AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup
Device Facts
| Record ID | K244043 |
|---|---|
| Device Name | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup |
| Applicant | Hangzhou AllTest Biotech Co., Ltd. |
| Product Code | NFT · Clinical Toxicology |
| Decision Date | Feb 27, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Indications for Use
AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencycline, Nortriptyline, Marijuana, Tramadol, Propoxyphene, Fentanyl and 6monoacetylmorphine in human urine at the cutoff concentrations of: [Table of drugs and cutoffs]. AllTest Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these crugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
Device Story
Lateral flow immunochromatographic assay cup for qualitative detection of drugs of abuse in human urine. Device uses competitive binding principle; drug in urine competes with drug-protein conjugate for limited antibody binding sites. Absence of colored test line indicates positive result (drug concentration at or above cutoff); presence of colored line indicates negative result. Control line confirms proper procedure. Used in OTC settings; operated by lay users. Provides preliminary screening results; requires professional clinical judgment and confirmatory testing (GC/MS or LC/MS) for definitive diagnosis. Benefits patient by providing rapid, point-of-care drug screening.
Clinical Evidence
No clinical trials performed. Evidence consists of bench testing (precision, specificity, interference) and a lay-user study. Lay-user study included 280 participants (diverse backgrounds, ages 20->50) testing spiked urine samples at various concentrations relative to cutoffs. Results showed high agreement with LC-MS/MS confirmed concentrations. Analytical performance confirmed via LC-MS/MS comparison.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Single-use disposable cup. No instrumentation required. Qualitative visual readout. Analyte-specific monoclonal antibodies. Detects 18 drugs/metabolites in human urine. Cutoff concentrations range from 1 ng/mL (Fentanyl) to 2000 ng/mL (Morphine).
Indications for Use
Indicated for the qualitative, simultaneous detection of drugs of abuse (Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, EDDP, Methamphetamine, MDMA, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Tramadol, Propoxyphene, Fentanyl, 6-MAM) in human urine. Intended for OTC use. Provides preliminary results; requires confirmation via GC/MS or LC/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
- AllTest Multi-Drug Rapid Test Cup (K233019)
Submission Summary (Full Text)
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**FDA** U.S. FOOD & DRUG
ADMINISTRATION
# **510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY**
# **I Background Information:**
# **A 510(k) Number**
K244043
# **B Applicant**
Hangzhou Alltest Biotech Co.,Ltd
# **C Proprietary and Established Names**
AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Test Cup
# **D Regulatory Information**
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NFT | Class II | 21 CFR 862.3100 - Amphetamine test system | TX - Clinical Toxicology |
| PTH | Class II | 21 CFR 862.3150 - Barbiturate test system | TX - Clinical Toxicology |
| NGL | Class II | 21 CFR 862.3650 - Opiate test system | TX - Clinical Toxicology |
| NFV | Class II | 21 CFR 862.3170 - Benzodiazepine test system | TX - Clinical Toxicology |
| NFY | Class II | 21 CFR 862.3250 - Cocaine and cocaine metabolite test system | TX - Clinical Toxicology |
| PTG | Class II | 21 CFR 862.3620 - Methadone test system | TX - Clinical Toxicology |
| NGG | Class II | 21 CFR 862.3610 - Methamphetamine test system | TX - Clinical Toxicology |
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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| QBF | Class II | 21 CFR 862.3700 - Propoxyphene test system | TX - Clinical Toxicology |
| --- | --- | --- | --- |
| NGM | Unclassified | | |
| QAW | Class II | 21 CFR 862.3910 - Tricyclic antidepressant drugs test system | TX - Clinical Toxicology |
| NFW | Class II | 21 CFR 862.3870 - Cannabinoid test system | TX - Clinical Toxicology |
| NGI | Class II | 21 CFR 862.3640 - Morphine test system | TX - Clinical Toxicology |
## II Submission/Device Overview:
### A Purpose for Submission:
New Device (adding four additional analytes to the previously cleared device under K233019)
### B Measurand:
Amphetamine, Secobarbital, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methadone, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine, Nortriptyline, Oxycodone, 2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine, Tramadol, Propoxyphene, Fentanyl and 6-monoacetylmorphine.
