BioTeke® Multi-Drug Urine Test Cup
Device Facts
| Record ID | K261409 |
|---|---|
| Device Name | BioTeke® Multi-Drug Urine Test Cup |
| Applicant | Bioteke Corporation (Wuxi) Co., Ltd. |
| Product Code | NFT · Clinical Toxicology |
| Decision Date | Sep 10, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Indications for Use
BioTeke® Multi-Drug Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay. It is a rapid drug test for the qualitative and simultaneous detection of drugs and drug metabolites in human urine. It is for in vitro diagnostic use only. Prescription Use Only. Drug test cut-off concentrations are listed below: [Table of analytes and cut-offs]. BioTeke® Multi-Drug Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. The test provides only preliminary test results. A more specific method must be used in order to obtain a confirmed result. GC/MS or LC/MS is the preferred method.
Device Story
BioTeke Multi-Drug Urine Test Cup is a lateral flow immunochromatographic assay for qualitative drug detection in human urine. The device uses a competitive binding principle; test region (T) is pre-coated with drug-protein conjugates; binding pad contains colored microsphere-labeled antibody conjugates. Urine is added directly to the cup; if no drug is present, antibody conjugates bind to the T-line (negative result); if drug is present, it saturates the antibody conjugate, preventing T-line formation (positive result). A control line (C) confirms proper flow. The device is a single-use cup format, packaged with desiccant. It is intended for prescription use in clinical settings. Results are preliminary and require confirmation by GC/MS or LC/MS. The device aids healthcare providers in identifying drug presence to inform clinical decision-making.
Clinical Evidence
Bench testing only. Precision/reproducibility studies were conducted over 25 days using three lots. Analytical specificity and cross-reactivity were evaluated against structurally related compounds. Method comparison study performed by three operators using 80 clinical urine samples (40 positive, 40 negative) per drug, compared against LC-MS/MS reference method. No clinical studies were required.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Materials include membrane pre-coated with drug-protein conjugates and binding pad with colored microsphere-labeled antibody conjugates. Cup format; packaged with desiccant. Shelf life of 24 months at 2-30°C. No electronic components, software, or connectivity.
Indications for Use
Indicated for the qualitative, simultaneous detection of drugs and drug metabolites (Amphetamine, Phenobarbital, Buprenorphine, Oxazepam, Benzoylecgonine, Fentanyl, MDMA, Methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, 11-nor-Δ9-THC-9-COOH, Nortriptyline) in human urine for prescription use.
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 Urine Test Cup (K241428)
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
K261409
B Applicant
Bioteke Corporation (Wuxi) Co., Ltd.
C Proprietary and Established Names
BioTeke Multi-Drug Urine Test Cup
D Regulatory Information
| Product Code(s) | Class | Regulation Section | Regulation Name | Panel |
| --- | --- | --- | --- | --- |
| NFT | II | 862.3100 | Amphetamine Test system | Toxicology (91) |
| PTH | II | 862.3150 | Barbiturate Test System | |
| NGL | II | 862.3650 | Opiate Test System | |
| NFV | II | 862.3170 | Benzodiazepines Test System | |
| NFY | II | 862.3250 | Cocaine and metabolites Test System | |
| PTG | II | 862.3620 | Methadone Test system | |
| NGG | II | 862.3610 | Methamphetamine Test System | |
| NGM | | Unclassified | Enzyme immunoassay Phencyclidine | |
| QAW | II | 862.3910 | Tricyclic Antidepressant Drugs Test System | |
| NFW | II | 862.3870 | Cannabinoids Test System | |
# II Submission/Device Overview:
A Purpose for Submission:
New Device
B Measurand:
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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Amphetamine, Phenobarbital, Buprenorphine, Oxazepam, Benzoylecgonine, Fentanyl, Methylenedioxymethamphetamine, Methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, 11-nor-Δ9-THC-9-COOH, Nortriptyline.
### 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:
BioTeke® Multi-Drug Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay. It is a rapid drug test for the qualitative and simultaneous detection of drugs and drug metabolites in human urine. It is for in vitro diagnostic use only. Prescription Use Only. Drug test cut-off concentrations are listed below:
| Test | Calibrator | Cut-off (ng/mL) |
| --- | --- | --- |
| Amphetamine (AMP) | Amphetamine | 500 |
| Phenobarbital (BAR) | Phenobarbital | 300 |
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Oxazepam (BZO) | Oxazepam | 300 |
| Cocaine (COC) | Benzoylecgonine | 150 |
| Fentanyl (FTY) | Fentanyl | 1 |
| Methylenedioxymethamphetamine (MDMA) | Methylenedioxymethamphetamine | 500 |
| Methamphetamine (MET) | Methamphetamine | 500 |
| Morphine (MOP/OPI) | Morphine | 300 |
| Methadone (MTD) | Methadone | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Marijuana (THC) | 11-nor-Δ9-THC-9-COOH | 50 |
| Nortriptyline (TCA) | Nortriptyline | 1000 |
BioTeke® Multi-Drug Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. The test provides only preliminary test results. A more specific method must be used in order to obtain a confirmed result. GC/MS or LC/MS is the preferred method.
