Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
Device Facts
| Record ID | K232659 |
|---|---|
| Device Name | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup |
| Applicant | Guangzhou Decheng Biotechnology Co., Ltd. |
| Product Code | DJG · Clinical Toxicology |
| Decision Date | Dec 13, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
Indications for Use
Dochek® Multi-Drug Urine Test Cup Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table. Dochek® Multi-Drug Urine Test Cup Rx offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device. It is intended for prescription use. For in vitro diagnostic use only. The test provides only preliminary results. 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 is needed. GC/MS or LC/MS is the recommended confirmatory method. Dochek® Multi-Drug Urine Test Cup is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table. Dochek® Multi-Drug Urine Test Cup offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.
Device Story
Lateral flow immunochromatographic assay for qualitative drug screening in human urine; cup format with integrated test strips. Urine sample collected directly into cup; capillary action draws sample across pre-coated membrane. Competitive binding mechanism: drug in sample competes with drug-protein conjugate for limited monoclonal antibody binding sites. Negative result: colored line in Test Region (T) indicates drug concentration below cutoff. Positive result: absence of colored line in Test Region (T) indicates drug concentration at or above cutoff. Control line (C) confirms proper test performance. Used in clinical or home settings; operated by healthcare professionals or lay users. Results are visual; preliminary only. Confirmatory testing via GC/MS or LC/MS required for positive results. Benefits: rapid, preliminary screening for drugs of abuse.
Clinical Evidence
No clinical diagnostic studies performed. Evidence includes analytical performance (precision, cross-reactivity, interference) and a lay user study (n=280) across three sites. Lay user study demonstrated high concordance with LC/MS confirmed samples across various drug concentrations relative to cutoffs. Bench testing confirmed performance across pH 4-9 and specific gravity 1.000-1.035.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Materials: test strips integrated into plastic cup. Energy source: none (capillary action). Connectivity: none. Sterilization: not stated. Software: none.
Indications for Use
Indicated for qualitative detection of single or multiple drugs in human urine for prescription or OTC use. Target population includes individuals requiring drug screening. Contraindications: None stated.
Regulatory Classification
Identification
An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An opiate 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
- AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests (K201630)
Related Devices
- K250727 — AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup · Hangzhou AllTest Biotech Co., Ltd. · Apr 4, 2025
- K242077 — PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup · Aicheck Biotech, Inc. · Aug 14, 2024
- K244043 — AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup · Hangzhou AllTest Biotech Co., Ltd. · Feb 27, 2025
- K163704 — Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card · Healgen Scientific,, LLC · Aug 2, 2017
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
K232659
B Applicant
Guangzhou Decheng Biotechnology Co., Ltd.
C Proprietary and Established Names
Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine 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 |
| DKZ | 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 |
| DIS | 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 |
| DJG | 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 |
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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K232659 - Page 2 of 38
| JXM | 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 |
| DIO | 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 |
| DJR | 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 |
| DJC | Class II | 21 CFR 862.3610 - Methamphetamine test system | TX - Clinical Toxicology |
| NGM | Unclassified | | |
| LCM | Unclassified | | |
| QBF | Class II | 21 CFR 862.3700 - Propoxyphene test system | TX - Clinical Toxicology |
| JXN | Class II | 21 CFR 862.3700 - Propoxyphene test system | TX - Clinical Toxicology |
| QAW | Class II | 21 CFR 862.3910 - Tricyclic antidepressant drugs test system | TX - Clinical Toxicology |
| LFG | 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 |
| LDJ | Class II | 21 CFR 862.3870 - Cannabinoid test system | TX - Clinical Toxicology |
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K232659 - Page 3 of 38
## II Submission/Device Overview:
### A Purpose for Submission:
New Device
### B Measurand:
Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline, Cannabinoids and 6-Acetylmorphine
### C Type of Test:
Qualitative lateral flow immunochromatographic assay
## III Intended Use/Indications for Use:
### A Intended Use(s):
See Indications for Use below.