### C Type of Test:
Qualitative lateral flow immunoassay
### III Intended Use/Indications for Use:
### A Intended Use(s):
See Indications for Use below.
### B Indication(s) for Use:
AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Tramadol, Propoxyphene, Fentanyl and 6-monoacetylmorphine in human urine at the cutoff concentrations of:
Drug (Identifier)
Cut-off level
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| Amphetamine (AMP) | 500 or 1000 ng/mL |
| --- | --- |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Benzodiazepines (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 or 300 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 500 or 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP/OPI) | 300 or 2000 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
| Tramadol (TRA) | 100 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Fentanyl (FYL) | 1 ng/mL |
| 6-monoacetylmorphine (6-MAM) | 10 ng/mL |
AllTest Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may yield positive results for the prescription drugs 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
AllTest Multi-Drug Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Tramadol, Propoxyphene Fentanyl and 6-monoacetylmorphine in human urine at the cutoff concentration of:
| Drug (Identifier) | Calibrator | Cut-off (ng/mL) |
| --- | --- | --- |
| Amphetamine (AMP) | d-Amphetamine | 500 or 1000 |
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Secobarbital (BAR) | Secobarbital | 300 |
| Benzodiazepines (BZO) | Oxazepam | 300 |
| Cocaine (COC) | Benzoylecgonine | 150 or 300 |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 |
| Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 |
| Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 |
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| Morphine (MOP/OPI) | Morphine | 300 or 2000 |
| --- | --- | --- |
| Methadone (MTD) | Methadone | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Nortriptyline (TCA) | Nortriptyline | 1000 |
| Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 50 |
| Tramadol (TRA) | Tramadol | 100 |
| Propoxyphene (PPX) | Propoxyphene | 300 |
| Fentanyl (FYL) | Fentanyl | 1 |
| 6-monoacetylmorphine (6-MAM) | 6-monoacetylmorphine | 10 |
AllTest Multi-Drug Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.
The tests may yield positive results for the prescription drugs 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
### **C Special Conditions for Use Statement(s):**
OTC - Over The Counter
### **D Special Instrument Requirements:**
Not Applicable. (These devices are single use and disposable.)
## **IV Device/System Characteristics:**
### **A Device Description:**
AllTest Multi-Drug Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Tramadol, Propoxyphene, Fentanyl and 6-monoacetylmorphine in human urine. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
### **B Principle of Operation:**
The Multi-Drug Rapid Test Cup is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels
K244043 - Page 4 of 20
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of specific drugs in urine. During testing, a urine specimen migrates upward by capillary action. A drug, if present in the urine specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody will then react with the drug-protein conjugate and a visible colored line will show up in the test region of the specific drug dipstick.
The presence of drug above the cut-off concentration will saturate all the binding sites of the antibody. Therefore, the colored line will not form in the test region.
A drug-positive urine specimen will not generate a colored line in the specific test region of the dipstick because of drug competition, while a drug-negative urine specimen will generate a line in the test region because of the absence of drug competition.
