CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test
Device Facts
| Record ID | K153741 |
|---|---|
| Device Name | CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test |
| Applicant | Hangzhou Clongene Biotech Co., Ltd. |
| Product Code | LDJ · Clinical Toxicology |
| Decision Date | Mar 18, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3870 |
| Device Class | Class 2 |
Indications for 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. 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 Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH in human urine at cut-off concentration of 50 ng/mL. The calibrator is 11-Nor-Δ9-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 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 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 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.
Device Story
Lateral flow immunochromatographic assays for qualitative detection of d-methamphetamine, morphine, and 11-Nor-△9-Tetrahydrocannabinol-9-COOH in human urine; competitive binding principle using monoclonal mouse antibodies; visible colored line indicates negative result (drug below cut-off) or absence of line indicates positive result (drug above cut-off); control line confirms proper test performance. Available in cassette, dip card, easy cup, and split-key cup formats. Intended for OTC consumer use as first step in two-step process; preliminary positive results require confirmation via GC/MS. Benefits include rapid, accessible drug screening for consumers.
Clinical Evidence
No clinical trials performed. Evidence includes analytical bench testing (precision, specificity, interference, stability) and a lay-user study (n=1680) across three sites. Lay-user study confirmed instructions were easily followed (Flesch-Kincaid Grade Level 7) and demonstrated high concordance with GC/MS results across various drug concentrations relative to cut-offs.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding; monoclonal mouse antibody-coated particles; immobilized drug-conjugate; visual readout; no instrumentation required; stable at 4-30°C for 24 months.
Indications for Use
Indicated for qualitative detection of d-methamphetamine (1000 ng/mL), 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH (50 ng/mL), and Morphine (300 ng/mL) in human urine. Intended for OTC consumer use as a preliminary screening step. Requires confirmatory testing via GC/MS.
Regulatory Classification
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 include delta-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.
Special Controls
*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).
Predicate Devices
- The FIRST CHECK MULTI DRUG CUP Urine Test (K052115)
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE
A. 510(k) Number:
k153741
B. Purpose for Submission:
New Device
C. Measurand:
Methamphetamine, Marijuana and Morphine
D. Type of Test:
Qualitative Lateral Flow chromatographic immunoassay
E. Applicant:
Hangzhou Clongene Biotech Co., Ltd.
F. Proprietary and Established Names:
CLUNGENE Methamphetamine Tests
CLUNGENE Morphine Tests
CLUNGENE Marijuana Tests
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DJG | Class II | 21 CFR 862.3650, Opiate Test System | Toxicology (91) |
| DJC | Class II | 21 CFR 862.3610, Methamphetamine Test System | Toxicology (91) |
| LDJ | Class II | 21 CFR 862.3870, Cannabinoids Test System | Toxicology (91) |
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H. Intended Use:
1. Intended use(s):
Refer to Indications for Use below.
2. Indication(s) for 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.
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 Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH in human urine at cut-off concentration of 50 ng/mL. The calibrator is 11-Nor-Δ9-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 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 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.
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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.
3. Special conditions for use statement(s):
For in vitro diagnostic use only, for over-the-counter use and for prescription use
4. Special instrument requirements:
Not applicable, the devices are visually-read single-use devices.
I. 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-Δ9-Tetrahydrocannabinol-9-COOH (target analytes) in human urine. The tests are available in cassette, dip card, easy cup and split key cup formats. Each test and format is available separately.
J. Substantial Equivalence Information:
1. Predicate device name(s):
The First Check Multi Drug Cup Urine Test
2. Predicate 510(k) number(s):
k052115
3. Comparison with predicate
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Comparison of CLUNGENE Methamphetamine Tests and the Predicate Device
| Item | Device - CLUNGENE Methamphetamine Tests | Predicate - K052115 First Check Multi Drug Cup Urine Test |
| --- | --- | --- |
| Indication(s) for Use | For the qualitative determination of drugs of abuse in human urine. | Same (but the number of drugs detected is different) |
| Calibrator | d-Methamphetamine | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 1000 ng/mL | Same |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Cassette, Dip Card, Easy Cup and Split Key Cup | Cup |
Comparison of CLUNGENE Morphine Tests and the Predicate Device
| Item | Device - CLUNGENE Morphine Tests | Predicate - K052115 First Check Multi Drug Cup Urine Test |
| --- | --- | --- |
| Indication(s) for Use | For the qualitative determination of drugs of abuse in human urine. | Same (but the number of drugs detected is different) |
| Calibrator | Morphine | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 300 ng/mL | Same |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Cassette, Dip Card, Easy Cup and Split Key Cup | Cup |
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Comparison of CLUNGENE Marijuana Tests and the Predicate Device
| Item | Device - CLUNGENE Marijuana Tests | Predicate - K052115 First Check Multi Drug Cup Urine Test |
| --- | --- | --- |
| Indication(s) for Use | For the qualitative determination of drugs of abuse in human urine. | Same (but the number of drugs detected is different) |
| Calibrator | 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| 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, Easy Cup and Split Key Cup | Cup |
## K. Standard/Guidance Document Referenced (if applicable):
In Vitro Diagnostic Devices; Guidance for the Preparation of 510(k) Submission, HHS Publication FDA 97-4224
## L. 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-Δ9-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 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.
