AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)
Device Facts
| Record ID | K153465 |
|---|---|
| Device Name | AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) |
| Applicant | Assure Tech. (Hangzhou) Co, Ltd. |
| Product Code | DKZ · Clinical Toxicology |
| Decision Date | Mar 31, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K153465 · Mar 31, 2016 | AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) | Assure Tech. (Hangzhou) Co, Ltd. | Clinical urine samples | Retrospective clinical urine samples were used to perform method comparison studies against GC/MS to validate the performance of the AssureTech drug tests. | Method comparison; Clinical samples; GC/MS comparison |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Method comparison study; Retrospective method comparison | Clinical urine samples; Sample Size: 80 samples per device; Number of Sites: In-house | GC/MS | Qualitative detection of d-Amphetamine, Benzoylecgonine, and Morphine |
Indications for Use
AssureTech Amphetamine Tests are immunochromatographic assays for the qualitative determination of d-Amphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Strip format, a Dip Card format and a Turn Key Split Cup format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. AssureTech Cocaine Tests are immunochromatographic assays for the qualitative determination of Benzoylecgonine in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Strip format, a Dip Card format and a Turn Key Split Cup format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. AssureTech Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 2000 ng/mL. The tests are available in a Strip format, a Dip Card format and a Turn Key Split Cup format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
Device Story
Lateral flow immunochromatographic assays for qualitative detection of d-Amphetamine, Benzoylecgonine, and Morphine in human urine; competitive binding principle using monoclonal mouse antibodies. Urine sample migrates via capillary action; target drugs below cut-off allow antibody-coated particles to bind immobilized drug-conjugate, forming visible test line. Drug presence above cut-off saturates binding sites, preventing test line formation. Control line indicates proper test performance. Available in strip, dip card, and split cup formats. Used by lay users (OTC) or clinicians (prescription) for preliminary drug screening. Positive results require confirmatory testing via GC/MS. Benefits include rapid, preliminary screening for drug abuse.
Clinical Evidence
Bench testing only. Precision/reproducibility studies conducted with 3 operators, 3 lots, over 25 days (n=50 per concentration). Analytical specificity tested against numerous endogenous/exogenous compounds. Method comparison performed against GC/MS using 80 clinical samples per device. Lay-user study conducted with 1638 participants across 3 sites, demonstrating high concordance with GC/MS results across various concentrations relative to cutoff. No clinical studies performed.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Materials: monoclonal mouse antibodies, immobilized drug-conjugate. Formats: strip, dip card, cup, turn-key split cup. Connectivity: none (standalone). Sterilization: not specified. Software: none.
Indications for Use
Indicated for qualitative detection of d-Amphetamine (1000 ng/mL), Benzoylecgonine (300 ng/mL), or Morphine (2000 ng/mL) in human urine. Intended for OTC and prescription use. Provides preliminary results; requires confirmation by GC/MS.
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 Chemtrue® Multi-Panel Drug Screen Dip Card Tests (K142396)
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION MEMORANDUM
ASSAY ONLY TEMPLATE
A. 510(k) Number:
K153465
B. Purpose for Submission:
New Device
C. Measurand:
Amphetamine, Cocaine, Morphine
D. Type of Test:
Qualitative immunochromatographic assay
E. Applicant:
Assure Tech. Co., Ltd.
F. Proprietary and Established Names:
Assure Tech Amphetamine Tests
Assure Tech Cocaine Tests
Assure Tech Morphine Tests
G. Regulatory Information:
1. Regulation section:
21 CFR, 862.3100 Amphetamine Test System
21 CFR, 862.3250 Cocaine Test System
21 CFR, 862.3640 Morphine Test System
2. Classification:
Class II
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3. Product code:
DKZ, DIO, DJG
4. Panel:
91, Toxicology
H. Intended Use:
1. Intended use(s):
See Indications for Use below.
2. Indication(s) for use:
AssureTech Amphetamine Tests are immunochromatographic assays for the qualitative determination of d-Amphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
AssureTech Cocaine Tests are immunochromatographic assays for the qualitative determination of Benzoylecgonine in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
AssureTech Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 2000 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
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3. Special conditions for use statement(s):
For Prescription and Over-the-counter use
4. Special instrument requirements:
Not applicable; this is a visually read single use device.