### C Special Conditions for Use Statement(s):
Rx Only
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# **D Special Instrument Requirements:**
N/A
# **IV Device/System Characteristics:**
# **A Device Description:**
BioTeke® Multi-Drug Urine Test Cup is immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
The device is a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is packaged in a ready-to-use format.
# **B Principle of Operation:**
The BioTeke® Multi-Drug Urine Test Cup utilizes a competitive binding immunochromatographic assay. The membrane's test region (T) is pre-coated with specific drug-protein conjugates, and the binding pad contains colored microsphere-labeled antibody conjugates. A visible control line in the control region (C) confirms adequate sample volume and proper flow, indicates a valid test. During testing, urine is added directly to the test cup; if no free drug is present, the antibody conjugate binds to the T-line conjugate and generates a red test line (negative result), whereas if the drug saturates the antibody conjugate, no line forms in the test region (positive result), with the C-line serving as the kit's internal control.
# **V Substantial Equivalence Information:**
# **A Predicate Device Name(s):**
AllTest Multi-Drug Urine Test Cup
# **B Predicate 510(k) Number(s):**
K241428
# **C Comparison with Predicate(s):**
| Device & Predicate Device(s): | K261409 | K241428 |
| --- | --- | --- |
| Device Trade Name | BioTeke Multi-Drug Urine Test Cup | AllTest Multi-Drug Urine Test Cup |
| General Device Characteristic Similarities | | |
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| Intended Use/Indications For Use | Qualitative detection of drugs of abuse in urine. | | Same |
| --- | --- | --- | --- |
| Specimen Type | Human Urine | | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assay | | Same |
| Target Drug and Cut Off Values | Target drugs | Cutoff | Same |
| | Amphetamine (AMP) | 500 | |
| | Barbiturates (BAR) | 300 | |
| | Buprenorphine (BUP) | 10 | |
| | Benzodiazepines (BZO) | 300 | |
| | Cocaine (COC) | 150 | |
| | Fentanyl (FTY) | 1 | |
| | Methylenedioxymethamphetamine (MDMA) | 500 | |
| | Methamphetamine (MET) | 500 | |
| | Morphine (MOP/OPI) | 300 | |
| | Methadone (MTD) | 300 | |
| | Oxycodone (OXY) | 100 | |
| | Phencyclidine (PCP) | 25 | |
| | Marijuana (THC) | 50 | |
| | Nortriptyline (TCA) | 1000 | |
| Configurations | Test Cup | | Same |
| General Device Characteristic Differences | | | |
| Use Setting | Prescription Use Only | | OTC |
## VI Standards/Guidance Documents Referenced:
None referenced.
## 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. Samples were prepared by spiking target drugs in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed
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two runs per day for 25 days using three lots of test cups. The results obtained are summarized in the following tables:
| Drug | Lot No. | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| AMP 500 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BAR 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 29-/21+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BUP 10 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 30-/20+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 28-/22+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 28-/22+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BZO 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| COC 150 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 28-/22+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| FTY 1 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 29-/21+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MDM A 500 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 28-/22+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MET 500 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MOP 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MTD 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
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| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| OXY 100 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| PCP 25 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 28-/22+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| THC 50 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 21-/29+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| TCA 100 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
## 2. Linearity:
Not applicable. This device is intended for qualitative use only.
## 3. Analytical Specificity/Interference:
To test the analytical specificity, drug metabolites and other structurally related compounds that are likely to cross-react in urine samples were spiked into drug-free urine. These urine samples were tested using three lots of the device.
Percent cross-reactivity, provided in the table below, was calculated as the cutoff concentration divided by the concentration of analyte tested that yielded a positive result, multiplied by 100%.
