AssureTech Panel Dip Test, AssureTech Quick Cup Test
Device Facts
| Record ID | K170049 |
|---|---|
| Device Name | AssureTech Panel Dip Test, AssureTech Quick Cup Test |
| Applicant | Assure Tech. (Hangzhou) Co, Ltd. |
| Product Code | NFT · Clinical Toxicology |
| Decision Date | May 2, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Indications for Use
AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone in human urine at the cutoff concentrations of: Drug(Identifier) Cut-off level Amphetamine 1000 ng/mL Oxazepam 300 ng/mL Cocaine 300 ng/mL Marijuana 50 ng/mL Methamphetamine 1000 ng/mL Morphine 300 ng/mL or 2000 ng/mL Oxycodone 100 ng/mL Secobarbital 300 ng/mL Buprenorphine 10 ng/mL Methylenedioxy-methamphetamine 500 ng/mL Phencyclidine 25 ng/mL Methadone 300 ng/mL Configuration of the AssureTech Panel Dip Tests and the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. These tests are intended for over-the counter and for prescription use.
Device Story
Lateral flow immunochromatographic assays for qualitative detection of drugs of abuse in human urine; competitive binding principle. Device formats: dip card (with collection cup) or quick cup (integrated test). User collects urine; device detects target analytes via monoclonal antibody-coated particles. If drug concentration is below cutoff, antibody binding sites remain available to bind immobilized drug-conjugate, forming visible test line. If drug concentration exceeds cutoff, binding sites are saturated, preventing test line formation. Control line confirms proper test performance. Used in clinical or home settings; operated by healthcare professionals or lay users. Results are preliminary; positive results require confirmation via GC/MS or LC/MS. Assists in identifying potential drug use; clinical judgment required for interpretation.
Clinical Evidence
Bench testing only. Precision/reproducibility studies performed over 25 days using spiked urine samples confirmed by LC/MS. Analytical specificity and cross-reactivity evaluated for various metabolites. Lay-user study conducted with 280 participants per format (Panel Dip and Quick Cup) across diverse demographics; results showed high concordance with LC/MS across all drug analytes. No clinical studies required for this qualitative screening assay.
Technological Characteristics
Lateral flow immunochromatographic assay. Components: urine collection cup, dip card/quick cup plastic casing. Principle: competitive binding with monoclonal mouse antibodies on gold particles. Qualitative visual readout. No instrumentation required. Stable at 4-30°C for 24 months.
Indications for Use
Indicated for qualitative, simultaneous detection of drugs of abuse (Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, MDMA, Phencyclidine, Methadone) in human urine. Intended for OTC and prescription use. Not intended to distinguish between prescription use and abuse.
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)
Related Devices
- K181790 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup · Hangzhou Clongene Biotech Co., Ltd. · Jul 26, 2018
- K182654 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card · Safecare Biotech (Hangzhou) Co., Ltd. · Nov 19, 2018
- K180878 — BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx · Shanghai Venture Bio-Tech Co., Ltd. · Dec 17, 2018
- K182530 — BIOEASY Multi-Drug Test Cup · Shenzhen Bioeasy Biotechnology Co., Ltd. · Nov 9, 2018
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k170049
B. Purpose for Submission:
Addition of oxazepam, methylenedioxymethamphetamine, and morphine (300 ng/mL cut-off) to a previously cleared device
C. Measurand:
Amphetamine, Marijuana, Cocaine, Methamphetamine, Morphine, Oxazepam, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Methadone
D. Type of Test:
Qualitative immunochromatographic assay
E. Applicant:
Assure Tech. Co, Ltd.
