(81 days)
Clungene Methamphetamine Tests are immunochromatographic assays for the qualitative determination of dmethamphetamine in human urine at cut-off concentration of 1000 ng/mL. The calibrator is d-methamphetamine. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card 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. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.
Clungene Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-Nor-△9-Tetrahydrocannabinol-9-COOH in human urine at cut-off concentration of 50 ng/mL. The calibrator is 11-Nor-△9-Tetrahydrocannabinol-9-COOH. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card 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. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing - the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.
Clungene Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 300 ng/mL. The callbrator is Morphine. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card 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. This test is intended for over the counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.
The CLUNGENE Methamphetamine Tests, CLUNGENE Morphine Tests, and CLUNGENE Marijuana Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Methamphetamine, Morphine and 11-Nor-A9-Tetrahydrocannabinol-9-COOH (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 breakdown of the acceptance criteria and study information for the Clungene Methamphetamine, Morphine, and Marijuana Tests, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a separate section with specific numerical thresholds for accuracy, sensitivity, or specificity that the device must meet for approval. Instead, it describes performance characteristics and then presents the results of those studies. The implicit acceptance criteria appear to be the demonstrated performance of the device showing appropriate qualitative detection relative to the cut-off concentrations when compared to GC/MS, and user readability for OTC use.
Performance Characteristics Summary (Implicit Acceptance Criteria and Reported Performance)
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision | Consistent results across different lots and concentrations around cut-off. | Across 3 lots and 9 different concentrations (-100% to +100% cut-off), the devices consistently showed 100% agreement for concentrations far from the cut-off. For samples at the cut-off, there was variability in positive/negative calls (e.g., for Methamphetamine Cassette, Lot 1: 22-/28+, Lot 2: 29-/21+, Lot 3: 29-/21+ at cut-off). This implies appropriate performance around the threshold. |
| Cut-off Accuracy | Samples below -25% cut-off should be negative, and samples above +25% cut-off should be positive. | All samples at and below -25% Cut-Off were negative. All samples at and above +25% Cut-Off were positive for Methamphetamine, Morphine, and Marijuana. |
| Interference | No interference from common physiological/pathological substances or drugs at specified concentrations. | Numerous substances (listed in the document) showed no interference at 100µg/mL. |
| Specificity (Cross-reactivity) | Limited cross-reactivity with structurally similar compounds; identified cross-reactive compounds should be listed with their reactivity percentage. | Detailed tables provided showing cross-reactivity percentages for various related compounds (e.g., Methamphetamine: MDEA 5%, D/L-Methamphetamine 33%; Morphine: O6-Acetylmorphine 100%, Codeine 100%; Marijuana: 11-Hydroxy-Δ9-Tetrahydrocannabinol 1%). |
| Effect of Urine Specific Gravity & pH | No significant impact on results within specified ranges (pH 4-9, SG 1.000-1.035). | All samples within these ranges showed expected positive/negative results when spiked at +/- 25% cut-off. |
| Method Comparison (Professional User) | High agreement with GC/MS results, especially for samples far from the cut-off. Discordant results should primarily occur near the cut-off. | Methamphetamine, Morphine, Marijuana: High agreement for negative, low negative, high positive samples. Discordant results were primarily observed for samples very close to the cut-off (e.g., GC/MS result 936 ng/mL for Methamphetamine vs. 1000 ng/mL cut-off). |
| Lay-user Study (Accuracy) | High percentage of correct results by lay users, particularly for samples clearly below or above the cut-off. | For concentrations -100%, -75%, -50% cut-off, lay users showed 100% correct negative results. For +50%, +75% cut-off, lay users showed 100% correct positive results. For -25% and +25% cut-off, correctness ranged from 90-95%. |
| Lay-user Study (Usability) | Instructions should be easily understood by lay users. | All lay users indicated the device instructions can be easily followed. Flesch-Kincaid Grade Level of 7. |
2. Sample Size Used for the Test Set and Data Provenance
- Professional User (Method Comparison) Test Set:
- Sample Size: 80 unaltered clinical urine samples per drug (40 negative, 40 positive).
- Data Provenance: Retrospective, described as "in-house" studies using "unaltered clinical samples." The country of origin is not explicitly stated, but the manufacturer is based in China.
- Lay-user Study Test Set:
- Sample Size:
- Participants: 1680 lay persons.
- Samples: 1 device per participant, with one blind-labeled urine sample.
- For each drug (Methamphetamine, Morphine, Marijuana) and each device format (Cassette, Dip Card, Split-Key Cup, Easy Cup), there were a total of 7 concentrations tested. For each concentration, 20 samples were used.
- Total samples per drug (e.g., Methamphetamine): 7 concentrations * 20 samples/concentration = 140 samples.
- Total samples for all 3 drugs across all 4 device formats: 3 drugs * 4 device formats * (7 concentrations * 20 samples/concentration) = 3 * 4 * 140 = 1680 samples. This matches the number of lay persons, implying each lay person tested one sample with one device.
- Data Provenance: Prospective, as it involved lay persons testing samples. The study was performed "at three intended user sites," but the country of origin for these sites is not specified. Samples were prepared by spiking known drug concentrations into drug-free pooled urine.
- Sample Size:
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Professional User (Method Comparison) Test Set:
- Number of "Experts": Three "laboratory assistants" were involved in running the visual tests for comparison. Their qualifications are not specified beyond being "laboratory assistants."
