(84 days)
Not Found
No
The device description and performance studies indicate a standard immunochromatographic assay, which does not typically involve AI/ML. There is no mention of AI, ML, or image processing in the summary.
No.
This device is an in vitro diagnostic assay used for qualitative determination of drugs in human urine, not for treating or preventing disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only," and the device is designed to qualitatively determine the presence of substances in human urine, which aligns with the definition of a diagnostic device.
No
The device is described as immunochromatographic assays in various physical formats (Strip, Cup, Dip Card, Turn Key Split Cup), which are hardware components for performing the chemical reaction. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The intended use section for each test explicitly states: "For in vitro diagnostic use only."
- Intended Use: The devices are designed to qualitatively determine the presence of specific substances (Marijuana metabolite, Methamphetamine, Phencyclidine) in human urine, which is a biological sample. This is a core function of in vitro diagnostics.
- Sample Type: The tests analyze human urine, which is a sample taken from the human body.
- Purpose: The tests are used to provide preliminary results about the presence of these substances, which can be used in a diagnostic context (e.g., drug screening).
The information provided clearly indicates that these devices are intended for use outside of the body to examine specimens from the human body for diagnostic purposes, which aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
AssureTech Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-Nor-△9-Tetrahydrocannabinol-9-COOH in human urine at cut-off concentration of 50 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
AssureTech Methamphetamine Tests are immunochromatographic assays for the qualitative determination of d-Methamphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
AssureTech Phencyclidine Tests are immunochromatographic assays for the qualitative determination of Phencyclidine in human urine at cut-off concentration of 25 ng/mL. The tests are available in a Strip format, a Dip Card format and a Turn Key Split Cup format.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
Product codes (comma separated list FDA assigned to the subject device)
DJC, LCM, LDJ
Device Description
The AssureTech Methamphetamine Tests, AssureTech Phencyclidine Tests, and AssureTech Marijuana Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Methamphetamine, Phencyclidine and Marijuana (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For over-the-counter and for prescription use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision studies:
Samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off, +50% cut off , +75% cut off and +100% cut off were tested. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order.
Methamphetamine: 0, 255, 509, 747, 1011, 1265, 1518, 1760 and 2015 ng/mL.
Phencyclidine: 0, 7, 13, 20, 27, 33, 39, 45 and 53ng/mL.
Marijuana: 0, 14, 28, 39, 53, 61, 73, 90 and 103ng/mL.
Cut-off study:
A total of 150 samples (25 native, 125 spiked) were used. Samples were equally distributed at concentrations of -50% Cut-Off, -25% Cut-Off, +25% Cut-Off, and +50% Cut-Off. Tested using three different lots of each device by three different operators. Results were all positive at and above +25% Cut-off and all negative at and below -25% Cut-off for Methamphetamine, Phencyclidine and Marijuana.
Interference study:
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. No interference observed for listed compounds at 100µg/mL.
Specificity study:
Drug metabolites and other components likely to interfere were tested using three batches of each device. The lowest concentration that caused a positive result for each compound was determined.
Effect of Urine Specific Gravity and pH:
Urine samples with 1.009 to 1.030 specific gravity or 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 negative for samples at and below -25% Cut-Off. Specific gravity from 1.009 to 1.030 and pH from 4 to 9 do not affect test results.
Method comparison studies:
Performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. Samples were blind labeled and compared to GC/MS results.
Lay-user study:
Performed at three intended user sites with 1638 lay persons. Lay users had diverse educational and professional backgrounds and ranged in age from 18 to > 50 years. Urine samples were prepared at concentrations of negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug-free pooled urine specimens. Concentrations confirmed by GC/MS. Each participant received the package insert, 1 blind labeled sample, and a device. All lay users indicated that the device instructions can be easily followed. Flesch-Kincaid reading analysis of package inserts revealed a reading Grade Level of 7.
Key results from Lay-user study:
Methamphetamine Strip: All samples at -100%, -75%, -50% cutoff, +25%, +50%, +75% cutoff showed 100% correct results. -25% cutoff showed 100% correct negative results.
Methamphetamine Dip Card: -100%, -75%, -50% cutoff, +50%, +75% cutoff showed 100% correct results. -25% cutoff had 1 positive out of 21 (95% correct). +25% tuvo 19 correct positives out of 21 (90% correct).
Methamphetamine Turn Key Split Cup: -100%, -75%, -50% cutoff, +25%, +50%, +75% cutoff showed 100% correct results. -25% cutoff had 1 positive out of 21 (95% correct).
Methamphetamine Quick Cup: -100%, -75%, -50% cutoff, +50%, +75% cutoff showed 100% correct results. -25% cutoff showed 100% correct negative results. +25% cutoff tuvo 20 correct positives out of 21 (95% correct).
Phencyclidine Strip: -100%, -75%, -50%, -25% cutoff showed 100% correct negative results. +50%, +75% cutoff showed 100% correct positive results. +25% cutoff had 20 correct positives out of 21 (95% correct).
Phencyclidine Dip Card: -100%, -75%, -50% cutoff, +50%, +75% cutoff showed 100% correct results. -25% cutoff had 1 positive out of 21 (95% correct). +25% cutoff had 20 positives out of 21 (95% correct).
Phencyclidine Turn Key Split Cup: -100%, -75%, -50%, -25% cutoff showed 100% correct negative results. +50%, +75% cutoff showed 100% correct positive results. +25% cutoff had 19 correct positives out of 21 (90% correct).
Phencyclidine Quick Cup: -100%, -75%, -50%, -25% cutoff showed 100% correct negative results. +50%, +75% cutoff showed 100% correct positive results. +25% cutoff had 19 correct positives out of 21 (90% correct).