| Drug/Cutoff | Compound | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
| --- | --- | --- | --- |
| AMP 500 | Amphetamine | 500 | 100% |
| | (+/-)-Methylenedioxyamphetamine(MDA) | 50 | 1000% |
| | (+/-)3,4-Methylenedioxyethylamphetamine (MDEA) | 100000 | 0.50% |
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| | (+/-)3,4-Methylenedioxymethamphetamine (MDMA) | 1000 | 50% |
| --- | --- | --- | --- |
| | R (-)-Amphetamine | 500 | 100% |
| | Methamphetamine | >100000 | <0.5% |
| | Ephedrine Hydrochloride | >100000 | <0.5% |
| | Pseudoephedrine Hydrochloride | >100000 | <0.5% |
| | Hydroxyamphetamine | >100000 | <0.5% |
| | D,L-Amphetamine | 1000 | 50% |
| | D-Amphetamine | 2000 | 25% |
| | L-Amphetamine | >100000 | <0.5% |
| | Phentermine | >100000 | <0.5% |
| | β-Phenylethylamine | >100000 | <0.5% |
| | Tyramine | >100000 | <0.5% |
| | p-Hydroxynorephedrine | >100000 | <0.5% |
| | D,L-Norephedrine | >100000 | <0.5% |
| | p-Hydroxyamphetamine | >100000 | <0.5% |
| | D-Methamphetamine | >100000 | <0.5% |
| | L-Methamphetamine | >100000 | <0.5% |
| | Phenylpropanolamine | >100000 | <0.5% |
| | Benzphetamine | >100000 | <0.5% |
| | L-Ephedrine | >100000 | <0.5% |
| | L-Epinephrine | >100000 | <0.5% |
| | D,L-Epinephrine | >100000 | <0.5% |
| BAR 300 | Phenobarbital | 300 | 100% |
| | Barbital | 300 | 100% |
| | Secobarbital Sodium | 2000 | 15% |
| | Pentobarbital | 2000 | 15% |
| | Alphenal | 300 | 100% |
| | Amobarbital | 300 | 100% |
| | Aprobarbital | 500 | 60% |
| | Butabarbital | >100000 | <0.3% |
| | Butethal | 300 | 100% |
| | Cyclopentobarbital | 500 | 60% |
| | Butalbital | >100000 | <0.3% |
| BUP 10 | Buprenorphine | 10 | 100% |
| | Buprenorphine-3-D-Glucuronide | 20 | 50% |
| | Norbuprenorphine | 20 | 50% |
| | Morphine | >100000 | <0.01% |
| | Oxymorphone | >100000 | <0.01% |
| | Hydromorphone | >100000 | <0.01% |
| | Codeine Phosphate | >100000 | <0.01% |
| | Norbuprenorphine-3-D-Glucuronide | 1000 | 1% |
| | Nalorphine | >100000 | <0.01% |
| BZO 300 | Oxazepam | 300 | 100% |
| | Alprazolam | 200 | 150% |
| | Chlordiazepoxide | 300 | 100% |
K261409 - Page 7 of 19
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| | Clobazam | 200 | 150% |
| --- | --- | --- | --- |
| | Clonazepam | 200 | 150% |
| | Diazepam | 300 | 100% |
| | Estazolam | 100 | 300% |
| | Flunitrazepam | 300 | 100% |
| | Midazolam | 10000 | 3% |
| | Nitrazepam | 200 | 150% |
| | Nordiazepam | 200 | 150% |
| | Temazepam | 100 | 300% |
| | Triazolam | 300 | 100% |
| | Flurazepam | 300 | 100% |
| | Lorazepam | 10000 | 3% |
| | Lormetazepam | 100 | 300% |
| | a-Hydroxyalprazolam | >100000 | <0.3% |
| | Bromazepam | >100000 | <0.3% |
| | Clorazepate Dipotassium | 300 | 100% |
| | Desalkylflurazepam | >100000 | <0.3% |
| | D,L-Lorazepam | >100000 | <0.3% |
| | Norchlordiazepoxide | 300 | 100% |
| | R,S-Lorazepam glucuronide | >100000 | <0.3% |
| | Demoxepam | >100000 | <0.3% |
| | Delorazepam | >100000 | <0.3% |
| COC 150 | Benzoylecgonine | 150 | 100% |
| | Cocaine Hydrochloride | 10000 | 1.50% |
| | Ecgonine methyl ester | >100000 | <0.15% |
| | Cocaethylene | >100000 | <0.15% |
| | Ecgonine | >100000 | <0.15% |
| FTY 1 | Fentanyl | 1 | 100% |
| | Acetyl fentanyl | 1 | 100% |
| | Sufentanil | 10 | 10% |
| | Alfentanil | 5000 | 0.02% |
| | Remifentanil | >100000 | <0.001% |
| | Norfentanyl | >100000 | <0.001% |
| | Acrylfentanyl | >100000 | <0.001% |
| | ω-1-Hydroxyfentanyl | >100000 | <0.001% |
| | Isobutyryl fentanyl | >100000 | <0.001% |
| | Ocfentanil | 5 | 20% |
| | Butyryl fentanyl | >100000 | <0.001% |
| | Furanyl fentanyl | >100000 | <0.001% |
| | Valeryl fentanyl | >100000 | <0.001% |
| | (±) β-hydroxythiofentanyl | 5 | 20% |