- Ground Truth: The ground truth for the clinical samples was established by Gas Chromatography/Mass Spectrometry (GC/MS) results. This is considered the gold standard for drug quantification.
- Lay-user Study Test Set:
- Number of Experts: No explicit "experts" were used to establish the ground truth for reading the device results in this specific study, as the lay users were the test subjects. The ground truth for the sample concentrations was established by GC/MS.
4. Adjudication Method for the Test Set
- Professional User (Method Comparison) Test Set: No formal adjudication method (like 2+1 or 3+1) is described for the visual interpretation by the three laboratory assistants. Each assistant's interpretation was recorded and compared to the GC/MS ground truth. Discordant results between the device and GC/MS were tabulated for each viewer individually.
- Lay-user Study Test Set: No adjudication. Each lay user read their own device result.
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 such MRMC comparative effectiveness study was done. The device is a qualitative immunochromatographic assay for drug detection, not an AI interpretation system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a manual, visually interpreted immunochromatographic assay, not an algorithm or AI system. Its performance is inherently "standalone" in that it produces a visual result without external algorithm assistance for interpretation, but it always requires human observation and interpretation.
7. The Type of Ground Truth Used
- For all studies (Precision, Cut-off, Specificity, Interference, Method Comparison, Lay-user): The primary ground truth for the presence and concentration of drugs in urine samples was Gas Chromatography/Mass Spectrometry (GC/MS). This is considered a highly accurate and quantitative analytical method.
8. The Sample Size for the Training Set
This information is not provided. The document describes performance testing of the finished device. For immunochromatographic assays, there isn't typically a "training set" in the machine learning sense. Instead, development involves R&D to optimize reagents, membrane materials, and assay parameters. The performance studies described serve to validate the finalized design.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a "training set" in the AI sense is not relevant for this type of device. During the development and optimization of the assay, standard reference materials of known drug concentrations (confirmed by methods like GC/MS) would be used to evaluate and refine the test's linearity, sensitivity, and specificity.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2016
HANGZHOU CLONGENE BIOTECH CO., LTD. C/O JOE SHIA MANAGER 504 E DIAMOND AVE., SUITE I GAITHERSBURG MD 20877
Re: K153741
Trade/Device Name: Clungene Methamphetamine Test, Clungene Morphine Test, Clungene Marijuana Test Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: II Product Code: LDJ, DJC, DJG Dated: December 19, 2015 Received: December 28, 2015
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 medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153741
Device Name Clungene Methamphetamine Tests Clungene Marijuana Tests Clungene Morphine Tests
Indications for Use (Describe)
Clungene Methamphetamine Tests are immunochromatographic assays for the qualitative determination of dmethamphetamine in human urine at cut-off concentration of 1000 ng/mL. The calibrator is d-methamphetamine. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card 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.
This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.
Clungene Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-Nor-△9-Tetrahydrocannabinol-9-COOH in human urine at cut-off concentration of 50 ng/mL. The calibrator is 11-Nor-△9-Tetrahydrocannabinol-9-COOH. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card 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.
This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing - the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.
Clungene Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 300 ng/mL. The callbrator is Morphine. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card 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.
This test is intended for over the counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.
Type of Use (Select one or both, as applicable)
|X | 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
-
- Date: February 22, 2016
- Hangzhou Clongene Biotech Co., Ltd. 2. Submitter: 20 Longquan Road Hangzhou 311121, China
-
- Contact person: Zheng Shujian Hangzhou Clongene Biotech Co., Ltd. 20 Longquan Road Hangzhou 311121, China Telephone: 86 571 88262120 Email: frank@clongene.com.
-
- Device Name: CLUNGENE Methamphetamine Tests CLUNGENE Morphine Tests CLUNGENE Marijuana Tests
Classification:
| Product Code | CFR | Panel |
|---|---|---|
| DJC | 21 CFR, 862.3610 Methamphetamine Test | Toxicology |
| LDJ | 21 CFR, 862.3870 Cannabinoid Test System | Toxicology |
| DJG | 21 CFR, 862.3650 Opiate Test System | Toxicology |
5. Predicate Devices: K052115
The FIRST CHECK MULTI DRUG CUP Urine Test
-
- Intended Use
Clungene Methamphetamine Tests are immunochromatographic assays for the qualitative determination of d-methamphetamine in human urine at cut-off concentration of 1000 ng/mL. The calibrator is d-methamphetamine. The tests are available in a Cassette format, an Easy Cup format, a Split Key Cup format and a Dip Card 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. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.
Clungene Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-Nor-A9-Tetrahydrocannabinol-9-COOH in human urine at cut-off concentration of 50 ng/mL. The calibrator is 11-Nor-A9-Tetrahydrocannabinol-9-COOH. The tests are available in a Cassette format, an Easy Cup format, a Split Key Cup format and a Dip Card format.
The tests provide only preliminary test results. A more specific alternative chemical 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. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.
Clungene Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 300 ng/mL. The calibrator is Morphine. The tests are available in a Cassette format, an Easy Cup format, a Split Key Cup format and a Dip Card 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. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.
-
- Device Description
The CLUNGENE Methamphetamine Tests, CLUNGENE Morphine Tests, and CLUNGENE Marijuana Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Methamphetamine, Morphine and 11-Nor-A9-Tetrahydrocannabinol-9-COOH (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
- Device Description
-
- Substantial Equivalence Information
A summary comparison of features of the CLUNGENE Methamphetamine Tests, CLUNGENE Morphine Tests and CLUNGENE Marijuana Tests and the predicate devices is provided in following tables.
