(121 days)
Not Found
No
The device description and performance studies focus on immunochromatographic assays and standard analytical methods (GC/MS). There is no mention of AI, ML, or image processing for result interpretation.
No
The device is described as an "immunochromatographic assay" for the qualitative determination of substances in human urine, indicating it is an in vitro diagnostic device used for testing, not for treating or preventing a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only." This phrase directly indicates that the device is intended for diagnostic purposes outside of a living organism.
No
The device is described as immunochromatographic assays in Strip, Dip Card, and Turn Key Split Cup formats, which are physical, hardware-based tests. The summary focuses on the performance of these physical test devices.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document explicitly states "For in vitro diagnostic use only" multiple times for each of the tests (Amphetamine, Cocaine, and Morphine).
- Intended Use: The intended use is the "qualitative determination of d-Amphetamine, Benzoylecgonine, and Morphine in human urine." This is a diagnostic purpose, analyzing a biological sample (urine) to detect the presence of specific substances.
- Device Description: The device is described as an "immunochromatographic assay," which is a common type of in vitro diagnostic test.
- Performance Studies: The document details various performance studies (Precision, Cut-off, Interference, Specificity, Comparison Studies, Lay-user study) which are typical evaluations for IVD devices to demonstrate their analytical and clinical performance.
- Comparison to Predicate Device: The document lists a predicate device (K142396; The Chemtrue® Multi-Panel Drug Screen Dip Card Tests), which is also an IVD, indicating that this device is intended for a similar diagnostic purpose.
Therefore, based on the provided information, the AssureTech Amphetamine, Cocaine, and Morphine Tests are clearly intended and described as In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
AssureTech Amphetamine Tests are immunochromatographic assays for the qualitative determination of d-Amphetamine in human urine at cut-off concentration of 1000 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.
AssureTech Cocaine Tests are immunochromatographic assays for the qualitative determination of Benzoylecgonine in human urine at cut-off concentration of 300 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.
AssureTech Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 2000 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
DKZ, DIO, DJG
Device Description
The AssureTech Amphetamine Tests, AssureTech Cocaine Tests, and AssureTech Morphine Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, Benzoylecgonine and Morphine (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 in vitro diagnostic use only. The tests are intended 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
Precision
Sample size: For each concentration, tests were performed two runs per day for 25 days per device.
Data source: Samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing.
Annotation protocol: Not Found
Cut-off
Sample size: A total of 150 samples equally distributed at concentrations of -50% Cut-Off; -25% Cut-Off; Cut-Off; +25% Cut-Off; +50% Cut-Off.
Data source: Not Found
Annotation protocol: Not Found
Interference
Sample size: Not Found
Data source: 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.
Annotation protocol: These urine samples were tested using three batches of each device.
Specificity
Sample size: Not Found
Data source: Drug metabolites and other components that are likely to interfere in urine samples.
Annotation protocol: Tested using three batches of each device.
Effect of Urine Specific Gravity and Urine pH
Sample size: Not Found
Data source: 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.
Annotation protocol: These samples were tested using three lots of each device.
Comparison Studies
Sample size: 80 (40 negative and 40 positive) unaltered clinical samples for each device.
Data source: Unaltered clinical samples.
Annotation protocol: The samples were blind labeled and compared to GC/MS results.
Lay-user study
Sample size: 1638 lay persons.
Data source: 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.
Annotation protocol: Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device was tested.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance - Precision
Study type: Precision studies
Sample size: For each concentration, tests were performed two runs per day for 25 days per device in a randomized order.
Key results: The tables provided show the number of negative and positive results for each Lot number at various concentrations relative to the cut-off (-100% to +100% of cut off). For concentrations at or below -25% cut-off, all results were negative. For concentrations at or above +25% cut-off, all results were positive. For a concentration at the cut-off (0%), results showed a mixture of negative and positive, indicating performance around the cut-off.
Analytical Performance - Cut-off
Study type: Cut-off verification
Sample size: A total of 150 samples.
Key results: Results were all positive at and above +25% Cut-off and all negative at and below -25% Cut-off for Amphetamine, Cocaine and Morphine. The verified cut-off values are: d-Amphetamine: 1000 ng/mL, Benzoylecgonine: 300 ng/mL, Morphine: 2000 ng/mL.