I. Device Description:
The Assure Tech Amphetamine Test is for the qualitative determination of d-Amphetamine in human urine.
The device has four formats – Strip, Dip Card, Quick Cup, Turn-Key Split Cup:
- The Strip comprises two items, a urine collection cup and a test strip with sample pad with a lateral flow.
- The Dip Card comprises two items, a urine collection cup and the dip card with a plastic casing as the lateral flow device.
- The Quick Cup comprises 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 comprises 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°.
The Assure Tech Cocaine Test is for the qualitative determination of Benzoylecgonine in human urine.
The device has four formats – Strip, Dip Card, Quick Cup, turn-key Split Cup:
- The Strip comprises two items, a urine collection cup and a test strip with sample pad with a lateral flow device.
- The Dip Card comprises two items, a urine collection cup and the dip card with a plastic casing as the lateral flow device.
- The Quick Cup comprises 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 comprises 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 1800.
The Assure Tech Morphine Test is for the qualitative determination of Morphine in human urine.
The device has four formats – Strip, Dip Card, Quick Cup, turn-key Split Cup:
- The Strip comprises two items, a urine collection cup and a test strip with sample pad with a lateral flow device.
- The Dip Card comprises two items, a urine collection cup and the dip card with a plastic casing as the lateral flow device.
- The Quick Cup comprises 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 comprises a urine collection cup and a turn-key Split Cup test
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with a lateral flow device that will start the test when the cap is screwed onto cup and key is turned 180°.
All devices are single-use and visually read.
## J. Substantial Equivalence Information:
1. Predicate device name(s):
Chemtrue® BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests
Chemtrue® Multi-Panel Drug Screen Dip Card Tests
Chemtrue® Multi-Panel Drug Screen Dip Card with OPI 2000 Tests
2. Predicate 510(k) number(s):
k142396
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device k153465 | Predicate device k142396 |
| Indication(s) for Use | For the qualitative determination of drugs of abuse in human urine | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen | Human Urine | Same |
| Cut-Off Values | Amphetamine: 1000 ng/mL
Cocaine: 300 ng/mL
Morphine: 2000 ng/mL | Same
Same
Same |
| Intended Use | Over-the-counter and prescription use. | Same |
| Differences | | |
| --- | --- | --- |
| Item | Candidate Device k153465 | Predicate device k142396 |
| Configurations | Strip, Dip Card, Quick Cup Turn-Key Split Cup | Dip Card |
| Calibrator | d-Amphetamine
Benzoylecgonine
Morphine | Amphetamine, Cocaine, Marijuana, Morphine, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants |
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K. Standard/Guidance Document Referenced (if applicable):
None referenced
L. Test Principle:
The AssureTech Amphetamine Tests, AssureTech Cocaine Tests, and AssureTech Morphine Tests are rapid tests for the qualitative detection of d-Amphetamine, Benzoylecgonine and Morphine in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If a target drug is 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 onto 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 and no binding sites will be available to allow the antibody coated particles to bind to the immobilized drug conjugate. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Precision studies were carried out for samples with concentrations of -100%, -75%, -50%, -25%, cutoff, +25%, +50%, +75% and +100% cut off. These samples were prepared by spiking drug into negative urine samples. Each drug concentration was confirmed by GC/MS. These studies were conducted by 3 operators with 3 lots of each device in two runs per day for 25 days (n=50). The results obtained are summarized in the following tables.
