CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests
Device Facts
| Record ID | K161251 |
|---|---|
| Device Name | CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests |
| Applicant | Hangzhou Clongene Biotech Co., Ltd. |
| Product Code | DKZ · Clinical Toxicology |
| Decision Date | Aug 30, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Indications for Use
CLUNGENE Amphetamine Tests are immunochromatographic assays for the qualitative determination of d-Amphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Cassette format, a Cup format, a Dip Card format, and a Split Key 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. CLUNGENE Cocaine Tests are immunochromatographic assays for the qualitative determination of Cocaine in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Cup format, a Dip Card format, and a Split Key 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. CLUNGENE Oxazepam Tests are immunochromatographic assays for the qualitative determination of Oxazepam in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Dip Card format, and a Split Key Cup format. The test may yield preliminary positive results even when prescription drug Oxazepam is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxazepam in urine. 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 detection of d-Amphetamine, Cocaine, and Oxazepam in human urine; competitive binding principle; antibody-coated particles bind to drug-specific conjugate; colored line indicates negative result (drug below cutoff); absence of line indicates positive result (drug above cutoff); procedural control line confirms proper migration; available in Cassette, Cup, Dip Card, and Split Key Cup formats; intended for OTC and prescription use; results are preliminary and require GC/MS confirmation; clinical judgment required for positive results.
Clinical Evidence
No clinical diagnostic studies performed. Analytical performance validated via precision/reproducibility studies (1350 results per analyte/format) and method comparison against GC/MS. Consumer study conducted with 1680 subjects (140 per format/analyte) demonstrated lay-user ability to correctly interpret results across various drug concentrations relative to cutoff.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle; qualitative; visually read; no instrumentation required; stable at 4-30°C for 24 months; internal procedural control line included.
Indications for Use
Indicated for qualitative detection of d-Amphetamine (1000 ng/mL), Cocaine (300 ng/mL), and Oxazepam (300 ng/mL) in human urine. Intended for OTC and prescription use to provide preliminary screening results. Not intended to distinguish between prescription use and abuse for Oxazepam.
Regulatory Classification
Identification
An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Predicate Devices
- The FIRST CHECK MULTI DRUG CUP Urine Test (k052115)
Related Devices
- K132630 — WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) · Guangzhou Wondfo Biotech Co., Ltd. · Sep 27, 2013
- K121987 — WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST · Guangzhou Wondfo Biotech Co., Ltd. · Aug 1, 2012
- K143187 — Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) · Healgen Scientific,, LLC · Jan 27, 2015
Submission Summary (Full Text)
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1
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION TEMPLATE
A. 510(k) Number:
k161251
B. Purpose for Submission:
New device
C. Measurand:
Amphetamines, Cocaine, and Oxazepam in urine
D. Type of Test:
Qualitative immunochromatographic assay
E. Applicant:
Hangzhou Clongene Biotech Co., Ltd.
F. Proprietary and Established Names:
Clungene Oxazepam Tests
Clungene Amphetamine Tests
Clungene Cocaine Tests
G. Regulatory Information:
1. Regulation section:
21 CFR, 862.3170 Benzodiazepine Test System
21 CFR, 862.3100 Amphetamine Test System
21 CFR, 862.3250 Cocaine Test System
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2. Classification:
All Class II
3. Product codes:
JXM, DKZ, DIO
4. Panel:
91- Toxicology
H. Intended Use:
1. Intended use(s):
See Indications for use below
2. Indication(s) for use:
CLUNGENE Amphetamine Tests are immunochromatographic assays for the qualitative determination of d-Amphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Cassette format, a Cup format, a Dip Card format, and a Split Key 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.
CLUNGENE Cocaine Tests are immunochromatographic assays for the qualitative determination of Cocaine in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Cup format, a Dip Card format, and a Split Key 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
2
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prescription use.
