(121 days)
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.
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.
Here's a summary of the acceptance criteria and study details for the AssureTech Amphetamine, Cocaine, and Morphine Tests, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as distinct, quantifiable thresholds for overall device performance (e.g., minimum sensitivity/specificity). Instead, it presents the results of various studies which demonstrate the device's acceptable performance in several analytical and user-related aspects. The performance is summarized below from the provided tables and text.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision | Consistent results across multiple lots and concentrations, accurately differentiating positive and negative samples around the cut-off. | For all three drug tests (Amphetamine, Cocaine, Morphine) and all device formats (Strip, Dip Card, Turn-Key Split Cup, Quick Cup): - Samples at -100%, -75%, -50% cut-off consistently showed 50-/0+ (negative results, 0 false positives). - Samples at +25%, +50%, +75%, +100% cut-off consistently showed 50+/0- (positive results, 0 false negatives). - At the cut-off concentration, results showed a mix of positive and negative, as expected (e.g., Amphetamine Strip Lot 1: 12-/38+; meaning 12 negative and 38 positive out of 50 tests). This demonstrates the ability to differentiate near the cut-off. |
| Cut-off | Accurate detection at and around defined cut-off concentrations. | For all three drug tests: - All samples at and above +25% Cut-Off were positive. - All samples at and below -25% Cut-Off were negative. Verified Cut-off Values: - d-Amphetamine: 1000 ng/mL - Benzoylecgonine: 300 ng/mL - Morphine: 2000 ng/mL |
| Interference | No significant interference from common physiological/pathological substances or drugs. | No interference observed for a wide range of compounds (listed in detail for each drug) at 100µg/mL. No differences observed across different device formats. |
| Specificity | Correct identification of target analytes and appropriate cross-reactivity with related compounds. | Detailed cross-reactivity tables provided, showing expected reactivity to metabolites and related compounds, and negative results for unrelated substances. For example: - Amphetamine: D-Amphetamine 100%, L-Amphetamine 5%, D,L-Amphetamine 33%. - Cocaine: Benzoylecgonine 100%, Cocaine HCl 40%. - Morphine: Morphine 100%, Codeine 200%, Acetylmorphine 80%. |
| Effect of Urine Specific Gravity and pH | No impact on results within biological ranges. | All samples spiked with target drugs at +/-25% Cut-Off within specific gravity (1.000-1.035) and pH (4-9) ranges yielded expected results (positive at +25% Cut-Off, negative at -25% Cut-Off). No differences observed across different device formats. |
| Method Comparison (vs. GC/MS) | High concordance with GC/MS results, especially for samples far from the cut-off. Discordant results should be concentrated near the cut-off. | Generally high concordance with GC/MS. Discordant results (where device result differs from GC/MS) primarily occur in samples with concentrations near the cut-off (between -50% and +50% of the cut-off), which is an expected characteristic of qualitative rapid tests. Specific numbers of concordant and discordant results are detailed for each drug and device format. |
| Lay-user Study (Correct Results) | High percentage of correct results by lay users for samples significantly above or below the cut-off. | For all three drug tests (Amphetamine, Cocaine, Morphine) and all device formats: - 100% correct results for samples at -100%, -75%, -50% cut-off. - 100% correct results for samples at +50%, +75% cut-off. - Performance slightly lower (e.g., 90-95%) for samples near the +/-25% cut-off, which is expected for qualitative tests. |
| Lay-user Study (Ease of Use) | Instructions easily understood and followed by lay users. | All lay users indicated that the device instructions could be easily followed. The Flesch-Kincaid reading analysis showed a Grade Level of 7 for the package insert. |
2. Sample Size Used for the Test Set and Data Provenance:
-
Analytical Performance (Precision, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and pH):
- Precision: For each drug and each device format, 3 lots were tested. For each lot, 8 concentrations were evaluated, with 50 tests per concentration (2 runs per day for 25 days). This amounts to 3 (lots) * 8 (concentrations) * 50 (tests/concentration) = 1200 tests per drug per device format.
- Cut-off: 150 samples (equally distributed at -50%, -25%, Cut-Off, +25%, +50% Cut-Off) were tested using three different lots of each device by three different operators. This sums up to 150 (samples) * 3 (lots) * 3 (operators) = 1350 tests per drug per device format.