F. Proprietary and Established Names:
AssureTech Panel Dip Tests
AssureTech Quick Cup Tests
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NFT | II | 21 CFR 862.3100, Amphetamine Test System | Toxicology (91) |
| NFW | II | 21 CFR 862.3870, Cannabinoids Test System | Toxicology (91) |
| NFY | II | 21 CFR 862.3250, Cocaine and Cocaine Metabolites Test System | Toxicology (91) |
| NGG | II | 21 CFR 862.3610, Methamphetamine Test System | Toxicology (91) |
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| NFV | II | 21 CFR 862.3170, Benzodiazepine Test System | Toxicology (91) |
| --- | --- | --- | --- |
| PTH | II | 21 CFR 862.3150, Barbiturate Test System | Toxicology (91) |
| NGL | II | 21 CFR 862.3650, Opiate Test System | Toxicology (91) |
| NGM | unclassified | Enzyme Immunoassay Phencyclidine | Toxicology (91) |
| PTG | II | 21 CFR 862.3620, Methadone Test System | Toxicology (91) |
## H. Intended Use:
1. Intended use(s):
See Indications for Use below.
2. Indication(s) for use:
AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
| --- | --- |
| Amphetamine | 1000 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Marijuana | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Morphine | 300 ng/mL or 2000 ng/mL |
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxy-methamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
| Methadone | 300 ng/mL |
Configuration of the AssureTech Panel Dip Tests and the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and
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professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
These tests are intended for over-the counter and for prescription use.
3. Special conditions for use statement(s):
For prescription or over-the-counter use.
4. Special instrument requirements:
Not applicable; this is a visually read single use device.
I. Device Description:
The AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine and Methadone (target analytes) in human urine. The tests are the first step in a two-step process.
The AssureTech Panel Dip Tests comprise two items, a urine collection cup and the dip card with a plastic casing as the lateral flow device. The AssureTech Quick Cup Tests comprise a urine collection cup and a quick cup test with a lateral flow device that will start when the cap is screwed onto cup.
J. Substantial Equivalence Information:
1. Predicate device name(s):
The Chemtrue® Multi-Panel Drug Screen Dip Card Tests
2. Predicate 510(k) number(s):
k142396
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3. Comparison with predicate:
| Item | Candidate Devices: AssureTech Panel Dip Tests and Assure Tech Quick Cup Tests | Chemtru Multi-Panel Drug Screen Dip Card k142396 |
| --- | --- | --- |
| Indication(s) for Use | For the qualitative determination of drugs of abuse in human urine. | Same |
| Analyte and Cut-Off Values | Amphetamine (AMP): 1,000 ng/ml
Oxazepam (BZO): 300 ng/ml
Cocaine (COC): 300 ng/ml
Marijuana (THC): 50 ng/ml
Methamphetamine (MET): 1,000 ng/ml
Morphine (MOR): 300ng/mL or 2000 ng/ml
Oxycodone (OXY): 100 ng/ml
Secobarbital (BAR): 300 ng/ml
Buprenorphine (BUP): 10 ng/ml
Methylenedioxymethamphetamine(MDMA): 500 ng/ml
Phencyclidine (PCP): 25 ng/ml
Methadone (MTD): 300 ng/ml | Same; but also Nortriptyline (1000 ng/mL cutoff) |
| 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 |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Dip Card, Cup | Dip Card |
K. Standard/Guidance Document Referenced (if applicable):
Not applicable.
L. Test Principle:
The AssureTech Panel Dip Tests, and AssureTech Quick Cup Tests are rapid tests for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine and Methadone in urine samples. The tests are lateral flow chromatographic
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immunoassays. During testing, a urine specimen migrates upward by capillary action. If a target drug present in the urine specimen is below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on gold particles. The antibody-coated particles will then be captured by immobilized drug-conjugate in the test line region and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices (coated with anti-mouse antibodies) 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% cut-off, -75% cut-off, -50% cut-off, -25% cut-off, cut-off, +25% cut-off, +50% cut-off, +75% cut-off and +100% cut-off. The samples used in the precision studies were prepared by spiking drug into negative urine samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and who did not take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables for Oxazepam, Methylenedioxymethamphetamine and Morphine. The precision data for the remaining drugs of abuse devices were reported in k153465, k151211, k152025, and k161044.