| | 4-Fluoro-isobutyrylfentanyl | >100000 | <0.001% |
| | Para-fluorobutyryl fentanyl | 5 | 20% |
| | Para-fluoro fentanyl | 5 | 20% |
| | (±)-3-cis-methyl fentanyl | >100000 | <0.001% |
| | Carfentanil | >100000 | <0.001% |
| | Despropionyl fentanyl (4-ANPP) | >100000 | <0.001% |
K261409 - Page 8 of 19
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| | 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% |
| | 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% |
| MDM A 500 | (±)3,4- Methylenedioxymethamphetamine(M DMA) | 500 | 100% |
| | (+/-)3,4- Methylenedioxyethylamphetamine (MDEA) | 1000 | 50% |
K261409 - Page 9 of 19
{9}
| | (+/-)-Methylenedioxyamphetamine(MDA) | 1000 | 50% |
| --- | --- | --- | --- |
| Amphetamine | 1000 | 50% |
| R (-)-Amphetamine | 1000 | 50% |
| Methamphetamine | 10000 | 5% |
| Ephedrine Hydrochloride | 10000 | 5% |
| Pseudoephedrine Hydrochloride | >100000 | <0.5% |
| L-Methamphetamine | >100000 | <0.5% |
| d-methamphetamine | >100000 | <0.5% |
| d-amphetamine | >100000 | <0.5% |
| l-amphetamine | >100000 | <0.5% |
| d,l-Amphetamine | >100000 | <0.5% |
| d,l-Methamphetamine | >100000 | <0.5% |
| Phentermine | >100000 | <0.5% |
| Phenylephrine | >100000 | <0.5% |
| MET 500 | Methamphetamine | 500 | 100% |
| (±)3,4-Methylenedioxymethamphetamine(MDMA) | 1000 | 50% |
| (+/-)3,4-Methylenedioxyethylamphetamine(MDEA) | 10000 | 5% |
| (+/-)-Methylenedioxyamphetamine(MDA) | 10000 | 5% |
| Methoxyphenamine Hydrochloride | >100000 | <0.5% |
| Chloroquine | 10000 | 5% |
| Amphetamine | 1000 | 50% |
| R (-)-Amphetamine | 1000 | 50% |
| Ephedrine Hydrochloride | 10000 | 5% |
| Pseudoephedrine Hydrochloride | >100000 | <0.5% |
| D-Methamphetamine | >100000 | <0.5% |
| L-Methamphetamine | >100000 | <0.5% |
| Fenfluramine | >100000 | <0.5% |
| p-Hydroxymethamphetamine | >100000 | <0.5% |
| D,L-Methamphetamine | 1000 | 50% |
| β-Phenylethylamine | >100000 | <0.5% |
| Mephetermine | >100000 | <0.5% |
| L-Amphetamine | >100000 | <0.5% |
| D-Amphetamine | >100000 | <0.5% |
| D,L-Amphetamine | >100000 | <0.5% |
| Trimethobenzamide | >100000 | <0.5% |
| l-phenylephrine | >100000 | <0.5% |
| (1R,2S)-(-)-Ephedrine | >100000 | <0.5% |
| Procaine hydrochloride | >100000 | <0.5% |
| Phentermine | >100000 | <0.5% |
| MOP 300 | Morphine | 300 | 100% |
| 6-acetylmorphine | 300 | 100% |
K261409 - Page 10 of 19
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| | Codeine Phosphate | 250 | 120% |
| --- | --- | --- | --- |
| | EthylMorphine | 200 | 150% |
| | Heroin | 500 | 60% |
| | Hydrocodone | 1000 | 30% |
| | Levorphanol tartrate | 1500 | 20% |
| | Morphine-3-β-d-glucuronide | 1000 | 30% |
| | Thebaine | 10000 | 3% |
| | Morphine-6-β-D-glucuronide | 1000 | 30% |
| | Dihydrocodeine | >100000 | <0.3% |
| | Hydromorphone | >100000 | <0.3% |
| | Nalorphine hydrochloride | 1000 | 30% |
| | s-Monoacetylmorphine | 500 | 60% |
| | 6-Monoacetylmorphine (6-MAM) | 500 | 60% |
| | Codeine-6-β-D-glucuronide | >100000 | <0.3% |
| | 6-Acetylcodeine | >100000 | <0.3% |
| | Normorphine | >100000 | <0.3% |
| | Oxycodone | >100000 | <0.3% |
| | Oxymorphone | >100000 | <0.3% |
| | Norcodeine | >100000 | <0.3% |
| | Procaine hydrochloride | >100000 | <0.3% |
| | Norpropoxyphene | >100000 | <0.3% |
| MTD 300 | Methadone | 300 | 100% |
| | EDDP | >100000 | <0.3% |
| | EMDP | >100000 | <0.3% |
| | Doxylamine | >100000 | <0.3% |
| | EsomeprazoleMagnesium | 10000 | 3% |
| | LAAM | >100000 | <0.3% |
| | Alpha Methadol | >100000 | <0.3% |
| | Disopyramide | >100000 | <0.3% |
| | Pheniramine | >100000 | <0.3% |
| OXY 100 | Oxycodone | 100 | 100% |
| | Hydrocodone | 50000 | 0.20% |
| | Hydromorphone | 25000 | 0.40% |
| | Naloxone Hydrochloride | >100000 | <0.1% |