- Substantial Equivalence Information
| Item | Device | Predicate - K052115 |
|---|---|---|
| Indication(s)for Use | For the qualitative determination of drugs ofabuse in human urine. | Same (but the number ofdrugs detected is different) |
| Calibrator | d-Methamphetamine | Same |
| Methodology | Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibodyimmunochemistry. | Same |
Table 1: Features Comparison of CLUNGENE Methamphetamine Tests and the Predicate Devices
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| 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 | Cassette, Dip Card and Cups | Cup |
Table 2: Features Comparison of CLUNGENE Morphine Tests and the Predicate Devices
| Item | Device | Predicate - K052115 |
|---|---|---|
| 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 | 300 ng/mL | Same |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Cassette, Dip Card and Cups | Cup |
Table 3: Features Comparison of CLUNGENE Marijuana Tests and the Predicate Devices
| Item | Device | Predicate - K052115 |
|---|---|---|
| Indication(s)for Use | For the qualitative determination ofdrugs of abuse in human urine. | Same (but the number ofdrugs detected is different) |
| Calibrator | 11-Nor-△9-Tetrahydrocannabinol-9-COOH | 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 | 50 ng/mL | Same |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Cassette, Dip Card and Cups | Cup |
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9. Test Principle
The CLUNGENE Methamphetamine Tests, CLUNGENE Morphine Tests, and CLUNGENE Marijuana Tests are rapid tests for the qualitative detection of d-Methamphetamine, Morphine and 11-Nor-A9-Tetrahydrocannabinol-9-COOH in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The 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
-
- 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.
| Cassette | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 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+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Split-Key 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+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
CLUNGENE Methamphetamine Tests
Easy Cup
Lot 1
Lot 2
Lot 3
50-/0+
50-/0+
50-/0+
50-/0+
50-10+
50-/0+
50-/0+
50-/0+
50-10+
50-/0+
50-/0+
50-/0+ 20-/30+ 50+/0-
17-/33+
21-/29+
50+/0-
50+/0-
50+/0-
50+/0-
50+/0-
50+/0-
50+/0-
50+/0-
50+/0-
50+/0-
50+/0-
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| 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+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 17-/33+ | 50+/0- | 50+/0- | 50+/0- |
CLUNGENE Morphine Tests
Cassette
| 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+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 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+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Split-Key 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+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 19-/31+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 32-/18+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Easy 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+ | 31-/19+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- |
CLUNGENE Marijuana Tests
Cassette
| 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+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 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+ | 19-/31+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- |
Split-Key Cup
{9}------------------------------------------------
| 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+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 31-/19+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Easy 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+ | 30-/20+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 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 Methamphetamine, Morphine and Marijuana.
The following cut-off values for the candidate devices have been verified.
| Calibrator | Cut-off (ng/mL) |
|---|---|
| d-Methamphetamine | 1000 |
| Morphine | 300 |
| 11-Nor-△9-Tetrahydrocannabinol-9-COOH | 50 |
e. Interference
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using 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.
| 4-Acetamidophenol | (-) Y Ephedrine | Penicillin-G |
|---|---|---|
| Acetophenetidin | Erythromycin | Pentazocaine |
| N-Acetylprocainamide | ß-Estradiol | Pentobarbital |
| Acetylsalicylic acid | Estrone-3-sulfate | Perphenazine |
| Aminopyrine | Ethyl-p-aminobenzoate | Phencyclidine |
| Amitriptyline | Fenfluramine | Phenelzine |
| Amobarbital | Fenoprofen | Phendimetrazine |
| Amoxicillin | Furosemide | Phenobarbital |
| Ampicillin | Gentisic acid | Phetoin |
| Ascorbic acid | Hemoglobin | L-Phenylephrine |
| Apomorphine | Hydralazine | β-Phenylethlamine |
