AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
Device Facts
| Record ID | K161044 |
|---|---|
| Device Name | AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) |
| Applicant | Assure Tech. (Hangzhou) Co, Ltd. |
| Product Code | DJC · Clinical Toxicology |
| Decision Date | Jul 6, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3610 |
| Device Class | Class 2 |
Indications for Use
AssureTech Methamphetamine Tests are immunochromatographic assays for the qualitative determination of d-Methamphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. AssureTech Phencyclidine Tests are immunochromatographic assays for the qualitative determination of Phencyclidine in human urine at cut-off concentration of 25 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. AssureTech Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH in human urine at cut-off concentration of 50 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
Device Story
Lateral flow immunochromatographic assays for qualitative drug screening in human urine; detects d-Methamphetamine, Phencyclidine, or 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH. Available in Strip, Dip Card, Quick Cup, and Turn-Key Split Cup formats. Principle: competitive binding; target drug in urine competes with drug-conjugate for limited antibody binding sites on colored particles. Absence of test line indicates drug concentration above cutoff; presence of test line indicates drug below cutoff. Control line confirms sufficient sample volume and proper flow. Used in home or clinical settings; visually read by user. Results are preliminary; require confirmation via GC/MS. Benefits: rapid, accessible screening for drug abuse.
Clinical Evidence
Bench testing only. Precision/reproducibility studies performed using spiked urine samples across multiple lots and formats. Analytical specificity evaluated against numerous endogenous/exogenous compounds. Lay-user study (n=1638) conducted at three sites demonstrated high concordance with GC/MS results across all formats and analytes.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Formats: Strip, Dip Card, Quick Cup, Turn-Key Split Cup. Visual readout. No instrumentation required. Stable at 4°C to 30°C for 24 months.
Indications for Use
Indicated for qualitative detection of d-Methamphetamine (1000 ng/mL), Phencyclidine (25 ng/mL), or 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH (50 ng/mL) in human urine. Intended for OTC and prescription use as a preliminary screening tool.
Regulatory Classification
Identification
A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.
Special Controls
*Classification.* Class II (special controls). A methamphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Predicate Devices
- The Chemtrue® Multi-Panel Drug Screen Dip Card Tests (K142396)
Submission Summary (Full Text)
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1
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE
A. 510(k) Number:
k161044
B. Purpose for Submission:
New Device
C. Measurand:
Methamphetamine, Phencyclidine, Marijuana
D. Type of Test:
Qualitative immunochromatographic assay
E. Applicant:
Assure Tech. Co., Ltd.
F. Proprietary and Established Names:
- AssureTech Methamphetamine Strip Test
- AssureTech Methamphetamine Cup Test
- AssureTech Methamphetamine Dip Card Test
- AssureTech Methamphetamine Turn Key Split Cup Test
- AssureTech Phencyclidine Strip Test
- AssureTech Phencyclidine Cup Test
- AssureTech Phencyclidine Dip Card Test
- AssureTech Phencyclidine Turn Key Split Cup Test
- AssureTech Marijuana Strip Test
- AssureTech Marijuana Cup Test
- AssureTech Marijuana Dip Card Test
- AssureTech Marijuana Turn Key Split Cup Test
G. Regulatory Information:
1. Regulation section:
- Methamphetamine Test System; 21 CFR 862.3610
- Enzyme Immunoassay, Phencyclidine; Unclassified, 510(k) required
- Cannabinoid Test System; 21 CFR 862.3870
2. Classification:
Class II
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3. Product code:
DJC, LCM, LDJ
4. Panel:
91, Toxicology
H. Intended Use:
1. Intended use(s):
See Indications for Use below.
2. Indication(s) for use:
AssureTech Methamphetamine Tests are immunochromatographic assays for the qualitative determination of d-Methamphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
AssureTech Phencyclidine Tests are immunochromatographic assays for the qualitative determination of Phencyclidine in human urine at cut-off concentration of 25 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
AssureTech Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH in human urine at cut-off concentration of 50 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical
2
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consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
3. Special conditions for use statement(s):
For over-the-counter use.
4. Special instrument requirements:
Not applicable; this is a visually read single use device.