### B Indication(s) for Use:
Dochek® Multi-Drug Urine Test Cup Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table.
| Drug(Identifier) | Cut-off level (ng/mL) |
| --- | --- |
| Amphetamine (AMP) | 1000 or 500 |
| Secobarbital (BAR) | 300 |
| Buprenorphine (BUP) | 10 |
| Oxazepam (BZO) | 300 |
| Cocaine (COC) | 300 or 150 |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 |
| Methylenedioxymethamphetamine (MDMA) | 500 |
| Methamphetamine (MET) | 1000 or 500 |
| Morphine (MOP300/OPI2000) | 2000 or 300 |
| Methadone (MTD) | 300 |
| Oxycodone (OXY) | 100 |
| Phencyclidine (PCP) | 25 |
| Propoxyphene (PPX) | 300 |
| Nortriptyline (TCA) | 1000 |
| Cannabinoids (THC) | 50 |
| 6-Monoacetylmorphine(6-MAM) | 10 |
Dochek® Multi-Drug Urine Test Cup Rx offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device.
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It is intended for prescription use. For in vitro diagnostic use only.
The test provides only preliminary results. 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 is needed. GC/MS or LC/MS is the recommended confirmatory method.
Dochek® Multi-Drug Urine Test Cup is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table.
| Drug(Identifier) | Cut-off level (ng/mL) |
| --- | --- |
| Amphetamine (AMP) | 1000 or 500 |
| Secobarbital (BAR) | 300 |
| Buprenorphine (BUP) | 10 |
| Oxazepam (BZO) | 300 |
| Cocaine (COC) | 300 or 150 |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 |
| Methylenedioxymethamphetamine (MDMA) | 500 |
| Methamphetamine (MET) | 1000 or 500 |
| Morphine (MOP300/OPI2000) | 2000 or 300 |
| Methadone (MTD) | 300 |
| Oxycodone (OXY) | 100 |
| Phencyclidine (PCP) | 25 |
| Propoxyphene (PPX) | 300 |
| Nortriptyline (TCA) | 1000 |
| Cannabinoids (THC) | 50 |
| 6-Monoacetylmorphine(6-MAM) | 10 |
Dochek® Multi-Drug Urine Test Cup offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device.
It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.
## C Special Conditions for Use Statement(s):
Rx and OTC
K232659 - Page 4 of 38
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D Special Instrument Requirements:
Not applicable.
IV Device/System Characteristics:
A Device Description:
Dochek® Multi-Drug Urine Test Cup Rx and Dochek® Multi-Drug Urine Test Cup are 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. The test strips are integrated into the cup provided and the urine sample is collected directly into the cup containing the strips. Each cup device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format.
B Principle of Operation:
The candidate device is a competitive immunoassay that is used to screen for the presence of various drugs and drug metabolites in urine. It is a chromatographic absorbent device in which, drugs within a urine sample, competitively combined to a limited number of drug monoclonal antibody (mouse) conjugate binding sites. When the test is activated, the urine is absorbed into each test strip by capillary action, mixes with the respective drug monoclonal antibody conjugate, and flows across a pre-coated membrane. When drug within the urine sample is below the detection level of the test, respective drug monoclonal antibody conjugate binds to the respective drug-protein conjugate immobilized in the Test Region (T) of the test strip. This produces a colored Test line in the Test Region (T) of the strip, which, regardless of its intensity, indicates a negative test result.
When sample drug levels are at or above the detection level of the test, the free drug in the sample binds to the respective drug monoclonal antibody conjugate, preventing the respective drug monoclonal antibody conjugate from binding to the respective drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result.
To serve as a procedure control, a colored line will appear at the Control Region (C) of each strip, if the test has been performed properly.
