tech. (Hangzhou) Co, Ltd. · Aug 20, 2018
- K181790 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup · Hangzhou Clongene Biotech Co., Ltd. · Jul 26, 2018
- K170049 — AssureTech Panel Dip Test, AssureTech Quick Cup Test · Assure Tech. (Hangzhou) Co, Ltd. · May 2, 2017
- K232736 — Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test · Chemtron Biotech, Inc. · Dec 20, 2023
- K201630 — AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests · Assure Tech. (Hangzhou) Co, Ltd. · Aug 12, 2021
Submission Summary (Full Text)
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April 5, 2018
Assure Tech (Hangzhou) Co., Ltd. % Joe Shia Manager LSI International 504 E Diamond Ave, Suite I Gaithersburg, MD 20877
Re: K180349
Trade/Device Name: AssureTech Panel Dip Tests, AssureTech Quick Cup Tests Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, NFW, NFY, NGG, NGL, NFV, PTH, NGM, PTG, QAW, QBF Dated: February 5, 2018 Received: February 8, 2018
Dear Joe Shia:
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 (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. 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR
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Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
> Sincerely, Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) k180349
Device Name AssureTech Panel Dip Tests AssureTech Quick Cup Tests
#### Indications for Use (Describe)
AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamine, Phencyclidine. Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|--------------------------------|-------------------------|
| Amphetamine | 1000 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Marijuana | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Morphine | 300 ng/mL or 2000 ng/mL |
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxy-methamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
| Methadone | 300 ng/mL |
| EDDP | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
| d-Propoxyphene | 300 ng/mL |
Configuration of the AssureTech Panel Dip Tests and the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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## k180349 510(k) SUMMARY
Email: customerservice@assurelabs.com.
- March 13, 2018 1. Date: 2. Submitter: Assure Tech. Co., Ltd. Building 1, No.10, Xiyuansan Road, Westlake Economic Zone Hangzhou, China, 310030 3. Contact person: Eric Lin Assure Tech. Co., Ltd. Building 1, No.10, Xiyuansan Road, Westlake Economic Zone Hangzhou, China, 310030 Telephone: 510-860-4680
- 4. Device Name: AssureTech Panel Dip Tests AssureTech Quick Cup Tests
| Classification: | Class 2 | | |
|-------------------------------------------|----------------|-------------------------------------------------------------------|-----------------|
| Product Code | Classification | Regulation Section | Panel |
| NFT<br>Amphetamine | II | 21 CFR § 862.3100, Amphetamine<br>Test System | Toxicology (91) |
| NFW<br>Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids<br>Test System | Toxicology (91) |
| NFY<br>Cocaine | II | 21 CFR § 862.3250, Cocaine and<br>Cocaine Metabolites Test System | Toxicology (91) |
| NGG<br>Methamphetamine | II | 21 CFR § 862.3610,<br>Methamphetamine Test System | Toxicology (91) |
| NGL<br>Morphine | II | 21 CFR § 862.3650, Morphine<br>Test System | Toxicology (91) |
| NFV<br>Oxazepam | II | 21 CFR § 862.3170,<br>Benzodiazepine Test System | Toxicology (91) |
| NGL<br>Oxycodone | II | 21 CFR § 862.3650, Opiate Test<br>System | Toxicology (91) |
| PTH<br>Secobarbital | II | 21 CFR § 862.3150, Barbiturate<br>Test System | Toxicology (91) |
| NGL<br>Buprenorphine | II | 21 CFR § 862.3650,<br>Opiate Test System | Toxicology (91) |
| NGG<br>Methylenedioxy-<br>methamphetamine | II | 21 CFR § 862.3610,<br>Methamphetamine Test System | Toxicology (91) |
| NGM<br>Phencyclidine | unclassified | Enzyme Immunoassay<br>Phencyclidine | Toxicology (91) |
| PTG<br>Methadone | II | 21 CFR § 862.3620, Methadone<br>Test System | Toxicology (91) |
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| PTG<br>2-ethylidene-1, 5-<br>dimethyl-3, 3-<br>diphenylpyrrolidine<br>(EDDP) | II | 21 CFR § 862.3620, Methadone<br>Test System | Toxicology (91) |
|------------------------------------------------------------------------------|----|----------------------------------------------------------------|-----------------|
| QAW<br>Nortriptyline | II | 21 CFR, 862.3910 Tricyclic<br>Antidepressant Drugs Test System | Toxicology (91) |
| QBF<br>Propoxyphene | II | 21 CFR, 862.3700 Propoxyphene<br>Test System | Toxicology (91) |
- 5. Predicate Devices: K153050
The CO-INNOVATION BIOTECH Rapid Multi-Drug Test Dip Card and Rapid Multi-Drug Test Cup
- 6. Indications for Use
AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|--------------------------------|-------------------------|
| Amphetamine | 1000 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Marijuana | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Morphine | 300 ng/mL or 2000 ng/mL |
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxy-methamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
| Methadone | 300 ng/mL |
| EDDP | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
| d-Propoxyphene | 300 ng/mL |
Configuration of the AssureTech Panel Dip Tests and the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes.