## Oxazepam
### Panel Dip
| Lot Number | -100% cut-off | -75% cut-off | -50% cut-off | -25% cut-off | cut-off | +25% cut-off | +50% cut-off | +75% cut-off | +100% cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
### Quick Cup
| Lot Number | -100% cut-off | -75% cut-off | -50% cut-off | -25% cut-off | cut-off | +25% cut-off | +50% cut-off | +75% cut-off | +100% cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 8-/42+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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# Methylenedioxymethamphetamine
Panel Dip
| Lot Number | -100% cut-off | -75% cut-off | -50% cut-off | -25% cut-off | cut-off | +25% cut-off | +50% cut-off | +75% cut-off | +100% cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 13-/37+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Quick Cup
| Lot Number | -100% cut-off | -75% cut-off | -50% cut-off | -25% cut-off | cut-off | +25% cut-off | +50% cut-off | +75% cut-off | +100% cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
# Morphine (300 ng/mL Cut-off)
Panel Dip
| Lot Number | -100% cut-off | -75% cut-off | -50% cut-off | -25% cut-off | cut-off | +25% cut-off | +50% cut-off | +75% cut-off | +100% cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Quick Cup
| Lot Number | -100% cut-off | -75% cut-off | -50% cut-off | -25% cut-off | cut-off | +25% cut-off | +50% cut-off | +75% cut-off | +100% cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 8-/42+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
b. Linearity/assay reportable range:
Not applicable, these devices are intended for qualitative use only.
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c. Traceability, Stability, Expected values (controls, calibrators, or methods):
External control materials are not supplied with the devices.
The devices are stable at 4 - 30°C for 24 months based on accelerated and real-time stability studies. Real time stability studies are ongoing.
d. Detection limit:
Not applicable.
e. Analytical specificity:
**Specificity:**
To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound is listed below for Oxazepam, Methylenedioxymethamphetamine and Morphine. The data for the remaining drugs of abuse devices were reported in k153465, k151211, k152025, and k161044. There were no differences observed for different devices.
| Oxazepam
(Cut-off = 300 ng/mL) | Concentration
(ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Oxazepam | 300 | 100% |
| Alprazolam | 150 | 200% |
| a-Hydroxyalprazolam | 1000 | 30% |
| Bromazepam | 1000 | 30% |
| Chiordiazepoxide | 63 | 476.2% |
| Clonazepam | 2500 | 12% |
| Clobazam | 75 | 400% |
| Clorazepate dipotassium | 100 | 300% |
| Desalkylflurazepam | 500 | 60% |
| Diazepam | 500 | 60% |
| Estazolam | 500 | 60% |
| Flunitrazepam | 50000 | <0.6% |
| D,L-Lorazepam | 10000 | 3% |
| Midazolam | 10000 | 3% |
| Nitrazepam | 75 | 400% |
| Norchiordiazepoxide | 62.5 | 480% |
| Nordiazepam | 125 | 240% |
| Temazepam | 75 | 400% |
| Trazolam | 1000 | 30% |
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| Methylenedioxymethamphetamine (Cut-off = 500 ng/mL) | Result Positive at (ng/ml) | % Cross-Reactivity |
| --- | --- | --- |
| Methylenedioxymethamphetamine (MDMA) | 500 | 100% |
| 3,4-Methylenedioxyamphetamine (MDA) | 5,000 | 10% |
| 3,4-Methylenedioxyethylamphetamine (MDEA) | 300 | 166.7% |
| d-methamphetamine | 50000 | <1% |
| d-amphetamine | 50000 | <1% |
| l-amphetamine | 50000 | <1% |
| l-methamphetamine | 50000 | <1% |
| Morphine (Cut-off = 300 ng/mL) | Result Positive at (ng/ml) | % Cross-Reactivity |
| --- | --- | --- |
| Morphine | 300 | 100% |
| Codeine | 300 | 100% |
| Ethylmorphine | 310 | 96.8% |
| Hydrocodone | 25000 | 1.2% |
| Hydromorphine | 10000 | 3% |
| Levorphanol | 100000 | 0.3% |
| 6-Acetylmorphine | 250 | 120% |
| Morphine 3-β-D-glucuronide | 10000 | 3% |
| Normorphine | 100000 | 0.3% |
| Oxycodone | 100000 | <0.3% |
| Oxymorphone | 100000 | <0.3% |
| Procaine | 100000 | <0.3% |
| Thebaine | 100000 | <0.3% |
| Heroine | 500 | 60% |
## Interference:
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and urine with target drug concentrations at 25% below and 25% above cut-off levels. These urine samples were tested using three lots of each device. The compounds in the following table were tested at a concentration of 100 µg/mL, and did not show positive or negative interference. Albumin at a concentration of 100 mg/dL did not cause positive or negative interference. There were no differences observed for different devices.