Amphetamine:
Assure Tech Amphetamine Strip
| Lot # | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 38+/12- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 39+/11- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 41+/9- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Assure Tech Amphetamine Dip Card
| Lot # | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 39+/11- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 37+/13- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 40+/10- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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Assure Tech Amphetamine Quick Cup
| Lot # | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 37+/13- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 39+/11- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 39+/11- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Assure Tech Amphetamine Turn Key Split Cup
| Lot # | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 39+/11- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 39+/11- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 39+/11- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
# Cocaine:
Assure Tech Cocaine Strip
| Lot # | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 38+/12- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 40+/10- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 39+/11- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Assure Tech Cocaine Dip Card
| Lot # | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 39+/11- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 42+/8- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 39+/11- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Assure Tech Cocaine Quick Cup
| Lot # | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 38+/12- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 41+/9- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 37+/13- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Assure Tech Cocaine Turn Key Split Cup
| Lot # | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 39+/11- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 38+/12- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 39+/11- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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# Morphine:
## AssureTech Morphine Strip
| Lot # | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 41+/9- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 40+/10- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 40+/10- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
## Assure Tech Morphine Dip Card
| Lot # | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 39+/11- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 40+/10- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 40+/10- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
## Assure Tech Morphine Quick Cup
| Lot # | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 39+/11- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 40+/10- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 41+/9- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
## Assure Tech Morphine Turn Key Split Cup
| Lot # | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 39+/11- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 41+/9- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 38+/12- | 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 2-30 °C for 24 months.
## d. Detection limit:
Not applicable.
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# e. Analytical specificity:
The potential effect of endogenous and exogenous interferents was tested by spiking the interferents into drug-free urine and target drug(s) urine with concentrations at $25\%$ below and $25\%$ above the cut-off levels by using 3 lots and 3 operators for each format. Compounds that showed no positive or negative interference at a concentration of $100~\mu \mathrm{g / mL}$ are summarized in the following tables. There were no differences observed for different devices.
Amphetamine:
| 4-Acetamidophenol | L-Ephedrine | Oxycodone |
| --- | --- | --- |