The test may vield positive results for the prescription drugs Buprenorphine. Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
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- 7. Device Description
The AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Panel Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch
- 8. Substantial Equivalence Information
A summary comparison of features of the AssureTech Panel Dip Tests and AssureTech Quick Cup Tests and the predicate devices is provided in following tables.
| Item | Device | Predicate - K153050 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of drugs of<br>abuse in human urine. | Same (but the number of<br>drugs detected is different) |
| Calibrator and<br>Cut-Off Values | Amphetamine (AMP): 1,000 ng/ml<br>Oxazepam (BZO):300 ng/ml<br>Cocaine(COC): 300 ng/ml<br>Marijuana (THC):50 ng/ml<br>Methamphetamine (MET): 1,000 ng/ml<br>Morphine (MOR): 300ng/mL or 2000 ng/ml<br>Oxycodone(OXY) : 100 ng/ml<br>Secobarbital (BAR): 300 ng/ml<br>Buprenorphine (BUP): 10 ng/ml<br>Methylenedioxy-methamphetamine(MDMA):<br>500 ng/ml<br>Phencyclidine (PCP): 25 ng/ml<br>Methadone (MTD): 300 ng/ml<br>2-ethylidene-1, 5-dimethyl-3, 3-<br>diphenylpyrrolidine (EDDP): 300 ng/ml<br>Nortriptyline (TCA): 1000 ng/ml<br>Propoxyphene (PPX): 300 ng/ml | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on the<br>principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For over-the-counter | Same |
Table 1: Features Comparison of AssureTech Panel Dip Tests and the Predicate Devices
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| Configurations | Dip Card | Same |
|----------------|----------|------|
|----------------|----------|------|
#### Table 2: Features Comparison of AssureTech Quick Cup Tests and the Predicate Devices
| Item | Device | Predicate - K153050 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of<br>drugs of abuse in human urine. | Same (but the number of<br>drugs detected is different) |
| Calibrator and Cut-Off<br>Values | Amphetamine (AMP): 1,000 ng/ml<br>Oxazepam (BZO):300 ng/ml<br>Cocaine(COC): 300 ng/ml<br>Marijuana (THC):50 ng/ml<br>Methamphetamine (MET): 1,000 ng/ml<br>Morphine (MOR): 300ng/mL or 2000 ng/ml<br>Oxycodone(OXY) : 100 ng/ml<br>Secobarbital (BAR): 300 ng/ml<br>Buprenorphine (BUP): 10 ng/ml<br>Methylenedioxy-<br>methamphetamine(MDMA): 500 ng/ml<br>Phencyclidine (PCP): 25 ng/ml<br>Methadone (MTD): 300 ng/ml<br>2-ethylidene-1, 5-dimethyl-3, 3-<br>diphenylpyrrolidine (EDDP): 300 ng/ml<br>Nortriptyline (TCA): 1000 ng/ml<br>Propoxyphene (PPX): 300 ng/ml | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on<br>the principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For over-the-counter | Same |
| Configurations | Cup | Same |
#### 9. Test Principle
The AssureTech Panel Dip Tests, and AssureTech Quick Cup Tests are rapid tests for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and Propoxyphene in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized
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drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.