CLUNGENE Oxazepam Tests are immunochromatographic assays for the qualitative determination of Oxazepam in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Cup format, a Dip Card format, and a Split Key Cup format.
The test may yield preliminary positive results even when prescription drug Oxazepam is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxazepam in urine. 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.
3. Special conditions for use statement(s):
For Over-The-Counter (OTC) use.
For In Vitro Diagnostic Use only.
4. Special instrument requirements:
Not applicable, as the device is a visually-read single use device
I. Device Description:
The CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, and CLUNGENE Oxazepam Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, Cocaine and Oxazepam (target analytes) in human urine. The tests are available in Cassette, Dip Card, Cup, and Split Key Cup formats. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
J. Substantial Equivalence Information:
1. Predicate device name(s):
The FIRST CHECK MULTI DRUG CUP Urine Test
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2. Predicate 510(k) number(s):
k052115
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Predicate (k052115) | Candidate Device |
| Indication(s) for Use | For the qualitative determination of drugs of abuse in human urine | Same (but the number of drugs detected is different) |
| 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 |
| Cutoff | AMP 1000 ng/mL, COC 300 ng/mL, BZO 300 ng/mL | Same |
| Intended Users | Lay Users (Over the Counter) | Same |
| Differences | | |
| Item | Predicate (k052115) | Candidate Device |
| Format | Cup | Cup, cassette, dip card |
| Analytes | Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, Phencyclidine, Benzodiazepines, Barbiturates, Methadone, Tricyclic Antidepressants, and Oxycodone | Amphetamines, cocaine, oxazepam |
K. Standard/Guidance Document Referenced (if applicable):
None referenced
L. Test Principle:
The CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, and CLUNGENE Oxazepam Tests utilize lateral flow immunochromatographic technology based on the principle of competitive binding. Drugs, if present in concentrations below the cutoff level,
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will not saturate the binding sites of antibody coated particles in the device. The antibody-coated particles will then be captured by immobilized drug-specific conjugate and a colored line will appear in the test line region. The colored line will not form if the sample contains drug in excess of the cutoff level because the drug will saturate all the binding sites of the drug-specific antibody. Each strip in the device contains a procedural control that appears in the control line region indicating that the sample has migrated properly on the test strip.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Precision study samples were prepared from negative urine samples spiked to nine different concentrations: +100%, +75% +50%, +25%, cut off, -25%, -50%, -75% and -100% of the drug cutoff concentration for each drug. All sample concentrations were confirmed by GC/MS. All aliquots for testing were blind labeled by the same person who prepared the samples but who did not take part in sample testing. For each combination of analyte and format, three operators read 50 results at each of the nine concentrations, for a total of 1350 results per analyte per format. Results are summarized below.
Cassette Format
| AMP | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | cutoff | +25% cutoff | +50% cutoff | +75% cutoff | +100% cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Dip card Format
| AMP | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | cutoff | +25% cutoff | +50% cutoff | +75% cutoff | +100% cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 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+ | 29-/21+ | 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- |
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Easy Cup Format
| AMP | -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+ | 28-/22+ | 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+ | 19-/31+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Split Key Cup
| AMP | -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+ | 20-/30+ | 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- |
Cassette Format
| COC | -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+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Dip card Format
| COC | -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+ | 24-/26+ | 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+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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Easy Cup Format
| COC | -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+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 31-/19+ | 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 Format
| COC | -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+ | 21-/29+ | 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- |
Cassette Format
| OXAZ | -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+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Dip card Format
| OXAZ | -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+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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Easy Cup Format
| OXAZ | -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+ | 28-/22+ | 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+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Split Key Cup Format
| OXAZ | -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+ | 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- |
b. Linearity/assay reportable range:
Not applicable. These devices are for qualitative use only.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Procedural controls are included in the test strip and device. A colored line appearing in the control zone is considered as an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique. Control standards are not supplied with these tests; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance. Users should follow local, state, and federal guidelines to run the external controls.