Marijuana Strip: -100%, -75%, -50% cutoff, +50%, +75% cutoff showed 100% correct results. -25% cutoff had 1 positive out of 21 (95% correct). +25% cutoff had 20 positives out of 21 (95% correct).
Marijuana Dip Card: -100%, -75%, -50% cutoff, +25%, +50%, +75% cutoff showed 100% correct results. -25% cutoff tuvo 2 positives out of 21 (90% correct).
Marijuana Turn Key Split Cup: -100%, -75%, -50% cutoff, +50%, +75% cutoff showed 100% correct results. -25% cutoff had 1 positive out of 21 (95% correct). +25% cutoff had 20 positives out of 21 (95% correct).
Marijuana Quick Cup: -100%, -75%, -50% cutoff, +25%, +50%, +75% cutoff showed 100% correct results. -25% cutoff had 1 positive out of 21 (95% correct).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Performance metrics are presented as positive/negative counts at various concentrations relative to cutoff rather than calculated sensitivity/specificity/PPV/NPV).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 6 2016
ASSURE TECH (HANGZHOU) CO., LTD. SHISHENG LING GENERAL MANAGER BUILDING 1, NO.10, XIYUANSAN ROAD WESTLAKE ECONOMIC ZONE HANGZHOU, ZHEJIANG 310030, CHINA
Re: K161044
Trade/Device Name: AssureTech Methamphetamine Strip Test AssureTech Methamphetamine Cup Test AssureTech Methamphetamine Dip Card Test AssureTech Methamphetamine Turn Key Split Cup Test AssureTech Phencyclidine Strip Test AssureTech Phencyclidine Cup Test AssureTech Phencyclidine Dip Card Test AssureTech Phencyclidine Turn Key Split Cup Test AssureTech Marijuana Strip Test AssureTech Marijuana Cup Test AssureTech Marijuana Dip Card Test AssureTech Marijuana Turn Key Split Cup Test Regulation Number: 21 CFR §862.3610 Regulation Name: Methamphetamine Test System Regulatory Class: II Product Code: DJC, LCM, LDJ Dated: April 09, 2016 Received: April 13, 2016
Dear Shisheng Ling:
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
1
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 Parts 801 and 809); medical device reporting (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 Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
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
2
Indications for Use
510(k) Number (if known) K161044
Device Name
AssureTech Marijuana Strip Test AssureTech Marijuana Dip Card Test AssureTech Marijuana Cup Test; AssureTech Marijuana Turn Key Split Cup Test
Indications for Use (Describe)
AssureTech Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-Nor-△9-Tetrahydrocannabinol-9-COOH in human urine at cut-off concentration of 50 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
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."
3
Indications for Use
510(k) Number (if known) K161044
Device Name
AssureTech Methamphetamine Strip Test AssureTech Methamphetamine Dip Card Test AssureTech Methamphetamine Cup Test; AssureTech Methamphetamine Turn Key Split Cup Test
Indications for Use (Describe)
AssureTech Methamphetamine Tests are immunochromatographic assays for the qualitative determination of d-Methamphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
| 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
Indications for Use
510(k) Number (if known) K161044
Device Name
AssureTech Phencyclidine Strip Test AssureTech Phencyclidine Dip Card Test AssureTech Phencyclidine Cup Test; AssureTech Phencyclidine Turn Key Split Cup Test
Indications for Use (Describe)
AssureTech Phencyclidine Tests are immunochromatographic assays for the qualitative determination of Phencyclidine in human urine at cut-off concentration of 25 ng/mL. The tests are available in a Strip format, a Dip Card format and a Turn Key Split Cup format.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
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."
5
510(k) SUMMARY
| 1. Date: | May 27, 2016 |
|---|---|
| 2. Submitter: | Assure Tech. (Hangzhou) Co., Ltd. |
| Building 1, No.10, Xiyuansan Road, Westlake | |
| Economic Zone | |
| Hangzhou, China, 310030 | |
| 3. Contact person: | Shisheng Ling |
| Assure Tech. (Hangzhou) Co., Ltd. | |
| Building 1, No.10, Xiyuansan Road, Westlake | |
| Economic Zone | |
| Hangzhou, China, 310030 | |
| Telephone: +86-571-88868960 | |
| Fax: +86-571-81022698 | |
| Email: ling@diareagent.com | |
| 4. Device Name: | AssureTech Methamphetamine Strip Test |
| AssureTech Methamphetamine Cup Test | |
| AssureTech Methamphetamine Dip Card Test | |
| AssureTech Methamphetamine Turn Key Split Cup Test | |
| AssureTech Phencyclidine Strip Test | |
| AssureTech Phencyclidine Cup Test | |
| AssureTech Phencyclidine Dip Card Test | |
| AssureTech Phencyclidine Turn Key Split Cup Test | |
| AssureTech Marijuana Strip Test | |
| AssureTech Marijuana Cup Test | |
| AssureTech Marijuana Dip Card Test | |
| AssureTech Marijuana Turn Key Split Cup Test |
| Classification: | Class II | |
|---|---|---|
| Product Code | CFR # | Panel |
| DJC | 21 CFR, 862.3610 Methamphetamine Test System | Toxicology |
| LCM | 21 CFR, 862.3100 Amphetamine Test System | Toxicology |
| LDJ | 21 CFR, 862.3870 Cannabinoids Test System | Toxicology |
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- Predicate Devices: K142396
The Chemtrue® Multi-Panel Drug Screen Dip Card Tests
- Predicate Devices: K142396
-
- Intended Use
AssureTech Methamphetamine Tests are immunochromatographic assays for the qualitative determination of d-Methamphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format.