#### 10. Performance Characteristics
- 1. Analytical Performance
- Precision a.
Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables for 2ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP), Nortriptyline (TCA) and Propoxyphene (PPX). The rest data were reported in the k170049.
#### EDDP
Panel Dip
| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Quick Cup
| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
### Nortriptyline
Panel Dip
| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Quick Cup
| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 8-/42+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 8-/42+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
### Propoxyphene
Panel Dip
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| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Quick Cup | | | | | | | | | |
| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 8-/42+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
#### c. Stability
The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 °C and real time stability determination at both 4 °C and 30 °C.
#### d. Interference
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration of 100µg/mL (albumin was tested at 100 mg/dL) are summarized in the following tables. There were no differences observed for different devices.
| Acetaminophen | β-Estradiol | Oxalic acid |
|----------------------|------------------------|--------------------------------------------|
| Acetophenetidin | Erythromycin | Oxolinic acid |
| N-Acetylprocainamide | Fenoprofen | Oxymetazoline |
| Acetylsalicylic acid | Furosemide | Papaverine |
| Albumin (100 mg/dL) | Gentisic acid | Penicillin G |
| Aminopyrine | Hemoglobin | Perphenazine |
| Amoxicillin | Hydralazine | Phenelzine |
| Ampicillin | Hydrochlorothiazide | Prednisone |
| Apomorphine | Hydrocortisone | (±)-Propranolol |
| Ascorbic acid | O-Hydroxyhippuric acid | Pseudoephedrine |
| Aspartame | 3-Hydroxytyramine | Quinine |
| Atropine | Ibuprofen | Ranitidine |
| Benzilic acid | Isoproterenol | Salicylic acid |
| Benzoic acid | Isoxsuprine | Serotonin (5- Hydroxytyramine) |
| Bilirubin | Ketamine | Sulfamethazine |
| Chloral hydrate | Ketoprofen | Sulindac |
| Chloramphenicol | Labetalol | Tetrahydrocortisone 3-(β-<br>Dglucuronide) |
| Chlorothiazide | Loperamide | Tetrahydrocortisone 3-acetate |
| Chlorpromazine | Meperidine | Tetrahydrozoline |
| Cholesterol | Meprobamate | Thiamine |
| Clonidine | Methoxyphenamine | Thioridazine |
| Cortisone | Nalidixic acid | Triamterene |
| (-)-Cotinine | Naloxone | Trifluoperazine |
| Creatinine | Naltrexone | Trimethoprim |
| Deoxycorticosterone | Naproxen | DL-Tryptophan |
| Dextromethorphan | Niacinamide | Tyramine |
{10}------------------------------------------------
| Diclofenac | Nifedipine | DL-Tyrosine |
|-----------------------|----------------|-------------|
| Diflunisal | Norethindrone | Uric acid |
| Digoxin | Noscapine | Verapamil |
| Diphenhydramine | (±)-Octopamine | Zomepirac |
| Ecgonine methyl ester | | |
#### e. Specificity
To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound are listed below for 2-ethylidene-1. 5dimethyl-3, 3-diphenylpyrrolidine (EDDP), Nortriptyline (TCA) and Propoxyphene (PPX). The rest data were reported in the k170049. There were no differences observed for different devices.