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.
d. Detection limit:
See Precision/Reproducibility section in M.1.a above.
e. Analytical specificity:
Cross reactivity was evaluated by spiking the structurally similar compounds shown
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below into drug free urine. The concentrations specified below represent the lowest concentration tested that produced a positive result. Testing was performed as instructed in the package insert and three lots of each device were evaluated. No differences were seen between formats. Results are summarized below.
Amphetamine
| Potential cross-reactant | Lowest Concentration producing a positive result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| D - Amphetamine | 1000 | 100% |
| L - Amphetamine | 50000 | 2% |
| D/L – Amphetamine | 3000 | 33% |
| Phentermine | 3000 | 33% |
| Hydroxyamphetamine | 5000 | 20% |
| MDA | 5000 | 20% |
| MDMA | Negative at 100000 | < 1% |
| MDE | Negative at 100000 | < 1% |
| D-methamphetamine | Negative at 100000 | < 1% |
| L-methamphetamine | Negative at 100000 | < 1% |
| Ephedrine | Negative at 100000 | < 1% |
| Pseudoephedrine | Negative at 100000 | < 1% |
Cocaine
| Potential cross-reactant | Highest Concentration producing a negative result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| Benzoylecgonine | 300 | 100 |
| Cocaine HCl | 780 | 38.5 |
| Cocaethylene | 12500 | 2.4 |
| Ecgonine HCl | 32000 | 0.9 |
| Norcocaine | 100000 | 0.3 |
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Oxazepam
| Potential cross-reactant | Highest Concentration producing a negative result (ng/ml) | % Cross Reactivity |
| --- | --- | --- |
| Oxazepam | 300 | 100% |
| Alprazolam | 200 | 150% |
| a-Hydroxyalprazolam | 1250 | 24% |
| Bromazepam | 1500 | 20% |
| Chlordiazepoxide | 1500 | 20% |
| Clobazam | 100 | 300% |
| Clonazepam | 800 | 37% |
| Clorazepate dipotassium | 200 | 150% |
| Delorazepam | 1500 | 20% |
| Desalkylflurazepam | 400 | 75% |
| Diazepam | 200 | 150% |
| Estazolam | 2500 | 12% |
| Flunitrazepam | 400 | 75% |
| Midazolam | 12500 | 2% |
| Nitrazepam | 100 | 300% |
| Norchlordiazepoxide | 200 | 150% |
| Nordiazepam | 400 | 75% |
| Temazepam | 100 | 300% |
| Triazolam | 2500 | 12% |
| D/L-Lorazepam | 1500 | 20% |
Potential interfering substances were evaluated by spiking the compounds below into drug free urine and urine with drug concentrations at +/-25% of the cutoff. Each compound was spiked at 100,000 ng/mL and tested on three lots of each device. No interference was detected.