I. Device Description:
The AssureTech Methamphetamine Test is for the qualitative determination of d-Methamphetamine in human urine. The AssureTech Phencyclidine Test is for the qualitative determination of Phencyclidine in human urine. The AssureTech Marijuana Test is for the qualitative determination of 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH in human urine. Each test device has four formats: Strip, Dip Card, Quick Cup, Turn-Key Split Cup. The Strip format is comprised of a urine collection cup and a test strip with sample pad with a lateral flow. The Dip Card format is comprised of a urine collection cup and the dip card with a plastic casing as the lateral flow device. The Quick Cup format is comprised of a urine collection cup and a quick cup test with a lateral flow device that will start when the cap is screwed onto cup. The Turn-Key Split Cup is comprised of a urine collection cup and a turn-key Split Cup test with a lateral flow device that will start the test when the cap is screwed onto cup and key is turned 180 degrees.
J. Substantial Equivalence Information:
1. Predicate device name(s):
Chemtrue® Multi-Panel Drug Screen Dip Card Tests
2. Predicate 510(k) number(s):
k142396
3. Comparison with predicate:
| Item | AssureTech Methamphetamine Tests (Candidate Device) | Chemtrue® Multi-Panel Drug Screen Dip Card Tests - k142396 (Predicate Device) |
| --- | --- | --- |
| Indication(s) for Use | For the qualitative determination of methamphetamine in human urine. | Same (but the number of drugs detected is different) |
| Calibrator | d-Methamphetamine | Same |
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| 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 use. | Same |
| Configurations | Strip, Dip Card, Cup, Turn Key Split Cup | Dip Card |
| Item | AssureTech Phencyclidine Tests (Candidate Device) | Chemtrue® Multi-Panel Drug Screen Dip Card Tests - k142396 (Predicate Device) |
| --- | --- | --- |
| Indication(s) for Use | For the qualitative determination of phencyclidine in human urine. | Same (but the number of drugs detected is different) |
| Calibrator | Phencyclidine | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 25 ng/mL | Same |
| Intended Use | For over-the-counter use. | Same |
| Configurations | Strip, Dip Card, Cup, Turn Key Split Cup | Dip Card |
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| Item | AssureTech Marijuana Tests (Candidate Device) | Chemtrue® Multi-Panel Drug Screen Dip Card Tests - k142396 (Predicate Device) |
| --- | --- | --- |
| Indication(s) for Use | For the qualitative determination of marijuana 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 use. | Same |
| Configurations | Strip, Dip Card, Cup, Turn Key Split Cup | DipCard |
# K. Standard/Guidance Document Referenced (if applicable):
None referenced.
# L. Test Principle:
The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drug present in the urine specimen is 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 sufficient volume of sample has been applied.
# M. Performance Characteristics (if/when applicable):
# 1. Analytical performance:
# a. Precision/Reproducibility:
Precision studies were carried out using samples at analyte concentrations of $-100\%$ cut off, $-75\%$ cut off, $-50\%$ cut off, $-25\%$ cut off, cut off, $+25\%$ cut off, $+50\%$ cut off,
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+75% cut off and +100% cut off. These samples were prepared by spiking drug in negative urine samples. Each drug concentration was confirmed by GC/MS. The concentration levels used in the study are: 0, 255, 509, 747, 1011, 1265, 1518, 1760 and 2015 ng/mL for Methamphetamine tests; 0, 7, 13, 20, 27, 33, 39, 45 and 53 ng/mL for Phencyclidine tests; and 0, 14, 28, 39, 53, 61, 73, 90 and 103 ng/mL for Marijuana tests. 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. Three lots of each format for each analytes test were used in the study. The results obtained are summarized in the following tables.
## AssureTech Methamphetamine Strip Test
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
## AssureTech Methamphetamine Dip Card Test
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
## AssureTech Methamphetamine Turn Key Split Cup Test
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
## AssureTech Methamphetamine Quick Cup Test
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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AssureTech Phencyclidine Strip Test
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
AssureTech Phencyclidine Dip Card Test
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
AssureTech Phencyclidine Turn Key Split Cup Test
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
AssureTech Phencyclidine Quick Cup Test
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
AssureTech Marijuana Strip Test
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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AssureTech Marijuana Dip Card Test
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 8-/42+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
AssureTech Marijuana Turn Key Split Cup Test
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
AssureTech Marijuana Quick Cup Test
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
b. Linearity/assay reportable range:
Not applicable, these devices are intended for qualitative use only.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
External control materials are not supplied with the devices; however, the package inserts list information on how to obtain control materials.