Analytical Performance - Interference
Study type: Interference study
Sample size: Not specified, but tested using three batches of each device.
Key results: Compounds listed in the tables showed no interference at a concentration of 100 µg/mL. There were no differences observed for different devices.
Analytical Performance - Specificity
Study type: Specificity study
Sample size: Not specified, but tested using three batches of each device.
Key results: Cross-reactivity results were provided for each drug, indicating the lowest concentration that caused a positive result and the percentage cross-reactivity. For Amphetamine, L-Amphetamine showed 5% cross-reactivity, D,L-Amphetamine 33%, Phentermine 3.3%, Hydroxyamphetamine 12.5%, and Methylenedioxyamphetamine (MDA) 5%. Other listed substances were not detected. For Cocaine, Cocaine HCl showed 40%, Cocaethylene 2.4%, Ecgonine 0.9%, and Norcocaine 0.3%. For Morphine, Acetylmorphine showed 80%, Codeine 200%, Ethyl Morphine 800%, Heroin 40%, Hydromorphone 80%, and Thebaine 15.4%.
Analytical Performance - Effect of Urine Specific Gravity and Urine pH
Study type: Effect of urine specific gravity and pH study
Sample size: Not specified, but tested using three lots of each device.
Key results: Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. There were no differences observed for different devices.
Comparison Studies (Method Comparison)
Study type: Method comparison studies
Sample size: 80 (40 negative and 40 positive) unaltered clinical samples for each device.
Key results: Detailed tables of agreement and discordant results compared to GC/MS for Amphetamine, Cocaine, and Morphine tests across different configurations (Strip, Dip Card, Turn-Key Split Cup, Quick Cup) and viewers (A, B, C). Overall, a high degree of concordance with GC/MS results was observed, particularly for samples well below or well above the cut-off. Discordant results were generally observed for samples near the cut-off concentration.
Lay-user study
Study type: Lay-user study
Sample size: 1638 lay persons.
Key results: The tables show the comparison between GC/MS results and lay person results for various cut-off concentrations. For -100%, -75%, -50% cut-off, the percentage of correct results was generally 100%, with occasional 95% for -25% cut-off. For +25% cut-off, results were mostly 95% or 90% correct, and for +50% and +75% cut-off, they were generally 100% correct. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis of the package insert resulted in a Grade Level of 7.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not directly reported as Sensitivity, Specificity, PPV, NPV in the summary, but derivable from the comparison studies.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3100 Amphetamine test system.
(a)
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.(b)
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).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2016
ASSURE TECH., INC. C/O JOE SHIA REGULATORY CONSULTANT 504 EAST DIAMOND AVE. SUITE I GAITHERSBURG MD 20877
Re: K153465 Trade/Device Name: AssureTech Amphetamine Tests, AssureTech Cocaine Tests, AssureTech Morphine Tests Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Dated: February 2, 2016 Received: February 17, 2016
Dear Mr. 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 Parts 801 and 809); medical device reporting (reporting of
1
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 regulation (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" (21CFR 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
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Indications for Use
510(k) Number (if known) K153465
Device Name AssureTech Amphetamine Tests AssureTech Cocaine Tests AssureTech Morphine Tests
Indications for Use (Describe)
AssureTech Amphetamine Tests are immunochromatographic assays for the qualitative determination of d-Amphetamine in human urine at cut-off concentration of 1000 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.
AssureTech Cocaine Tests are immunochromatographic assays for the qualitative determination of Benzoylecgonine in human urine at cut-off concentration of 300 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.
AssureTech Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 2000 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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510(k) SUMMARY
| 1. Date: | March 26, 2016 |
|---|---|
| 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 | |
| Email: customerservice@assurelabs.com. | |
| 4. Device Name: | AssureTech Amphetamine Tests |
| AssureTech Cocaine Tests | |
| AssureTech Morphine Tests |
Classification:
| Product Code | CFR | Panel |
|---|---|---|
| DKZ | 21 CFR, 862.3100 Amphetamine Test System | Toxicology |
| DIO | 21 CFR, 862.3250 Cocaine Test System | Toxicology |
| DJG | 21 CFR, 862.3650 Opiate Test System | Toxicology |
5. Predicate Devices: K142396
The Chemtrue® Multi-Panel Drug Screen Dip Card Tests
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- Intended Use
AssureTech Amphetamine Tests are immunochromatographic assays for the qualitative determination of d-Amphetamine 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
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 Cocaine Tests are immunochromatographic assays for the qualitative determination of Benzoylecgonine in human urine at cut-off concentration of 300 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
5
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 Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 2000 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 Amphetamine Tests, AssureTech Cocaine Tests, and AssureTech Morphine Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, Benzoylecgonine and Morphine (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
8. Substantial Equivalence Information
A summary comparison of features of the AssureTech Amphetamine Tests, AssureTech Cocaine Tests and AssureTech Morphine Tests and the predicate devices is provided in following tables.