| Amphetamine | | |
| --- | --- | --- |
| 4-Acetamidophenol | Diazepam | O-Hydroxyhippuric acid |
| (-)-Cotinine | Diclofenac | Oxalic acid |
| (-)-Isoproterenol | Diflunisal | Oxazepam |
| (-)-Y-Ephedrine | Digoxin | Oxolinic acid |
| (±)-Chlorpheniramine | Diphenhydramine | Oxycodone |
| (IR,2S)-(-)-Ephedrine | Doxylamine | Oxymetazoline |
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| Amphetamine | | |
| --- | --- | --- |
| 3-Hydroxytyramine | Ecgonine hydrochloride | Papaverine |
| Acetophenetidin | Ecgonine methylester | Penicillin-G |
| Acetylsalicylic acid | Erythromycin | Pentazocaine |
| Aminopyrine | Estrone-3-sulfate | Pentobarbital |
| Amitriptyline | Ethyl-p-aminobenzoate | Perphenazine |
| Amobarbital | Fenfluramine | Phencyclidine |
| Amoxicillin | Fenoprofen | Phenelzine |
| Ampicillin | Furosemide | Phenobarbital |
| Ascorbic acid | Gentisic acid | Phenylpropanolamine |
| Aspartame | Hemoglobin | Prednisolone |
| Atropine | Hydralazine | Prednisone |
| Benzilic acid | Hydrochlorothiazide | Procaine |
| Benzoic acid | Hydrocodone | Promazine |
| Benzoylecgonine | Hydrocortisone | Promethazine |
| Bilirubin | Ibuprofen | Quinidine |
| Brompheniramine | Imipramine | Quinine |
| Caffeine | Isoxsuprine | Ranitidine |
| Cannabidiol | Ketamine | Salicylic acid |
| Cannabinol | Ketoprofen | Secobarbital |
| Chloralhydrate | L-Ephedrine | Sulfamethazine |
| Chloramphenicol | L-Phenylephrine | Sulindac |
| Chlordiazepoxide | Labetalol | Temazepam |
| Chloroquine | Levorphanol | Tetracycline |
| Chlorothiazide | Loperamide | Tetrahydrocortisone |
| Chlorpromazine | Maprotiline | Tetrahydrozoline |
| Cholesterol | Meperidine | Thebaine |
| Clomipramine | Meprobamate | Thiamine |
| Clonidine | Methadone | Thioridazine |
| Cocaine hydrochloride | Methylphenidate | Tolbutamine |
| Codeine | Morphine-3-D-glucuronide | Triamterene |
| Cortisone | N-Acetylprocainamide | Trifluoperazine |
| Creatinine | Nalidixic acid | Trimethoprim |
| D-Norpropoxyphene | Naloxone | Trimipramine |
| D-Propoxyphene | Naltrexone | Tryptamine |
| D/L-Octopamine | Naproxen | Uric acid |
| D/L-Propanolol | Niacinamide | Verapamil |
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| Amphetamine | | |
| --- | --- | --- |
| D/L-Thyroxine | Nifedipine | Zomepirac |
| D/L-Tyrosine | Norcodeine | β-Estradiol |
| Deoxycorticosterone | Norethindrone | Δ9-THC-COOH |
| Dextromethorphan | Noscapine | |
| Cocaine | | |
| --- | --- | --- |
| Acetaminophen | Diflunisal | Oxazepam |
| (-)-Cotinine | Digoxin | Oxolinic acid |
| (-)-Ψ-Ephedrine | Diphenhydramine | Oxycodone |
| (±)-3,4-Methylene dioxyamphetamine | Doxylamine | Oxymetazoline |
| (±)-Brompheniramine | Ecgonine methylester | p-Hydroxymethamphetamine |
| (±)-Chlorpheniramine | Erythromycin | Papaverine |
| (±)-Isoproterenol | Estrone-3-sulfate | Penicillin-G |
| 3-Hydroxytyramine | Ethyl-p-aminobenzoate | Pentobarbital |
| Acetophenetidin | Fenoprofen | Perphenazine |
| Acetylsalicylic acid | Furosemide | Phencyclidine |
| Aminopyrine | Gentisic acid | Phenelzine |
| Amitriptyline | Hemoglobin | Phenobarbital |
| Amobarbital | Hydralazine | Phentermine |
| Amoxicillin | hydrochloride | Phenylpropanolamine |
| Ampicillin | hydrochloride(±)-3,4-Methylene-dioxymethamphetamine | Prednisolone |
| Apomorphine | Hydrochlorothiazide | Prednisone |
| Aspartame | Hydrocodone | Procaine |
| Atropine | Hydrocortisone | Promazine |
| Benzilic acid | Ibuprofen | Promethazine |
| Benzoic acid | Imipramine | Quinidine |
| Benzphetamine | Iproniazid | Quinine |
| Caffeine | Isoxsuprine | Ranitidine |