| Aspartame | Hydrochlorothiazide | Phenylpropanolamine |
| Atropine | Hydrocodone | Prednisolone |
| Benzilic acid | Hydrocortisone | Prednisone |
| Benzoic acid | O-Hydroxyhippuric acid | Procaine |
| Benzoylecgonine | 3-Hydroxytyramine | Promazine |
| Bilirubin | Ibuprofen | Promethazine |
| Brompheniramine | Imipramine | D,L-Propranolol |
| Caffeine | (-) Isoproterenol | Propiomazine |
| Cannabidiol | Isoxsuprine | D-Propoxyphene |
| Cannabinol | Ketamine | Quinidine |
| Chloralhydrate | Ketoprofen | Quinine |
| Chloramphenicol | Labetalol | Ranitidine |
| Chlordiazepoxide | Levorphanol | Salicylic acid |
| Chlorothiazide | Loperamide | Secobarbital |
| (+) Chlorpheniramine | Maprotiline | Serotonin |
| Chlorpromazine | Meperidine | Sulfamethazine |
| Chlorquine | Meprobamate | Sulindac |
| Cholesterol | Methadone | Temazepam |
| Clomipramine | Methylphenidate | Tetracycline |
| Clonidine | Morphine-3-Dglucuronide | Tetrahydrocortisone |
| Cocaine hydrochloride | Nalidixic acid | Tetrahydrozoline |
| Codeine | Naloxone | Δ9-THC-COOH |
| Cortisone | Naltrexone | Thebaine |
| (-) Cotinine | Naproxen | Thiamine |
| Creatinine | Niacinamide | Thioridazine |
| Deoxycorticosterone | Nifedipine | D,L-Thyroxine |
| Dextromethorphan | Norcodein | Tolbutamine |
| Diazepam | Norethindrone | Triamterene |
| Diclofenac | D-Norpropoxyphene | Trifluoperazine |
| Diflunisal | Noscapine | Trimethoprim |
| Digoxin | D,L-Octopamine | Trimipramine |
| Diphenhydramine | Oxalic acid | Tryptamine |
| Doxylamine | Oxazepam | D, L-Tyrosine |
| Ecgonine hydrochloride | Oxolinic acid | Uric acid |
| Ecgonine methylester | Oxycodone | Verapamil |
| (IR,2S)-(-)-Ephedrine | Oxymetazoline | Zomepirac |
| L-Ephedrine | Papaverine |
Methamphetamine:
{10}------------------------------------------------
Morphine
{11}------------------------------------------------
| Acebutolol | (-) Y Ephedrine | Hydroxymethamphetamine |
|---|---|---|
| Acetopromazine - d6 | Erythromycin | Papaverine |
| 4-Acetamidophenol | β-Estradiol | Penicillin-G |
| Acetophenetidin | Estrone-3-sulfate | Pentazocaine |
| N-Acetylprocainamide | Ethyl-p-aminobenzoate | Pentobarbital |
| Acetylsalicylic acid | Fenoprofen | Perphenazine |
| D,L-Amphetamine | Furosemide | Phencyclidine |
| L-Amphetamine | Gentisic acid | Phenelzine |
| Aminopyrine | Hemoglobin | Phenobarbital |
| Amitryptyline | Hydralazine | Phentermine |
| Amobarbital | Hydrochlorothiazide | β-Phenylethylamine |
| Amoxicillin | Hydrocortisone | L-Phenylephrine |
| Ampicillin | O-Hydroxyhippuric acid | β-Phenylethlamine |
| Ascorbic acid | 3-Hydroxytyramine | Phenylpropanolamine |
| Apomorphine | Ibuprofen | Prednisolone |
| Aspartame | Imipramine | Prednisone |
| Atropine | Iproniazid | Promazine |
| Benzilic acid | (-) Isoproterenol | Promethazine |
| Benzoic acid | Isoxsuprine | D,L-Propanolol |
| Benzoylecgonine | Ketamine | D-Propoxyphene |
| Benzphetamine | Ketoprofen | D-Pseudoephedrine |
| Bilirubin | Labetalol | Quinidine |
| Brompheniramine | Loperamide | Quinine |
| Caffeine | Maprotiline | Salicylic acid |
| Chloramphenicol | Meprobamate | Secobarbital |
| Chlordiazepoxide | Methoxyphenamine | Serotonin |
| Chlorothiazide | Methylenedioxyamphetamine | Sulfamethazine |
| (±) Chlorpheniramine | Methylenedioxymethamphetamine | Sulindac |
| Chlorpromazine | Methadone | Temazepam |
| Chlorquine | Methylphenidate | Tetracycline |
| Cholesterol | Methyprylon | Tetrahydrozoline |
| Clomipramine | Nalorphine | Tetrahydrocortisone |
| Clonidine | Nalidixic acid | Tetrahydrocortisone-(5-Dglucuronide) |
| Cocaine hydrochloride | Naloxone | Thiamine |
| Cortisone | Naltrexone | Thioridazine |
| (-) Cotinine | Naproxen | D,L-Thyroxine |
| Creatinine | Niacinamide | Tolbutamine |
| Deoxycorticosterone | Nifedipine | Triamterene |
| Dextromethorphan | Norcodein | Trifluoperazine |
{12}------------------------------------------------
| Diazepam | Norethindrone | Trimethoprim |
|---|---|---|
| Diclofenac | D-Norpropoxyphene | Trimipramine |
| Diflunisal | Noscapine | Tryptamine |
| Digoxin | D,L-Octopamine | D,L-Tyrosine |
| Diphenhydramine | Oxalic acid | Uric acid |
| Doxylamine | Oxazepam | Verapamil |
| Ecgonine | Oxolinic acid | Zomepirac |
| Ecgonine methylester | Oxymetazoline |
Marijuana
| Marijuana | ||
|---|---|---|
| 4-Acetamidophenol | Estrone-3-sulfate | Penicillin-G |
| Acetophenetidin | Ethyl-p-aminobenzoate | Pentazocine |
| N-Acetylprocainamide | Fenoprofen | Pentobarbital |
| Acetylsalicylic acid | Furosemide | Perphenazine |
| Aminopyrine | Gentisic acid | Phencyclidine |
| Amitryptyline | Hemoglobin | Phenelzine |
| Amobarbital | Hydralazine | Phenobarbital |
| Amoxicillin | Hydrochlorothiazide | Phentermine |
| Ampicillin | Hydrocodone | L-Phenylephrine |
| Ascorbic acid | Hydrocortisone | β-Phenylethlamine |
| D,L-Amphetamine | O-Hydroxyhippuric acid | β-Phenyllethylamine |