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M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
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 this person did not take part in the sample testing. For each concentration, tests were performed by 12 operators in two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables.
CLUNGENE Methamphetamine Tests
Cassette
| 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+ | 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
| 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+ | 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
| 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+ | 17-/33+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Easy Cup
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 17-/33+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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# CLUNGENE Morphine Tests
Cassette
| 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+ | 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
| 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+ | 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
| 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+ | 31-/19+ | 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- |
# CLUNGENE Marijuana Tests
Cassette
| 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+ | 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
| 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+ | 19-/31+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 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- |
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Split-Key Cup
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 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 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+ | 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/assay reportable range:
Not applicable.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Device stability has been evaluated through accelerated and real-time studies. A transport simulation study was performed to test extreme shipping temperatures. Protocols and acceptance criteria were reviewed and found to be acceptable. The manufacturer claims that the devices are stable at 4-30 °C for 24 months based on the accelerated stability study at 45°C, real time stability determination at both 4°C and 30°C and transport simulation conditions at -20°C and 40°C.
This device has internal process controls. A colored line appearing in the control region confirms that sufficient sample volume and that the correct technique has been used. Users are informed not to interpret the test if a colored line failed to appear in the control region. External control materials are not supplied with these devices; however the labeling provides information on how to obtain quality control materials.
d. Detection limit:
Not applicable.
e. Analytical specificity:
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 lots 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.
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# CLUNGENE Methamphetamine Tests
| 4-Acetamidophenol | (-) Y Ephedrine | Penicillin-G |
| --- | --- | --- |
| Acetophenetidin | Erythromycin | Pentazocaine |
| N-Acetylprocainamide | β-Estradiol | Pentobarbital |
| Acetylsalicylic acid | Estrone-3-sulfate | Perphenazine |
| Aminopyrine | Ethyl-p-aminobenzoate | Phencyclidine |
| Amitryptyline | Fenfluramine | Phenelzine |
| Amobarbital | Fenoprofen | Phendimetrazine |
| Amoxicillin | Furosemide | Phenobarbital |
| Ampicillin | Gentisic acid | Phetoin |
| Ascorbic acid | Hemoglobin | L-Phenylephrine |
| Apomorphine | Hydralazine | β-Phenylethylamine |
| 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-Propanolol |
| 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 |
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| 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 | |
CLUNGENE Morphine Tests
| Acebutolol | (-) Y Ephedrine | Hydroxymethamphetamine |
| --- | --- | --- |
| Acetopromazined-d-6 | 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 |
{10}
11
| Chlorothiazide | Methylenedioxyamphetamine | Sulfamethazine |
| --- | --- | --- |
| (±) Chlorpheniramine | Methylenedioxymethamphetamine | Sulindac |
| Chlorpromazine | Methadone | Temazepam |
| Chlorquine | Methylphenidate | Tetracycline |
| Cholesterol | Methyprylon | Tetrahydrozoline |
| Clomipramine | Nalorphine | Tetrahydrocortisone |
| Clonidine | Nalidixic acid | Tetrahydrocortisone-(5-D-glucuronide) |
| Cocaine hydrochloride | Naloxone | Thiamine |
| Cortisone | Naltrexone | Thioridazine |
| (-) Cotinine | Naproxen | D,L-Thyroxine |
| Creatinine | Niacinamide | Tolbutamine |
| Deoxycorticosterone | Nifedipine | Triamterene |
| Dextromethorphan | Norcodein | Trifluoperazine |
| 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 | |
## CLUNGENE Marijuana Tests
| 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 |
{11}
| 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-Hydroxytyramine) |
| (±) Chlorpheniramine | (+/-) 3,4Methylenedioxyamphetamine | Sulfamethazine |
| Chlorpromazine | (+) 3,4 Methylenedioxymethamphetamine | Sulindac |
| Chlorquine | Methylphenidate | Temazepam |
| Cholesterol | Methyprylon | Tetracycline |
| Clomipramine | Morphine-3-β-D-glucuronide | Tetrahydrocortisone, 3 |
| Clonidine | Nalorphine | Tetrahydrocortisone3 (5-D-glucuronide) |
| Cocaine hydrochloride | Naloxone | Tetrahydrozoline |
| 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 |
12
{12}
13
| (-) Y Ephedrine | Oxymetazoline | Verapamil |
| --- | --- | --- |
| Erythromycin | p-Hydroxymethamphetamine | Zomepirac |
| β-Estradiol | Papaverine | |
To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three lots of each device. The lowest concentration that caused a positive result for each device are listed below. There were no differences observed for different devices.