Sample Storage and Stability - Protocols and acceptance criteria for real time, accelerated and transportation simulation stability studies were described and found to be acceptable. The real time stability data supports the sponsor's claim that the devices are stable at $39.2^{\circ}\mathrm{F}$ to $86^{\circ}\mathrm{F}$ ($4^{\circ}\mathrm{C}$ to $30^{\circ}\mathrm{C}$) for 24 months.
d. Detection limit:
Not applicable.
e. Analytical specificity:
The potential effect of endogenous and exogenous interferents was tested by spiking the interferents into drug-free urine, and target drug urine with concentrations at $25\%$ below and $25\%$ above the cut-off levels by using three lots and three operators for each format. Compounds that showed no interference at a concentration of $100\mu \mathrm{g / mL}$ are summarized in the following tables. There were no differences
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observed for different device formats for an analyte test.
Methamphetamine
| Acetamidophenol | (+/-)-Ephedrine | Oxymetazoline |
| --- | --- | --- |
| Acetaminophen | Erythromycin | Papaverine |
| Acetophenetidin | β-Estradiol | Penicillin G |
| N-Acetylprocainamide | Estrone-3-sulfate | Pentobarbital |
| Acetylsalicylate | Fenoprofen | Perphenazine |
| Aminopyrine | Furosemide | Phencyclidine |
| Amitryptyline | Gentisic acid | Phenelzine |
| Amobarbital | Hemoglobin | Phenobarbital |
| Amoxicillin | Hydralazine | L-Phenylephrine |
| Ampicillin | Hydrochlorothiazide | β-Phenylethylamine |
| D-Amphetamine | Hydrocodone | Phenylpropanolamine |
| L-Amphetamine | Hydrocortisone | Prednisone |
| L-Ascorbic Acid | α-Hydroxyhippuric acid | Prednisolone |
| Apomorphine | 3Hydroxytyramine | Procaine |
| Aspartame | Ibuprofen | D/L-Propanolol |
| Atropine | Imipramine | D-Propoxyphene |
| Benzilic acid | (+/-)-Isoproterenol | D-Pseudoephedrine |
| Benzoic acid | Isoxsuprine | Quinidine |
| Benzoylecgonine | Ketamine | Quinine |
| Bilirubin | Ketoprofen | Ranitidine |
| Caffeine | Labetalol | Salicylic acid |
| Cannabidiol | Loperamide | Secobarbital |
| Chloralhydrate | Loxapine succinate | Serotonin (5-Hydroxytyramine) |
| Chloramphenicol | Maprotiline | Sulfamethazine |
| Chlordiazepoxide | Meperidine | Sulindac |
| Chlorothiazide | Meprobamate | Temazepam |
| Chloroquine | Methadone | Tetracycline |
| Chlorpromazine | Methoxyphenamine | Tetrahydrocortisone, 3Acetate |
| Cholesterol | Morphine-3-β-D-glucuronide | Tetrahydrocortisone 3 (β-D-glucuronide) |
| Clomipramine | Nalidixic acid | Tetrahydrozoline |
| Clonidine | Nalorphine | Thebaine |
| Cocaine hydrochloride | Naloxone | Thiamine |
| Codeine | Naltrexone | Thioridazine |
| Cortisone | Naproxen | Tolbutamide |
| Cotinine | Niacinamide | Triamterene |
| Creatinine | Nifedipine | Trifluoperazine |
| Deoxycorticosterone | Norcodein | Trimethobenzamide |
| Dextromethorphan | Norethindrone | Trimethoprim |
| Diazepam | Noroxymorphone | Trimipramine |
| Diclofenac | D-Norpropoxyphene | D/L-Tryptophan |
| Diflunisal | Noscapine | Tyramine |
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10
| Digoxin | D/L-Octopamine | D/ L-Tyrosine |