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| Acetominophen | EMDP | Oxalic acid |
| --- | --- | --- |
| Acetophenetidin | Erythromycin | Oxolinic acid |
| N-Acetylprocainamide | β-Estradiol | Oxymetazoline |
| Albumin (100 mg/dL) | Fenoprofen | Papaverine |
| Acetylsalicylic acid | Furosemide | Penicillin-G |
| Aminopyrine | Gentisic acid | Perphenazine |
| Amoxicillin | Hemoglobin | Phenelzine |
| Ampicillin | Hydralazine | Prednisone |
| Ascorbic Acid | Hydrochlorothiazide | DL-Propranolol |
| Apomorphine | Hydrocortisone | D-Pseudoephedrine |
| Aspartame | O-Hydroxyhippuric acid | Quinine |
| Atropine | 3-Hydroxytyramine | Ranitidine |
| Benzilic acid | Ibuprofen | Salicylic acid |
| Benzoic acid | D,L-Isoproterenol | Serotonin (5- Hydroxytyramine) |
| Bilirubin | Isoxsuprine | Sulfamethazine |
| Chloralhydrate | Ketamine | Sulindac |
| Chloramphenicol | Ketoprofen | Tetrahydrocortisone, 3-acetate |
| Chlorothiazide | Labetalol | Tetrahydrocortisone 3-(β-D glucuronide) |
| Chlorpromazine | Loperamide | Tetrahydrozoline |
| Cholesterol | Maprotiline | Thiamine |
| Clonidine | Meperidine | Thioridazine |
| Cortisone | Meprobamate | Triamterene |
| (-) Cotinine | Methoxyphenamine | DL-Tyrosine |
| Creatinine | Nalidixic acid | Trifluoperazine |
| Deoxycorticosterone | Naloxone | Trimethoprim |
| Dextromethorphan | Naltrexone | D L-Tryptophan |
| Diclofenac | Naproxen | Tyramine |
| Diflunisal | Niacinamide | Uric acid |
| Digoxin | Nifedipine | Verapamil |
| Diphenhydramine | Norethindrone | Zomepirac |
| Disopyramide | Noscapine | |
| EDDP | D,L-Octopamine | |
| Ecgonine methyl ester | | |
## Effect of Urine Specific Gravity and Urine pH:
To investigate the effect of urine specific gravity and urine pH, urine samples with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 in increments of 1 pH unit were spiked with target drugs at 25% below and 25% above cut-off levels. These samples were tested using three lots of each device. For all devices, results were all positive for samples at 25% above cut-off and all negative for samples at 25% below cut-off.
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f. Assay cut-off:
Characterization of how the device performs analytically around the claimed cut-off concentration appears in the precision/reproducibility section above.