| 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 | d-Amphetamine | 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 Cup | Dip Card |
| Table 1: Features Comparison of AssureTech Amphetamine Tests and the | |||||
|---|---|---|---|---|---|
| Predicate Devices |
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| Table 2: Features Comparison of AssureTech Cocaine 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 | Benzoylecgonine | 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 | 300 ng/mL | Same |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Strip, Dip Card, Cup, Turn Key Cup | Dip Card |
Table 2: Features Comparison of AssureTech Cocaine Tests and the Predicate Devices
Table 3: Features Comparison of AssureTech Morphine 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 | Morphine | 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 | 2000 ng/mL | Same |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Strip, Dip Card, Cup, Turn Key Cup | DipCard |
9. Test Principle
The AssureTech Amphetamine Tests, AssureTech Cocaine Tests, and AssureTech Morphine Tests are rapid tests for the qualitative detection of d-Amphetamine, Benzoylecgonine and Morphine 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
7
monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.
10. Performance Characteristics
1. Analytical Performance
- a. Precision
Precision studies were carried out for samples with concentrations of -100% cut off. -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/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.
| Strip | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Lot | |||||||||
| Number | -100% | ||||||||
| cut off | -75% | ||||||||
| cut off | -50% | ||||||||
| cut off | -25% | ||||||||
| cutoff | +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+ | 11-/39+ | 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% | ||||||||
| cutoff | +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+ | 13-/37+ | 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- |
| Turn-Key Split Cup | |||||||||
| Lot | |||||||||
| Number | -100% | ||||||||
| cut off | -75% | ||||||||
| cut off | -50% | ||||||||
| cut off | -25% | ||||||||
| cutoff | +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 | +25% | ||||||||
| cut off | +50% | ||||||||
| cut off | +75% | ||||||||
| cut off | +100% | ||||||||
| cut off | |||||||||
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 13-/37+ | 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- |
AssureTech Amphetamine Tests
AssureTech Cocaine Tests Strip
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| Lot | -100% | -75% | -50% | -25% | +25% | +50% | +75% | +100% | ||
|---|---|---|---|---|---|---|---|---|---|---|
| Number | cut off | cut off | cut off | cutoff | cut off | cut off | cut off | cut off | 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+ | 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 | -100% | -75% | -50% | -25% | +25% | +50% | +75% | +100% | ||
| Number | cut off | cut off | cut off | cutoff | cut off | cut off | cut off | cut off | 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+ | 8-/42+ | 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 | -100% | -75% | -50% | -25% | +25% | +50% | +75% | +100% | ||
| Number | cut off | cut off | cut off | cutoff | cut off | cut off | cut off | cut off | 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+ | 12-/38+ | 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 | -100% | -75% | -50% | -25% | +25% | +50% | +75% | +100% | ||
| Number | cut off | cut off | cut off | cutoff | cut off | cut off | cut off | cut off | 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+ | 13-/37+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
AssureTech Morphine Tests
Strip
| 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+ | 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+ | 10-/40+ | 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+ | 10-/40+ | 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+ | 9-/41+ | 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
9
| 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+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
b. Linearity
Not applicable.
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. Cut-off
A total of 150 samples equally distributed at concentrations of -50% Cut-Off; -25% Cut-Off; Cut-Off; +25% 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 Amphetamine, Cocaine and Morphine.
The following cut-off values for the candidate devices have been verified.
| Calibrator | Cut-off (ng/mL) |
|---|---|
| d-Amphetamine | 1000 |
| Benzoylecgonine | 300 |
| Morphine | 2000 |
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 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.