To serve as a procedural control, a colored line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
## V Substantial Equivalence Information:
### A Predicate Device Name(s):
AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx
### B Predicate 510(k) Number(s):
K233019
### C Comparison with Predicate(s):
| Device & Predicate Device(s): | Candidate K244043 | Predicate K233019 |
| --- | --- | --- |
| Device Trade Name | AllTest Multi-Drug Rapid Test Cup AllTest Multi-Drug Test Cup | AllTest Multi-Drug Rapid Test Cup AllTest Multi-Drug Rapid Test Cup Rx AllTest Multi-Drug Rapid Test Panel AllTest Multi-Drug Rapid Test Panel Rx |
| **General Device Characteristic Similarities** | | |
| Intended Use/Indications For Use | For the qualitative determination of drugs and drug metabolites in human urine. | Same |
| Specimen Type | Human Urine | Same |
| Methodology | Competitive binding, lateral flow immunochromatographi | Same |
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| | c assays based on the principle of antigen antibody immunochemistry. | |
| --- | --- | --- |
| **General Device Characteristic Differences** | | |
| Calibrator and Cutoff Values | Amphetamine (AMP): 500 or 1000 ng/ml Benzodiazepines (BZO): 300 ng/mL Cocaine (COC): 150 or 300 ng/mL 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH (THC): 50 ng/mL Methamphetamine (MET): 500 or 1000 ng/mL Morphine (MOP/OPI): 300 or 2000 ng/mL Oxycodone (OXY): 100 ng/mL Secobarbital (BAR): 300 ng/mL Methadone (MTD): 300 ng/mL Buprenorphine (BUP): 10 ng/mL D,L-Methylenedioxymethamphetamine (MDMA): 500 ng/mL Phencyclidine (PCP): 25 ng/mL Nortriptyline (TCA): 1000 ng/mL 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP): 300 ng/mL Tramadol (TRA): 100 ng/mL Propoxyphene (PPX): 300 ng/mL Fentanyl (FYL): 1 ng/mL | Same except TRA 100 ng/mL PPX 300 ng/mL FYL 1 ng/mL 6-MAM 10 ng/mL |
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| | 6-Monoacetylmorphine(6-MAM): 10 ng/mL | |
| --- | --- | --- |
### VI Standards/Guidance Documents Referenced:
None.
### VII Performance Characteristics (if/when applicable):
#### A Analytical Performance:
##### 1. Precision/Reproducibility:
Precision studies were carried out for samples with concentrations of -100% cutoff, -75% cutoff, -50% cutoff, -25% cutoff, cutoff, +25% cutoff, +50% cutoff, +75% cutoff and +100% cutoff using 3 lots of the AllTest Multi-Drug Rapid Test Cup. These samples were prepared by spiking drug in negative urine samples. Each drug concentration was confirmed by LC-MS/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed 1 replicate per run per lot (one operator per lot), 2 runs per day for 25 days in a randomized order. The results obtained for Tramadol 100, Propoxyphene 300, Fentanyl 1 and 6-monoacetylmorphine 10 are summarized in the following tables. The rest of the data for Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, EDDP, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana were reported in k233019.
Tramadol (TRA) 100 ng/mL
| Lot # | Concentration by LC/MS (ng/mL) | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | cutoff | +25% cutoff | +50% cutoff | +75% cutoff | +100% cut-off |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 24-/26+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ |
Propoxyphene (PPX) 300 ng/mL
| Lot # | Concentration by LC/MS (ng/mL) | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | cutoff | +25% cutoff | +50% cutoff | +75% cutoff | +100% cut-off |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 22-/28+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 1-/49+ | 0-/50+ | 0-/50+ | 0-/50+ |
Fentanyl (FYL) 1 ng/mL
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| Lot # | Concentration by LC/MS (ng/mL) | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | -100% Cutoff | -75% Cutoff | -50% Cutoff | -25% Cutoff | Cutoff | Cutoff +25% | Cutoff +50% | Cutoff +75% | Cutoff +100% |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 23-/27+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 24-/26+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ |
#### 6-monoacetylmorphine (6-MAM) 10 ng/mL
| Lot # | Concentration by LC/MS (ng/mL) | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | -100% Cutoff | -75% Cutoff | -50% Cutoff | -25% Cutoff | Cutoff | Cutoff +25% | Cutoff +50% | Cutoff +75% | Cutoff +100% |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 24-/26+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 1-/49+ | 0-/50+ | 0-/50+ | 0-/50+ |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 23-/27+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ |
## 2. Linearity:
Not applicable.
## 3. Analytical Specificity/Interference:
### Cross-reactivity
To test the cross reactivity, target drugs, drug metabolites within the same class of drugs, or substances with similar molecular structures that potentially cross-react were spiked to drug-free specimens and these samples were tested by three different operators using three lots of Multi-Drug Rapid Test Cup. The cross-reacting substances with the lowest concentration that produced a positive result was identified and are listed in the table below. If no cross-reactivity was observed the highest concentration tested is shown.