2. Comparison studies:
a. Method comparison with predicate device:
Method comparison studies for the AssureTech Panel Dip Tests and the AssureTech Quick Cup Tests were performed with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below for Oxazepam, Methylenedioxymethamphetamine and Morphine. The data for the remaining drugs of abuse were reported in k153465, k151211, k152025, and k161044.
Oxazepam Panel Dip
| Panel Dip | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cut-off) | Near Cutoff Positive by LC/MS (Between the cut-off and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
Discordant Results of Oxazepam Panel Dip
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer C | 41261 | 289.61 | Positive |
| Viewer A | 35578 | 310.69 | Negative |
| Viewer B | 35578 | 310.69 | Negative |
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Oxazepam Quick Cup
| Quick Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cut-off) | Near Cutoff Positive by LC/MS (Between the cut-off and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
Discordant Results of Ozaxepam Quick Cup
| Viewer | Sample Number | LC/MS Result | Quick Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer C | 41261 | 289.61 | Positive |
| Viewer A | 73291 | 311.75 | Negative |
| Viewer B | 35578 | 310.69 | Negative |
Methylenedioxymethamphetamine Panel Dip
| Panel Dip | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cut-off) | Near Cutoff Positive by LC/MS (Between the cut-off and +50%) | High Positive by LC/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 |
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Discordant Results for Methylenedioxymethamphetamine Panel Dip
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 37623 | 491.17 | Positive |
| Viewer B | 37623 | 491.17 | Positive |
| Viewer C | 37623 | 491.17 | Positive |
| Viewer A | 61074 | 508.34 | Negative |
| Viewer B | 61074 | 508.34 | Negative |
Methylenedioxymethamphetamine Quick Cup
| Quick Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cut-off) | Near Cutoff Positive by LC/MS (Between the cut-off and +50%) | High Positive by LC/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 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
Discordant Results Methylenedioxymethamphetamine Panel Dip
| Viewer | Sample Number | LC/MS Result | Quick Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 37623 | 491.17 | Positive |
| Viewer B | 37623 | 491.17 | Positive |
| Viewer C | 37623 | 491.17 | Positive |
| Viewer A | 61074 | 508.34 | Negative |
| Viewer C | 61074 | 508.34 | Negative |
Morphine Panel Dip
| Panel Dip | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cut-off) | Near Cutoff Positive by LC/MS (Between the cut-off and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
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| 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 for Morphine Panel Dip
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 90003 | 278.16 | Positive |
| Viewer B | 80161 | 280.75 | Positive |
| Viewer A | 59386 | 322.85 | Negative |
| Viewer B | 98199 | 306.08 | Negative |
| Viewer C | 98199 | 306.08 | Negative |
## Morphine Quick Cup
| Quick Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cut-off) | Near Cutoff Positive by LC/MS (Between the cut-off and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 20 | 10 | 0 | 0 |
## Discordant Results for Morphine Quick Cup
| Viewer | Sample Number | LC/MS Result | Quick Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 80161 | 280.75 | Positive |
| Viewer B | 80161 | 280.75 | Positive |
| Viewer B | 59386 | 322.85 | Negative |
## Lay-user Study
A lay user study was performed at three intended user sites with 280 lay persons for each device format (Panel Dip and Quick Cup) and morphine cut-off of 300 ng/mL and 2000 ng/mL. The lay users who tested the Panel Dip format were different from those who tested the Quick Cup format. The lay users had diverse educational and professional
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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 drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device (panel dip and panel cup) containing all drugs was tested. Results were similar between panel dip and panel cup formats. Below, results are provided for the Panel Dip format.