| L-Amphetamine | 3-Hydroxytyramine | Phenylpropanolamine |
| Apomorphine | Ibuprofen | Prednisolone |
| Aspartame | Imipramine | Prednisone |
| Atropine | Iproniazid | Procaine |
| Benzilic acid | (-) Isoproterenol | Promazine |
| Benzoic acid | Isoxsuprine | Promethazine |
| Benzoylecgonine | Ketamine | D,L-Propanolol |
| Benzphetamine | Ketoprofen | D-Propoxyphene |
| Bilirubin | Labetalol | D-Pseudoephedrine |
| Brompheniramine | Levorphanol | Quinidine |
| Caffeine | Loperamide | Quinine |
| Chloralhydrate | Maprotiline | Ranitidine |
| Chloramphenicol | Meprobamate | Salicylic acid |
| Chlordiazepoxide | Methadone | Secobarbital |
| Chlorothiazide | Methoxyphenamine | Serotonin (5- |
| (±) Chlorpheniramine | (+)3,4- | Sulfamethazine |
| Chlorpromazine | (+)3,4- | Sulindac |
| Chlorquine | Methylphenidate | Temazepam |
| Cholesterol | Methyprylon | Tetracycline |
| Clomipramine | Morphine-3-β-Dglucuronide | Tetrahydrocortisone,3 |
{13}------------------------------------------------
| Clonidine | Nalorphine | Tetrahydrocortisone3 (5-Dglucuronide) |
|---|---|---|
| Cocaine hydrochloride | Naloxone | Tetrahydrozoline |
| Codeine | Nalidixic acid | Thebaine |
| Cortisone | Naltrexone | Thiamine |
| (-) Cotinine | Naproxen | Thioridazine |
| Creatinine | Niacinamide | D, L-Thyroxine |
| Deoxycorticosterone | Nifedipine | Tolbutamine |
| Dextromethorphan | Norcodein | Triamterene |
| Diazepam | Norethindrone | Trifluoperazine |
| Diclofenac | D-Norpropoxyphene | Trimethoprim |
| Diflunisal | Noscapine | Trimipramine |
| Digoxin | D,L-Octopamine | Tryptamine |
| Diphenhydramine | Oxalic acid | D, L-Tryptophan |
| Doxylamine | Oxazepam | Tyramine |
| Ecgonine hydrochloride | Oxolinic acid | D, L-Tyrosine |
| Ecgonine methylester | Oxycodone | Uric acid |
| (-) Y Ephedrine | Oxymetazoline | Verapamil |
| Erythromycin | p-Hydroxymethamphetamine | Zomepirac |
| β-Estradiol | Papaverine |
f. Specificity
To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound are listed below. There were no differences observed for different devices.
| Methamphetamine | Result | % Cross- |
|---|---|---|
| (Cut-off=1000 ng/mL) | Positive at (ng/mL) | Reactivity |
| D - Methamphetamine | 1000 | 100% |
| (+/-)3,4-Methylenedioxy-n-ethylamphetamine(MDEA) | 20000 | 5% |
| D/L-Methamphetamine | 3000 | 33% |
| p-Hydroxymethamphetamine | 30000 | 3.3% |
| L-Methamphetamine | 8000 | 12.5% |
| (+/-)3,4-Methylenedioxyamphetamine(MDA) | 20000 | 5% |
| (+/-)3,4-methylenedioxymethamphetamine(MDMA) | Negative at 100000 | <1% |
| D-Amphetamine | Negative at 100000 | <1% |
| L-Amphetamine | Negative at 100000 | <1% |
| Morphine(Cut-off=300 ng/mL) | ResultPositive at (ng/mL) | % Cross-Reactivity |
|---|---|---|
| Morphine | 300 | 100% |
{14}------------------------------------------------
| O6-Acetylmorphine | 300 | 100% |
|---|---|---|
| Codeine | 300 | 100% |
| EthylMorphine | 6000 | 5% |
| Heroin | 300 | 100% |
| Hydromorphone | 3000 | 10% |
| Hydrocodone | 50000 | 0.6% |
| Levorphanol | 1500 | 20% |
| Oxycodone | 30000 | 1% |
| Procaine | 15000 | 2% |
| Thebaine | 6000 | 5% |
| Morphine-3-glucuronide | >100000 | <0.3% |
| Marijuana | Result | % Cross-Reactivity |
|---|---|---|
| (Cut-off=50 ng/mL) | Positive at(ng/mL) | |
| 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH | 50 | 100% |
| 11-Hydroxy-Δ9-Tetrahydrocannabinol | 5000 | 1% |
| 11-Nor-Δ8-Tetrahydrocannabinol-9-COOH | 50 | 100% |
| Cannabinol | 20000 | 0.3% |
| Δ8-Tetrahydrocannabinol | 10000 | 0.5% |
| Δ9-Tetrahydrocannabinol | 10000 | 0.5% |
| Cannabidiol | 20000 | 0.3% |
| 11-Nor-Δ9-THC-carboxy glucuronide | 2500 | 2% |
| (-)-11-nor-9-carboxy-Δ 9-THC | 2500 | 2% |
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 CLUNGENE Methamphetamine Tests, the CLUNGENE Morphine Tests and the CLUNGENE Marijuana 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. The results are presented in the tables below:
| Methamphetamine | |||||
|---|---|---|---|---|---|
| Cassette | 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%) |
Methamphetamine
{15}------------------------------------------------
| Viewer | 0 | 0 | 1 | 18 | 21 | |
|---|---|---|---|---|---|---|
| A | Negative | 14 | 12 | 13 | 1 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 17 | 21 |
| B | Negative | 14 | 12 | 13 | 2 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 17 | 21 |
| C | Negative | 14 | 12 | 13 | 2 | 0 |
Discordant Results of Methamphetamine Cassette
| Viewer | Sample Number | GC/MS Result | CassetteViewer Results |
|---|---|---|---|
| Viewer A | MET09 | 936 | Positive |
| Viewer B | MET60 | 963 | Positive |
| Viewer C | MET60 | 963 | Positive |
| Viewer A | MET15 | 1010 | Negative |
| Viewer B | MET15 | 1010 | Negative |
| Viewer B | MET69 | 1100 | Negative |
| Viewer C | MET15 | 1010 | Negative |
| Viewer C | MET69 | 1100 | Negative |