The study is reported only for Tramadol (TRA)100, Propoxyphene (PPX) 300, Fentanyl (FYL) 1 and 6-monoacetylmorphine (6-MAM)10. The data for Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, EDDP, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana were reported in k233019.
| TRA (Tramadol) Cutoff=100 ng/mL | Lowest concentration (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Tramadol | 100 | 100% |
| N-Desmethyl-cis-tramadol | 200 | 50% |
| O-Desmethyl-cis-tramadol | 1000 | 10% |
| Venlafaxine | 100000 | 0.1% |
| (±)-O-Desmethylvenlafaxine | 100000 | 0.1% |
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| PPX (Propoxyphene) Cutoff=300 ng/mL | Lowest concentration (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| (+)-Propoxyphene | 300 | 100% |
| (+)-Norpropoxyphene | 500 | 60% |
| FYL (Fentanyl) Cut-off=1 ng/mL | Lowest concentration (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Fentanyl | 1 | 100% |
| Acetyl fentanyl | 1 | 100% |
| Acrylfentanyl | 1 | 100% |
| ω-1-Hydroxyfentanyl | 20000 | 0.005% |
| Isobutyryl fentanyl | 1 | 100% |
| Ocfentanil | 2.5 | 40% |
| Butyryl fentanyl | 2.5 | 40% |
| Furanyl fentanyl | 5 | 20% |
| Valeryl fentanyl | 10 | 10% |
| (±) β-hydroxythiofentanyl | 2 | 50% |
| 4-Fluoro-isobutyrylfentanyl | 50 | 2% |
| Para-fluorobutyryl fentanyl | 4 | 25% |
| Para-fluoro fentanyl | 3 | 33.3% |
| (±)-3-cis-methyl fentanyl | 50 | 2% |
| Carfentanil | 2 | 50% |
| Sufentanil | 10 | 10% |
| Alfentanil | 5000 | 0.02% |
| Despropionyl fentanyl (4-ANPP) | 2500 | 0.04% |
| Remifentanil | >100000 | <0.001% |
| Norfentanyl | >100000 | <0.001% |
| Acetyl norfentanyl | >100000 | <0.001% |
| Norcarfentanil | >100000 | <0.001% |
| 6-Acetyl morphine | >100000 | <0.001% |
| Amphetamine | >100000 | <0.001% |
| Buprenorphine | >100000 | <0.001% |
| Buprenorphineglucuronide | >100000 | <0.001% |
| Codeine | >100000 | <0.001% |
| Dextromethorphan | >100000 | <0.001% |
| Dihydrocodeine | >100000 | <0.001% |
| EDDP | >100000 | <0.001% |
| EMDP | >100000 | <0.001% |
| Fluoxetine | >100000 | <0.001% |
| Heroin | >100000 | <0.001% |
| Hydrocodone | >100000 | <0.001% |
| Hydromorphone | >100000 | <0.001% |
| Ketamine | >100000 | <0.001% |
| Levorphanol | >100000 | <0.001% |
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| Meperidine | >100000 | <0.001% |
| --- | --- | --- |
| Methadone | >100000 | <0.001% |
| Morphine | >100000 | <0.001% |
| Morphine-3-glucuronide | >100000 | <0.001% |
| Naloxone | >100000 | <0.001% |
| Naltrexone | >100000 | <0.001% |
| Norbuprenorphine | >100000 | <0.001% |
| Norcodeine | >100000 | <0.001% |
| Norketamine | >100000 | <0.001% |
| Normeperidine | >100000 | <0.001% |
| Normorphine | >100000 | <0.001% |
| Noroxycodone | >100000 | <0.001% |
| Oxycodone | >100000 | <0.001% |
| Oxymorphone | >100000 | <0.001% |