| EDDP<br>(Cut-off=300 ng/mL) | Result<br>Positive at (ng/mL) | % Cross-Reactivity |
|-------------------------------------------------------------|-------------------------------|--------------------|
| EDDP(2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine) | 300 | 100% |
| EMDP (2-Ethyl-5-methyl-3,3-<br>diphenylpyrroline) | >100000 | <0.3% |
| Disopyramide | 75 | 400% |
| Methadone | >100000 | <0.3% |
| LAAM (Levo-alpha-acetylmethadol) HCl | >100000 | <0.3% |
| Alpha Methadol | >100000 | <0.3% |
| Doxylamine | >100000 | <0.3% |
| Nortriptyline<br>(Cut-off=1000 ng/mL) | Result<br>Positive at (ng/mL) | % Cross-Reactivity |
|---------------------------------------|-------------------------------|--------------------|
| Nortriptyline | 1000 | 100% |
| Amitriptyline | 750 | 133.3% |
| Clomipramine | 10000 | 10% |
| Desipramine | 200 | 500% |
| Doxepin | 1250 | 80% |
| Imipramine | 625 | 160% |
| Maprotiline | 2000 | 50% |
| Nordoxepin | 1000 | 100% |
| Promazine | 1500 | 66.7% |
| Promethazine | 25000 | 4% |
| Trimipramine | 3000 | 33.3% |
| Cyclobenzaprine Hydrochloride | 5000 | 20% |
| Norclomipramine | 3000 | 33.3% |
| Propoxyphene<br>(Cut-off=300 ng/mL) | Result<br>Positive at (ng/ml) | % Cross-Reactivity |
|-------------------------------------|-------------------------------|--------------------|
| d-Propoxyphene | 300 | 100% |
| Norpropoxyphene | 333 | 90.1% |
f. Effect of Urine Specific Gravity and Urine pH
To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +25% Cut-Off and all
{11}------------------------------------------------
negative for samples at and below -25% Cut-Off. There were no differences observed for different devices.
# 2. Comparison Studies
Method comparison studies for the AssureTech Panel Dip Tests and the AssureTech Quick Cup Tests were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below for 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP), Nortriptyline (TCA) and Propoxyphene (PPX). The rest data were reported in the k170049.
# EDDP
| Panel<br>Dip | | Negative | Low<br>Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|--------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 2 | 14 | 25 |
| | Negative | 10 | 20 | 8 | 1 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 20 | 10 | 0 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
## Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
|----------|---------------|--------------|-------------------------|
| Viewer A | 86905 | 295 | Positive |
| Viewer A | 36355 | 290 | Positive |
| Viewer C | 63254 | 295 | Positive |
| Viewer A | 24973 | 308 | Negative |
| Viewer C | 24082 | 307 | Negative |
| Quick<br>Cup | Negative | Low Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) | |
|--------------|----------|-------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------|----|
| Viewer<br>A | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
### Discordant Results
{12}------------------------------------------------
| Viewer | Sample Number | LC/MS Result | Quick Cup<br>Viewer Results |
|----------|---------------|--------------|-----------------------------|
| Viewer A | 47796 | 296 | Positive |
| Viewer B | 63254 | 295 | Positive |
| Viewer C | 36355 | 290 | Positive |
| Viewer B | 24082 | 307 | Negative |
| Viewer C | 24973 | 308 | Negative |
# Nortriptyline
| Panel<br>Dip | | Negative | Low Negative by<br>LC/MS<br>(less than -50%) | Near Cutoff Negative by<br>LC/MS<br>(Between -50% and<br>cutoff) | Near Cutoff Positive by<br>LC/MS<br>(Between the cutoff and<br>+50%) | High Positive by<br>LC/MS<br>(greater than +50%) |
|--------------|----------|----------|----------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 20 | 10 | 0 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
# Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer B | 50313 | 942 | Positive |
| Viewer B | 77063 | 1081 | Negative |
| Viewer C | 77063 | 1081 | Negative |
| Quick<br>Cup | Negative | Low Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|----------------------|----------|-------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A Positive | 0 | 0 | 0 | 14 | 25 |
| Viewer<br>A Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer<br>B Positive | 0 | 0 | 0 | 14 | 25 |
| Viewer<br>B Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer<br>C Positive | 0 | 0 | 1 | 15 | 25 |
| Viewer<br>C Negative | 10 | 20 | 9 | 0 | 0 |
# Discordant Results
| Viewer | Sample Number | LC/MS Result | Quick Cup<br>Viewer Results |
|----------|---------------|--------------|-----------------------------|
| Viewer C | 50313 | 942 | Positive |
| Viewer A | 77063 | 1081 | Negative |
{13}------------------------------------------------
| Viewer B | 54803 | 1130 | Negative |
|----------|-------|------|----------|
|----------|-------|------|----------|
# Propoxyphene
| Panel<br>Dip | | Negative | Low Negative by<br>LC/MS<br>(less than -50%) | Near Cutoff Negative by<br>LC/MS<br>(Between -50% and<br>cutoff) | Near Cutoff Positive by<br>LC/MS<br>(Between the cutoff and<br>+50%) | High Positive by LC/MS<br>(greater than +50%) |
|--------------|----------|----------|----------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 20 | 10 | 0 | 0 |
# Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer A | 31727 | 294 | Positive |
| Viewer B | 34150 | 298 | Positive |
| Quick<br>Cup | | Negative | Low Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|--------------|----------|----------|-------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 0 | 14 | 25 |
| Viewer<br>A | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 15 | 25 |
| Viewer<br>B | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 14 | 25 |
| Viewer<br>C | Negative | 10 | 20 | 9 | 1 | 0 |
### Discordant Results
| Viewer | | | Quick Cup | |
|----------|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|--|
| | Sample Number | LC/MS Result | Viewer Results | |
| Viewer B | ર્ભ્યતેત્તેર | 287 | Positive | |
| Viewer C | 34150 | 298 | Positive | |
| Viewer A | 27051 | રેતે જેવે છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થ | Negative | |
| Viewer C | 27051 | 359 | Negative | |
Lay-user study
A lay user study was performed at three intended user sites with 310 lay persons for each device format. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to > 50 years. Urine samples were prepared at the following concentrations; negative,
{14}------------------------------------------------
+/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device was tested. Typical results are shown below. The results summary for AMP:
| % of Cutoff | Number of samples | Drug Concentration by LC/MS (ng/mL) | Lay person Results | | The percentage of correct results (%) |
|--------------|-------------------|-------------------------------------|--------------------|-----------------|---------------------------------------|
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 248 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 508 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 752 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 1255 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 1506 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1748 | 20 | 0 | 100 |
The results summary for BAR:
| % of Cutoff | Number of<br>samples | Drug Concentration<br>by LC/MS(ng/mL) | Lay person Results | | The percentage<br>of correct results<br>(%) |
|--------------|----------------------|---------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of<br>Positive | No. of<br>Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 73 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 151 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 223 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 378 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 456 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 521 | 20 | 0 | 100 |
The results summary for COC:
| % of Cutoff | Number of<br>samples | Drug<br>Concentration by<br>LC/MS(ng/mL) | Lay person Results | | The percentage of<br>correct results<br>(%) |
|--------------|----------------------|------------------------------------------|-------------------------|--------------------------|---------------------------------------------|
| -100% Cutoff | 20 | 0 | No. of<br>Positive<br>0 | No. of<br>Negative<br>20 | 100 |
| -75% Cutoff | 20 | 76 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 154 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 222 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 377 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 452 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 528 | 20 | 0 | 100 |
The results summary for BUP:
| % of Cutoff | Number of<br>samples | Drug<br>Concentration by<br>LC/MS(ng/mL) | Lay person Results | | The percentage of<br>correct results<br>(%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of<br>Positive | No. of<br>Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 2.6 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 4.8 | 0 | 170 | 100 |
{15}------------------------------------------------
| -25% Cutoff | 20 | С Г<br>لك ه | | 19 | તેર |
|-------------|----|-------------|----|----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| +25% Cutoff | 20 | 12.6 | 19 | | તેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉપયોગ મુખ્યત્વે આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય |
| +50% Cutoff | 40 | 15.4 | 40 | | 100 |
| +75% Cutoff | 20 | 17.3 | 20 | | 100 |
The results summary for MET:
| % of Cutoff | Number of<br>samples | Drug<br>Concentration by<br>LC/MS(ng/mL) | Lay person Results | | The percentage of |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|------------------------|
| | | | No. of<br>Positive | No. of<br>Negative | correct results<br>(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 255 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 496 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 757 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 1258 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 1504 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1744 | 20 | 0 | 100 |
The results summary for MTD:
| % of Cutoff | Number of samples | Drug Concentration by LC/MS(ng/mL) | Lay person Results | | The percentage of correct results (%) |