V Substantial Equivalence Information:
A Predicate Device Name(s):
AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
B Predicate 510(k) Number(s):
K201630
K232659 - Page 5 of 38
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C Comparison with Predicate(s):
| Device & Predicate Device(s): | K232659 | K201630 |
| --- | --- | --- |
| Device Trade Name | Dochek® Multi-Drug Urine Test Cup Rx
Dochek® Multi-Drug Urine Test Cup | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Qualitative detection of drugs of abuse in urine. | Same. |
| Specimen | Human urine | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assay based on antigen-antibody reaction | Same |
| General Device Characteristic Differences | | |
| Intended users | Over the Counter (OTC) Use and Prescription Use | Prescription Use Only |
| Cutoff (ng/mL) | Amphetamine (AMP)
1000 or 500
Secobarbital (BAR)
300
Buprenorphine (BUP)
10
Oxazepam (BZO)
300
Cocaine (COC)
300 or 150
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)
300
Methylenedioxymethamphetamine (MDMA)
500
Methamphetamine (MET)
1000 or 500
Morphine (MOP300/OPI2000)
2000 or 300
Methadone (MTD)
300
Oxycodone (OXY)
100
Phencyclidine (PCP)
25 | Same except Amphetamine (AMP): 500 ng/mL
Cocaine (COC): 150 ng/mL
Methamphetamine (MET): 500 ng/mL
Cannabinoids (THC): 20 ng/mL |
K232659 - Page 6 of 38
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| | Propoxyphene (PPX)
300
Nortriptyline (TCA)
1000
Cannabinoids (THC) 50
6-MAM 10 | |
| --- | --- | --- |
VI Standards/Guidance Documents Referenced:
Not applicable.
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
Precision studies were carried out in-house for samples with concentrations of +100% cutoff, +75% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cut off and -100% cutoff. These samples were prepared by spiked target drug in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test cups with two configurations by three operators. Configuration 1 included AMP1000, COC300, MET1000 and OPI2000. Configuration s included AMP500, COC150, MET500 and MOP300. All sample aliquots were tested in a blinded fashion. The results obtained are summarized in the following tables:
K232659 - Page 7 of 38
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| Drug test | % of cutoff | Number of Determinations per lot | Result | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | + | - | + | - | + | - |
| AMP 500 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -75%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 38 | 12 | 38 | 12 | 38 | 12 |
| | +25%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| AMP 1000 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 0 |
| | -75%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 36 | 14 | 37 | 13 | 37 | 13 |
| | +25%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| BAR 300 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -75%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 38 | 12 | 36 | 14 | 36 | 14 |
| | +25%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| BUP 10 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -75%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 35 | 15 | 35 | 15 | 34 | 16 |
| | +25%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| BZO 300 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -75%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 37 | 13 | 38 | 12 | 39 | 11 |
K232659 - Page 8 of 38
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| Drug test | % of cutoff | Number of Determinations per lot | Result | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | + | - | + | - | + | - |
| | +25%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| COC 150 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -75%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 36 | 14 | 36 | 14 | 35 | 15 |
| | +25%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| COC 300 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -75%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 37 | 13 | 38 | 12 | 38 | 12 |
| | +25%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| EDDP 300 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 0 |
| | -75%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 38 | 12 | 38 | 12 | 37 | 13 |
| | +25%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| MDMA 500 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -75%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 40 | 10 | 39 | 11 | 40 | 10 |
| | +25%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| MET 500 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -75%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
K232659 - Page 9 of 38
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| Drug test | % of cutoff | Number of Determinations per lot | Result | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | + | - | + | - | + | - |
| | cutoff | 50 | 35 | 15 | 37 | 13 | 38 | 12 |
| | +25%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| +100%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| MET 1000 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -75%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 40 | 10 | 39 | 11 | 39 | 11 |
| | +25%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| MOP 300 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -75%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 35 | 15 | 36 | 14 | 36 | 14 |
| | +25%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| OPI 2000 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -75%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 41 | 9 | 40 | 10 | 40 | 11 |
| | +25%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| MTD 300 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -75%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 35 | 15 | 36 | 14 | 36 | 14 |
| | +25%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| OXY 100 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 0 |
| | -75%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
K232659 - Page 10 of 38
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| Drug test | % of cutoff | Number of Determinations per lot | Result | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | + | - | + | - | + | - |
| | -25%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 35 | 15 | 35 | 15 | 37 | 13 |
| | +25%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| PCP 25 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -75%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 34 | 16 | 36 | 14 | 35 | 15 |
| | +25%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| PPX 300 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -75%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 38 | 12 | 38 | 12 | 38 | 12 |
| | +25%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| TCA 1000 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -75%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 39 | 11 | 39 | 11 | 38 | 12 |
| | +25%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| THC 50 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -75%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 37 | 13 | 36 | 14 | 36 | 14 |
| | +25%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| 6-AM 10 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 0 |
| | -75%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
K232659 - Page 11 of 38
{11}
K232659 - Page 12 of 38
| Drug test | % of cutoff | Number of Determinations per lot | Result | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | + | - | + | - | + | - |
| | -50%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25%cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 35 | 15 | 35 | 15 | 36 | 14 |
| | +25%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| +100%cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 | |
2. Linearity:
Not Applicable.