| --- | --- | --- |
| Diphenhydramine | Oxalic acid | Uric acid |
| Doxylamine | Oxazepam | Verapamil |
| Ecgonine hydrochloride | Oxolinic acid | Zomepirac |
| Ecgoninemethylester | Oxycodone | |
## Phencyclidine
| Acetaminophen | (-) Y Ephedrine | Oxycodone |
| --- | --- | --- |
| Acetophenetidin | Erythromycin | Oxymetazoline |
| N- | β-Estradiol | Papaverine |
| Acetylsalicylic acid | Estrone-3-sulfate | Penicillin-G |
| Aminopyrine | Ethyl-p-aminobenzoate | Pentazocine hydrochloride |
| Amitryptyline | Fenoprofen | Pentobarbital |
| Amobarbital | Furosemide | Perphenazine |
| Amoxicillin | Gentisic acid | Phenelzine |
| Ampicillin | Hemoglobin | Phenobarbital |
| Ascorbic acid | Hydralazine | Phentermine |
| D,L-Amphetamine | Hydrochlorothiazide | L-Phenylephrine |
| Apomorphine acid | Hydrocodone | β-Phenylethylamine |
| Aspartame | Hydrocortisone | Phenylpropanolamine |
| Atropine | O-Hydroxyhippuric | Prednisolone |
| Benzilic acid | p- | Prednisone |
| Benzoic acid | 3-Hydroxytyramine | Procaine |
| Benzoylecgonine | Ibuprofen | Promazine |
| Benzphetamine | Imipramine | Promethazine |
| Bilirubin | Iproniazid | D,L-Propanolol |
| Brompheniramine | (±) - Isoproterenol | D-Propoxyphene |
| Caffeine | Isoxsuprine | D-Pseudoephedrine |
| Cannabidiol | Ketamine | Quinidine |
| Cannabinol | Ketoprofen | Quinine |
| Chloralhydrate | Labetalol | Ranitidine |
| Chloramphenicol | Loperamide | Salicylic acid |
| Chlordiazepoxide | Maprotiline | Secobarbital |
| Chlorothiazide | Meperidine | Serotonin (5-Hydroxytyramine) |
| (±) | Meprobamate | Sulfamethazine |
| Chlorpromazine | Methadone | Sulindac |
| Chloroquine | Methoxyphenamine | Temazepam |
| Cholesterol | (+) 3,4-Methylenedioxy- | Tetracycline |
| Clomipramine | (+)3,4-Methylenedioxy- | Tetrahydrocortisone3 (β-D glucuronide) |
| Clonidine | Morphine-3-β-D | Tetrahydrozoline |
| Cocaine | Morphine Sulfate | Thiamine |
| Codeine | Nalidixic acid | Thioridazine |
| Cortisone | Naloxone | D, L-Tyrosine |
{10}
| (-) Cotinine | Naltrexone | Tolbutamide |
| --- | --- | --- |
| Creatinine | Naproxen | Triamterene |
| Deoxycorticosterone | Niacinamide | Trifluoperazine |
| Dextromethorphan | Nifedipine | Trimethoprim |
| Diazepam | Norcodein | Trimipramine |
| Diclofenac | Norethindrone | Tryptamine |
| Diflunisal | D-Norpropoxyphene | D, L-Tryptophan |
| Digoxin | Noscapine | Tyramine |
| Diphenhydramine | D,L-Octopamine | Uric acid |
| Doxylamine | Oxalic acid | Verapamil |
| Ecgonine | Oxazepam | Zomepirac |
| Ecgonine methylester | Oxolinic acid | |
Marijuana
| Acetamidophenol | β-Estradiol | Papaverine |
| --- | --- | --- |
| Acetophenetidin | Estrone-3-sulfate | Penicillin G |
| N-Acetylprocainamide | Ethyl-p-aminobenzoate | Pentazocine |
| Acetylsalicylic acid | Fenoprofen | Pentobarbital |
| Aminopyrine | Furosemide | Perphenazine |
| Amitryptyline | Gentisic acid | Phencyclidine |
| Amobarbital | Hemoglobin | Phenelzine |
| Amoxicillin | Hydralazine | Phenobarbital |
| Ampicillin | Hydrochlorothiazide | Phentermine |
| Ascorbic acid | Hydrocodone | L-Phenylephrine |
| D/L-Amphetamine | Hydrocortisone | β-Phenylethlamine |