| PanelDip | 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 | 1 | 18 | 21 |
| Negative | 14 | 12 | 13 | 1 | 0 | |
| ViewerB | Positive | 0 | 0 | 1 | 18 | 21 |
| Negative | 14 | 12 | 13 | 1 | 0 | |
| ViewerC | Positive | 0 | 0 | 1 | 19 | 21 |
| Negative | 14 | 12 | 13 | 0 | 0 |
Discordant Results of Methamphetamine Panel Dip
| Viewer | Sample Number | GC/MS Result | Panel DipViewer Results |
|---|---|---|---|
| Viewer A | MET60 | 963 | Positive |
| Viewer B | MET60 | 963 | Positive |
| Viewer C | MET60 | 963 | Positive |
| Viewer A | MET69 | 1100 | Negative |
| Viewer B | MET15 | 1010 | Negative |
| Split-KeyCup | 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%) |
|---|---|---|---|---|---|
{16}------------------------------------------------
| Viewer | 0 | 0 | 2 | 19 | 21 | |
|---|---|---|---|---|---|---|
| A | Positive | 0 | 0 | 2 | 19 | 21 |
| A | Negative | 14 | 12 | 12 | 0 | 0 |
| B | Positive | 0 | 0 | 1 | 18 | 21 |
| B | Negative | 14 | 12 | 13 | 1 | 0 |
| C | Positive | 0 | 0 | 1 | 18 | 21 |
| C | Negative | 14 | 12 | 13 | 1 | 0 |
Discordant Results of Methamphetamine Split-Key Cup
| Viewer | Sample Number | GC/MS Result | Split-Key CupViewer Results | |
|---|---|---|---|---|
| Viewer A | MET05 | 947 | Positive | |
| Viewer A | MET60 | તે જેવી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડ | Positive | |
| Viewer B | MET60 | તે જિલ્લામાં આવેલું એક ગામનાં મુખ્યત્વે ખેત-ઉત્પત્તમજૂરી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો | Positive | |
| Viewer C | MET60 | તે ઉત્તર | Positive | |
| Viewer B | MET15 | 1010 | Negative | |
| Viewer C | MET15 | 1010 | Negative |
| Easy Cup | Negative | Low Negative by GC/MS(less than -50%) | Near Cutoff Negative by GC/MS(Between -50% and cutoff) | Near Cutoff Positive by GC/MS(Between the cutoff and +50%) | High Positive by GC/MS(greater than +50%) | |
|---|---|---|---|---|---|---|
| ViewerA | Positive | 0 | 0 | 0 | 16 | 21 |
| Negative | 14 | 12 | 14 | 3 | 0 | |
| ViewerB | Positive | 0 | 0 | 0 | 17 | 21 |
| Negative | 14 | 12 | 14 | 2 | 0 | |
| ViewerC | Positive | 0 | 0 | 0 | 18 | 21 |
| Negative | 14 | 12 | 14 | 1 | 0 |
Discordant Results of Methamphetamine Easy Cup
| Viewer | Sample Number | GC/MS Result | Easy CupViewer Results |
|---|---|---|---|
| Viewer A | MET65 | 1065 | Negative |
| Viewer A | MET69 | 1100 | Negative |
| Viewer A | MET15 | 1010 | Negative |
| Viewer B | MET69 | 1100 | Negative |
| Viewer B | MET15 | 1010 | Negative |
| Viewer C | MET69 | 1100 | Negative |
Morphine
| Cassette | 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%) |
|---|---|---|---|---|---|
{17}------------------------------------------------
| Viewer | ||||||
|---|---|---|---|---|---|---|
| A | Positive | 0 | 0 | 0 | 16 | 23 |
| Negative | 9 | 19 | 12 | 1 | 0 | |
| B | Positive | 0 | 0 | 2 | 17 | 23 |
| Negative | 9 | 19 | 10 | 0 | 0 | |
| C | Positive | 0 | 0 | 2 | 17 | 23 |
| Negative | 9 | 19 | 10 | 0 | 0 |
Discordant Results of Morphine Cassette
| Viewer | Sample Number | GC/MS Result | Cassette Viewer Results |
|---|---|---|---|
| Viewer B | MOP53 | 274 | Positive |
| Viewer B | MOP01 | 297 | Positive |
| Viewer C | MOP53 | 274 | Positive |
| Viewer C | MOP01 | 297 | Positive |
| Viewer A | MOP43 | 314 | Negative |
| Panel Dip | Negative | Low Negative by GC/MS(less than -50%) | Near Cutoff Negative by GC/MS(Between -50% and cutoff) | Near Cutoff Positive by GC/MS(Between the cutoff and +50%) | High Positive by GC/MS(greater than +50%) |
|---|---|---|---|---|---|
| Viewer A Positive | 0 | 0 | 0 | 16 | 23 |
| Viewer A Negative | 9 | 19 | 12 | 1 | 0 |
| Viewer B Positive | 0 | 0 | 0 | 16 | 23 |
| Viewer B Negative | 9 | 19 | 12 | 1 | 0 |
| Viewer C Positive | 0 | 0 | 0 | 17 | 23 |
| Viewer C Negative | 9 | 19 | 12 | 0 | 0 |
Discordant Results of Morphine Panel Dip
| Viewer | Sample Number | GC/MS Result | Panel Dip Viewer Results |
|---|---|---|---|
| Viewer A | MOP43 | 314 | Negative |
| Viewer B | MOP43 | 314 | Negative |
| Split-KeyCup | 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 | 1 | 16 | 23 |
| Negative | 9 | 19 | 11 | 1 | 0 | |
| ViewerB | Positive | 0 | 0 | 1 | 17 | 23 |
| Negative | 9 | 19 | 11 | 0 | 0 | |
| ViewerC | Positive | 0 | 0 | 0 | 17 | 23 |
| Negative | 9 | 19 | 12 | 0 | 0 |
{18}------------------------------------------------
| Discordant Results of Morphine Split-Key Cup | |||
|---|---|---|---|
| Viewer | Sample Number | GC/MS Result | Split Cup Viewer Results |
| Viewer A | MOP01 | 297 | Positive |
| Viewer B | MOP01 | 297 | Positive |
| Viewer A | MOP43 | 314 | Negative |
Discordant Results of Morphine Split-Ke Cun
| Easy | 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%) | |
|---|---|---|---|---|---|---|
| Cup | ||||||
| Viewer | Positive | 0 | 0 | 2 | 17 | 23 |
| A | Negative | 9 | 19 | 10 | 0 | 0 |
| Viewer | Positive | 0 | 0 | 2 | 17 | 23 |