- Interference/Specificity/Effect of Urine Specific Gravity and pH: Samples were prepared with interfering substances/varied conditions and spiked with target drugs at 25% below and 25% above Cut-Off levels. Tested using three batches of each device. Specific sample numbers for these studies are not explicitly provided beyond these descriptions.
- Data Provenance: Not specified, but generally analytical performance studies are conducted internally by the manufacturer. No country of origin is mentioned. These are retrospective studies in the sense that samples are prepared/manipulated for the experiment.
-
Method Comparison Studies (vs. GC/MS):
- For each drug and each device format, 80 unaltered clinical samples were tested by three laboratory assistants. These samples were categorised as 10 Negative, 20 Low Negative (less than -50%), 10 Near Cutoff Negative (between -50% and cutoff), 15 Near Cutoff Positive (between cutoff and +50%), and 25 High Positive (greater than +50%).
- Total samples per drug (e.g., Amphetamine) across all device types: 80 (samples) * 4 (device formats) = 320 samples (clinical).
- Total tests per drug: 80 (samples) * 3 (viewers) * 4 (device formats) = 960 tests (clinical).
- Data Provenance: "Unaltered clinical samples" - implies prospective or retrospectively collected human urine samples. Country of origin not specified.
-
Lay-user Study:
- 1638 lay persons were involved. Each participant tested 1 blind-labeled sample.
- Samples were prepared at 7 different concentrations for each drug and device (negative, +/-75%, +/-50%, +/-25% of the cutoff).
- For each drug and each device format, there were 21 samples per concentration. So, 7 (concentrations) * 21 (samples/concentration) = 147 samples per drug per device format.
- Therefore, 147 samples * 3 (drugs) * 4 (device formats) = 1764 samples in total for the lay-user study. Given there were 1638 lay persons, this suggests some lay persons might have tested multiple devices/drugs, or the "number of samples" refers to unique sample types at each concentration. The phrasing "Each participant was provided with... 1 blind labeled sample and a device" implies each of the 1638 participants tested one particular drug/device combination sample. The specific breakdown of which participant tested which of the 1764 total samples isn't detailed, but the total number of lay users is 1638.
- Data Provenance: "three intended user sites." Implied prospective data collection from human lay users. Country of origin not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Analytical Performance & Lay-user Study Test Sets: The ground truth for these samples was established using GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate chemical method used as the "preferred confirmatory method" for drug testing. No human experts were involved in establishing the ground truth for these controlled samples; it's a quantitative chemical analysis.
- Method Comparison Study Test Set: The ground truth for the 80 unaltered clinical samples was also established through GC/MS.
- Qualifications of Experts: Not applicable, as GC/MS is the ground truth determinant. The "laboratory assistants" and "lay persons" were the ones performing the device tests, not establishing the ground truth.
4. Adjudication Method (for the test set):
- Analytical Performance & Lay-user Study: The ground truth was based on GC/MS results. The device results were compared directly to the GC/MS quantitative concentration relative to the cut-off. No human adjudication method was described as the ground truth was objective chemical analysis.
- Method Comparison Study: The ground truth was based on GC/MS results. Discordant results (where the viewer's result differed from the GC/MS) are reported individually for each viewer. There is no mention of an adjudication process among the three laboratory assistants (Viewers A, B, C) for these comparisons.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This document describes a medical device (drug screening tests) which is not an AI-powered image analysis tool. It is a qualitative immunoassay. The "Viewers" mentioned in the method comparison study are laboratory assistants reading the results of the strips, not radiologists or medical professionals interpreting AI output. Therefore, there is no discussion of AI assistance or effect size on human reader improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, standalone performance data is presented, but not for an algorithm. The devices are qualitative immunochromatographic assays. Their "standalone" performance is assessed by comparing their output (presence/absence of a line, indicating positive/negative) directly against the GC/MS ground truth in various analytical studies (precision, cut-off, interference, specificity, specific gravity/pH effects).
- The "Method Comparison Studies" where three laboratory assistants read the devices can be seen as testing the device's performance with a human-in-the-loop (laboratory assistant).
- The "Lay-user study" specifically evaluates the device's performance with a human-in-the-loop (lay person), focusing on ease of use and ability to correctly interpret results.