Comparison between LC/MS and Lay Person Results for Amphetamine:
| % of Cut-off | Number of samples | Drug Concentration by LC/MS (ng/mL) | Lay person Results | |
| --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative |
| -100% Cut-off | 20 | 0 | 0 | 20 |
| -75% Cut-off | 20 | 248 | 0 | 20 |
| -50% Cut-off | 140 | 508 | 0 | 140 |
| -25% Cut-off | 20 | 752 | 1 | 19 |
| +25% Cut-off | 20 | 1255 | 19 | 1 |
| +50% Cut-off | 40 | 1506 | 40 | 0 |
| +75% Cut-off | 20 | 1748 | 20 | 0 |
Comparison between LC/MS and Lay Person Results for Barbiturates:
| % of Cut-off | Number of samples | Drug Concentration by LC/MS (ng/mL) | Lay person Results | |
| --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative |
| -100% Cut-off | 20 | 0 | 0 | 20 |
| -75% Cut-off | 20 | 73 | 0 | 20 |
| -50% Cut-off | 140 | 151 | 0 | 140 |
| -25% Cut-off | 20 | 223 | 1 | 19 |
| +25% Cut-off | 20 | 378 | 20 | 0 |
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Comparison between LC/MS and Lay Person Results for Cocaine:
| % of Cut-off | Number of samples | Drug Concentration by LC/MS (ng/mL) | Lay person Results | |
| --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative |
| -100% Cut-off | 20 | 0 | 0 | 20 |
| -75% Cut-off | 20 | 76 | 0 | 20 |
| -50% Cut-off | 140 | 154 | 0 | 140 |
| -25% Cut-off | 20 | 222 | 1 | 19 |
| +25% Cut-off | 20 | 377 | 20 | 0 |
| +50% Cut-off | 40 | 452 | 40 | 0 |
| +75% Cut-off | 20 | 528 | 20 | 0 |
Comparison between LC/MS and Lay Person Results for Buprenorphine:
| % of Cut-off | Number of samples | Drug Concentration by LC/MS (ng/mL) | Lay person Results | |
| --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative |
| -100% Cut-off | 20 | 0 | 0 | 20 |
| -75% Cut-off | 20 | 2.6 | 0 | 20 |
| -50% Cut-off | 140 | 4.8 | 0 | 140 |
| -25% Cut-off | 20 | 7.2 | 2 | 18 |
| +25% Cut-off | 20 | 12.6 | 20 | 0 |
| +50% Cut-off | 40 | 15.4 | 40 | 0 |
| +75% Cut-off | 20 | 17.3 | 20 | 0 |
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Comparison between LC/MS and Lay Person Results for Methamphetamine:
| % of Cut-off | Number of samples | Drug Concentration by LC/MS (ng/mL) | Lay person Results | |
| --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative |
| -100% Cut-off | 20 | 0 | 0 | 20 |
| -75% Cut-off | 20 | 255 | 0 | 20 |
| -50% Cut-off | 140 | 496 | 0 | 140 |
| -25% Cut-off | 20 | 757 | 1 | 19 |
| +25% Cut-off | 20 | 1258 | 20 | 0 |
| +50% Cut-off | 40 | 1504 | 40 | 0 |
| +75% Cut-off | 20 | 1744 | 20 | 0 |
Comparison between LC/MS and Lay Person Results for Methadone:
| % of Cut-off | Number of samples | Drug Concentration by LC/MS(ng/mL) | Lay person Results | |
| --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative |
| -100% Cut-off | 20 | 0 | 0 | 20 |
| -75% Cut-off | 20 | 73 | 0 | 20 |
| -50% Cut-off | 140 | 155 | 0 | 140 |
| -25% Cut-off | 20 | 228 | 0 | 20 |
| +25% Cut-off | 20 | 377 | 19 | 1 |
| +50% Cut-off | 40 | 454 | 40 | 0 |
| +75% Cut-off | 20 | 528 | 20 | 0 |
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Comparison between LC/MS and Lay Person Results for Morphine:
| % of Cut-off | Number of samples | Drug Concentration by LC/MS (ng/mL) | Lay person Results | |
| --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative |
| -100% Cut-off | 20 | 0 | 0 | 20 |
| -75% Cut-off | 20 | 77 | 0 | 20 |
| -50% Cut-off | 140 | 155 | 0 | 140 |
| -25% Cut-off | 20 | 227 | 1 | 19 |
| +25% Cut-off | 20 | 371 | 20 | 0 |
| +50% Cut-off | 40 | 447 | 40 | 0 |
| +75% Cut-off | 20 | 521 | 20 | 0 |
Comparison between LC/MS and Lay Person Results for Oxycodone:
| % of Cut-off | Number of samples | Drug Concentration by LC/MS (ng/mL) | Lay person Results | |
| --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative |
| -100% Cut-off | 20 | 0 | 20 | 0 |
| -75% Cut-off | 20 | 23 | 20 | 0 |
| -50% Cut-off | 140 | 53 | 0 | 140 |
| -25% Cut-off | 20 | 72 | 1 | 19 |
| +25% Cut-off | 20 | 128 | 19 | 1 |
| +50% Cut-off | 40 | 154 | 40 | 0 |
| +75% Cut-off | 20 | 171 | 20 | 0 |
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Comparison between LC/MS and Lay Person Results for Phencyclidine :
| % of Cut-off | Number of samples | Drug Concentration by LC/MS (ng/mL) | Lay person Results | |
| --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative |
| -100% Cut-off | 20 | 0 | 0 | 20 |
| -75% Cut-off | 20 | 7 | 0 | 20 |
| -50% Cut-off | 140 | 11 | 0 | 140 |
| -25% Cut-off | 20 | 18 | 2 | 18 |
| +25% Cut-off | 20 | 32 | 20 | 0 |
| +50% Cut-off | 40 | 39 | 40 | 0 |
| +75% Cut-off | 20 | 44 | 20 | 0 |
Comparison between LC/MS and Lay Person Results for Tetrahydrocannabinol:
| % of Cut-off | Number of samples | Drug Concentration by LC/MS (ng/mL) | Lay person Results | |
| --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative |
| -100% Cut-off | 20 | 0 | 0 | 20 |
| -75% Cut-off | 20 | 13 | 0 | 20 |
| -50% Cut-off | 140 | 24 | 0 | 140 |
| -25% Cut-off | 20 | 38 | 1 | 19 |
| +25% Cut-off | 20 | 64 | 19 | 1 |
| +50% Cut-off | 40 | 77 | 40 | 0 |
| +75% Cut-off | 20 | 86 | 20 | 0 |
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Comparison between LC/MS and Lay Person Results for Benzodiazepines:
| % of Cut-off | Number of samples | Drug Concentration by LC/MS(ng/mL) | Lay person Results | |
| --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative |
| -100% Cut-off | 20 | 0 | 0 | 20 |
| -75% Cut-off | 20 | 73 | 0 | 20 |
| -50% Cut-off | 140 | 146 | 0 | 140 |
| -25% Cut-off | 20 | 228 | 1 | 19 |
| +25% Cut-off | 20 | 377 | 20 | 0 |
| +50% Cut-off | 40 | 452 | 40 | 0 |
| +75% Cut-off | 20 | 519 | 20 | 0 |
Comparison between LC/MS and Lay Person Results for Methylenedioxymethamphetamine:
| % of Cut-off | Number of samples | Drug Concentration by LC/MS(ng/mL) | Lay person Results | |
| --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative |
| -100% Cut-off | 20 | 0 | 0 | 20 |
| -75% Cut-off | 20 | 121 | 0 | 20 |
| -50% Cut-off | 140 | 253 | 0 | 140 |
| -25% Cut-off | 20 | 371 | 0 | 20 |
| +25% Cut-off | 20 | 628 | 19 | 1 |
| +50% Cut-off | 40 | 756 | 40 | 0 |
| +75% Cut-off | 20 | 879 | 20 | 0 |
Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the
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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 (when a. and b. are not applicable):
Not applicable.
4. Clinical cut-off:
Not applicable.
5. Expected values/Reference range:
Not applicable.
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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