| L-Amphetamine | α-Hydroxyhippuric acid | β-Phenylethylamine |
| Apomorphine | 3-Hydroxytyramine | Phenylpropanolamine |
| Aspartame | Ibuprofen | Prednisolone |
| Atropine | Imipramine | Prednisone |
| Benzilic acid | Iproniazid | Procaine |
| Benzoic acid | (+/-)-Isoproterenol | Promazine |
| Benzoylecgonine | Isoxsuprine | Promethazine |
| Benzphetamine | Ketamine | D/L-Propanolol |
| Bilirubin | Labetalol | D-Propoxyphene |
| Brompheniramine | Levorphanol | D-Pseudoephedrine |
| Caffeine | Loperamide | Quinidine |
| Chloralhydrate | Maprotiline | Quinine |
| Chloramphenicol | Meprobamate | Ranitidine |
| Chlordiazepoxide | Methadone | Salicylic acid |
| Chlorothiazide | Methoxyphenamine | Secobarbital |
| (+/-)-Chlorpheniramine | (+/-) | Serotonin (5-Hydroxytyramine) |
| Chlorpromazine | (+/-) | Sulfamethazine |
| Chloroquine | Methylphenidate | Sulindac |
| Cholesterol | Methyprylon | Temazepam |
{11}
To test cross-reactivity, drug metabolites and other components in urine samples that are likely to interfere were tested using three batches of each device format. The lowest concentration that caused a positive result for each compound is listed below. There were no differences observed for different device formats for each analyte test. Results are summarized below:
| Methamphetamine (Cutoff=1000 ng/mL) | Result Positive at (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| D(+)-Methamphetamine | 1000 | 100% |
| (+/-)3,4-Methylenedioxy-n-ethylamphetamine(MDEA) | 10000 | 10% |
| D/L-Methamphetamine | 1000 | 100% |
| p-Hydroxymethamphetamine | 10000 | 10% |
| D-Amphetamine | Negative at ≤100000 | <1% |
| L-Amphetamine | Negative at ≤100000 | <1% |
| Chloroquine | 50000 | 2% |
| (+/-)-Ephedrine | 4000 | 25% |
| L-Methamphetamine | 10000 | 10% |
| (+/-)3,4-Methylenedioxyamphetamine (MDA) | Negative at ≤100000 | <1% |
| (+/-)3,4-methylenedioxymethamphetamine(MDMA) | 500 | 200% |
| β-Phenylethylamine | 7500 | 13.3% |
| Trimethobenzamide | 20000 | 5% |
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| Phencyclidine
(Cut-off=25 ng/mL) | Result
Positive at (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Phencyclidine | 25 | 100% |
| 4-Hydroxyphencyclidine | 75 | 33.3% |
| Marijuana
(Cut-off=50 ng/mL) | Result
Positive at (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| 11-Nor-Δ⁹-Tetrahydrocannabinol-9-COOH | 50 | 100% |
| 11-Hydroxy-Δ⁹-Tetrahydrocannabinol | 50 | 100% |
| 11-Nor-Δ⁸-Tetrahydrocannabinol-9-COOH | 50 | 100% |
| Cannabinol | 20000 | 0.25% |
| Δ⁸-Tetrahydrocannabinol | 15000 | 0.33% |
| Δ⁹-Tetrahydrocannabinol | 15000 | 0.33% |
| Cannabidiol | Negative at ≤100000 | <0.05% |
| 11-Nor-Δ⁹-THC-carboxy glucuronide | 75 | 66.7% |
| (-)-11-nor-9-carboxy-Δ 9-THC | 50 | 100% |
To investigate the effect of urine specific gravity and urine pH, urine samples with 1.009 to 1.030 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above the cutoff 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 format of each analyte test.
f. Assay cut-off:
Characterization of how the device performs analytically around the claimed cut-off concentration appears in the precision/reproducibility section above.