- Intended Use
6
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
AssureTech Phencyclidine Tests are immunochromatographic assays for the qualitative determination of Phencyclidine in human urine at cut-off concentration of 25 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
AssureTech Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-Nor-A9-Tetrahydrocannabinol-9-COOH in human urine at cut-off concentration of 50 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
-
- Device Description
The AssureTech Methamphetamine Tests, AssureTech Phencyclidine Tests, and AssureTech Marijuana Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Methamphetamine, Phencyclidine and Marijuana (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
- Device Description
-
- Substantial Equivalence Information
A summary comparison of features of the AssureTech Methamphetamine Tests, AssureTech Phencyclidine Tests and AssureTech Marijuana Tests and the predicate devices is provided in following tables.
- Substantial Equivalence Information
Table 1: Features Comparison of AssureTech Methamphetamine Tests and the Predicate Devices
| Item | Device | Predicate - K142396 |
|---|---|---|
| Indication(s) | ||
| for Use | For the qualitative determination of drugs of | |
| abuse in human urine. | Same (but the number of | |
| drugs detected is different) |
7
| Calibrator | d-Methamphetamine | Same |
|---|---|---|
| Methodology | Competitive binding, lateral flow | |
| immunochromatographic assays based on the | ||
| principle of antigen antibody | ||
| immunochemistry. | Same | |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 1000 ng/mL | Same |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Strip, Dip Card, Cup, Turn Key Split Cup | Dip Card |
Table 2: Features Comparison of AssureTech Phencyclidine Tests and the Predicate Devices
| Item | Device | Predicate - K142396 |
|---|---|---|
| Indication(s) | ||
| for Use | For the qualitative determination of | |
| drugs of abuse in human urine. | Same (but the number of | |
| drugs detected is different) | ||
| Calibrator | Phencyclidine | Same |
| Methodology | Competitive binding, lateral flow | |
| immunochromatographic assays based on the | ||
| principle of antigen antibody | ||
| immunochemistry. | Same | |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 25 ng/mL | Same |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Strip, Dip Card, Cup, Turn Key Split Cup | Dip Card |
Table 3: Features Comparison of AssureTech Marijuana Tests and the Predicate Devices
| Item | Device | Predicate - K142396 |
|---|---|---|
| Indication(s) | ||
| for Use | For the qualitative determination of | |
| drugs of abuse in human urine. | Same (but the number of | |
| drugs detected is different) | ||
| Calibrator | 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH | Same |
| Methodology | Competitive binding, lateral flow | |
| immunochromatographic assays based on the | ||
| principle of antigen antibody | ||
| immunochemistry. | Same | |
| Type of Test | Qualitative | Same |
8
| Specimen Type | Human Urine | Same |
|---|---|---|
| Cut-Off Values | 50 ng/mL | Same |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Strip, Dip Card, Cup, Turn Key Split Cup | DipCard |
-
- Test Principle
The AssureTech Methamphetamine Tests, AssureTech Phencyclidine Tests, and AssureTech Marijuana Tests are rapid tests for the qualitative detection of d-Methamphetamine, Phencyclidine and Marijuana in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibodycoated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.
- Test Principle
10. Performance Characteristics
-
- Analytical Performance
- a. Precision
Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off, +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 GC/MS. They are 0, 255, 509, 747, 1011, 1265, 1518, 1760 and 2015 ng/mL for Methamphetamine, 0, 7, 13, 20, 27, 33, 39, 45 and 53ng/mL for Phencyclidine, and 0, 14, 28, 39, 53, 61, 73, 90 and 103ng/mL for Marijuana. 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.
AssureTech Methamphetamine Tests
Strip
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
|---|---|---|---|---|---|---|---|---|---|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 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+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Dip Card
| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cut off | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
9
| 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+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Turn Key Split Cup | |||||||||
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 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 Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
12-/38+
9-/41+
11-/39+
50+/0-
50+/0-
50+/0-
50+/0-
50+/0-
50+/0-
50+/0-
50+/0-
50+/0-
50+/0-
50+/0-
50+/0-
50-/0+
50-/0+
50-/0+
AssureTech Phencyclidine Tests
50-/0+
50-10+
50-10+
50-/0+
50-/0+
50-/0+
50-/0+
50-/0+
50-/0+
Lot 1
Lot 2
Lot 3
| Strip | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Lot | |||||||||