Amphetamine:
| 4-Acetamidophenol | L-Ephedrine | Oxycodone |
|---|---|---|
| Acetophenetidin | (-) Y Ephedrine | Oxymetazoline |
| N-Acetylprocainamide | Erythromycin | Papaverine |
| Acetylsalicylic acid | $\beta$ -Estradiol | Penicillin-G |
| Aminopyrine | Estrone-3-sulfate | Pentazocaine |
| Amitriptyline | Ethyl-p-aminobenzoate | Pentobarbital |
| Amobarbital | Fenfluramine | Perphenazine |
| Amoxicillin | Fenoprofen | Phencyclidine |
| Ampicillin | Furosemide | Phenelzine |
| Ascorbic acid | Gentisic acid | Phenobarbital |
| Aspartame | Hemoglobin | Phenytoin |
| Atropine | Hydralazine | L-Phenylephrine |
| Benzilic acid | Hydrochlorothiazide | Phenylpropanolamine |
10
| Benzoic acid | Hydrocodone | Prednisolone |
|---|---|---|
| Benzoylecgonine | Hydrocortisone | Prednisone |
| Bilirubin | O-Hydroxyhippuric acid | Procaine |
| Brompheniramine | 3-Hydroxytyramine | Promazine |
| Caffeine | Ibuprofen | Promethazine |
| Cannabidiol | Imipramine | D,L-Propanolol |
| Cannabinol | (-) Isoproterenol | D-Propoxyphene |
| Chloralhydrate | Isoxsuprine | Quinidine |
| Chloramphenicol | Ketamine | Quinine |
| Chlordiazepoxide | Ketoprofen | Ranitidine |
| Chlorothiazide | Labetalol | Salicylic acid |
| (±) Chlorpheniramine | Levorphanol | Secobarbital |
| Chlorpromazine | Loperamide | Sulfamethazine |
| Chloroquine | Maprotiline | Sulindac |
| Cholesterol | Meperidine | Temazepam |
| Clomipramine | Meprobamate | Tetracycline |
| Clonidine | Methadone | Tetrahydrocortisone |
| Cocaine hydrochloride | Methylphenidate | Tetrahydrozoline |
| Codeine | Morphine-3-Dglucuronide | Δ9-THC-COOH |
| Cortisone | Nalidixic acid | Thebaine |
| (-) Cotinine | Naloxone | Thiamine |
| Creatinine | Naltrexone | Thioridazine |
| Deoxycorticosterone | Naproxen | D,L-Thyroxine |
| Dextromethorphan | Niacinamide | Tolbutamide |
| Diazepam | Nifedipine | Triamterene |
| Diclofenac | Norcodein | Trifluoperazine |
| Diflunisal | Norethindrone | Trimethoprim |
| Digoxin | D-Norpropoxyphene | Trimipramine |
| Diphenhydramine | Noscapine | Tryptamine |
| Doxylamine | D,L-Octopamine | D, L-Tyrosine |
| Ecgonine hydrochloride | Oxalic acid | Uric acid |
| Ecgonine methylester | Oxazepam | Verapamil |
| (IR,2S)-(-)-Ephedrine | Oxolinic acid | Zomepirac |
Cocaine
| Cocaine | ||
|---|---|---|
| Acetaminophen | Estrone-3-sulfate | Oxymetazoline |
| Acetophenetidin | Ethyl-p-aminobenzoate | Papaverine |
| N-Acetylprocainamide | Fenoprofen | Penicillin-G |
| Acetylsalicylic acid | Furosemide | Pentobarbital |
| Aminopyrine | Gentisic acid | Perphenazine |
| Amitryptyline | Hemoglobin | Phencyclidine |
| Amobarbital | Hydralazine | Phenelzine |
| Amoxicillin | Hydrochlorothiazide | Phenobarbital |
11
| Ampicillin | Hydrocodone | Phentermine |
|---|---|---|
| L-Ascorbic acid | Hydrocortisone | L-Phenylephrine |
| DL-Amphetamine | O-Hydroxyhippuric acid | β-Phenylethylamine |
| Apomorphine | p-Hydroxymethamphetamine | Phenylpropanolamine |
| Aspartame | 3-Hydroxytyramine | Prednisolone |
| Atropine | Ibuprofen | Prednisone |
| Benzilic acid | Imipramine | Procaine |
| Benzoic acid | Iproniazid | Promazine |
| Benzphetamine | (±) - Isoproterenol | Promethazine |
| (±) -Brompheniramine | Isoxsuprine | DL-Propranolol |
| Caffeine | Ketamine | D-Propoxyphene |
| Cannabidiol | Ketoprofen | D-Pseudoephedrine |
| Cannabinol | Labetalol | Quinidine |
| Chloralhydrate | Levorphanol | Quinine |
| Chloramphenicol | Loperamide | Ranitidine |
| Chlordiazepoxide | Maprotiline | Salicylic acid |
| Chlorothiazide | Meperidine | Secobarbital |