| CLUNGENE Methamphetamine Tests (Cut-off=1000 ng/mL) | Result Positive at (ng/mL) | % Cross-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% |
{13}
| CLUNGENE Morphine Tests (Cut-off=300 ng/mL) | Result Positive at (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Morphine | 300 | 100% |
| 6-Acetylmorphine | 300 | 100% |
| Codeine | 300 | 100% |
| Ethylmorphine | 6000 | 5% |
| Heroin | 300 | 100% |
| Hydromorphone | 3000 | 10% |
| Hydrocodone | 5000 | 0.6% |
| Levorphanol | 1500 | 20% |
| Oxycodone | 3000 | 1% |
| Procaine | 1500 | 2% |
| Thebaine | 6000 | 5% |
| Morphine-3-glucuronide | >100000 | <0.3% |
| CLUNGENE Marijuana Tests (Cut-off=50 ng/mL) | Result Positive at(ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| 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% |
## 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 (1.000, 1.003, 1.008, 1.014, 1.018, 1.020, 1.022, 1.025, 1.028, 1.030, 1.032, and 1.035) and urine samples with pH 4 to 9 (4.0, 5.0, 6.0, 7.0, 8.0, and 9.0) 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 and the sponsor claims that pH and specific gravity do not affect the results of the device.
{14}
# f. Assay 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 Tests. This study supports the following claimed cut-off values for the devices.
| Calibrator | Cut-off (ng/mL) |
| --- | --- |
| d-Methamphetamine | 1000 |
| Morphine | 300 |
| 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH | 50 |
# 2. Comparison studies:
a. Method comparison with predicate device:
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
| 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%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 18 | 21 |
| | Negative | 14 | 12 | 13 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 17 | 21 |
| | Negative | 14 | 12 | 13 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 17 | 21 |
| | Negative | 14 | 12 | 13 | 2 | 0 |
{15}
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# Discordant Results of Methamphetamine Cassette
| Viewer | Sample Number | GC/MS Result (ng/mL) | Cassette Viewer 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 |
# Methamphetamine Panel Dip
| 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 | 1 | 18 | 21 |
| | Negative | 14 | 12 | 13 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 18 | 21 |
| | Negative | 14 | 12 | 13 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 19 | 21 |
| | Negative | 14 | 12 | 13 | 0 | 0 |
# Discordant Results of Methamphetamine Panel Dip
| Viewer | Sample Number | GC/MS Result (ng/mL) | Panel Dip Viewer 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 |
{16}
Methamphetamine Split-Key Cup
| Split-Key Cup | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 2 | 19 | 21 |
| | Negative | 14 | 12 | 12 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 18 | 21 |
| | Negative | 14 | 12 | 13 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 18 | 21 |
| | Negative | 14 | 12 | 13 | 1 | 0 |
Discordant Results of Methamphetamine Split-Key Cup
| Viewer | Sample Number | GC/MS Result (ng/mL) | Split-Key Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | MET05 | 947 | Positive |
| Viewer A | MET60 | 963 | Positive |
| Viewer B | MET60 | 963 | Positive |
| Viewer C | MET60 | 963 | Positive |
| Viewer B | MET15 | 1010 | Negative |
| Viewer C | MET15 | 1010 | Negative |
Methamphetamine Easy Cup
| 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%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 16 | 21 |
| | Negative | 14 | 12 | 14 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 17 | 21 |
| | Negative | 14 | 12 | 14 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 18 | 21 |
| | Negative | 14 | 12 | 14 | 1 | 0 |
17
{17}
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# Discordant Results of Methamphetamine Easy Cup
| Viewer | Sample Number | GC/MS Result (ng/mL) | Easy Cup Viewer 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
| 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%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 16 | 23 |
| | Negative | 9 | 19 | 12 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 17 | 23 |
| | Negative | 9 | 19 | 10 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 17 | 23 |
| | Negative | 9 | 19 | 10 | 0 | 0 |
# Discordant Results of Morphine Cassette
| Viewer | Sample Number | GC/MS Result (ng/mL) | 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 |
{18}
19
# Morphine Panel Dip
| 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 |
| | Negative | 9 | 19 | 12 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 16 | 23 |
| | Negative | 9 | 19 | 12 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 17 | 23 |
| | Negative | 9 | 19 | 12 | 0 | 0 |
# Discordant Results of Morphine Panel Dip
| Viewer | Sample Number | GC/MS Result (ng/mL) | Panel Dip Viewer Results |
| --- | --- | --- | --- |
| Viewer A | MOP43 | 314 | Negative |
| Viewer B | MOP43 | 314 | Negative |
# Morphine Split-Key Cup
| Split-Key Cup | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 16 | 23 |
| | Negative | 9 | 19 | 11 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 17 | 23 |
| | Negative | 9 | 19 | 11 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 17 | 23 |
| | Negative | 9 | 19 | 12 | 0 | 0 |
{19}
20
Discordant Results of Morphine Split-Key Cup
| Viewer | Sample Number | GC/MS Result (ng/mL) | Split Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | MOP01 | 297 | Positive |
| Viewer B | MOP01 | 297 | Positive |
| Viewer A | MOP43 | 314 | Negative |
Morphine Easy Cup