2. Comparison studies:
a. Method comparison with predicate device:
Method comparison studies for the AssureTech Methamphetamine Tests, the AssureTech Phencyclidine Tests and the AssureTech Marijuana Tests were performed in-house by 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:
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Methamphetamine Strip
| Viewer | Results | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
Discordant Results of Methamphetamine Strip
| Viewer | Sample Number | GC/MS Result (ng/mL of d-Methamphetamine) | Strip Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 50368 | 974 | Positive |
| Viewer C | 50368 | 974 | Positive |
| Viewer A | 96378 | 1045 | Negative |
| Viewer B | 79610 | 1094 | Negative |
| Viewer C | 96378 | 1045 | Negative |
Methamphetamine Dip Card
| Viewer | Results | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 20 | 10 | 0 | 0 |
14
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Discordant Results of Methamphetamine Dip Card
| Viewer | Sample Number | GC/MS Result (ng/mLof d-Methamphetamine) | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 50368 | 974 | Positive |
| Viewer B | 50368 | 974 | Positive |
| Viewer B | 96378 | 1045 | Negative |
Methamphetamine Turn Key Split Cup
| Viewer | Results | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
Discordant Results of Methamphetamine Turn Key Split Cup
| Viewer | Sample Number | GC/MS Result (ng/mLof d-Methamphetamine) | Turn Key Split Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 50368 | 974 | Positive |
| Viewer C | 50368 | 974 | Positive |
| Viewer A | 96378 | 1045 | Negative |
| Viewer B | 96378 | 1045 | Negative |
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Methamphetamine Quick Cup
| Viewer | Results | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 20 | 10 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
Discordant Results of Methamphetamine Quick Cup
| Viewer | Sample Number | GC/MS Result (ng/mLof d-Methamphetamine) | Quick Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 50368 | 974 | Positive |
| Viewer A | 96378 | 1045 | Negative |
| Viewer C | 79610 | 1094 | Negative |
Phencyclidine Strip
| Viewer | Results | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
{16}
Discordant Results of Phencyclidine Strip
| Viewer | Sample Number | GC/MS Result (ng/mLof Phencyclidine) | Strip Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 68414 | 22 | Positive |
| Viewer B | 49090 | 24 | Positive |
| Viewer C | 49090 | 24 | Positive |
| Viewer A | 34825 | 27 | Negative |
| Viewer B | 46717 | 27 | Negative |
Phencyclidine Dip Card
| Viewer | Results | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 2 | 14 | 25 |
| | Negative | 10 | 20 | 8 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
Discordant Results of Phencyclidine Dip Card
| Viewer | Sample Number | GC/MS Result (ng/mLof Phencyclidine) | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 49090 | 24 | Positive |
| Viewer A | 68414 | 22 | Positive |
| Viewer C | 68414 | 22 | Positive |
| Viewer A | 34825 | 27 | Negative |
| Viewer B | 61443 | 27 | Negative |
| Viewer C | 46717 | 27 | Negative |
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Phencyclidine Turn Key Split Cup
| Viewer | Results | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
Discordant Results of Phencyclidine Turn Key Split Cup
| Viewer | Sample Number | GC/MS Result (ng/mL of Phencyclidine) | Turn Key Split Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 68414 | 22 | Positive |
| Viewer B | 68414 | 22 | Positive |
| Viewer C | 68414 | 22 | Positive |
| Viewer A | 34825 | 27 | Negative |
| Viewer B | 46717 | 27 | Negative |
Phencyclidine Quick Cup
| Viewer | Results | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 14 | 25 |
| | Negative | 10 | 20 | 8 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
{18}
Discordant Results of Phencyclidine Quick Cup
| Viewer | Sample Number | GC/MS Result (ng/mL of Phencyclidine) | Quick Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 68414 | 22 | Positive |
| Viewer B | 68414 | 22 | Positive |
| Viewer B | 49090 | 24 | Positive |
| Viewer B | 46717 | 27 | Negative |
| Viewer C | 46717 | 27 | Negative |
Marijuana Strip
| Viewer | Results | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 13 | 25 |
| | Negative | 10 | 20 | 10 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
Discordant Results of Marijuana Strip
| Viewer | Sample Number | GC/MS Result (ng/mL of 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH) | Strip Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 87180 | 46 | Positive |
| Viewer C | 87180 | 46 | Positive |
| Viewer A | 97898 | 52 | Negative |
| Viewer B | 97898 | 52 | Negative |
| Viewer B | 32995 | 53 | Negative |
| Viewer C | 32995 | 53 | Negative |
{19}
Marijuana Dip Card
| Viewer | Results | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
Discordant Results of Marijuana Dip Card
| Viewer | Sample Number | GC/MS Result (ng/mL of 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH) | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 38785 | 44 | Positive |
| Viewer B | 87180 | 46 | Positive |
| Viewer A | 97898 | 52 | Negative |
| Viewer C | 32995 | 53 | Negative |
Marijuana Turn Key Split Cup
| Viewer | Results | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
{20}
Discordant Results of Marijuana Turn Key Split Cup
| Viewer | Sample Number | GC/MS Result (ng/mL of 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH) | Turn Key Split Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 38785 | 44 | Positive |
| Viewer B | 87180 | 46 | Positive |
| Viewer A | 99015 | 54 | Negative |
| Viewer B | 97898 | 52 | Negative |
| Viewer C | 32995 | 53 | Negative |
Marijuana Quick Cup
| Viewer | Results | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
Discordant Results of Marijuana Quick Cup
| Viewer | Sample Number | GC/MS Result (ng/mL of 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH) | Quick Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer B | 43788 | 43 | Positive |