| (±) -Chlorpheniramine | Meprobamate | Serotonin |
| Chlorpromazine | Methadone | Sulfamethazine |
| Chloroquine | Methoxyphenamine | Sulindac |
| Cholesterol | 3,4-Methylene dioxyamphetamine | Temazepam |
| Clomipramine | 3,4-Methylene- | Tetrahydrocortisone 3-(β- |
| dioxymethamphetamine | D glucuronide) | |
| Clonidine | Morphine-3-β-D glucuronide | Tetracycline |
| Codeine | Morphine Sulfate | Tetrahydrozoline |
| Cortisone | Nalidixic acid | Thebaine |
| (-) Cotinine | Naloxone | Thiamine |
| Creatinine | Naltrexone | Thioridazine |
| Deoxycorticosterone | Naproxen | DL-Tyrosine |
| Dextromethorphan | Niacinamide | Tolbutamide |
| Diazepam | Nifedipine | Triamterene |
| Diclofenac | Norcodein | Trifluoperazine |
| Diflunisal | Norethindrone | Trimethoprim |
| Digoxin | D-Norpropoxyphene | Trimipramine |
| Diphenhydramine | Noscapine | Tryptamine |
| Doxylamine | DL-Octopamine | DL-Tryptophan |
| Ecgonine methylester | Oxalic acid | Tyramine |
| (-) - Ψ-Ephedrine | Oxazepam | Uric acid |
| Erythromycin | Oxolinic acid | Verapamil |
| β-Estradiol | Oxycodone | Zomepirac |
| Morphine | ||
| Acebutolol | L -Ψ-Ephedrine | Papaverine |
| Acetopromazined-6 | Erythromycin | Penicillin G |
| Acetamidophenol | β-Estradiol | Pentazocine |
| Acetophenetidin | Estrone-3-sulfate | Pentobarbital |
| Acetylprocainamide | Ethylpaminobenzoate | Perphenazine |
| Acetylsalicylic acid | Fenoprofen | Phencyclidine |
| Aminopyrine | Furosemide | Phenelzine |
| Amitryptyline | Gentisic acid | Phenobarbital |
| Amobarbital | Hemoglobin | Phentermine |
| Amoxicillin | Hydralazine | L-Phenylephrine |
| Ampicillin | Hydrochlorothiazide | β-Phenethylamine |
| Ascorbic acid | Hydrocortisone | Phenylpropanolamine |
| D/L-Amphetamine | α-Hydroxyhippuric acid | Prednisolone |
| L-Amphetamine | 3-Hydroxytyramine | Prednisone |
| Apomorphine | Ibuprofen | Promazine |
| Aspartame | Imipramine | Promethazine |
| Atropine | Iproniazid | D/L-Propranolol |
| Benzilic acid | (+/-)-Isoproterenol | D-Propoxyphene |
| Benzoic acid | Isoxsuprine | D-Pseudoephedrine |
| Benzoylecgonine | Ketamine | Quinidine |
| Benzphetamine | Ketoprofen | Quinine |
| Bilirubin | Labetalol | Ranitidine |
| Brompheniramine | Loperamide | Salicylic acid |
| Caffeine | Maprotiline | Secobarbital |
| Chloralhydrate | Meprobamate | Serotonin (5- |
| Chloramphenicol | Methadone | Sulfamethazine |
| Chlordiazepoxide | Methoxyphenamine | Sulindac |
| Chlorothiazide | 3,4Methylenedioxyamphetamine | Temazepam |
| Chlorpheniramine | 3,4Methylenedioxymethamphetamin | Tetracycline |
| Chlorpromazine | Methylphenidate | Tetrahydrocortisone |
| Chloroquine | Methyprylon | Tetrahydrocortisone3 (β- |
| Cholesterol | Nalorphine | Tetrahydrozoline |
| Clomipramine | Naloxone | Thiamine |
| Clonidine | Nalidixic acid | Thioridazine |
| Cocaine hydrochloride | Naltrexone | D/L-Thyroxine |
| Cortisone | Naproxen | Tolbutamide |
| (-)- Cotinine | Niacinamide | Triamterene |
| Creatinine | Nifedipine | Trifluoperazine |
| Deoxycorticosterone | Norcodein | Trimethoprim |
| Dextromethorphan | Norethindrone | Trimipramine |
| Diazepam | D-Norpropoxyphene | Tryptamine |
| Diclofenac | Noscapine | D/L-Tryptophan |
| Diflunisal | D/L-Octopamine | Tyramine |
| Digoxin | Oxalic acid | D/L-Tyrosine |
| Diphenhydramine | Oxazepam | Uric acid |
| Doxylamine | Oxolinic acid | Verapamil |
| Ecgonine hydrochloride | Oxymetazoline | Zomepirac |
| Ecgoninemethylester | p-Hydroxymethamphetamine |
12
13
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.