| Cannabidiol | Ketamine | Salicylic acid |
| Cannabinol | Ketoprofen | Secobarbital |
| Chloralhydrate | L-Ascorbic acid | Serotonin |
| Chloramphenicol | L-Phenylephrine | Sulfamethazine |
| Chlordiazepoxide | Labetalol | Sulindac |
| Chloroquine | Levorphanol | Temazepam |
{12}
| Cocaine | | |
| --- | --- | --- |
| Chlorothiazide | Loperamide | Tetracycline |
| Chlorpromazine | Maprotiline | Tetrahydrocortisone 3 (β-D-glucuronide) |
| Cholesterol | Meperidine | Tetrahydrozoline |
| Clomipramine | Meprobamate | Thebaine |
| Clonidine | Methadone | Thiamine |
| Codeine | Methoxyphenamine | Thioridazine |
| Cortisone | Morphine Sulfate | Tolbutamide |
| Creatinine | Morphine-3-β-D-glucuronide | Triamterene |
| D-Norpropoxyphene | N-Acetylprocainamide | Trifluoperazine |
| D-Propoxyphene | Nalidixic acid | Trimethoprim |
| D-Pseudoephedrine | Naloxone | Trimipramine |
| D/L-Amphetamine Sulfate | Naltrexone | Tryptamine |
| D/L-Octopamine | Naproxen | Tyramine |
| D/L-Propranolol | Niacinamide | Uric acid |
| D/L-Tryptophan | Nifedipine | Verapamil |
| D/L-Tyrosine | Norcodeine | Zomepirac |
| Deoxycorticosterone | Norethindrone | β-Estradiol |
| Dextromethorphan | Noscapine | β-Phenylethylamine |
| Diazepam | O-Hydroxyhippuric acid | |
| Diclofenac | Oxalic acid | |
| Oxazepam | | |
| --- | --- | --- |
| 4-Acetamidophenol | D-Propoxyphene | Naproxen |
| (-)-cotinine | D-Pseudoephedrine | Niacinamide |
| (-)-Y-Ephedrine | D/L-Amphetamine | Nifedipine |
| (+)-3,4-Methylenedioxy-amphetamine | D/L-Octopamine | Norethindrone |
| (+)-3,4-Methylenedioxy-methamphetamine | D/L-Propranolol | Noscapine |
| (±)-Chlorpheniramine | D/L-Tryptophan | O-Hydroxyhippuric acid |
| (±)-Chlorpheniramine | D/L-Tyrosine | Oxalic acid |
| (±)-Isoproterenol | Dextromethorphan | Oxolinic acid |
| 3-Hydroxytyramine | Diclofenac | p-Hydroxy- methamphetamine |
| Acetophenetidin | Diflunisal | Pentobarbital |
| Acetylsalicylic acid | Digoxin | Perphenazine |
| Aminopyrine | Diphenhydramine | Phencyclidine |
| Amitriptyline | Doxylamine | Phenelzine |
{13}
| Oxazepam | | |
| --- | --- | --- |
| Amobarbital | Ecgonine hydrochloride | Phenobarbital |
| Amoxicillin | Ecgonine methylester | Phentermine |
| Ampicillin | Fenoprofen | Phenylpropanolamine |
| Apormorphine | Furosemide | Prednisone |
| Aspartame | Gentisic acid | Quinine |
| Atropine | Hemoglobin | Ranitidine |
| Benzilic acid | Hydrocortisone | Salicylic acid |
| Benzoic acid | Ibuprofen | Secobarbital |
| Benzoylecgonine | Imipramine | Serotonin (5-Hydroxytyramine) |
| Benzphetamine | Iproniazid | Sertraline |
| Bilirubin | Isoxsuprine | Sulfamethazine |
| Brompheniramine | Ketamine | Sulindac |
| Caffeine | Ketoprofen | Tetrahydrocortisone |
| Caffeine | l-Ascorbic Acid | Tetrahydrozoline |
| Cannabidiol | L-Phenylephrine | Thiamine |
| Chloralhydrate | Labetalol | Thioridazine |
| Chloramphenicol | Loperamide | Tolbutamide |
| Chloroquine | Maprotiline | Triamterene |
| Chlorothiazide | Meperidine | Trifluoperazine |
| Chlorpromazine | Meprobamate | Trimethoprim |
| Cholesterol | Methadone | Tryptamine |
| Clomipramine | Methoxyphenamine | Tyramine |
| Clonidine | N-Acetylprocainamide | Uric acid |
| Cocaine hydrochloride | Nalidixic acid | Verapamil |
| Cortisone | Nalorphine | Zomepirac |
| Creatinine | Naloxone | β-Phenylethylamine |
| D-Norpropoxyphene | Naltrexone | |
To evaluate the effect of specific gravity, twelve drug free urine samples with specific gravities ranging from 1.000-1.035 were spiked with each drug to $\pm 25\%$ of the cutoff values. Three lots of each device were used to test all samples.