| Acetophenetidin | (-) Y Ephedrine | Oxymetazoline |
| N-Acetylprocainamide | Erythromycin | Papaverine |
| Acetylsalicylic acid | β-Estradiol | Penicillin-G |
| Aminopyrine | Estrone-3-sulfate | Pentazocaine |
| Amitryptyline | Ethyl-p-aminobenzoate | Pentobarbital |
| Amobarbital | Fenfluramine | Perphenazine |
| Amoxicillin | Fenoprofen | Phencyclidine |
| Ampicillin | Furosemide | Phenelzine |
| Ascorbic acid | Gentisic acid | Phenobarbital |
| Aspartame | Hemoglobin | Phenytoin |
| Atropine | Hydralazine | L-Phenylephrine |
| Benzilic acid | Hydrochlorothiazide | Phenylpropanolamine |
| Benzoic acid | Hydrocodone | Prednisolone |
| Benzoylecgonine | Hydrocortisone | Prednisone |
| Bilirubin | O-Hydroxyhippuric acid | Procaine |
| Brompheniramine | 3-Hydroxytyramine | Promazine |
| Caffeine | Ibuprofen | Promethazine |
| Cannabidiol | Imipramine | D,L-Propanolol |
| Cannabinol | (-) Isoproterenol | D-Propoxyphene |
| Chloralhydrate | Isoxsuprine | Quinidine |
| Chloramphenicol | Ketamine | Quinine |
| Chlordiazepoxide | Ketoprofen | Ranitidine |
| Chlorothiazide | Labetalol | Salicylic acid |
| (±) Chlorpheniramine | Levorphanol | Secobarbital |
| Chlorpromazine | Loperamide | Sulfamethazine |
| Chloroquine | Maprotiline | Sulindac |
| Cholesterol | Meperidine | Temazepam |
| Clomipramine | Meprobamate | Tetracycline |
| Clonidine | Methadone | Tetrahydrocortisone |
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| Cocaine | Methylphenidate | Tetrahydrozoline |
| --- | --- | --- |
| Codeine | Morphine-3-Dglucuronide | Δ9-THC-COOH |
| Cortisone | Nalidixic acid | Thebaine |
| (-) Cotinine | Naloxone | Thiamine |
| Creatinine | Naltrexone | Thioridazine |
| Deoxycorticosterone | Naproxen | D,L-Thyroxine |
| Dextromethorphan | Niacinamide | Tolbutamide |
| Diazepam | Nifedipine | Triamterene |
| Diclofenac | Norcodein | Trifluoperazine |
| Diflunisal | Norethindrone | Trimethoprim |
| Digoxin | D-Norpropoxyphene | Trimipramine |
| Diphenhydramine | Noscapine | Tryptamine |
| Doxylamine | D,L-Octopamine | D, L-Tyrosine |
| Ecgonine | Oxalic acid | Uric acid |
| Ecgonine methylester | Oxazepam | Verapamil |
| (IR,2S)-(-)-Ephedrine | Oxolinic acid | Zomepirac |
Cocaine
| Acetaminophen | Estrone-3-sulfate | Oxymetazoline |
| --- | --- | --- |
| Acetophenetidin | Ethyl-p-aminobenzoate | Papaverine |
| N-Acetylprocainamide | Fenoprofen | Penicillin-G |
| Acetylsalicylic acid | Furosemide | Pentobarbital |
| Aminopyrine | Gentisic acid | Perphenazine |
| Amitryptyline | Hemoglobin | Phencyclidine |
| Amobarbital | Hydralazine | Phenelzine |
| Amoxicillin | Hydrochlorothiazide | Phenobarbital |
| Ampicillin | Hydrocodone | Phentermine |
| L-Ascorbic acid | Hydrocortisone | L-Phenylephrine |
| DL-Amphetamine Sulfate | O-Hydroxyhippuric acid | β-Phenylethylamine |
| Apomorphine | p-Hydroxymethamphetamine | Phenylpropanolamine |
| Aspartame | 3-Hydroxytyramine | Prednisolone |
| Atropine | Ibuprofen | Prednisone |
| Benzilic acid | Imipramine | Procaine |
| Benzoic acid | Iproniazid | Promazine |
| Benzphetamine | (±) - Isoproterenol | Promethazine |
{9}
| (±) - Brompheniramine | Isoxsuprine | DL-Propranolol |
| --- | --- | --- |
| Caffeine | Ketamine | D-Propoxyphene |
| Cannabidiol | Ketoprofen | D-Pseudoephedrine |
| Cannabinol | Labetalol | Quinidine |
| Chloralhydrate | Levorphanol | Quinine |
| Chloramphenicol | Loperamide | Ranitidine |
| Chlordiazepoxide | Maprotiline | Salicylic acid |
| Chlorothiazide | Meperidine | Secobarbital |
| (±) - Chlorpheniramine | Meprobamate | Serotonin |
| Chlorpromazine | Methadone | Sulfamethazine |
| Chloroquine | Methoxyphenamine | Sulindac |
| Cholesterol | 3,4-Methylene dioxyamphetamine | Temazepam |
| Clomipramine | 3,4-Methylene-dioxymethamphetamine | Tetrahydrocortisone 3-(β-D glucuronide) |
| Clonidine | Morphine-3-β-D glucuronide | Tetracycline |
| Codeine | Morphine Sulfate | Tetrahydrozoline |
| Cortisone | Nalidixic acid | Thebaine |
| (-) Cotinine | Naloxone | Thiamine |
| Creatinine | Naltrexone | Thioridazine |
| Deoxycorticosterone | Naproxen | DL-Tyrosine |
| Dextromethorphan | Niacinamide | Tolbutamide |
| Diazepam | Nifedipine | Triamterene |