| 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%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 2 | 17 | 23 |
| | Negative | 9 | 19 | 10 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 17 | 23 |
| | Negative | 9 | 19 | 10 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 16 | 23 |
| | Negative | 9 | 19 | 11 | 1 | 0 |
Discordant Results of Morphine Easy Cup
| Viewer | Sample Number | GC/MS Result (ng/mL) | Easy Cup Viewer 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 |
{20}
Marijuana Cassette
| 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%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 2 | 24 | 16 |
| | Negative | 8 | 18 | 12 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 23 | 16 |
| | Negative | 8 | 18 | 13 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 24 | 16 |
| | Negative | 8 | 18 | 12 | 0 | 0 |
Discordant Results of Marijuana Cassette
| Viewer | Sample Number | GC/MS Result (ng/mL) | Cassette Viewer 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 |
Marijuana Panel Dip
| 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 | 22 | 16 |
| | Negative | 8 | 18 | 14 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 22 | 16 |
| | Negative | 8 | 18 | 14 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 20 | 16 |
| | Negative | 8 | 18 | 14 | 4 | 0 |
{21}
22
Discordant Results of Marijuana Panel Dip
| Viewer | Sample Number | GC/MS Result (ng/mL) | Panel Dip Viewer 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 |
Marijuana Split-Key Cup
| Split-Key Cup | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 22 | 16 |
| | Negative | 8 | 18 | 13 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 23 | 16 |
| | Negative | 8 | 18 | 13 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 23 | 16 |
| | Negative | 8 | 18 | 14 | 1 | 0 |
Discordant Results of Marijuana Split-Key Cup
| Viewer | Sample Number | GC/MS Result (ng/mL) | Split Cup Viewer 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 |
{22}
Marijuana Easy Cup
| 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%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 23 | 16 |
| | Negative | 8 | 18 | 14 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 21 | 16 |
| | Negative | 8 | 18 | 14 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 23 | 16 |
| | Negative | 8 | 18 | 14 | 1 | 0 |
Discordant Results of Marijuana Easy Cup
| Viewer | Sample Number | GC/MS Result (ng/mL) | Easy Cup Viewer 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 |
b. Matrix comparison:
Not applicable. This device is for use with urine samples only.
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
{23}
c. Other clinical supportive data (when a. and b. are not applicable):
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 in English only, 1 blind labeled sample and a device. Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions could be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.
Comparison between GC/MS and Lay Person Results for Methamphetamine Cassette
| % of Cutoff | Number of samples | d-Methamphetamine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 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 | 1250 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Methamphetamine Dip Card
| % of Cutoff | Number of samples | d-Methamphetamine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -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 | 1250 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100 |
{24}
Comparison between GC/MS and Lay Person Results for Methamphetamine Split-KeyCup
| % of Cutoff | Number of samples | d-Methamphetamine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 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 | 1250 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Methamphetamine Easy Cup
| % of Cutoff | Number of samples | d-Methamphetamine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 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 | 1250 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Morphine Cassette
| % of Cutoff | Number of samples | Morphine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 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 | 1 | 1 | 95 |
| +50% Cutoff | 20 | 450 | 2 | 0 | 10 |
| +75% Cutoff | 20 | 525 | 2 | 0 | 10 |
{25}
Comparison between GC/MS and Lay Person Results for Morphine Dip Card
| % of Cutoff | Number of samples | Morphine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 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 | Number of samples | Morphine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 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 | 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
| % of Cutoff | Number of samples | Morphine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 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 |
26
{26}
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 (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -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 (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -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 | 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 | Number of samples | Marijuana Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 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 |
{27}
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 (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -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 |
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
Not applicable
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