- The closest to "algorithm only" performance comes from the precision and cut-off studies, where the device's inherent ability to react to specific concentrations is measured.
7. The type of ground truth used:
- The primary ground truth used for all performance studies (analytical, method comparison, and lay-user studies) was Gas Chromatography/Mass Spectrometry (GC/MS).
- GC/MS is referred to as the "preferred confirmatory method," making it the clinical gold standard for quantitative drug concentration in urine, providing an objective and highly accurate ground truth.
8. The sample size for the training set:
- This document is a 510(k) submission for an in-vitro diagnostic device (immunoassay), not an AI/Machine Learning algorithm. Therefore, there is no concept of a "training set" in the traditional AI sense described here. The device's performance is based on its chemical and biological design, not on being trained with data.
9. How the ground truth for the training set was established:
- As there is no training set for an AI/ML algorithm, this question is not applicable. The device's functionality is inherent to its design as an immunoassay.
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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
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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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510(k) SUMMARY
| 1. Date: | March 26, 2016 |
|---|---|
| 2. Submitter: | Assure Tech. Co., Ltd.Building 1, No.10, Xiyuansan Road, WestlakeEconomic ZoneHangzhou, China, 310030 |
| 3. Contact person: | Eric LinAssure Tech. Co., Ltd.Building 1, No.10, Xiyuansan Road, WestlakeEconomic ZoneHangzhou, China, 310030Telephone: 510-860-4680Email: customerservice@assurelabs.com. |
| 4. Device Name: | AssureTech Amphetamine TestsAssureTech Cocaine TestsAssureTech 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
-
- 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
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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 ofabuse in human urine. | Same (but the number ofdrugs detected is different) |
| Calibrator | d-Amphetamine | Same |
| Methodology | Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibodyimmunochemistry. | 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 ofdrugs of abuse in human urine. | Same (but the number ofdrugs detected is different) |
| Calibrator | Benzoylecgonine | Same |
| Methodology | Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibodyimmunochemistry. | 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 ofdrugs of abuse in human urine. | Same (but the number ofdrugs detected is different) |
| Calibrator | Morphine | Same |
| Methodology | Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibodyimmunochemistry. | 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
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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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| LotNumber | -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 | |||||||||
| LotNumber | -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 | |||||||||
| LotNumber | -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 | |||||||||
| LotNumber | -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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| LotNumber | -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
| LotNumber | -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
| LotNumber | -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) | ResultPositive 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) | ResultPositive 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) | ResultPositive 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 | <1% |