| Number | -100% | ||||||||
| cut off | -75% | ||||||||
| cut off | -50% | ||||||||
| cut off | -25% | ||||||||
| cutoff | cut off | +25% | |||||||
| cut off | +50% | ||||||||
| cut off | +75% | ||||||||
| cut off | +100% | ||||||||
| cut off | |||||||||
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 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- |
| Dip Card | |||||||||
| Lot | |||||||||
| Number | -100% | ||||||||
| cut off | -75% | ||||||||
| cut off | -50% | ||||||||
| cut off | -25% | ||||||||
| cutoff | cut off | +25% | |||||||
| cut off | +50% | ||||||||
| cut off | +75% | ||||||||
| cut off | +100% | ||||||||
| cut off | |||||||||
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 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+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Tum Key Split Cup | |||||||||
| Lot | |||||||||
| Number | -100% | ||||||||
| cut off | -75% | ||||||||
| cut off | -50% | ||||||||
| cut off | -25% | ||||||||
| cutoff | cut off | +25% | |||||||
| cut off | +50% | ||||||||
| cut off | +75% | ||||||||
| cut off | +100% | ||||||||
| cut off | |||||||||
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 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+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Quick Cup | |||||||||
| Lot | |||||||||
| Number | -100% | ||||||||
| cut off | -75% | ||||||||
| cut off | -50% | ||||||||
| cut off | -25% | ||||||||
| cutoff | cut off | +25% | |||||||
| cut off | +50% | ||||||||
| cut off | +75% | ||||||||
| cut off | +100% | ||||||||
| cut off | |||||||||
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 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+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
AssureTech Marijuana Tests
Strip
| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cut off | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
| --------------- | ------------------ | ----------------- | ----------------- | ----------------- | --------- | ----------------- | ----------------- | ----------------- | ------------------ |
|---|
10
| 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+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Dip Card | |||||||||
| Lot | |||||||||
| Number | -100% | ||||||||
| cut off | -75% | ||||||||
| cut off | -50% | ||||||||
| cut off | -25% | ||||||||
| cutoff | cut off | +25% | |||||||
| cut off | +50% | ||||||||
| cut off | +75% | ||||||||
| cut off | +100% | ||||||||
| cut off | |||||||||
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 8-/42+ | 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+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Tum Key Split Cup | |||||||||
| Lot | |||||||||
| Number | -100% | ||||||||
| cut off | -75% | ||||||||
| cut off | -50% | ||||||||
| cut off | -25% | ||||||||
| cutoff | cut off | +25% | |||||||
| cut off | +50% | ||||||||
| cut off | +75% | ||||||||
| cut off | +100% | ||||||||
| cut off | |||||||||
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Quick Cup | |||||||||
| Lot | |||||||||
| Number | -100% | ||||||||
| cut off | -75% | ||||||||
| cut off | -50% | ||||||||
| cut off | -25% | ||||||||
| cutoff | cut off | +25% | |||||||
| cut off | +50% | ||||||||
| cut off | +75% | ||||||||
| cut off | +100% | ||||||||
| cut off | |||||||||
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 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- |
b. Linearity
Not applicable.
c. Stability
The devices are stable at 39.2°F to 86°F (4°C to 30°C) for 24 months based on the accelerated stability study at 45 ℃ and real time stability determination at both 4 ℃ and 30 °C.
d. Cut-off
A total of 150 samples of which 25 are native samples and 125 were spiked samples are used in the cut-off study. These samples are equally distributed at concentrations of -50% Cut-Off; -25% Cut-Off; +25% Cut-Off; +50% Cut-Off; +50% Cut-Off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% Cut-off and all negative at and below -25% Cut-off for Methamphetamine, Phencyclidine and Marijuana .
The following cut-off values for the candidate devices have been verified.
| Calibrator | Cut-off (ng/mL) |
|---|---|
| d-Methamphetamine | 1000 |
| Phencyclidine | 25 |
| Marijuana | 50 |
e. 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
11
three batches of each device. Compounds that showed no interference at a concentration of 100µg/mL are summarized in the following tables. There were no differences observed for different devices.
| Methamphetamine: | ||
|---|---|---|
| Acetamidophenol | (+/-)-Ephedrine | Oxymetazoline |
| Acetaminophen | Erythromycin | Papaverine |
| Acetophenetidin | β-Estradiol | Penicillin G |
| N-Acetylprocainamide | Estrone-3-sulfate | Pentobarbital |
| Acetylsalicylate | Fenoprofen | Perphenazine |
| Aminopyrine | Furosemide | Phencyclidine |
| Amitryptyline | Gentisic acid | Phenelzine |
| Amobarbital | Hemoglobin | Phenobarbital |
| Amoxicillin | Hydralazine | L-Phenylephrine |
| Ampicillin | Hydrochlorothiazide | β-Phenylethylamine |
| D-Amphetamine | Hydrocodone | Phenylpropanolamine |
| L-Amphetamine | Hydrocortisone | Prednisone |