| Diclofenac | Norcodein | Trifluoperazine |
| Diflunisal | Norethindrone | Trimethoprim |
| Digoxin | D-Norpropoxyphene | Trimipramine |
| Diphenhydramine | Noscapine | Tryptamine |
| Doxylamine | DL-Octopamine | DL-Tryptophan |
| Ecgonine methylester | Oxalic acid | Tyramine |
| (-) - Ψ-Ephedrine | Oxazepam | Uric acid |
| Erythromycin | Oxolinic acid | Verapamil |
| β-Estradiol | Oxycodone | Zomepirac |
{10}
Morphine
| Acebutolol | L -Ψ-Ephedrine | Papaverine |
| --- | --- | --- |
| Acetopromazined-6 | Erythromycin | Penicillin G |
| Acetamidophenol | β-Estradiol | Pentazocine |
| Acetophenetidin | Estrone-3-sulfate | Pentobarbital |
| Acetylprocainamide | Ethyl-p-aminobenzoate | Perphenazine |
| Acetylsalicylic acid | Fenoprofen | Phencyclidine |
| Aminopyrine | Furosemide | Phenelzine |
| Amitryptyline | Gentisic acid | Phenobarbital |
| Amobarbital | Hemoglobin | Phentermine |
| Amoxicillin | Hydralazine | L-Phenylephrine |
| Ampicillin | Hydrochlorothiazide | β-Phenethylamine |
| Ascorbic acid | Hydrocortisone | Phenylpropanolamine |
| D/L-Amphetamine | α-Hydroxyhippuric acid | Prednisolone |
| L-Amphetamine | 3-Hydroxytyramine | Prednisone |
| Apomorphine | Ibuprofen | Promazine |
| Aspartame | Imipramine | Promethazine |
| Atropine | Iproniazid | D/L-Propranolol |
| Benzilic acid | (+/-)-Isoproterenol | D-Propoxyphene |
| Benzoic acid | Isoxsuprine | D-Pseudoephedrine |
| Benzoylecgonine | Ketamine | Quinidine |
| Benzphetamine | Ketoprofen | Quinine |
| Bilirubin | Labetalol | Ranitidine |
| Brompheniramine | Loperamide | Salicylic acid |
| Caffeine | Maprotiline | Secobarbital |
| Chloralhydrate | Meprobamate | Serotonin (5-Hydroxytyramine) |
| Chloramphenicol | Methadone | Sulfamethazine |
| Chlordiazepoxide | Methoxyphenamine | Sulindac |
| Chlorothiazide | 3,4Methylenedioxyamphetamine | Temazepam |
| Chlorpheniramine | 3,4Methylenedioxymethamphetamine | Tetracycline |
| Chlorpromazine | Methylphenidate | Tetrahydrocortisone |
| Chloroquine | Methyprylon | Tetrahydrocortisone 3 (β-D-glucuronide) |
| Cholesterol | Nalorphine | Tetrahydrozoline |
| Clomipramine | Naloxone | Thiamine |
11
{11}
To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound is listed below. There were no differences observed for different devices. Results are summarized below:
| Amphetamine (Cut-off=1000 ng/mL) | Result Positive at (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| D - Amphetamine | 1000 | 100% |
| L - Amphetamine | 20000 | 5% |
| D,L - Amphetamine | 3000 | 33% |
| Phentermine | 30000 | 3.3% |
| Hydroxyamphetamine | 8000 | 12.5% |
| Methylenedioxyamphetamine (MDA) | 20000 | 5% |
| d-Methamphetamine | Negative at 100000 | <1% |
| 1-Methamphetamine | Negative at 100000 | <1% |
| ephedrine | Negative at 100000 | <1% |
| Methylenedioxyethylamphetamine (MDE) | Negative at 100000 | <1% |
| 3,4-methylenedioxy-methamphetamine (MDMA) | Negative at 100000 | <1% |
| D - Methylenedioxyamphetamine (MDMA) | Negative at 100000 | <1% |
| D,L - Methylenedioxyamphetamine (MDMA) | Negative at 100000 | <1% |
{12}
| Cocaine (Cut-off=300 ng/mL) | Result Positive at (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Benzoylecgonine | 300 | 100% |
| Cocaine HCl | 750 | 40% |
| Cocaethylene | 12500 | 2.4% |
| Ecgonine | 32000 | 0.9% |
| Norcocaine | 100000 | 0.3% |
| Morphine (Cut-off=2000 ng/mL) | Result Positive at(ng/mL) | %Cross-Reactivity |
| --- | --- | --- |
| Morphine | 2000 | 100% |
| Acetylmorphine | 2500 | 80% |
| Codeine | 1000 | 200% |
| Ethyl Morphine | 250 | 800% |
| Heroin | 5000 | 40% |
| Hydromorphone | 2500 | 80% |
| Hydrocodone | 5000 | 40% |
| Thebaine | 13000 | 15.4% |
| Morphine-3-β-glucuronide | Negative at 200000 | <1% |
| Oxycodone | Negative at 400000 | <0.5% |
| Oxymorphine | Negative at 400000 | <0.5% |
| Procaine | Negative at 400000 | <0.5% |
| Levorphanol | Negative at 400000 | <0.5% |
To investigate the effect of urine specific gravity and urine pH, urine samples with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above 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 formats.
f. Assay cut-off:
Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision/reproducibility section above.