| Amphetamine
(Cut-off=1000 ng/mL) | Result
Positive at (ng/mL) | % Cross-Reactivity |
|----------------------------------------------|-------------------------------|--------------------|
| D - Amphetamine | 1000 | 100% |
| L - Amphetamine | 20000 | 5% |
| D,L - Amphetamine | 3000 | 33% |
| Phentermine | 30000 | 3.3% |
| Hydroxyamphetamine | 8000 | 12.5% |
| Methylenedioxyamphetamine (MDA) | 20000 | 5% |
| d-Methamphetamine | Negative at 100000 | Not Detected |
| 1-Methamphetamine | Negative at 100000 | Not Detected |
| ephedrine | Negative at 100000 | Not Detected |
| Methylenedioxyethylamphetamine (MDE) | Negative at 100000 | Not Detected |
| 3,4-methylenedioxy-methamphetamine
(MDMA) | Negative at 100000 | Not Detected |
| Cocaine
(Cut-off=300 ng/mL) | Result
Positive at (ng/mL) | % Cross-Reactivity |
|--------------------------------|-------------------------------|--------------------|
| Benzoylecgonine | 300 | 100% |
| Cocaine HCl | 750 | 40% |
| Cocaethylene | 12500 | 2.4% |
| Ecgonine | 32000 | 0.9% |
| Norcocaine | 100000 | 0.3% |
| Morphine
(Cut-off=2000 ng/mL) | Result
Positive at(ng/mL) | % Cross-Reactivity |
|----------------------------------|------------------------------|--------------------|
| Morphine | 2000 | 100% |
| Acetylmorphine | 2500 | 80% |
14
| Codeine | 1000 | 200% |
|---|---|---|
| Ethyl Morphine | 250 | 800% |
| Heroin | 5000 | 40% |
| Hydromorphone | 2500 | 80% |
| Hydrocodone | 5000 | 40% |
| Thebaine | 13000 | 15.4% |
| Morphine-3- β-glucuronide | Negative at 200000 | 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. |
Comparison between GC/MS and Lay Person Results for Amphetamine Strip
| % of Cutoff | Number
of
samples | d-Amphetamine
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 | 2.2 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 5.5 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 7.6 | 1 | 20 | 95 |
| +25% Cutoff | 21 | 12.6 | 20 | 1 | 95 |
| +50% Cutoff | 21 | 16.2 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 17.8 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Amphetamine Dip Card
21
| % of Cutoff | Number of samples | d-Amphetamine 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 | 2.2 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 5.5 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 7.6 | 1 | 20 | 95 |
| +25% Cutoff | 21 | 12.6 | 20 | 1 | 95 |
| +50% Cutoff | 21 | 16.2 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 17.8 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Amphetamine Turn-Key Split Cup
| % of Cutoff | Number of samples | d-Amphetamine Concentration by GC/MS (ng/mL) | Lay person results No. of Positive | Lay person results No. of Negative | The percentage of correct results (%) |
|---|---|---|---|---|---|
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 2.2 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 5.5 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 7.6 | 0 | 21 | 100 |
| +25% Cutoff | 21 | 12.6 | 19 | 2 | 90 |
| +50% Cutoff | 21 | 16.2 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 17.8 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Amphetamine Quick Cup
| % of Cutoff | Number of
samples | d-Amphetamine
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 | 2.2 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 5.5 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 7.6 | 2 | 19 | 90 |
| +25% Cutoff | 21 | 12.6 | 20 | 1 | 95 |
| +50% Cutoff | 21 | 16.2 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 17.8 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Cocaine Strip
| % of Cutoff | Number of samples | Benzoylecgonine Concentration by GC/MS (ng/mL) | Lay person results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 69 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 162 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 251 | 0 | 21 | 100 |
22
| +25% Cutoff | 21 | 389 | 20 | 1 | 95 |
|---|---|---|---|---|---|
| +50% Cutoff | 21 | 463 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 510 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Cocaine Dip Card