|--------------|-------------------|------------------------------------|--------------------|-----------------|---------------------------------------|
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 73 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 155 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 228 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 377 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 454 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 528 | 20 | 0 | 100 |
The results summary for MOR:
| % of Cutoff | Number of<br>samples | Drug Concentration<br>by LC/MS(ng/mL) | Lay person Results | | The percentage of |
|--------------|----------------------|---------------------------------------|--------------------|--------------------|------------------------|
| | | | No. of<br>Positive | No. of<br>Negative | correct results<br>(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 77 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 155 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 227 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 371 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 447 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 521 | 20 | 0 | 100 |
The results summary for OXY:
| % of Cutoff | Number of<br>samples | Drug Concentration<br>by LC/MS(ng/mL) | Lay person Results | | The percentage of<br>correct results<br>(%) |
|--------------|----------------------|---------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of<br>Positive | No. of<br>Negative | |
| -100% Cutoff | 20 | 0 | 20 | 0 | 100 |
| -75% Cutoff | 20 | 23 | 20 | 0 | 100 |
| -50% Cutoff | 170 | 53 | 0 | 170 | 100 |
{16}------------------------------------------------
| -25% Cutoff | 20 | 72 | 1 | 19 | 95 |
|-------------|----|-----|----|----|-----|
| +25% Cutoff | 20 | 128 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 154 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 171 | 20 | 0 | 100 |
The results summary for PCP:
| % of Cutoff | Number of<br>samples | Drug Concentration<br>by LC/MS(ng/mL) | Lay person Results | | The percentage of<br>correct results<br>(%) |
|--------------|----------------------|---------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of<br>Positive | No. of<br>Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 7 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 11 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 18 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 32 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 39 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 44 | 20 | 0 | 100 |
The results summary for THC:
| % of Cutoff | Number of<br>samples | Drug Concentration<br>by LC/MS(ng/mL) | Lay person Results | | The percentage of<br>correct results<br>(%) |
|--------------|----------------------|---------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of<br>Positive | No. of<br>Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 13 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 24 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 38 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 64 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 77 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 86 | 20 | 0 | 100 |
The results summary for BZO:
| % of Cutoff | Number of<br>samples | Drug<br>Concentration by<br>LC/MS(ng/mL) | Lay person Results | | The percentage of |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------|
| | | | No. of<br>Positive | No. of<br>Negative | correct results (%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 73 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 146 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 228 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 377 | 20 | 0 | 100 |
| +50% Cutoff | 40 | 452 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 519 | 20 | 0 | 100 |
The results summary for MDMA:
| % of Cutoff | Number of<br>samples | Drug Concentration<br>by LC/MS(ng/mL) | Lay person Results | | The percentage of |
|--------------|----------------------|---------------------------------------|--------------------|--------------------|------------------------|
| | | | No. of<br>Positive | No. of<br>Negative | correct results<br>(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 121 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 253 | 0 | 170 | 100 |
{17}------------------------------------------------
| -25% Cutoff | 20 | 371 | 1 | 19 | 95 |
|-------------|----|-----|----|----|-----|
| +25% Cutoff | 20 | 628 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 756 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 879 | 20 | 0 | 100 |
The results summary for TCA:
| % of Cutoff | Number of<br>samples | Drug Concentration<br>by LC/MS(ng/mL) | Lay person Results | | The percentage of<br>correct results (%) |
|--------------|----------------------|---------------------------------------|--------------------|-----|------------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 254 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 505 | 0 | 170 | 100…