2. Comparison studies:
a. Method comparison with predicate device:
Method comparison studies for the AssureTech Amphetamine Tests, the AssureTech Cocaine Tests and the AssureTech Morphine Tests were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to
{13}
GC/MS results. The results are presented in the tables below:
## Amphetamine Strip:
| Strip | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer 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 | 13 | 25 |
| | Negative | 10 | 20 | 9 | 2 | 0 |
## Discordant Results of Amphetamine Strip:
| Viewer | Sample Number | GC/MS Result | Strip Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 78081 | 984 | Positive |
| Viewer B | 78081 | 984 | Positive |
| Viewer C | 78081 | 984 | Positive |
| Viewer A | 72430 | 1083 | Negative |
| Viewer B | 79915 | 1024 | Negative |
| Viewer C | 79915 | 1024 | Negative |
| Viewer C | 72430 | 1083 | Negative |
## Amphetamine Dip Card:
| Dip Card | | 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 |
{14}
15
Discordant Results of Amphetamine Dip Card:
| Viewer | Sample Number | GC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer B | 78081 | 984 | Positive |
| Viewer A | 79915 | 1024 | Negative |
| Viewer C | 79915 | 1024 | Negative |
Amphetamine Turn Key Split Cup:
| Turn-Key Split 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 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 13 | 25 |
| | Negative | 10 | 20 | 9 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
Discordant Results of Amphetamine Turn-Key Split Cup:
| Viewer | Sample Number | GC/MS Result | Turn-Key Split Cup |
| --- | --- | --- | --- |
| Viewer A | 78081 | 984 | Positive |
| Viewer B | 78081 | 984 | Positive |
| Viewer A | 79915 | 1024 | Negative |
| Viewer B | 79915 | 1024 | Negative |
| Viewer B | 79915 | 1024 | Negative |
| Viewer C | 87184 | 1257 | Negative |
{15}
16
Amphetamine Quick Cup:
| Quick 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 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 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 |
Discordant Results of Amphetamine Quick Cup:
| Viewer | Sample Number | GC/MS Result | Quick Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer B | 78081 | 984 | Positive |
| Viewer A | 79915 | 1024 | Negative |
| Viewer B | 79915 | 1024 | Negative |
Cocaine Strip:
| Strip | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 15 | 25 |
| | Negative | 10 | 20 | 8 | 0 | 0 |
{16}
17
# Discordant Results of Cocaine Strip:
| Viewer | Sample Number | GC/MS Result | Strip Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 38238 | 285 | Positive |
| Viewer C | 58356 | 280 | Positive |
| Viewer C | 38238 | 285 | Positive |
| Viewer B | 71282 | 312 | Negative |
# Cocaine Dip Card:
| Dip Card | | 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 | 15 | 25 |
| | Negative | 10 | 20 | 8 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 20 | 10 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 13 | 25 |
| | Negative | 10 | 20 | 9 | 2 | 0 |
# Discordant Results of Cocaine Dip Card:
| Viewer | Sample Number | GC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 38238 | 285 | Positive |
| Viewer A | 58356 | 280 | Positive |
| Viewer C | 38238 | 285 | Positive |
| Viewer C | 71282 | 312 | Negative |
| Viewer C | 35525 | 317 | Negative |
{17}
18
# Cocaine Turn Key Split Cup:
| Turn-Key Split Cup | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 2 | 15 | 25 |