| | Naltrexone Hydrochloride | >100000 | <0.1% |
| | Oxymorphone | 100 | 100% |
| | Noroxycodone | 1000 | 10% |
| | Noroxymorphone | 25000 | 0.40% |
| | Dihydrocodeine | 12500 | 0.80% |
| | Codeine Phosphate | 100000 | 0.10% |
| | Morphine | >100000 | <0.1% |
| | Buprenorphine | >100000 | <0.1% |
| | Ethyl Oxycodone | >100000 | <0.1% |
| | Levorphanol tartrate | >100000 | <0.1% |
| | Oxymorphone-3β-D-glucuronide | >100000 | <0.1% |
| | Acetylmorphine | >100000 | <0.1% |
| | Ethylmorphine | >100000 | <0.1% |
K261409 - Page 11 of 19
{11}
| | Thebaine | >100000 | <0.1% |
| --- | --- | --- | --- |
| | 6-acetylmorphine | >100000 | <0.1% |
| PCP 25 | Phencyclidine | 25 | 100% |
| | Pheniramine | 50000 | 0.05% |
| | 4-Hydroxyphencyclidine | >100000 | <0.025% |
| TCA 1000 | Nortriptyline | 1000 | 100% |
| | Amitriptyline Hydrochloride | 1500 | 66.70% |
| | Chlorphenamine Maleate | >100000 | <1% |
| | Clomipramine Hydrochloride | 1000 | 100% |
| | Cyclobenzaprine Hydrochloride | >100000 | <1% |
| | Desipramine | 300 | 333.3% |
| | Doxepin Hydrochloride | 10000 | 10% |
| | Duloxetine Hydrochloridum | >100000 | <1% |
| | Imipramine Hydrochloride | 500 | 200% |
| | Desmethylimipramine Hydrochloride | 250 | 400% |
| | Chlorpromazine Hydrochloride | >100000 | <1% |
| | Maprotiline Hydrochloride | >100000 | <1% |
| | Promethazine Hydrochloride | 50000 | 2% |
| | Norclomipramine | >100000 | <1% |
| | Nordoxepine | >100000 | <1% |
| | Promazine | >100000 | <1% |
| | Trimipramine | >100000 | <1% |
| | Maprotiline | >100000 | <1% |
| THC 50 | 11-nor-9-Carboxy-Δ9-THC | 50 | 100% |
| | (±)-11-nor-9-Carboxy-Δ9-THC | 50 | 100% |
| | Δ8-Tetrahydrocannabinol | >100000 | <0.05% |
| | Δ9-Tetrahydrocannabinol | 1000 | 5% |
| | Cannabinol | 10000 | 0.50% |
| | Cannabidiol | >100000 | <0.05% |
| | 11-nor-Δ8-THC-9-COOH | >100000 | <0.05% |
| | 11-nor-Δ9 -THC - carboxyglucuronide | 100 | 50% |
| | 11-hydroxy-Δ9 - Tetrahydrocannabinol | >100000 | <0.05% |
To evaluate potential interference, non-structurally related compounds were added to drug-free urine and to urine samples containing the target drugs at 50% below and 50% above each corresponding cutoff.
Compounds that show no interference at a concentration of \( 100 \mu g/mL \) are summarized in the following table.
| Ranitidine Hydrochloride | Sertraline Hydrochloride | Nitroglycerin |
| --- | --- | --- |
| Gatifloxacin | Diflunisal | Nordoxepin |
| Naloxone Hydrochloride | Fenofibrate | Norethindrone |
| Cefalexin | Aripiprazole | Norfentanyl |
K261409 - Page 12 of 19
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| Benzylpenicillin | Propranolol Hydrochloride | O-Hydroxyhippuric acid |
| --- | --- | --- |
| Ibuprofen | Citalopram Hydrobromide | Albumin (100mg/dL) |
| Aspirin | Lisinopril | Albuterol sulfate (Proair HFA) |
| Caffeine | Quetiapine Fumarate | Alpha Methadol |
| Atropine Sulfate | Apomorphine Hydrochloride | Aminophylline |
| Bilirubin | Estrone | Aminopyrine |
| Dopamine Hydrochloride | Creatine | Ascorbic acid |
| Salicylic Acid | Desloratadine | Benzilic acid |
| Ampicillin | Baclofen | Benzphetamine |
| Creatinine | Olanzapine | Boric Acid |
| Loratadine | Pregabalin | Cannabidiol |
| γ-Cyclodextrin | 4-(methylamino)-antipyrine | Carfentanil |
| Urea | Cortisone | Cephalexin |
| Vitamin C | Chlorothiazide | Chloralhydrate |
| Oxalic Acid | D-Glucoseanhydrous | Chloroquine |
| Benzoic Acid | Cholesterol | Chlorpheniramine |
| Methoxyphenamine Hydrochloride | 5 - Hydroxytryptamine Hydrochloride | Doxepin (except TCA test) |
| Digoxin | Chloramphenicol | Sodium Carbonate |
| Paracetamol | Tetracycline | Ecgonine methyl ester |
| Metformin Hydrochloride | Erythromycin | EMDP |
| Chlorphenamine Maleate | Clarithromycin | Ephedrine (except MDMA and MET test) |