| Oxycodone | Negative at 400000 | <0.5% |
| Oxymorphine | Negative at 400000 | <0.5% |
| Procaine | Negative at 400000 | <0.5% |
| Levorphanol | Negative at 400000 | <0.5% |
g. Effect of Urine Specific Gravity and Urine pH
To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. There were no differences observed for different devices.
2. Comparison Studies
Method comparison studies for the AssureTech Amphetamine Tests, the AssureTech Cocaine Tests and the AssureTech Morphine Tests were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to GC/MS results are presented in the tables below:
| Amphetamine | ||||||
|---|---|---|---|---|---|---|
| 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 | 1 | 14 | 25 |
| B | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 13 | 25 |
| C | Negative | 10 | 20 | 9 | 2 | 0 |
| 10 | 20 | 5 |
|---|---|---|
| Discordant Results of Amphetamine Strip |
| Viewer | Sample Number | GC/MS Result | StripViewer Results |
|---|---|---|---|
| Viewer A | 78081 | 984 | Positive |
| Viewer B | 78081 | 984 | Positive |
| Viewer C | 78081 | 984 | Positive |
| Viewer A | 72430 | 1083 | Negative |
{15}------------------------------------------------
| Viewer B | 79915 | 1024 | Negative |
|---|---|---|---|
| Viewer C | 79915 | 1024 | Negative |
| Viewer C | 72430 | 1083 | Negative |
| DipCard | Negative | Low Negative byGC/MS(less than-50%) | Near Cutoff Negative byGC/MS(Between-50% andcutoff) | Near Cutoff Positive byGC/MS(Between thecutoff and+50%) | High Positiveby GC/MS(greater than+50%) | |
|---|---|---|---|---|---|---|
| ViewerA | Positive | 0 | 0 | 0 | 14 | 25 |
| Negative | 10 | 20 | 10 | 1 | 0 | |
| ViewerB | Positive | 0 | 0 | 1 | 15 | 25 |
| Negative | 10 | 20 | 9 | 0 | 0 | |
| ViewerC | Positive | 0 | 0 | 0 | 14 | 25 |
| Negative | 10 | 20 | 10 | 1 | 0 |
Discordant Results of Amphetamine Dip Card
| Viewer | Sample Number | GC/MS Result | Dip Card Viewer Results |
|---|---|---|---|
| Viewer B | 78081 | 984 | Positive |
| Viewer A | 79915 | 1024 | Negative |
| Viewer C | 79915 | 1024 | Negative |
| Turn-KeySplitCup | Negative | Low Negative byGC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcutoff) | Near CutoffPositive byGC/MS(Between thecutoff and+50%) | High Positiveby GC/MS(greater than+50%) | |
|---|---|---|---|---|---|---|
| ViewerA | Positive | 0 | 0 | 1 | 14 | 25 |
| Negative | 1 | 20 | 9 | 1 | 0 | |
| ViewerB | Positive | 0 | 0 | 1 | 13 | 25 |
| Negative | 1 | 20 | 9 | 2 | 0 | |
| ViewerC | Positive | 0 | 0 | 0 | 14 | 25 |
| Negative | 1 | 20 | 10 | 1 | 0 |
Discordant Results of Amphetamine Turn-Key Split Cup
| Viewer | Sample Number | GC/MS Result | Turn-Key SplitCup |
|---|---|---|---|
| Viewer A | 78081 | 984 | Positive |
| Viewer B | 78081 | 984 | Positive |
| Viewer A | 79915 | 1024 | Negative |
| Viewer B | 79915 | 1024 | Negative |
| Viewer B | 79915 | 1024 | Negative |
| Viewer C | 87184 | 1257 | Negative |
{16}------------------------------------------------
| Quick | Low | Near Cutoff | Near Cutoff | |||
|---|---|---|---|---|---|---|
| Cup | Negative | Negative by | Negative by | Positive by | High Positive | |
| GC/MS | GC/MS | GC/MS | by GC/MS | |||
| (less than | (Between | (Between the | (greater than | |||
| -50%) | -50% and | cutoff and | +50%) | |||
| cutoff) | +50%) | |||||
| Viewer | Positive | 0 | 0 | 0 | 14 | 25 |
| A | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 14 | 25 |
| B | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer | Positive | 0 | 0 | 0 | 15 | 25 |
| C | Negative | 10 | 20 | 10 | 0 | 0 |
Discordant Results of Amphetamine Quick Cup
| Viewer | Sample Number | GC/MS Result | Quick CupViewer Results |
|---|---|---|---|
| Viewer B | 78081 | 984 | Positive |
| Viewer A | 79915 | 1024 | Negative |
| Viewer B | 79915 | 1024 | Negative |
Cocaine
| Strip | Negative | LowNegative byGC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcutoff) | Near CutoffPositive byGC/MS(Between thecutoff and+50%) | High Positiveby GC/MS(greater than+50%) | |