| L-Ascorbic Acid | α-Hydroxyhippuric acid | Prednisolone |
| Apomorphine | 3Hydroxytyramine | Procaine |
| Aspartame | Ibuprofen | D/L-Propanolol |
| Atropine | Imipramine | D-Propoxyphene |
| Benzilic acid | (+/-)-Isoproterenol | D-Pseudoephedrine |
| Benzoic acid | Isoxsuprine | Quinidine |
| Benzoylecgonine | Ketamine | Quinine |
| Bilirubin | Ketoprofen | Ranitidine |
| Caffeine | Labetalol | Salicylic acid |
| Cannabidiol | Loperamide | Secobarbital |
| Chloralhydrate | Loxapine succinate | Serotonin (5-Hydroxytyramine) |
| Chloramphenicol | Maprotiline | Sulfamethazine |
| Chlordiazepoxide | Meperidine | Sulindac |
| Chlorothiazide | Meprobamate | Temazepam |
| Chloroquine | Methadone | Tetracycline |
| Chlorpromazine | Methoxyphenamine | Tetrahydrocortisone, 3Acetate |
| Cholesterol | Morphine-3-β-D-glucuronide | Tetrahydrocortisone 3 (β-D-glucuronide) |
| Clomipramine | Nalidixic acid | Tetrahydrozoline |
| Clonidine | Nalorphine | Thebaine |
| Cocaine hydrochloride | Naloxone | Thiamine |
| Codeine | Naltrexone | Thioridazine |
| Cortisone | Naproxen | Tolbutamide |
| Cotinine | Niacinamide | Triamterene |
| Creatinine | Nifedipine | Trifluoperazine |
| Deoxycorticosterone | Norcodein | Trimethobenzamide |
| Dextromethorphan | Norethindrone | Trimethoprim |
| Diazepam | Noroxymorphone | Trimipramine |
| Diclofenac | D-Norpropoxyphene | D/ L-Tryptophan |
| Diflunisal | Noscapine | Tyramine |
| Digoxin | D/L-Octopamine | D/ L-Tyrosine |
| Diphenhydramine | Oxalic acid | Uric acid |
| Doxylamine | Oxazepam | Verapamil |
Methamphetamine:
12
| Ecgoninemethylester | Oxycodone | |
|---|---|---|
| Phencyclidine | ||
|---|---|---|
| Acetaminophen | (-) Y Ephedrine | Oxycodone |
| Acetophenetidin | Erythromycin | Oxymetazoline |
| N-Acetylprocainamide | ẞ-Estradiol | Papaverine |
| Acetylsalicylic acid | Estrone-3-sulfate | Penicillin-G |
| Aminopyrine | Ethyl-p-aminobenzoate | Pentazocine hydrochloride |
| Amitryptyline | Fenoprofen | Pentobarbital |
| Amobarbital | Furosemide | Perphenazine |
| Amoxicillin | Gentisic acid | Phenelzine |
| Ampicillin | Hemoglobin | Phenobarbital |
| Ascorbic acid | Hydralazine | Phentermine |
| D,L-Amphetamine | Hydrochlorothiazide | L-Phenylephrine |
| Apomorphine acid | Hydrocodone | ẞ-Phenylethylamine |
| Aspartame | Hydrocortisone | Phenylpropanolamine |
| Atropine | O-Hydroxyhippuric | Prednisolone |
| Benzilic acid | p-Hydroxymethamphetamine | Prednisone |
| Benzoic acid | 3-Hydroxytyramine | Procaine |
| Benzoylecgonine | Ibuprofen | Promazine |
| Benzphetamine | Imipramine | Promethazine |
| Bilirubin | Iproniazid | D,L-Propanolol |
| Brompheniramine | (±) - Isoproterenol | D-Propoxyphene |
| Caffeine | Isoxsuprine | D-Pseudoephedrine |
| Cannabidiol | Ketamine | Quinidine |
| Cannabinol | Ketoprofen | Quinine |
| Chloralhydrate | Labetalol | Ranitidine |
| Chloramphenicol | Loperamide | Salicylic acid |
| Chlordiazepoxide | Maprotiline | Secobarbital |
| Chlorothiazide | Meperidine | Serotonin (5-Hydroxytyramine) |
| (±) Chlorpheniramine | Meprobamate | Sulfamethazine |
| Chlorpromazine | Methadone | Sulindac |
| Chloroquine | Methoxyphenamine | Temazepam |
| Cholesterol | (+) 3,4-Methylenedioxy- | Tetracycline |
| Clomipramine | (+)3,4-Methylenedioxy- | Tetrahydrocortisone3 (β-D glucuronide) |
| Clonidine | Morphine-3-ẞ-D glucuronide | Tetrahydrozoline |
| Cocaine hydrochloride | Morphine Sulfate | Thiamine |
| Codeine | Nalidixic acid | Thioridazine |
| Cortisone | Naloxone | D, L-Tyrosine |
| (-) Cotinine | Naltrexone | Tolbutamide |
| Creatinine | Naproxen | Triamterene |
| Deoxycorticosterone | Niacinamide | Trifluoperazine |
| Dextromethorphan | Nifedipine | Trimethoprim |
| Diazepam | Norcodein | Trimipramine |
| Diclofenac | Norethindrone | Tryptamine |
| Diflunisal | D-Norpropoxyphene | D, L-Tryptophan |
| Digoxin | Noscapine | Tyramine |
| Diphenhydramine | D,L-Octopamine | Uric acid |
| Doxylamine | Oxalic acid | Verapamil |
Phencyclidine
13
| Ecgonine hydrochloride | Oxazepam | Zomepirac |
|---|---|---|
| Ecgonine methylester | Oxolinic acid |
| Marijuana | ||
|---|---|---|
| Acetamidophenol | β-Estradiol | Papaverine |
| Acetophenetidin | Estrone-3-sulfate | Penicillin G |
| N-Acetylprocainamide | Ethyl-p-aminobenzoate | Pentazocine |
| Acetylsalicylic acid | Fenoprofen | Pentobarbital |
| Aminopyrine | Furosemide | Perphenazine |
| Amitryptyline | Gentisic acid | Phencyclidine |
| Amobarbital | Hemoglobin | Phenelzine |
| Amoxicillin | Hydralazine | Phenobarbital |
| Ampicillin | Hydrochlorothiazide | Phentermine |
| Ascorbic acid | Hydrocodone | L-Phenylephrine |
| D/L-Amphetamine | Hydrocortisone | β-Phenylethlamine |
| L-Amphetamine | α-Hydroxyhippuric acid | β-Phenyllethylamine |
| Apomorphine | 3-Hydroxytyramine | Phenylpropanolamine |
| Aspartame | Ibuprofen | Prednisolone |
| Atropine | Imipramine | Prednisone |
| Benzilic acid | Iproniazid | Procaine |
| Benzoic acid | (+/-)-Isoproterenol | Promazine |
| Benzoylecgonine | Isoxsuprine | Promethazine |
| Benzphetamine | Ketamine | D/L-Propanolol |
| Bilirubin | Labetalol | D-Propoxyphene |