| % of Cutoff | Number
of
samples | Benzoylecgonine
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|------------------------------------------------------|--------------------|----|------------------------------------------------|
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 69 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 162 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 251 | 1 | 20 | 95 |
| +25% Cutoff | 21 | 389 | 20 | 1 | 95 |
| +50% Cutoff | 21 | 463 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 510 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Cocaine Turn-Key Split Cup
| % of Cutoff | Number of samples | Benzoylecgonine 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 | 69 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 162 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 251 | 1 | 20 | 95 |
| +25% Cutoff | 21 | 389 | 19 | 2 | 90 |
| +50% Cutoff | 21 | 463 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 510 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Cocaine Quick Cup
| % of Cutoff | Number of samples | Benzoylecgonine Concentration by GC/MS (ng/mL) | Lay person results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 69 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 162 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 251 | 1 | 20 | 95 |
| +25% Cutoff | 21 | 389 | 20 | 1 | 95 |
| +50% Cutoff | 21 | 463 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 510 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Morphine Strip
| % of Cutoff | Number of samples | Morphine Concentration by GC/MS (ng/mL) | Lay person results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| No. of Positive | No. of Negative |
23
| % of Cutoff | of
comniac | by GC/MS (ng/mL) | No. of
The Callery | No. of | percentage of
correct results | | | |
|-----------------------------------------------------------------------|---------------|------------------------|-----------------------|--------|----------------------------------|--|--|--|
| | Number | Morphine Concentration | Lay person results | | The | | | |
| Comparison between GC/MS and Lay Person Results for Morphine Dip Card | | | | | | | | |
| +75% Cutoff | 21 | 210 | 21 | 0 | 100 | | | |
| +50% Cutoff | 21 | 463 | 21 | 0 | 100 | | | |
| +25% Cutoff | 21 | 389 | 20 | 1 | તેર | | | |
| -25% Cutoff | 21 | 251 | 2 | 19 | 90 | | | |
| -50% Cutoff | 21 | 162 | 0 | 21 | 100 | | | |
| -75%Cutoff | 21 | રતે | 0 | 21 | 100 | | | |
| -100%Cutoff | 21 | 0 | 0 | 21 | 100 | | | |
| samples | Positive | Negative | (%) | ||
|---|---|---|---|---|---|
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 69 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 162 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 251 | 2 | 19 | 90 |
| +25% Cutoff | 21 | 389 | 21 | 0 | 100 |
| +50% Cutoff | 21 | 463 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 510 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Morphine Turn-Key Split Cup
| % of Cutoff | Number
of
samples | Morphine 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 | 69 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 162 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 251 | 0 | 21 | 100 |
| +25% Cutoff | 21 | 389 | 20 | 1 | 95 |
| +50% Cutoff | 21 | 463 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 510 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Morphine Quick Cup
| | Number
of
samples | Morphine 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 | 69 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 162 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 251 | 1 | 20 | 95 |
| +25% Cutoff | 21 | 389 | 21 | 0 | 100 |
| +50% Cutoff | 21 | 463 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 510 | 21 | 0 | 100 |
Lay-users were also given surveys on the ease of understanding the package insert instructions.
24
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.
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 Amphetamine Tests, AssureTech Cocaine Tests and AssureTech Morphine Tests are substantially equivalent to the predicate.