| B | Negative | 9 | 19 | 10 | 0 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 16 | 23 |
| C | Negative | 9 | 19 | 11 | 1 | 0 |
Discordant Results of Morphine Easy Cup
| Viewer | Sample Number | GC/MS Result | Easy CupViewer Results |
|---|---|---|---|
| Viewer A | MOP53 | 274 | Positive |
| Viewer A | MOP01 | 297 | Positive |
| Viewer B | MOP53 | 274 | Positive |
| Viewer B | MOP01 | 297 | Positive |
| Viewer C | MOP01 | 297 | Positive |
| Viewer C | MOP43 | 314 | Negative |
| Marijuana | |
|---|---|
| Cassette | Marijuana | ||||
|---|---|---|---|---|---|
| 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 | 2 | 24 | 16 |
| A Negative | 8 | 18 | 12 | 0 | 0 |
| Viewer Positive | 0 | 0 | 1 | 23 | 16 |
| B Negative | 8 | 18 | 13 | 1 | 0 |
| Viewer Positive | 0 | 0 | 2 | 24 | 16 |
{19}------------------------------------------------
| C | Negative | 8 | 18 | 12 | 0 | 0 |
|---|---|---|---|---|---|---|
| Discordant Results of Marijuana Cassette |
| Viewer | Sample Number | GC/MS Result | CassetteViewer Results |
|---|---|---|---|
| Viewer A | THC05 | 49 | Positive |
| Viewer A | THC67 | 47 | Positive |
| Viewer B | THC05 | 49 | Positive |
| Viewer C | THC05 | 49 | Positive |
| Viewer C | THC67 | 47 | Positive |
| Viewer B | THC79 | 51 | Negative |
| PanelDip | 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 | 0 | 22 | 16 |
| Negative | 8 | 18 | 14 | 2 | 0 | |
| ViewerB | Positive | 0 | 0 | 0 | 22 | 16 |
| Negative | 8 | 18 | 14 | 2 | 0 | |
| ViewerC | Positive | 0 | 0 | 0 | 20 | 16 |
| Negative | 8 | 18 | 14 | 4 | 0 |
Discordant Results of Marijuana Panel Dip
| Viewer | Sample Number | GC/MS Result | Panel DipViewer Results |
|---|---|---|---|
| Viewer A | THC66 | 52 | Negative |
| Viewer A | THC79 | 51 | Negative |
| Viewer B | THC66 | 52 | Negative |
| Viewer B | THC79 | 51 | Negative |
| Viewer C | THC04 | 53 | Negative |
| Viewer C | THC66 | 52 | Negative |
| Viewer C | THC68 | 52 | Negative |
| Viewer C | THC79 | 51 | Negative |
| Split-KeyCup | 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 | 22 | 16 |
| Negative | 8 | 18 | 13 | 2 | 0 | |
| ViewerB | Positive | 0 | 0 | 1 | 23 | 16 |
| Negative | 8 | 18 | 13 | 1 | 0 | |
| Viewer | Positive | 0 | 0 | 0 | 23 | 16 |
{20}------------------------------------------------
| C | Negative | 8 | 18 | 14 | 1 | 0 |
|---|---|---|---|---|---|---|
| Discordant Results of Marijuana Split-Key Cup |
| Viewer | Sample Number | GC/MS Result | Split CupViewer Results |
|---|---|---|---|
| Viewer A | THC05 | 49 | Positive |
| Viewer B | THC05 | 49 | Positive |
| Viewer A | THC68 | 52 | Negative |
| Viewer A | THC79 | 51 | Negative |
| Viewer B | THC68 | 52 | Negative |
| Viewer C | THC68 | 52 | Negative |
| EasyCup | 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 | 0 | 23 | 16 |
| Negative | 8 | 18 | 14 | 1 | 0 | |
| ViewerB | Positive | 0 | 0 | 0 | 21 | 16 |
| Negative | 8 | 18 | 14 | 3 | 0 | |
| ViewerC | Positive | 0 | 0 | 0 | 23 | 16 |
| Negative | 8 | 18 | 14 | 1 | 0 |
Discordant Results of Marijuana Easy Cup
| Viewer | Sample Number | GC/MS Result | Easy CupViewer Results |
|---|---|---|---|
| Viewer A | THC66 | 52 | Negative |
| Viewer B | THC04 | 53 | Negative |
| Viewer B | THC66 | 52 | Negative |
| Viewer B | THC79 | 51 | Negative |
| Viewer C | THC16 | 53 | Negative |
Lay-user study
A lay user study was performed at three intended user sites with 1680 lay persons. The lay users had diverse educational and professional backgrounds and ranged in age from 20 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 Methamphetamine Cassette
| Lay person results | The | |
|---|---|---|
{21}------------------------------------------------
| % of Cutoff | Numberofsamples | d-MethamphetamineConcentration by GC/MS(ng/mL) | No. ofPositive | No. ofNegative | percentage ofcorrect results(%) |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 25 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 750 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 1,250 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 1,500 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1,750 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Methamphetamine Dip Card
| % of Cutoff | Numberofsamples | d-MethamphetamineConcentration by GC/MS(ng/mL) | Lay person results | Thepercentage ofcorrect results(%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 25 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 750 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 1,250 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 1,500 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1,750 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Methamphetamine Split-Key Cup
| Numberofsamples | d-MethamphetamineConcentration by GC/MS(ng/mL) | Lay person results | The | ||
|---|---|---|---|---|---|