| Brompheniramine | Levorphanol | D-Pseudoephedrine |
| Caffeine | Loperamide | Quinidine |
| Chloralhydrate | Maprotiline | Quinine |
| Chloramphenicol | Meprobamate | Ranitidine |
| Chlordiazepoxide | Methadone | Salicylic acid |
| Chlorothiazide | Methoxyphenamine | Secobarbital |
| (+/-)-Chlorpheniramine | (+/-) | Serotonin (5-Hydroxytyramine) |
| Chlorpromazine | (+/- | Sulfamethazine |
| Chloroquine | Methylphenidate | Sulindac |
| Cholesterol | Methyprylon | Temazepam |
| Clomipramine | Morphine-3-β-D-glucuronide | Tetracycline |
| Clonidine | Nalorphine | Tetrahydrocortisone3(β-D-glucuronide) |
| Cocaine hydrochloride | Naloxone | Tetrahydrozoline |
| Codeine | Nalidixic acid | Thebaine |
| Cortisone | Naltrexone | Thiamine |
| (-)-Cotinine | Naproxen | Thioridazine |
| Creatinine | Niacinamide | D/L-Thyroxine |
| Deoxycorticosterone | Nifedipine | Tolbutamide |
| Dextromethorphan | Norcodein | Triamterene |
| Diazepam | Norethindrone | Trifluoperazine |
| Diclofenac | D-Norpropoxyphene | Trimethoprim |
| Diflunisal | Noscapine | Trimipramine |
| Digoxin | D/L-Octopamine | Tryptamine |
| Diphenhydramine | Oxalic acid | D/L-Tryptophan |
| Doxylamine | Oxazepam | Tyramine |
| Ecgonine hydrochloride | Oxolinic acid | D/L-Tyrosine |
14
| Ecgoninemethylester | Oxycodone | Uric acid |
|---|---|---|
| L - Ψ-Ephedrine | Oxymetazoline | Verapamil |
| Erythromycin | p-Hydroxymethamphetamine | Zomepirac |
f. 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. There were no differences observed for different devices.
| Methamphetamine | Result | % Cross-Reactivity |
|---|---|---|
| (Cutoff=1000 ng/mL) | Positive at (ng/mL) | |
| D(+)-Methamphetamine | 1000 | 100% |
| (+/-)3,4-Methylenedioxy-n-ethylamphetamine(MDEA) | 10000 | 10% |
| D/L-Methamphetamine | 1000 | 100% |
| p-Hydroxymethamphetamine | 10000 | 10% |
| D-Amphetamine | Negative at ≤100000 | Viewer A |
17
| Viewer A | 96378 | 1045 | Negative |
|---|---|---|---|
| Viewer C | 79610 | 1094 | Negative |
| Strip | Phencyclidine | |||||
|---|---|---|---|---|---|---|
| Negative | Low | |||||
| Negative by | ||||||
| GC/MS | ||||||
| (less than | ||||||
| -50%) | Near Cutoff | |||||
| Negative by | ||||||
| GC/MS | ||||||
| (Between | ||||||
| -50% and | ||||||
| cutoff) | Near Cutoff | |||||
| Positive by | ||||||
| GC/MS | ||||||
| (Between the | ||||||
| cutoff and | ||||||
| +50%) | High Positive | |||||
| by GC/MS | ||||||
| (greater than | ||||||
| +50%) | ||||||
| Viewer | Positive | 0 | 0 | 1 | 14 | 25 |
| A | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 14 | 25 |
| B | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 15 | 25 |
| C | Negative | 10 | 20 | 9 | 0 | 0 |
Phencyclidine
Discordant Results of Phencyclidine Strip
| Viewer | Sample Number | GC/MS Result
(ng/mLof Phencyclidine) | Strip
Viewer Results |
|----------|---------------|-----------------------------------------|-------------------------|
| Viewer A | 68414 | 22 | Positive |
| Viewer B | 49090 | 24 | Positive |
| Viewer C | 49090 | 24 | Positive |
| Viewer A | 34825 | 27 | Negative |
| Viewer B | 46717 | 27 | Negative |
| Dip
Card | | Negative | Low Negative by
GC/MS
(less than -50%) | Near Cutoff Negative by
GC/MS
(Between -50% and cutoff) | Near Cutoff Positive by
GC/MS
(Between the cutoff and +50%) | High Positive
by GC/MS
(greater than +50%) |
|-------------|----------|----------|----------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------------|--------------------------------------------------|
| Viewer
A | Positive | 0 | 0 | 2 | 14 | 25 |
| | Negative | 10 | 20 | 8 | 1 | 0 |
| Viewer
B | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer
C | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
Discordant Results of Phencyclidine Dip Card
| Viewer | Sample Number | GC/MS Result
(ng/mLof Phencyclidine) | Dip Card
Viewer Results |
|----------|---------------|-----------------------------------------|----------------------------|
| Viewer A | 49090 | 24 | Positive |
| Viewer A | 68414 | 22 | Positive |
| Viewer C | 68414 | 22 | Positive |
18
| Viewer A | 34825 | 27 | Negative |
|---|---|---|---|
| Viewer B | 61443 | 27 | Negative |
| Viewer C | 46717 | 27 | Negative |
| Turn Key
Split Cup | | Negative | Low
Negative by
GC/MS
(less than
-50%) | Near Cutoff
Negative by
GC/MS
(Between
-50% and
cutoff) | Near Cutoff
Positive by
GC/MS
(Between the
cutoff and
+50%) | High Positive
by GC/MS
(greater than
+50%) |
|-----------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
Discordant Results of Phencyclidine Turn Key Split Cup
| Viewer | Sample Number | GC/MS Result
(ng/mLof Phencyclidine) | Turn Key Split Cup
Viewer Results |
|----------|---------------|-----------------------------------------|--------------------------------------|
| Viewer A | 68414 | 22 | Positive |
| Viewer B | 68414 | 22 | Positive |
| Viewer C | 68414 | 22 | Positive |
| Viewer A | 34825 | 27 | Negative |
| Viewer B | 46717 | 27 | Negative |
| Quick
Cup | | Negative | Low Negative by
GC/MS
(less than
-50%) | Near Cutoff Negative by
GC/MS
(Between
-50% and
cutoff) | Near Cutoff Positive by
GC/MS
(Between the
cutoff and
+50%) | High Positive