| Diphenhydramine Hydrochloride | Amoxicillin | Esomeprazole Magnesium (except MTD test) |
| Clonidine Hydrochloride | Cefradine | Ethanol |
| Levonorgestrel | Ciprofloxacin | Fenoprofen |
| Metoprolol Tartrate | Levofloxacin | Galactose |
| Phenacetin | Phenoxymethylpenicillin | Gamma Globulin (500mg/dL) |
| Nicotinamide | Rifampicin | Gentisic acid |
| Vitamin B6 | Azithromycin | Glucose (3000mg/dL) |
| Theophylline | Tyrosine | Hemoglobin |
| Perphenazine | Tryptophan | Hydroxytyramine |
| Carbamazepine | Pethidine Hydrochloride | Isoproterenol |
| Hydrocortisone | Papaverine Hydrochloride | L-Ephedrine |
| Epinephrine | Noscapine | L-Epinephrine |
| Fluphenazine Hydrochloride | Tramadol Hydrochloride | LAAM HCl |
K261409 - Page 13 of 19
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| Isoprenaline Hydrochloride | Ketamine Hydrochloride | L-Thyroxine |
| --- | --- | --- |
| Norepinephrine Bitartrate | Paliperidone | Octopamine |
| Estradiol | Quinine Sulfate | Oxolinic acid |
| Metronidazole | Mifepristone | Penicillin-G |
| Naproxen | Phenelzine | Penicillin-V Potassium |
| Prednisone | Sildenafil Citrate | Phentermine |
| Dextromethorphan Hydrobromide | Aspartame | Promethazine (except TCA test) |
| Sulpiride | Nalidixic Acid | Propoxyphene |
| Phenylpropanolamine Hydrochloride | Isoxsuprine Hydrochloride | Pseudoephedrine |
| Verapamil Hydrochloride | Atomoxetine Hydrochloride | Riboflavin |
| Desoxycortone Acetate | Duloxetine Hydrochloride | Sulfamethazine |
| Oxymetazoline Hydrochloride | Doxylamine | Tetrahydrocortisone 3-β-D-glucuronide |
| Maprotiline Hydrochloride | Interferonalpha | Tetrahydrocortisone 3-acetate |
| Phenylephrine Hydrochloride | Zanamivir | Conjugated Estrogens |
| Hydralazine Hydrochloride | Ribavirin | Cotinine |
| Gemfibrozil | Oseltamivir | Cyclobenzaprine |
| Loperamide Hydrochloride | Peramivir | D-Pseudoephedrine |
| Hydrochlorothiazide | Lopinavir | D,L-Epinephrine |
| Captopril | Tetrahydrozoline | D,L-Isoproterenol |
| Clozapine | Arbidol | D,L-Octopamine |
| Salbutamol Sulfate | L-Phenylephrine | D,L-Propranolol |
| Sulindac | Ceftriaxone | D,L-Tryptophan |
| Ketoprofen | Meropenem | D,L-Tyrosine |
| Nifedipine | Tobramycin | Delorazepam |
| Lidocaine Hydrochloride | Phenethylamine | Deoxycorticosterone |
| Thioridazine Hydrochloride | Beclomethasone | Diclofenac sodium |
| Omeprazole | Dexamethasone | Magnesium |
| Vitamin B2 | Flunisolide | Meperidine |
| Vitamin B1 | Triamcinolone acetonide | Meprobamate |
| Procaine Hydrochloride | Budesonide | Methapyrilene |
| Triamterene | Mometasone | Methaqualone |
| Nicotinic Acid | Fluticasone | N-Acetylprocainamide |
| Chlorpromazine Hydrochloride | Histamine Hydrochloride | NaCl |
K261409 - Page 14 of 19
{14}
| Labetalol Hydrochloride | DL-Menthol | Naltrexone hydrochloride |
| --- | --- | --- |
| Aminophenazone | Benzocaine | Niacinamide |
| Fluoxetine Hydrochloride | Mupirocin | Nicotine |
| Venlafaxine Hydrochloride | 3-Hydroxytyramine | Thiamine |
| Furosemide | Acetaminophen | Trifluoperazine |
| Risperidone | Acetone (1000mg/dL) | Trimethobenzamide |
| Atorvastatin Calcium | Acetophenetidin | Trimethoprim |
| Simvastatin | Acetylsalicylic acid | Tyramine |
| Telmisartan | Acyclovir | Uric acid |
| Gabapentin | Disopyramide | Valproic acid (250ug/ml) |
| Zaleplon | DL-Tryptophan | Zomepirac |
| Bupropion Hydrochloride | DL-Tyrosine | β-Estradiol |
### Effect of Urine Density and Urine pH
Interference by urine pH and specific gravity was evaluated using pooled urine specimens with concentrations of 0 (drug-free), 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 did not affect the results of the assays.