|---|---|---|---|---|---|---|
| Viewer | Positive | 0 | 0 | 1 | 15 | 25 |
| A | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer | Positive | 0 | 0 | 0 | 14 | 25 |
| B | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer | Positive | 0 | 0 | 2 | 15 | 25 |
| C | Negative | 10 | 20 | 8 | 0 | 0 |
Discordant Results of Cocaine Strip
| Viewer | Sample Number | GC/MS Result | StripViewer Results |
|---|---|---|---|
| Viewer A | 38238 | 285 | Positive |
| Viewer C | 58356 | 280 | Positive |
| Viewer C | 38238 | 285 | Positive |
| Viewer B | 71282 | 312 | Negative |
{17}------------------------------------------------
| DipCard | Negative | LowNegative byGC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcutoff) | Near CutoffPositive byGC/MS(Between thecutoff and+50%) | High Positiveby GC/MS(greater than+50%) | |
|---|---|---|---|---|---|---|
| ViewerA | Positive | 0 | 0 | 2 | 15 | 25 |
| ViewerA | Negative | 10 | 20 | 8 | 0 | 0 |
| ViewerB | Positive | 0 | 0 | 0 | 15 | 25 |
| ViewerB | Negative | 10 | 20 | 10 | 0 | 0 |
| ViewerC | Positive | 0 | 0 | 1 | 13 | 25 |
| ViewerC | Negative | 10 | 20 | 9 | 2 | 0 |
Discordant Results of Cocaine Dip Card
| Viewer | Sample Number | GC/MS Result | Dip CardViewer Results |
|---|---|---|---|
| Viewer A | 38238 | 285 | Positive |
| Viewer A | 58356 | 280 | Positive |
| Viewer C | 38238 | 285 | Positive |
| Viewer C | 71282 | 312 | Negative |
| Viewer C | 35525 | 317 | Negative |
| Turn-KeySplitCup | Negative | Low Negative byGC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcutoff) | Near CutoffPositive byGC/MS(Between thecutoff and+50%) | High Positiveby GC/MS(greater than+50%) | |
|---|---|---|---|---|---|---|
| ViewerA | Positive | 0 | 0 | 2 | 15 | 25 |
| ViewerA | Negative | 1 | 20 | 8 | 0 | 0 |
| ViewerB | Positive | 0 | 0 | 0 | 14 | 25 |
| ViewerB | Negative | 1 | 20 | 10 | 1 | 0 |
| ViewerC | Positive | 0 | 0 | 0 | 14 | 25 |
| ViewerC | Negative | 1 | 20 | 10 | 1 | 0 |
Discordant Results of Cocaine Turn-Key Split Cup
| Viewer | Sample Number | GC/MS Result | Split CupViewer Results |
|---|---|---|---|
| Viewer A | 38238 | 285 | Positive |
| Viewer A | 58356 | 280 | Positive |
| Viewer B | 71282 | 312 | Negative |
| Viewer C | 35525 | 317 | Negative |
{18}------------------------------------------------
| QuickCup | Negative | Low Negative byGC/MS(less than-50%) | Near Cutoff Negative byGC/MS(Between-50% andcutoff) | Near Cutoff Positive byGC/MS(Between thecutoff and+50%) | High Positiveby GC/MS(greater than+50%) | |
|---|---|---|---|---|---|---|
| ViewerA | Positive | 0 | 0 | 1 | 15 | 25 |
| Negative | 10 | 20 | 9 | 0 | 0 | |
| ViewerB | Positive | 0 | 0 | 1 | 14 | 25 |
| Negative | 10 | 20 | 9 | 1 | 0 | |
| ViewerC | Positive | 0 | 0 | 1 | 14 | 25 |
| Negative | 10 | 20 | 9 | 1 | 0 |
Discordant Results of Cocaine Quick Cup
| Viewer | Sample Number | GC/MS Result | Quick CupViewer Results |
|---|---|---|---|
| Viewer A | 38238 | 285 | Positive |
| Viewer B | 38238 | 285 | Positive |
| Viewer C | 63906 | 225 | Positive |
| Viewer B | 71282 | 312 | Negative |
| Viewer C | 71282 | 312 | Negative |
Morphine
| Strip | Morphine | |||||
|---|---|---|---|---|---|---|
| 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 | 15 | 25 |
| Negative | 10 | 20 | 10 | 0 | 0 |
Discordant Results of Morphine Strip
| Viewer | Sample Number | GC/MS Result | StripViewer Results |
|---|---|---|---|
| Viewer A | 91558 | 1890 | Positive |
| Viewer B | 99379 | 1917 | Positive |
| Viewer A | 65159 | 2231 | Negative |
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| DipCard | Negative | LowNegative byGC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcutoff) | Near CutoffPositive byGC/MS(Between thecutoff and+50%) | High Positiveby GC/MS(greater than+50%) | |
|---|---|---|---|---|---|---|