by GC/MS
(greater than
+50%) |
|--------------|----------|----------|-------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer
A | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer
B | Positive | 0 | 0 | 2 | 14 | 25 |
| | Negative | 10 | 20 | 8 | 1 | 0 |
| Viewer
C | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
Discordant Results of Phencyclidine Quick Cup
| Viewer | Sample Number | GC/MS Result
(ng/mLof Phencyclidine) | Quick Cup
Viewer Results |
|----------|---------------|-----------------------------------------|-----------------------------|
| Viewer A | 68414 | 22 | Positive |
| Viewer B | 68414 | 22 | Positive |
| Viewer B | 49090 | 24 | Positive |
19
| Viewer B | 46717 | 27 | Negative |
|---|---|---|---|
| Viewer C | 46717 | 27 | Negative |
| Marijuana | ||||||
|---|---|---|---|---|---|---|
| Strip | Negative | Low | ||||
| Negative by | ||||||
| GC/MS | ||||||
| (less than | ||||||
| -50%) | Near Cutoff | |||||
| Negative by | ||||||
| GC/MS | ||||||
| (Between | ||||||
| -50% and | ||||||
| cutoff) | Near Cutoff | |||||
| Positive by | ||||||
| GC/MS | ||||||
| (Between the | ||||||
| cutoff and | ||||||
| +50%) | High Positive | |||||
| by GC/MS | ||||||
| (greater than | ||||||
| +50%) | ||||||
| Viewer | Positive | 0 | 0 | 1 | 14 | 25 |
| A | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer | Positive | 0 | 0 | 0 | 13 | 25 |
| B | Negative | 10 | 20 | 10 | 2 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 14 | 25 |
| C | Negative | 10 | 20 | 9 | 1 | 0 |
Discordant Results of Marijuana Strip
| Viewer | Sample Number | GC/MS Result
(ng/mL of
11-Nor-Δ9-Tetrahydrocannabinol-9-COOH) | Strip
Viewer Result |
|----------|---------------|---------------------------------------------------------------------|------------------------|
| Viewer A | 87180 | 46 | Positive |
| Viewer C | 87180 | 46 | Positive |
| Viewer A | 97898 | 52 | Negative |
| Viewer B | 97898 | 52 | Negative |
| Viewer B | 32995 | 53 | Negative |
| Viewer C | 32995 | 53 | Negative |
| Dip
Card | | Negative | Low
Negative by
GC/MS
(less than
-50%) | Near Cutoff
Negative by
GC/MS
(Between
-50% and
cutoff) | Near Cutoff
Positive by
GC/MS
(Between the
cutoff and
+50%) | High Positive
by GC/MS
(greater than
+50%) |
|-------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer
A | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer
B | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer
C | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
Discordant Results of Marijuana Dip Card
| Viewer | Sample Number | GC/MS Result
(ng/mL of
11-Nor-△9-Tetrahydrocannabinol-9-COOH) | Dip Card
Viewer
Results |
|----------|---------------|---------------------------------------------------------------------|-------------------------------|
| Viewer A | 38785 | 44 | Positive |
20
| Viewer B | 87180 | 46 | Positive |
|---|---|---|---|
| Viewer A | 97898 | 52 | Negative |
| Viewer C | 32995 | 53 | Negative |
| Turn
Key
Split
Cup | | Negative | Low
Negative by
GC/MS
(less than
-50%) | Near Cutoff
Negative by
GC/MS
(Between
-50% and
cutoff) | Near Cutoff
Positive by
GC/MS
(Between the
cutoff and
+50%) | High Positive
by GC/MS
(greater than
+50%) |
|-----------------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer
A | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer
B | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer
C | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
Discordant Results of Marijuana Turn Key Split Cup
| Viewer | Sample Number | GC/MS Result
(ng/mL of
11-Nor-Δ9-Tetrahydrocannabinol-9-COOH) | Turn Key Split
Cup
Viewer Results |
|----------|---------------|---------------------------------------------------------------------|-----------------------------------------|
| Viewer A | 38785 | 44 | Positive |
| Viewer B | 87180 | 46 | Positive |
| Viewer A | 99015 | 54 | Negative |
| Viewer B | 97898 | 52 | Negative |
| Viewer C | 32995 | 53 | Negative |
| Quick
Cup | | Negative | Low Negative by
GC/MS
(less than
-50%) | Near Cutoff Negative by
GC/MS
(Between
-50% and
cutoff) | Near Cutoff Positive by
GC/MS
(Between the
cutoff and
+50%) | High Positive
by GC/MS
(greater than
+50%) |
|--------------|----------|----------|-------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer
A | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer
B | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer
C | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
Discordant Results of Marijuana Quick Cup
| Viewer | Sample Number | GC/MS Result
(ng/mL of
11-Nor-△9-Tetrahydrocannabinol-9-COOH) | Quick Cup
Viewer Results |
|----------|---------------|---------------------------------------------------------------------|-----------------------------|
| Viewer B | 43788 | 43 | Positive |
21
| Viewer A | 32995 | 53 | Negative |
|---|---|---|---|
| Viewer C | 94567 | 55 | Negative |
Lay-user study
A lay user study was performed at three intended user sites with 1638 lay persons. 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, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/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.