To evaluate the effects of pH, a negative urine pool was aliquoted and the pH of each aliquot was adjusted to 4.00 to 9.00, in increments of $1\mathrm{pH}$ unit. Three lots of each device were used to test all samples. The aliquots were then spiked with amphetamine, cocaine, or Oxazepam to concentrations $25\%$ below and $25\%$ above the cutoff concentrations.
The pH and specific gravity ranges tested did not affect the results from the device.
{14}
f. Assay cut-off:
Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section, M.1.a., above.
# 2. Comparison studies:
a. Method comparison with predicate device:
Method comparison samples consisted of 80 clinical samples (40 negative and 40 positive) for each drug. The samples were masked and randomized by a person who prepared the samples and who didn't take part in the sample testing. Operators were blinded to the sample identity. Each sample concentration of the drug was confirmed by GC-MS. The drug concentration ranges tested were as follows: drug-free, $\leq 50\%$ cut-off, $-50\%$ cut-off to cut-off, Cut-off to $+50\%$ cut-off, and $\geq 50\%$ cut-off, for each drug.
The above samples were tested using one lot of each format of the devices. Twelve (three for each format) laboratory assistants performed the test following the instructions for use. The obtained results were compared to the GC/MS results. The results are summarized below:
Amphetamine
| 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 | 20 | 20 |
| | Negative | 10 | 15 | 14 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 19 | 20 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 18 | 20 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
Discordant Results with Amphetamine Cassette
| Viewer | GC/MS Result | Cassette Viewer Results |
| --- | --- | --- |
| Viewer A | 963 | Positive |
| Viewer B | 1005 | Negative |
| Viewer C | 1005 | Negative |
| Viewer C | 1037 | Negative |
{15}
16
| 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 | 19 | 20 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 18 | 20 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 20 | 20 |
| | Negative | 10 | 15 | 14 | 0 | 0 |
Discordant Results with Amphetamine Panel Dip
| Viewer | GC/MS Result | Panel Dip Viewer Results |
| --- | --- | --- |
| Viewer C | 963 | Positive |
| Viewer A | 1005 | Negative |
| Viewer B | 1005 | Negative |
| Viewer B | 1037 | Negative |
| 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 | 0 | 20 | 20 |
| | Negative | 1 | 15 | 15 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 1 | 15 | 14 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 19 | 20 |
| | Negative | 1 | 15 | 15 | 1 | 0 |
{16}
Discordant Results with Amphetamine Split-Key Cup
| Viewer | GC/MS Result | Split-Key Cup Viewer Results |
| --- | --- | --- |
| Viewer B | 963 | Positive |
| Viewer B | 1005 | Negative |
| Viewer C | 1005 | Negative |
| Easy Cup | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 18 | 20 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 20 | 20 |
| | Negative | 10 | 15 | 13 | 0 | 0 |
Discordant Results with Amphetamine Easy Cup
| Viewer | GC/MS Result | Easy Cup Viewer Results |
| --- | --- | --- |
| Viewer B | 963 | Positive |
| Viewer C | 963 | Positive |
| Viewer C | 952 | Positive |
| Viewer A | 1005 | Negative |
| Viewer A | 1037 | Negative |
| Viewer B | 1005 | Negative |
{17}
18
# Cocaine
| 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 | 20 | 20 |
| | Negative | 10 | 15 | 14 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 20 | 20 |
| | Negative | 10 | 15 | 15 | 0 | 0 |
# Discordant Results with Cocaine Cassette
| Viewer | GC/MS Result | Cassette Viewer Results |
| --- | --- | --- |
| Viewer A | 284 | Positive |
| Viewer B | 284 | Positive |
| Viewer B | 307 | Negative |
{18}
19
| 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 | 2 | 20 | 20 |
| | Negative | 10 | 15 | 13 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 19 | 20 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 19 | 20 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
Discordant Results with Cocaine Panel Dip
| Viewer | GC/MS Result | Panel Dip Viewer Results |