| % of Cutoff | No. ofPositive | No. ofNegative | percentage ofcorrect results(%) | ||
| -100%Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75%Cutoff | 20 | 25 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 750 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 1,250 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 1,500 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1,750 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Methamphetamine Easy Cup
| % of Cutoff | Numberofsamples | d-MethamphetamineConcentration by GC/MS(ng/mL) | Lay person results | Thepercentage ofcorrect results(%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | No. ofPositive | No. ofNegative | 100 |
| -75% Cutoff | 20 | 25 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 750 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 1,250 | 19 | 1 | 95 |
{22}------------------------------------------------
| +50% Cutoff | 20 | 1,500 | 20 | 0 | 100 |
|---|---|---|---|---|---|
| +75% Cutoff | 20 | 1,750 | 20 | 0 | 100 |
| % of Cutoff | Numberofsamples | Morphine Concentrationby GC/MS (ng/mL) | Lay person results | Thepercentage ofcorrect results(%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Morphine Cassette
Comparison between GC/MS and Lay Person Results for Morphine Dip Card
| % of Cutoff | Number ofsamples | Morphine Concentrationby GC/MS (ng/mL) | Lay person results | Thepercentage ofcorrect results(%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Morphine Split-Key Cup
| % of Cutoff | Numberofsamples | Morphine Concentrationby GC/MS (ng/mL) | Lay person results | Thepercentage ofcorrect results(%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | No. ofPositive | No. ofNegative | 100 |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 375 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Morphine Easy Cup
| Lay person results | The | ||
|---|---|---|---|
| -- | -- | -------------------- | ----- |
{23}------------------------------------------------
| % of Cutoff | Numberofsamples | Morphine Concentrationby GC/MS (ng/mL) | No. ofPositive | No. ofNegative | percentage ofcorrect results(%) |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Marijuana Cassette
| % of Cutoff | Number of samples | Marijuana Concentration by GC/MS (ng/mL) | Lay person results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 12.5 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 25 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 37.5 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 62.5 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 75 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 87.5 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Marijuana Dip Card
| % of Cutoff | Number of samples | Marijuana Concentration by GC/MS (ng/mL) | Lay person results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | No. of Positive | No. of Negative | 100 |
| -75% Cutoff | 20 | 12.5 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 25 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 37.5 | 0 | 20 | 10 |
| +25% Cutoff | 20 | 62.5 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 75 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 87.5 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Marijuana Split-Key Cup
| % of Cutoff | Numberofsamples | Marijuana Concentrationby GC/MS (ng/mL) | Lay person results | The | |
|---|---|---|---|---|---|
| No. ofPositive | No. ofNegative | percentage ofcorrect results(%) | |||
| -100%Cutoff | 20 | 0 | 0 | 20 | 100 |
{24}------------------------------------------------
| -75% Cutoff | 20 | 12.5 | 0 | 20 | 100 |
|---|---|---|---|---|---|
| -50% Cutoff | 20 | 25 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 37.5 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 62.5 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 75 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 87.5 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Marijuana Easy Cup
| % of Cutoff | Number of samples | Marijuana Concentration by GC/MS (ng/mL) | Lay person results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 12.5 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 25 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 37.5 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 62.5 | 20 | 0 | 100 |
| +50% Cutoff | 20 | 75 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 87.5 | 20 | 0 | 100 |
Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.
-
- Clinical Studies
Not applicable.
- Clinical Studies
11. Conclusion
Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison, and lay-user studies of the devices, it's concluded that the CLUNGENE Methamphetamine Tests, CLUNGENE Morphine Tests and CLUNGENE Marijuana Tests are substantially equivalent to the predicate.
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).