| | Number
of
samples | d-Methamphetamine
Concentration by GC/MS
(ng/mL) | Lay person results | | The |
|--------------|-------------------------|--------------------------------------------------------|--------------------|--------------------|-----------------------------------------|
| % of Cutoff | | | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 260 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 489 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 769 | 0 | 21 | 100 |
| +25% Cutoff | 21 | 1276 | 21 | 0 | 100 |
| +50% Cutoff | 21 | 1468 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 1795 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Methamphetamine Strip
Comparison between GC/MS and Lay Person Results for Methamphetamine Dip Card
| % of Cutoff | Number of
samples | d-Methamphetamine
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|----------------------|--------------------------------------------------------|---------------------|----------------------|------------------------------------------------|
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 260 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 489 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 769 | No. of
Positive1 | No. of
Negative20 | 95 |
| +25% Cutoff | 21 | 1276 | 19 | 2 | 90 |
| +50% Cutoff | 21 | 1468 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 1795 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Methamphetamine Turn Key Split Cup
| % of Cutoff | Number
of
samples | d-Methamphetamine
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|--------------------------------------------------------|--------------------|--------------------|------------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 260 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 489 | 0 | 21 | 100 |
22
| -25% Cutoff | 21 | 769 | 1 | 20 | 95 |
|---|---|---|---|---|---|
| +25% Cutoff | 21 | 1276 | 21 | 0 | 100 |
| +50% Cutoff | 21 | 1468 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 1795 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Methamphetamine Quick Cup
| % of Cutoff | Number of samples | d-Methamphetamine Concentration by GC/MS (ng/mL) | Lay person results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 260 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 489 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 769 | 0 | 21 | 100 |
| +25% Cutoff | 21 | 1276 | 20 | 1 | 95 |
| +50% Cutoff | 21 | 1468 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 1795 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Phencyclidine Strip
| % of Cutoff | Number of samples | Phencyclidine Concentration by GC/MS (ng/mL) | Lay person results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| No. of Positive | No. of Negative | ||||
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 8 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 12 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 20 | 0 | 21 | 100 |
| +25% Cutoff | 21 | 30 | 20 | 1 | 95 |
| +50% Cutoff | 21 | 39 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 43 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Phencyclidine Dip Card
| % of Cutoff | Number of samples | Phencyclidine
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------------------------------------------------------------------------------|-------------------|----------------------------------------------------|--------------------|--------------------|------------------------------------------------|
| -100% Cutoff | 21 | 0 | No. of
Positive | No. of
Negative | 100 |
| -75% Cutoff | 21 | 8 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 12 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 20 | 1 | 20 | 95 |
| +25% Cutoff | 21 | 30 | 20 | 1 | 95 |
| +50% Cutoff | 21 | 39 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 43 | 21 | 0 | 100 |
| Comparison between GC/MS and Lay Person Results for Phencyclidine Turn Key Split Cup | | | | | |
23
| % of Cutoff | Number
of
samples | Phencyclidine
Concentration by GC/MS
(ng/mL) | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
|--------------|-------------------------|----------------------------------------------------|--------------------|--------------------|-----------------------------------------|
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 8 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 12 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 20 | 0 | 21 | 100 |
| +25% Cutoff | 21 | 30 | 19 | 2 | 90 |
| +50% Cutoff | 21 | 39 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 43 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Phencyclidine Quick Cup
| % of Cutoff | Number of samples | Phencyclidine Concentration by GC/MS (ng/mL) | Lay person results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 8 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 12 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 20 | 0 | 21 | 100 |
| +25% Cutoff | 21 | 30 | 19 | 2 | 90 |
| +50% Cutoff | 21 | 39 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 43 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Marijuana Strip
| % of Cutoff | Number of samples | Marijuana Concentration by GC/MS (ng/mL) | Lay person results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 13 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 26 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 39 | 1 | 20 | 95 |
| +25% Cutoff | 21 | 61 | 20 | 1 | 95 |
| +50% Cutoff | 21 | 76 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 86 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Marijuana Dip Card
| % of Cutoff | Number
of
samples | Marijuana
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|------------------------------------------------|--------------------|----|------------------------------------------------|
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 13 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 26 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 39 | 2 | 19 | 90 |
| +25% Cutoff | 21 | 61 | 21 | 0 | 100 |
24
| +50% Cutoff | 21 | 76 | 21 | 0 | 100 |
|---|---|---|---|---|---|
| +75% Cutoff | 21 | 86 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Marijuana Turn Key Split Cup
| % of Cutoff | Number of samples | Marijuana Concentration by GC/MS (ng/mL) | Lay person results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| No. of Positive | No. of Negative | ||||
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 13 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 26 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 39 | 1 | 20 | 95 |
| +25% Cutoff | 21 | 61 | 20 | 1 | 95 |
| +50% Cutoff | 21 | 76 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 86 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Marijuana Quick Cup
| % of Cutoff | Number
of
samples | Marijuana
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|------------------------------------------------|--------------------|--------------------|------------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 13 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 26 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 39 | 1 | 20 | 95 |
| +25% Cutoff | 21 | 61 | 21 | 0 | 100 |
| +50% Cutoff | 21 | 76 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 86 | 21 | 0 | 100 |
Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.
-
- Clinical Studies
Not applicable.
- Clinical Studies
11. Conclusion
Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison, and lay-user studies of the devices, it's concluded that the AssureTech Methamphetamine Tests, AssureTech Phencyclidine Tests and AssureTech Marijuana Tests are substantially equivalent to the predicate.