| ViewerA | Positive | 0 | 0 | 2 | 15 | 25 |
| Negative | 10 | 20 | 8 | 0 | 0 | |
| ViewerB | Positive | 0 | 0 | 1 | 14 | 25 |
| Negative | 10 | 20 | 9 | 1 | 0 | |
| ViewerC | Positive | 0 | 0 | 0 | 14 | 25 |
| Negative | 10 | 20 | 10 | 1 | 0 |
Discordant Results of Morphine Dip Card
| Viewer | Sample Number | GC/MS Result | Dip CardViewer Results |
|---|---|---|---|
| Viewer A | 99379 | 1917 | Positive |
| Viewer A | 91558 | 1890 | Positive |
| Viewer B | 91558 | 1890 | Positive |
| Viewer B | 62657 | 2115 | Negative |
| Viewer C | 59704 | 2022 | Negative |
| Turn-KeySplitCup | Negative | Low Negative byGC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcutoff) | Near CutoffPositive byGC/MS(Between thecutoff and+50%) | High Positiveby GC/MS(greater than+50%) | |
|---|---|---|---|---|---|---|
| ViewerA | Positive | 0 | 0 | 1 | 14 | 25 |
| Negative | 1 | 20 | 9 | 1 | 0 | |
| ViewerB | Positive | 0 | 0 | 1 | 14 | 25 |
| Negative | 1 | 20 | 9 | 1 | 0 | |
| ViewerC | Positive | 0 | 0 | 1 | 15 | 25 |
| Negative | 1 | 20 | 9 | 0 | 0 |
Discordant Results of Morphine Turn-Key Split Cup
| Viewer | Sample Number | GC/MS Result | Split CupViewer Results |
|---|---|---|---|
| Viewer A | 99379 | 1917 | Positive |
| Viewer B | 49390 | 1856 | Positive |
| Viewer C | 91558 | 1890 | Positive |
| Viewer A | 65159 | 2231 | Negative |
| Viewer B | 62657 | 2115 | Negative |
{20}------------------------------------------------
| QuickCup | Negative | LowNegative byGC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcutoff) | Near CutoffPositive byGC/MS(Between thecutoff and+50%) | High Positiveby GC/MS(greater than+50%) | |
|---|---|---|---|---|---|---|
| ViewerA | Positive | 0 | 0 | 2 | 14 | 25 |
| Negative | 10 | 20 | 8 | 1 | 0 | |
| ViewerB | Positive | 0 | 0 | 1 | 14 | 25 |
| Negative | 10 | 20 | 9 | 1 | 0 | |
| ViewerC | Positive | 0 | 0 | 1 | 14 | 25 |
| Negative | 10 | 20 | 9 | 1 | 0 |
Discordant Results of Morphine Quick Cup
| Viewer | Sample Number | GC/MS Result | Quick CupViewer Results |
|---|---|---|---|
| Viewer A | 99379 | 1917 | Positive |
| Viewer A | 91558 | 1890 | Positive |
| Viewer B | 91558 | 1890 | Positive |
| Viewer C | 91558 | 1890 | Positive |
| Viewer A | 65159 | 2231 | Negative |
| Viewer B | 59704 | 2022 | Negative |
| Viewer C | 65159 | 2231 | 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.
Comparison between GC/MS and Lay Person Results for Amphetamine Strip
| % of Cutoff | Numberofsamples | d-AmphetamineConcentration by GC/MS(ng/mL) | Lay person results | Thepercentage ofcorrect results(%) | |
|---|---|---|---|---|---|
| No. ofPositive | No. ofNegative | ||||
| -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
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| % 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 ofsamples | d-AmphetamineConcentration by GC/MS(ng/mL) | Lay person results | Thepercentage ofcorrect results(%) | |
|---|---|---|---|---|---|
| No. ofPositive | No. ofNegative | ||||
| -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 | Numberofsamples | BenzoylecgonineConcentration by GC/MS(ng/mL) | Lay person results | Thepercentage ofcorrect 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 | ofcomniac | by GC/MS (ng/mL) | No. ofThe Callery | No. of | percentage ofcorrect 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 | Numberofsamples | Morphine Concentrationby GC/MS (ng/mL) | Lay person results | Thepercentage ofcorrect results(%) | |
|---|---|---|---|---|---|
| No. ofPositive | No. ofNegative | ||||
| -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
| Numberofsamples | Morphine Concentrationby GC/MS (ng/mL) | Lay person results | The | ||
|---|---|---|---|---|---|
| % of Cutoff | No. ofPositive | No. ofNegative | percentage ofcorrect 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.
§ 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).