| Pentazocine (Talwin) | >100000 | <0.001% |
| Pipamperone | >100000 | <0.001% |
| Risperidone | >100000 | <0.001% |
| Tapentadol | >100000 | <0.001% |
| Thioridazine | >100000 | <0.001% |
| Tilidine | >100000 | <0.001% |
| Tramadol | >100000 | <0.001% |
| Tramadol-O-Desmethyl | >100000 | <0.001% |
| Tramadol-N-Desmethyl | >100000 | <0.001% |
| Isotoninize | >100000 | <0.001% |
| Cyclopropylfentanyl | 3 | 33.3% |
| AH-7921 HCL | >100000 | <0.001% |
| 6-MAM (6-monoacetylmorphine) Cutoff=10ng/mL | Lowest concentration (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| 6-Monoacetylmorphine | 10 | 100% |
| Hydrocodone | >100000 | <0.01% |
| Hydromorphone | >100000 | <0.01% |
| Morphine | >100000 | <0.01% |
| Oxymorphone | >100000 | <0.01% |
| Procaine | >100000 | <0.01% |
| Thebaine | >100000 | <0.01% |
| Diacetylmorphine (heroin) | 300 | 3.3% |
| Acetylcodeine | >100000 | <0.01% |
| Buprenorphine | >100000 | <0.01% |
| Dihydrocodeine | >100000 | <0.01% |
| Nalorphine | >100000 | <0.01% |
| Mitragynine (kratom) | >100000 | <0.01% |
| Norbuprenorphine | >100000 | <0.01% |
| s-Monoacetylmorphine | 10 | 100% |
| Codeine | >100000 | <0.01% |
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| Ethylmorphine | >100000 | <0.01% |
| --- | --- | --- |
| Levorphanol tartrate | >100000 | <0.01% |
| Morphine-3-β-D-glucuronide | >100000 | <0.01% |
| Norcodeine | >100000 | <0.01% |
| Normorphine | >100000 | <0.01% |
| Oxycodone | >100000 | <0.01% |
| Dextromethorphan | >100000 | <0.01% |
| Imipramine hydrochloride | >100000 | <0.01% |
| Levacetylmethadol (LAAM) | >100000 | <0.01% |
| Meperidine | >100000 | <0.01% |
| (±)-Methadone | >100000 | <0.01% |
| Naloxone hydrochloride | >100000 | <0.01% |
| Naltrexone hydrochloride | >100000 | <0.01% |
| Naproxen | >100000 | <0.01% |
| Noroxycodone HCL | >100000 | <0.01% |
| Noroxymorphone HCL | >100000 | <0.01% |
| (+)-Norpropoxyphene maleate | >100000 | <0.01% |
| Oxymorphone-3β-D-glucuronide | >100000 | <0.01% |
| Tapentadol HCl | >100000 | <0.01% |
| Tramadol hydrochloride | >100000 | <0.01% |
| Chlordiazepoxide | >100000 | <0.01% |
| Clobazam | >100000 | <0.01% |
| D-Amphetamine | >100000 | <0.01% |
| (±)-Amphetamine | >100000 | <0.01% |
## Interfering substances
Clinical urine samples may contain substances that could potentially interfere with the test. To evaluate interference, potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 50% below and 50% above cut-off levels in the test. These urine samples were tested using three lots of Multi-Drug Rapid Test Cup and two configurations (combination of different cut off values) by six operators (three operator for each configuration). Compounds that showed no interference at a concentration of 100 μg/mL or at specified concentrations are summarized in the following table.