| --- | --- | --- |
| Viewer B | 311 | Negative |
| Viewer C | 311 | Negative |
| Viewer A | 296 | Positive |
| Viewer A | 284 | Positive |
| 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 | 0 | 20 | 20 |
| | Negative | 10 | 15 | 15 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 18 | 20 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 20 | 20 |
| | Negative | 10 | 15 | 14 | 0 | 0 |
{19}
20
Discordant Results with Cocaine Split-Key Cup
| Viewer | GC/MS Result | Split Cup Viewer Results |
| --- | --- | --- |
| Viewer C | 284 | Positive |
| Viewer B | 311 | Negative |
| Viewer B | 307 | Negative |
Discordant Results with Cocaine 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 | 18 | 20 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 19 | 20 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer | Sample Number | GC/MS Result | Easy Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer B | COC45 | 284 | Positive |
| Viewer A | COC35 | 311 | Negative |
| Viewer A | COC66 | 307 | Negative |
| Viewer B | COC66 | 307 | Negative |
| Viewer C | COC35 | 311 | Negative |
{20}
Oxazepam
| 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 | 19 | 20 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 19 | 20 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
Discordant Results with Oxazepam Cassette
| Viewer | GC/MS Result | Cassette Viewer Results |
| --- | --- | --- |
| Viewer B | 291 | Positive |
| Viewer A | 309 | Negative |
| Viewer B | 311 | Negative |
| Viewer C | 308 | Negative |
| Panel Dip | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 20 | 20 |
| | Negative | 10 | 15 | 15 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 20 | 20 |
| | Negative | 10 | 15 | 14 | 0 | 0 |
{21}
Discordant Results with Oxazepam Panel Dip
| Viewer | GC/MS Result | Panel Dip Viewer Results |
| --- | --- | --- |
| Viewer A | 291 | Positive |
| Viewer C | 298 | Positive |
| Viewer A | 308 | Negative |
| Split- Key Cup | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and | 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 | 20 |
| | Negative | 10 | 15 | 14 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 15 | 14 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 19 | 20 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
Discordant Results with Oxazepam Split-Key Cup
| Viewer | GC/MS Result | Split Cup Viewer Results |
| --- | --- | --- |
| Viewer A | 298 | Positive |
| Viewer B | 291 | Positive |
| Viewer A | 311 | Negative |
| Viewer A | 309 | Negative |
| Viewer B | 311 | Negative |
| Viewer B | 323 | Negative |
| Viewer C | 308 | Negative |
{22}
23
| 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 | 1 | 18 | 20 |
| | Negative | 10 | 15 | 14 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 18 | 20 |
| | Negative | 10 | 15 | 13 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 15 | 14 | 1 | 0 |
Discordant Results for Oxazepam Easy Cup
| Viewer | GC/MS result | Easy Cup Viewer Results |
| --- | --- | --- |
| Viewer A | 298 | Positive |
| Viewer B | 298 | Positive |
| Viewer B | 291 | Positive |
| Viewer B | 311 | Negative |
| Viewer A | 308 | Negative |
| Viewer A | 309 | Negative |
| Viewer B | 309 | Negative |
| Viewer C | 291 | Positive |
| Viewer C | 311 | Negative |
b. Matrix comparison:
Not applicable
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 consumer study was performed at three testing sites with a total of 1680 test subjects, with diverse educational backgrounds representative of U.S. demographics. A total of 140 users tested each format of each analyte. The study was performed by spiking drug free urine sample pools with drug at concentrations of 0%, 25%, 50%, 75%, 125%, 150%, and 175% of each drug cutoff. Each participant received one blinded sample, one test device format, and one English language package insert for the device they were to test. The only instructions provided to users were the package inserts for the device being tested. Participants ranged in age from 21 to greater than 50 years of age. None of the participants had experience using drug testing products before.