4. Detection Limit and Assay Reportable Range:
Not applicable. This device is intended for qualitative use only.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The stability results support a shelf life of 24 months at 35.6-86°F (2-30°C) based on real-time stability study data.
6. Assay Cut-Off:
Analytical performance of the device around the claimed cutoff is described in the precision section VII.A1. above.
### B Comparison Studies:
1. Method Comparison with Predicate Device:
The method comparison study for the device was conducted by three operators. Operators ran 80 (40 negative and 40 positive) unaltered urine clinical samples for each drug. The samples were blind labeled and compared to LC-MS/MS results. The results are presented in the table below:
K261409 - Page 15 of 19
{15}
| Drug test | 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%) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| AMP | Operator A | Positive | 0 | 0 | 0 | 22 | 18 |
| | | Negative | 12 | 16 | 12 | 0 | 0 |
| | Operator B | Positive | 0 | 0 | 0 | 21 | 18 |
| | | Negative | 12 | 16 | 12 | 1 | 0 |
| | Operator C | Positive | 0 | 0 | 0 | 21 | 18 |
| | | Negative | 12 | 16 | 12 | 1 | 0 |
| BAR | Operator A | Positive | 0 | 0 | 0 | 21 | 18 |
| | | Negative | 12 | 16 | 12 | 1 | 0 |
| | Operator B | Positive | 0 | 0 | 0 | 22 | 18 |
| | | Negative | 12 | 16 | 12 | 0 | 0 |
| | Operator C | Positive | 0 | 0 | 1 | 22 | 18 |
| | | Negative | 12 | 16 | 11 | 0 | 0 |
| BUP | Operator A | Positive | 0 | 0 | 1 | 22 | 18 |
| | | Negative | 12 | 16 | 11 | 0 | 0 |
| | Operator B | Positive | 0 | 0 | 0 | 21 | 18 |
| | | Negative | 12 | 16 | 12 | 1 | 0 |
| | Operator C | Positive | 0 | 0 | 0 | 22 | 18 |
| | | Negative | 12 | 16 | 12 | 0 | 0 |
| BZO | Operator A | Positive | 0 | 0 | 0 | 19 | 21 |
| | | Negative | 12 | 16 | 12 | 0 | 0 |
| | Operator B | Positive | 0 | 0 | 0 | 19 | 21 |
| | | Negative | 12 | 16 | 12 | 0 | 0 |
| | Operator C | Positive | 0 | 0 | 1 | 19 | 21 |
| | | Negative | 12 | 16 | 11 | 0 | 0 |
| COC | Operator A | Positive | 0 | 0 | 0 | 20 | 20 |
| | | Negative | 12 | 14 | 14 | 0 | 0 |
| | Operator B | Positive | 0 | 0 | 0 | 20 | 20 |
| | | Negative | 12 | 14 | 14 | 0 | 0 |
| | Operator C | Positive | 0 | 0 | 1 | 20 | 20 |
| | | Negative | 12 | 14 | 13 | 0 | 0 |
| FTY | Operator A | Positive | 0 | 0 | 0 | 21 | 18 |
| | | Negative | 12 | 16 | 12 | 1 | 0 |
| | Operator B | Positive | 0 | 0 | 1 | 22 | 18 |
| | | Negative | 12 | 16 | 11 | 0 | 0 |
| | Operator C | Positive | 0 | 0 | 1 | 22 | 18 |
| | | Negative | 12 | 16 | 11 | 0 | 0 |
| MD MA | Operator A | Positive | 0 | 0 | 0 | 23 | 16 |
| | | Negative | 12 | 17 | 11 | 1 | 0 |
| | Operator B | Positive | 0 | 0 | 0 | 22 | 16 |
| | | Negative | 12 | 17 | 11 | 2 | 0 |
| | | Positive | 0 | 0 | 0 | 24 | 16 |
K261409 - Page 16 of 19
{16}
| | Operator C | Negative | 12 | 17 | 11 | 0 | 0 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| MET | Operator A | Positive | 0 | 0 | 0 | 22 | 18 |
| | | Negative | 12 | 16 | 12 | 0 | 0 |
| | Operator B | Positive | 0 | 0 | 0 | 21 | 18 |
| | | Negative | 12 | 16 | 12 | 1 | 0 |
| | Operator C | Positive | 0 | 0 | 0 | 22 | 18 |
| | | Negative | 12 | 16 | 12 | 0 | 0 |