| Acetaminophen | D-Pseudoephedrine | Norfentanyl |
| --- | --- | --- |
| Acetone (1000mg/dL) | Duloxetine | Noscapine |
| Acetophenetidin | 4-Dimethyl-aminoantipyrine | (+)-Naproxen |
| Acetylsalicylic Acid | 5, 5-Diphenylhydantoin | 19-Norethindrone |
| Acyclovir | Ecgonine methyl ester | Octopamine |
| Albumin (100mg/dL) | EMDP | O-Hydroxyhippuric acid |
| Albuterol sulfate (Proair HFA) | Ephedrine | Olanzapine |
| Alpha Methadol | Erythromycin | Omeprazole |
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| Aminophylline | Esomeprazole Magnesium (except MTD test) | Oxalic acid (100 mg/dL) |
| --- | --- | --- |
| Aminopyrine | Estradiol | Oxolinic acid |
| Amoxicillin | Estrone | Oxymetazoline |
| Ampicillin | Ethanol (1%) | Paliperidone |
| Aripiprazole | Fenofibrate | Papaverine |
| Aspartame | Fenoprofen | Penicillin-G |
| Aspirin | Fentanyl (except FYL test) | PenicillinV Potassium |
| Atomoxetine | Fluoxetine Hydrochloride | Perphenazine |
| Atorvastatin Calcium | Fluphenazine | Phenacetin |
| Atropine | Fotemustine | Phenelzine |
| Azithromycin | Furosemide | Phenethylamine |
| Baclofen | Gabapentin | Phenylethylamine |
| Benzilic acid | Galactose (10mg/dL) | Phenylpropanolamine |
| Benzocaine | Gamma Globulin (500mg/dL) | Prednisone |
| Benzoic Acid | Gatifloxacin | Pregablin |
| Benzphetamine | Gemfibrozil | Procaine |
| Bilirubin | Gentisic acid | Promazine |
| Boric Acid (1%) | Glucose (3000mg/dL) | Promethazine |
| Bupropion | Guaiacol glyceryl ether | Propoxyphene (except PPX test) |
| Caffeine | Hemoglobin | Propranolol |
| Cannabidiol | Hydralazine | Pseudoephedrine |
| Captopril | Hydrochlorothiazide | Pyridoxine |
| Carbamazepine | Hydrocortisone | Pyrilamine |
| Carfentanil (except FYL test) | 3-Hydroxytyramine | Pyrogallol |
| Carisoprodol | Ibuprofen | Quetiapine |
| Cefradine | Isoxsuprine | Quinine |
| Cephalexin | (+/-)-Isoproterenol | Quinolinic Acid |
| Chloralhydrate | Ketamine | R- (-)-Apomorphine |
| Chloramphenicol | Ketoprofen | Ranitidine |
| Chlordiazepoxide (except BZO test) | LAAM HCl | Riboflavin (10mg/dL) |
| Chloroquine (except MET test) | Labetalol | Rifampicin |
| Chlorothiazide | L-Ascorbic Acid | Risperidone |
| Chlorpromazine | L-Ephedrine | Salicylic Acid |
| Cholesterol | L-Epinephrine | Serotonin (5-Hydroxytyramine) |
| Ciprofloxacin Hydrochloride | Levofloxacin Hydrochloride | Sertraline |
| Citalopram | Levonorgestrel | Sildenafil Citrate |
| Clarithromycin | Levothyroxine Sodium | Simvastatin |
| Clonidine | Lidocaine Hydrochloride | Sulfamethazine |
| Clozapine | Lisinopril | Sulindac |
| Conjugated Estrogens | Loperamide | Telmisartan |
| Cortisone | Loratadine | Tetracycline |
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| Creatine Hydrate | L-phenylephrine | Tetrahydrocortisone 3-(β-Dglucuronide) |
| --- | --- | --- |
| Creatinine | Magnesium | Tetrahydrocortisone, 3-acetate |
| Cyclobenzaprine | Maprotiline | Tetrahydrozoline |
| Cyclodextrin | Meperidine | Theophylline |
| (-)-Cotinine | Meprobamate | Thiamine |
| (+)-Chlorpheniramine | Methapyrilene | Thioridazine |
| D,L-Epinephrine | Methaqualone | Tramadol (except TRA test) |
| D,L-Octopamine | Methoxyphenamine (except AMP/MET test) | Triamterene |
| d,l-Propranolol | Methylphenidate | Trifluoperazine |
| D,L-Tryptophan | Metoprolol Tartrate | Trimethobenzamide |
| D,L-Tyrosine | Metronidazole (300ug/ml) | Trimethoprim |
| Delorazepam (except BZO test) | Mifepristone | Tryptamine |
| Deoxycorticosterone | N-Acetylprocainamide | Tyramine |
| Desloratadine | NaCl (4000mg/dL) | Urea (2000mg/dL) |
| Dextromethorphan | Nalidixic Acid | Uric Acid |
| Diclofenac | Naloxone hydrochloride (except OXY test) | Valproic acid (250ug/ml) |
| Diflunisal | Naltrexone | Venlafaxine HCl (except TRA test) |
| Digoxin | Niacinamide | Verapamil |
| Diphenhydramine HCl | Nicotine | Vitamin B2 |
| Disopyramide (except MTD test) | Nicotinic Acid | Vitamin C |
| Dopamine HCl | Nifedipine | Zaleplon |
| Doxepin | Nitroglycerin | Zomepirac sodium salt |
| Doxylamine | Nordoxepin | |
## Effect of Urine Specific Gravity and Urine pH
The effect of pH and specific gravity on the accuracy of test measurement of the Multi-Drug Rapid Test Cup were evaluated using pooled urine specimens with concentrations of 0 (drug-free), at 50% below and 50% above each corresponding cutoff. The results demonstrated that pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 do not affect the results of the assays.