Each person performed the test and filled out a questionnaire to evaluate the ease of use of the device. All of the users correctly answered the questions on the questionnaire and rated the clarity of the package insert as either "very clear" or "clear". The participant test results were compared to GC/MS results and are summarized below.
Comparison between GC/MS and Lay Person Results for Amphetamine Cassette
| % of Cutoff | Number of samples | d-Amphetamine Concentration by GC/MS (ng/mL) | Lay person results | | Percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 250 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 750 | 0 | 20 | 100 |
| +25% Cutoff | 20 | 1250 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100 |
{24}
Comparison between GC/MS and Lay Person Results for Amphetamine Dip Card
| % of Cutoff | Number of samples | d-Amphetamine Concentration by GC/MS (ng/mL) | Lay person results | | Percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 250 | 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 Amphetamine Split-Key Cup
| % of Cutoff | Number of samples | d-Amphetamine Concentration by GC/MS (ng/mL) | Lay person results | | Percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 250 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 750 | 2 | 18 | 90 |
| +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 Amphetamine Easy Cup
| % of Cutoff | Number of samples | d-Amphetamine Concentration by GC/MS (ng/mL) | Lay person results | | Percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 250 | 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 |
{25}
Comparison between GC/MS and Lay Person Results for Cocaine Cassette
| % of Cutoff | Number of samples | Cocaine Concentration by GC/MS (ng/mL) | Lay person results | | 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 Cocaine Dip Card
| % of Cutoff | Number of samples | Cocaine Concentration by GC/MS (ng/mL) | Lay person results | | 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 Cocaine Split-Key Cup
| % of Cutoff | Number of samples | Cocaine Concentration by GC/MS (ng/mL) | Lay person results | | 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 |
{26}
Comparison between GC/MS and Lay Person Results for Cocaine Easy Cup
| % of Cutoff | Number of samples | Cocaine Concentration by GC/MS (ng/mL) | Lay person results | | 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 Oxazepam Cassette
| % of Cutoff | Number of samples | Oxazepam Concentration by GC/MS (ng/mL) | Lay person results | | 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 | 0 | 20 | 100 |
| +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 Oxazepam Dip Card
| % of Cutoff | Number of samples | Oxazepam Concentration by GC/MS (ng/mL) | Lay person results | | 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 | 20 | 0 | 100 |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100 |
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Comparison between GC/MS and Lay Person Results for Oxazepam Split-Key Cup
| % of Cutoff | Number of samples | Oxazepam Concentration by GC/MS (ng/mL) | Lay person results | | 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 |
Comparison between GC/MS and Lay Person Results for Oxazepam Easy Cup
| % of Cutoff | Number of samples | Oxazepam Concentration by GC/MS (ng/mL) | Lay person results | | 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 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 525 | 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.
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R. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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