| MOP | Operator A | Positive | 0 | 0 | 0 | 22 | 18 |
| | | Negative | 12 | 15 | 13 | 0 | 0 |
| | Operator B | Positive | 0 | 0 | 1 | 20 | 18 |
| | | Negative | 12 | 15 | 12 | 2 | 0 |
| | Operator C | Positive | 0 | 0 | 1 | 22 | 18 |
| | | Negative | 12 | 15 | 12 | 0 | 0 |
| MTD | Operator A | Positive | 0 | 0 | 1 | 22 | 18 |
| | | Negative | 12 | 16 | 11 | 0 | 0 |
| | Operator B | Positive | 0 | 0 | 0 | 21 | 18 |
| | | Negative | 12 | 16 | 12 | 1 | 0 |
| | Operator C | Positive | 0 | 0 | 1 | 21 | 18 |
| | | Negative | 12 | 16 | 11 | 1 | 0 |
| OXY | Operator A | Positive | 0 | 0 | 0 | 22 | 18 |
| | | Negative | 12 | 16 | 12 | 0 | 0 |
| | Operator B | Positive | 0 | 0 | 0 | 21 | 18 |
| | | Negative | 12 | 16 | 12 | 1 | 0 |
| | Operator C | Positive | 0 | 0 | 2 | 22 | 18 |
| | | Negative | 12 | 16 | 10 | 0 | 0 |
| PCP | Operator A | Positive | 0 | 0 | 0 | 21 | 17 |
| | | Negative | 12 | 17 | 11 | 2 | 0 |
| | Operator B | Positive | 0 | 0 | 0 | 22 | 17 |
| | | Negative | 12 | 17 | 11 | 1 | 0 |
| | Operator C | Positive | 0 | 0 | 0 | 23 | 17 |
| | | Negative | 12 | 17 | 11 | 0 | 0 |
| THC | Operator A | Positive | 0 | 0 | 0 | 22 | 18 |
| | | Negative | 12 | 16 | 12 | 0 | 0 |
| | Operator B | Positive | 0 | 0 | 0 | 21 | 18 |
| | | Negative | 12 | 16 | 12 | 1 | 0 |
| | Operator C | Positive | 0 | 0 | 0 | 22 | 18 |
| | | Negative | 12 | 16 | 12 | 0 | 0 |
| TCA | Operator A | Positive | 0 | 0 | 0 | 24 | 16 |
| | | Negative | 12 | 18 | 10 | 0 | 0 |
| | Operator B | Positive | 0 | 0 | 0 | 23 | 16 |
| | | Negative | 12 | 18 | 10 | 1 | 0 |
| | Operator C | Positive | 0 | 0 | 0 | 24 | 16 |
| | | Negative | 12 | 18 | 10 | 0 | 0 |
Discordant results are summarized below:
K261409 - Page 17 of 19
{17}
| Drug | Operator | Sample No. | LC-MS/MS Result | Accurate Result |
| --- | --- | --- | --- | --- |
| AMP 500 | B | A57 | 524.71 | - |
| | C | A57 | 524.71 | - |
| BAR 300 | A | B31 | 315.09 | - |
| | C | B61 | 288.47 | + |
| BUP 10 | A | C13 | 9.6 | + |
| | B | C58 | 10.59 | - |
| BZO 300 | C | D73 | 286.45 | + |
| COC 150 | C | E21 | 143.13 | + |
| FTY 1 | B | F11 | 0.97 | + |
| | C | F11 | 0.97 | + |
| | A | F02 | 1.07 | - |
| MDMA 500 | A | G04 | 512.53 | - |
| | B | G04 | 512.53 | - |
| | B | G53 | 516.96 | - |
| MET 500 | B | H56 | 530.03 | - |
| MOP 300 | B | I04 | 282.25 | + |
| | C | I04 | 282.25 | + |
| | B | I66 | 307.47 | - |
| | B | I75 | 307.73 | - |
| MTD 300 | A | J03 | 292.51 | + |
| | C | J51 | 293.03 | + |
| | B | J40 | 311.38 | - |
| | C | J67 | 312.27 | - |
| OXY 100 | C | K58 | 96.03 | + |
| | C | K22 | 97.38 | + |
| | B | K01 | 103.35 | - |
| PCP 25 | A | L45 | 26 | - |
| | A | L70 | 26.11 | - |
| | B | L45 | 26 | - |
| THC 50 | B | M07 | 51.89 | - |
| TCA 1000 | B | N12 | 1055.42 | - |
# 2. Matrix Comparison:
Not applicable.
# C Clinical Studies:
# 1. Clinical Sensitivity:
Not applicable.
K261409 - Page 18 of 19
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2. Clinical Specificity:
Not applicable.
3. Clinical Cut-Off:
Not applicable.
4. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable.
# **D 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 support a substantial equivalence decision.
K261409 - Page 19 of 19