| | Negative | 10 | 20 | 8 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
# Discordant Results of Cocaine Turn-Key Split Cup:
| Viewer | Sample Number | GC/MS Result | Split Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 38238 | 285 | Positive |
| Viewer A | 58356 | 280 | Positive |
| Viewer B | 71282 | 312 | Negative |
| Viewer C | 35525 | 317 | Negative |
# Cocaine Quick Cup:
| Quick 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 | 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 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
{18}
19
# Discordant Results of Cocaine Quick Cup
| Viewer | Sample Number | GC/MS Result | Quick Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 38238 | 285 | Positive |
| Viewer B | 38238 | 285 | Positive |
| Viewer C | 63906 | 225 | Positive |
| Viewer B | 71282 | 312 | Negative |
| Viewer C | 71282 | 312 | Negative |
# Morphine Strip:
| Strip | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 20 | 10 | 0 | 0 |
# Discordant Results of Morphine Strip
| Viewer | Sample Number | GC/MS Result | Strip Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 91558 | 1890 | Positive |
| Viewer B | 99379 | 1917 | Positive |
| Viewer A | 65159 | 2231 | Negative |
{19}
20
Morphine Turn Dip Card:
| Dip Card | | 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 | 15 | 25 |
| | Negative | 10 | 20 | 8 | 0 | 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 |
Discordant Results of Morphine Dip Card:
| Viewer | Sample Number | GC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 99379 | 1917 | Positive |
| Viewer A | 91558 | 1890 | Positive |
| Viewer B | 91558 | 1890 | Positive |
| Viewer B | 62657 | 2115 | Negative |
| Viewer C | 59704 | 2022 | Negative |
Morphine Turn Key Split Cup:
| Turn-Key Split 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 | 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 |
{20}
21
Discordant Results of Morphine Turn-Key Split Cup
| Viewer | Sample Number | GC/MS Result | Split Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 99379 | 1917 | Positive |
| Viewer B | 49390 | 1856 | Positive |
| Viewer C | 91558 | 1890 | Positive |
| Viewer A | 65159 | 2231 | Negative |
| Viewer B | 62657 | 2115 | Negative |
Morphine Quick Cup:
| Quick Cup | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 2 | 14 | 25 |
| | Negative | 10 | 20 | 8 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
Discordant Results of Morphine Quick Cup
| Viewer | Sample Number | GC/MS Result | Quick Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 99379 | 1917 | Positive |
| Viewer A | 91558 | 1890 | Positive |
| Viewer B | 91558 | 1890 | Positive |
| Viewer C | 91558 | 1890 | Positive |
| Viewer A | 65159 | 2231 | Negative |
| Viewer B | 59704 | 2022 | Negative |
| Viewer C | 65159 | 2231 | Negative |
Lay-user study:
A lay user study was performed at three intended user sites with 1638 lay persons. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to >50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled.
{21}
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 Result for Amphetamine (AMP)/Cocaine (COC)/Morphine (MOR) Strip
| % Cutoff | N | Concentration by GC/MS(ng/mL) | | | Lay person results | | | Correct results (%) | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | AMP | COC | MOR | AMP | COC | MOR | AMP | COC | MOR |