| Viewer A | 32995 | 53 | Negative |
| Viewer C | 94567 | 55 | Negative |
Lay-user study:
A lay user study was performed at three intended user sites with 1638 lay persons. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to >50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and
{21}
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 Strip
| % of Cutoff | Number of samples | d-Methamphetamine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 260 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 489 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 769 | 0 | 21 | 100 |
| +25% Cutoff | 21 | 1276 | 21 | 0 | 100 |
| +50% Cutoff | 21 | 1468 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 1795 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Methamphetamine 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 | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 260 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 489 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 769 | 1 | 20 | 95 |
| +25% Cutoff | 21 | 1276 | 19 | 2 | 90 |
| +50% Cutoff | 21 | 1468 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 1795 | 21 | 0 | 100 |
{22}
Comparison between GC/MS and Lay Person Results for Methamphetamine Turn Key Split Cup
| % of Cutoff | Number of samples | d-Methamphetamine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 260 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 489 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 769 | 1 | 20 | 95 |
| +25% Cutoff | 21 | 1276 | 21 | 0 | 100 |
| +50% Cutoff | 21 | 1468 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 1795 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Methamphetamine Quick Cup
| % of Cutoff | Number of samples | d-Methamphetamine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 260 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 489 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 769 | 0 | 21 | 100 |
| +25% Cutoff | 21 | 1276 | 20 | 1 | 95 |
| +50% Cutoff | 21 | 1468 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 1795 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Phencyclidine Strip
| % of Cutoff | Number of samples | Phencyclidine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 8 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 12 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 20 | 0 | 21 | 100 |
| +25% Cutoff | 21 | 30 | 20 | 1 | 95 |
| +50% Cutoff | 21 | 39 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 43 | 21 | 0 | 100 |
{23}
Comparison between GC/MS and Lay Person Results for Phencyclidine Dip Card
| % of Cutoff | Number of samples | Phencyclidine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 8 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 12 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 20 | 1 | 20 | 95 |
| +25% Cutoff | 21 | 30 | 20 | 1 | 95 |
| +50% Cutoff | 21 | 39 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 43 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Phencyclidine Turn Key Split Cup
| % of Cutoff | Number of samples | Phencyclidine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 8 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 12 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 20 | 0 | 21 | 100 |
| +25% Cutoff | 21 | 30 | 19 | 2 | 90 |
| +50% Cutoff | 21 | 39 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 43 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Phencyclidine Quick Cup
| % of Cutoff | Number of samples | Phencyclidine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 8 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 12 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 20 | 0 | 21 | 100 |
| +25% Cutoff | 21 | 30 | 19 | 2 | 90 |
| +50% Cutoff | 21 | 39 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 43 | 21 | 0 | 100 |
{24}
Comparison between GC/MS and Lay Person Results for Marijuana Strip
| % of Cutoff | Number of samples | Marijuana Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 13 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 26 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 39 | 1 | 20 | 95 |
| +25% Cutoff | 21 | 61 | 20 | 1 | 95 |
| +50% Cutoff | 21 | 76 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 86 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Marijuana 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 | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 13 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 26 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 39 | 2 | 19 | 90 |
| +25% Cutoff | 21 | 61 | 21 | 0 | 100 |
| +50% Cutoff | 21 | 76 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 86 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for Marijuana Turn Key Split Cup
| % of Cutoff | Number of samples | Marijuana Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 13 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 26 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 39 | 1 | 20 | 95 |
| +25% Cutoff | 21 | 61 | 20 | 1 | 95 |
| +50% Cutoff | 21 | 76 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 86 | 21 | 0 | 100 |
{25}
Comparison between GC/MS and Lay Person Results for Marijuana Quick Cup
| % of Cutoff | Number of samples | Marijuana Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 13 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 26 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 39 | 1 | 20 | 95 |
| +25% Cutoff | 21 | 61 | 21 | 0 | 100 |
| +50% Cutoff | 21 | 76 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 86 | 21 | 0 | 100 |
Lay users performed a survey on the ease of understanding of the package insert instructions. Overall the device use instructions were found to easy to follow. All package insert were scored at a reading grade level of 7 using the Flesch-Kincaid reading analysis.
b. Matrix comparison:
Not applicable
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable
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.