# 4. Assay Reportable Range:
Not applicable.
# 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
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All drug calibrators of the device are traceable to available commercial reference materials.
# 6. Detection Limit:
See precision data in Section VII.A.1., above, for assay performance around the claimed cutoff concentrations.
# 7. Assay Cut-Off:
Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section VII.A.1., above.
# **B Comparison Studies:**
# 1. Method Comparison with Predicate Device:
Eighty (40 negative and 40 positive) unaltered clinical urine samples for each drug were analyzed by LC/MS and by three lots of Multi-Drug Rapid Test Cup device. Samples concentrations are confirmed by LC/MS, ranging from drug-free, < -50% Cutoff, -50% Cutoff ~ Cutoff, Cutoff ~ +50% Cutoff, >+50% Cutoff. The study was conducted by 3 operators (one operator per lot) at an in-house laboratory. Method comparison data were reported only for Tramadol (TRA)100, Propoxyphene (PPX) 300, Fentanyl (FYL) 1 and 6-monoacetylmorphine (6-MAM)10. The data for Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, EDDP, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana were reported in k233019.
| Drug | Test Cup Result | Drug-Free | Low Negative by LC-MS/MS (less than -50%) | Near Cutoff Negative by LC-MS/MS (Between -50% and the Cutoff) | Near Cutoff Positive by LC-MS/MS (Between the cutoff and +50%) | High Positive by LC-MS/MS (greater than +50%) | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | | | | |
| TRA | Operator A | + | 0 | 0 | 1 | 11 | 29 |
| | | - | 12 | 14 | 13 | 0 | 0 |
| | Operator B | + | 0 | 0 | 0 | 10 | 29 |
| | | - | 12 | 14 | 14 | 1 | 0 |
| | Operator C | + | 0 | 0 | 1 | 10 | 29 |
| | | - | 12 | 14 | 13 | 1 | 0 |
| PPX | Operator A | + | 0 | 0 | 1 | 10 | 30 |
| | | - | 12 | 13 | 14 | 0 | 0 |
| | Operator B | + | 0 | 0 | 1 | 10 | 30 |
| | | - | 12 | 13 | 14 | 0 | 0 |
| | Operator C | + | 0 | 0 | 0 | 9 | 30 |
| | | - | 12 | 13 | 15 | 1 | 0 |
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| 6-MAM | Operator A | + | 0 | 0 | 1 | 14 | 26 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | - | 12 | 11 | 16 | 0 | 0 |
| | Operator B | + | 0 | 0 | 1 | 13 | 26 |
| | | - | 12 | 11 | 16 | 1 | 0 |
| | Operator C | + | 0 | 0 | 2 | 13 | 26 |
| | | - | 12 | 11 | 15 | 1 | 0 |
| FYL | Operator A | + | 0 | 0 | 2 | 22 | 16 |
| | | - | 12 | 13 | 13 | 2 | 0 |
| | Operator B | + | 0 | 0 | 3 | 22 | 16 |
| | | - | 12 | 13 | 12 | 2 | 0 |
| | Operator C | + | 0 | 0 | 2 | 22 | 16 |
| | | - | 12 | 13 | 13 | 2 | 0 |
Discordant Results are summarized below.