| -100% | 21 | 0 | 0 | 0 | 0+/21- | 0+/21- | 0+/21- | 100 | 100 | 100 |
| -75% | 21 | 252 | 70 | 514 | 0+/21- | 0+/21- | 0+/21- | 100 | 100 | 100 |
| -50% | 21 | 506 | 165 | 982 | 0+/21- | 0+/21- | 0+/21- | 100 | 100 | 100 |
| -25% | 21 | 749 | 255 | 1487 | 1+/20- | 1+/20- | 2+/19- | 95 | 95 | 90 |
| +25% | 21 | 1253 | 384 | 2479 | 20+/1- | 21+/0- | 20+/1- | 95 | 100 | 95 |
| +50% | 21 | 1504 | 459 | 3011 | 21+/0- | 21+/0- | 21+/0- | 100 | 100 | 100 |
| +75% | 21 | 1755 | 517 | 3518 | 21+/0- | 21+/0- | 21+/0- | 100 | 100 | 100 |
Comparison between GC/MS and Lay Person Result for Amphetamine (AMP)/Cocaine (COC)/Morphine (MOR) Dip Card
| % Cutoff | N | Concentration by GC/MS(ng/mL) | | | Lay person results | | | Correct results (%) | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | AMP | COC | MOR | AMP | COC | MOR | AMP | COC | MOR |
| -100% | 21 | 0 | 0 | 0 | 0+/21- | 0+/21- | 0+/21- | 100 | 100 | 100 |
| -75% | 21 | 252 | 70 | 514 | 0+/21- | 0+/21- | 0+/21- | 100 | 100 | 100 |
| -50% | 21 | 506 | 165 | 982 | 0+/21- | 0+/21- | 0+/21- | 100 | 100 | 100 |
| -25% | 21 | 749 | 255 | 1487 | 1+/20- | 1+/20- | 2+/19- | 95 | 95 | 90 |
| +25% | 21 | 1253 | 384 | 2479 | 20+/1- | 20+/1- | 21+/0- | 95 | 95 | 100 |
| +50% | 21 | 1504 | 459 | 3011 | 21+/0- | 21+/0- | 21+/0- | 100 | 100 | 100 |
| +75% | 21 | 1755 | 517 | 3518 | 21+/0- | 21+/0- | 21+/0- | 100 | 100 | 100 |
Comparison between GC/MS and Lay Person Result for Amphetamine (AMP)/Cocaine (COC)/Morphine (MOR) Quick Cup
| % Cutoff | N | Concentration by GC/MS(ng/mL) | | | Lay person results | | | Correct results (%) | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | AMP | COC | MOR | AMP | COC | MOR | AMP | COC | MOR |
| -100% | 21 | 0 | 0 | 0 | 0+/21- | 0+/21- | 0+/21- | 100 | 100 | 100 |
| -75% | 21 | 252 | 70 | 514 | 0+/21- | 0+/21- | 0+/21- | 100 | 100 | 100 |
| -50% | 21 | 506 | 165 | 982 | 0+/21- | 0+/21- | 0+/21- | 100 | 100 | 100 |
| -25% | 21 | 749 | 255 | 1487 | 2+/19- | 1+/20- | 1+/20- | 90 | 95 | 90 |
| +25% | 21 | 1253 | 384 | 2479 | 20+/1- | 20+/1- | 21+/0- | 95 | 95 | 100 |
| +50% | 21 | 1504 | 459 | 3011 | 21+/0- | 21+/0- | 21+/0- | 100 | 100 | 100 |
| +75% | 21 | 1755 | 517 | 3518 | 21+/0- | 21+/0- | 21+/0- | 100 | 100 | 100 |
{22}
Comparison between GC/MS and Lay Person Result for Amphetamine (AMP)/Cocaine (COC)/Morphine (MOR) Turn-Key Split Cup
| % Cutoff | N | Concentration by GC/MS(ng/mL) | | | Lay person results | | | Correct results (%) | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | AMP | COC | MOR | AMP | COC | MOR | AMP | COC | MOR |
| -100% | 21 | 0 | 0 | 0 | 0+/21- | 0+/21- | 0+/21- | 100 | 100 | 100 |
| -75% | 21 | 252 | 70 | 514 | 0+/21- | 0+/21- | 0+/21- | 100 | 100 | 100 |
| -50% | 21 | 506 | 165 | 982 | 0+/21- | 0+/21- | 0+/21- | 100 | 100 | 100 |
| -25% | 21 | 749 | 255 | 1487 | 0+/21- | 0+/21- | 0+/21- | 100 | 95 | 100 |
| +25% | 21 | 1253 | 384 | 2479 | 19+/2- | 19+/2- | 19+/2- | 90 | 90 | 95 |
| +50% | 21 | 1504 | 459 | 3011 | 21+/0- | 21+/0- | 21+/0- | 100 | 100 | 100 |
| +75% | 21 | 1755 | 517 | 3518 | 21+/0- | 21+/0- | 21+/0- | 100 | 100 | 100 |
All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.
b. Matrix comparison:
Not applicable
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data:
Not applicable
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
Not applicable
{23}
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.
24