| Drug | Operator | Sample Number | LC/MS/MS Result (ng/mL) | Test Result |
| --- | --- | --- | --- | --- |
| TRA 100 | A, C | S2148 | 91.6 | + |
| | B, C | S2157 | 103.0 | - |
| PPX 300 | A | S2052 | 286.3 | + |
| | B | S2017 | 280.6 | + |
| | C | S2018 | 319.8 | - |
| 6-MAM 10 | A, C | S2249 | 9.5 | + |
| | B, C | S2236 | 9.6 | + |
| | B, C | S2228 | 10.2 | - |
| FYL 1 | A, C | S1425 | 1.02 | - |
| | A | S1420 | 0.87 | + |
| | A, B | S1447 | 1.01 | - |
| | A, B | S1442 | 0.91 | + |
| | B, C | S1402 | 0.92 | + |
| | B | S1422 | 1.08 | - |
| | B | S1465 | 0.92 | + |
| | C | S1453 | 0.82 | + |
| | C | S1439 | 1.02 | - |
### Lay User Study
A lay user study was conducted to evaluate its two configurations of the 18 drugs for the Multi-Drug Rapid Test Cup. Configuration 1 included COC 300, OPI/MOP 2000, AMP 1000 and MET 1000, AND configuration 2 included COC 150, MOP 300, AMP 500 and MET 500. The study was performed at three intended user sites by 280 lay users (140 for each configuration), and each lay user tested only one sample. The lay users had diverse educational and professional backgrounds and ranged in age from 20 to > 50 years. Urine samples were prepared at the following concentrations: -100%, +/-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/MS. Each sample was aliquoted into individual
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containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Results are shown below.
# **Results for configuration 1**
| Drug | Cutoff (ng/mL) | Results | Concentration | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff |
| AMP | 1000 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% |
| BAR | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% |
| BZO | 300 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% |
| BUP | 10 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% |
| COC | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% |
| EDDP | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% |
| MDMA | 500 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% |
| MET | 1000 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% |
| MOP | 2000 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
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| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% |
| MTD | 300 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% |
| OXY | 100 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% |
| PCP | 25 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% |
| TCA | 1000 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% |
| THC | 50 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% |
| TRA | 100 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% |
| PPX | 300 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% |
| FYL | 1 | Negative | 20 | 20 | 20 | 17 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 3 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 85.0% | 100.0% | 100% | 100% |
| 6-MAM | 10 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 90.0% | 100% | 100% |
## Results for configuration 2
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| Drug | Cutoff (ng/mL) | Results | Concentration | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff |
| AMP | 500 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% |
| BAR | 300 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% |
| BZO | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% |
| BUP | 10 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% |
| COC | 150 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% |
| EDDP | 300 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% |
| MDMA | 500 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% |
| MET | 500 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% |
| MOP | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
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| MTD | 300 | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% |
| OXY | 100 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% |
| PCP | 25 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% |
| TCA | 1000 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% |
| THC | 50 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% |
| TRA | 100 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 90.0% | 100% | 100% |
| PPX | 300 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% |
| FYL | 1 | Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 100.0% | 100% | 100% |
| 6-MAM | 10 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 90.0% | 100% | 100% |
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 scores revealed a reading Grade Level of 7.
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# 2. Matrix Comparison:
Not applicable.
# **C Clinical Studies:**
# 1. Clinical Sensitivity:
Not applicable.
# 2. Clinical Specificity:
Not applicable.
# 3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable.
# **D Clinical Cut-Off:**
Not applicable.
# **E Expected Values/Reference Range:**
Not applicable
# **VIII Proposed Labeling:**
The labeling supports the finding of substantial equivalence for this device.
# **IX Conclusion:**
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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