3. Analytical Specificity/Interference:
Cross-Reactivity:
To test cross-reactivity, drug metabolites and other structurally related compounds that are likely to cross-react in urine samples were spiked into negative urine and were tested using three lots of each device. The lowest concentration that caused a positive result for each compound is listed below. If no cross reactivity was observed, the highest concentration tested is shown.
| AMP 500 | Result
Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| d-Amphetamine | 500 | 100% |
| d/l-Amphetamine | 1,500 | 33.3% |
| l-Amphetamine | 25,000 | 2% |
| (+/-) 3,4-methylenedioxyamphetamine (MDA) | 2,500 | 20% |
| Phentermine | 1,500 | 33.3% |
| Hydroxyamphetamine | 5,000 | 10% |
| β-Phenylethylamine | 100,000 | 0.5% |
| Tyramine | 100,000 | 0.5% |
| p-Hydroxynorephedrine | 100,000 | 0.5% |
| p-Hydroxyamphetamine | 100,000 | 0.5% |
| d/l-Norephedrine | 100,000 | 0.5% |
| AMP 1000 | Result
Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| d-Amphetamine | 1,000 | 100% |
| d/l-Amphetamine | 3,000 | 33.3% |
| l-Amphetamine | 50,000 | 2% |
| (+/-) 3,4-methylenedioxyamphetamine (MDA) | 2000 | 20% |
| Phentermine | 3,000 | 33.3% |
{12}
| Hydroxyamphetamine | 10,000 | 10% |
| --- | --- | --- |
| β-Phenylethylamine | 100,000 | 1% |
| Tyramine | 100,000 | 1% |
| p-Hydroxynorephedrine | 100,000 | 1% |
| p-Hydroxyamphetamine | 100,000 | 1% |
| d/l-Norephedrine | 100,000 | 1% |
| BAR 300 | Result
Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| Secobarbital | 300 | 100% |
| Amobarbital | 1,000 | 3% |
| Alphenal | 75 | 400% |
| Aprobarbital | 250 | 120% |
| Butabarbital | 100 | 300% |
| Butalbital | 5,000 | 6% |
| Butethal | 500 | 60% |
| Cyclopentobarbital | 500 | 60% |
| Pentobarbital | 200 | 150% |
| Phenobarbital | 300 | 100% |
| BUP 10 | Result
Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| Buprenorphine | 10 | 100% |
| Norbuprenorphine | 50 | 20% |
| Buprenorphine 3-D-glucuronide | 10 | 100% |
| Norbuprenorphine 3-D-glucuronide | 10 | 100% |
| BZO 300 | Result
Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| Oxazepam | 300 | 100% |
| Alprazolam | 150 | 200% |
| α-Hydroxyalprazolam | 1,500 | 20% |
| Bromazepam | 100 | 300% |
| Chlordiazepoxide | 500 | 60% |
| Clobazam | 750 | 40% |
| Clonazepam | 1,500 | 20% |
| Clorazepate dipotassium | 100 | 300% |
| Diazepam | 500 | 60% |
| Estazolam | 500 | 60% |
| Flunitrazepam | 2,500 | 12% |
| Midazolam | 2,000 | 15% |
| Nitrazepam | 2,000 | 15% |
| Nordiazepam | 500 | 60% |
| Temazepam | 250 | 120% |
| Triazolam | 1,000 | 30% |
| Desalkylflurazepam | 500 | 60% |
K232659 - Page 13 of 38
{13}
| Lorazepam | 5,000 | 6% |
| --- | --- | --- |
| Norchlordiazepoxide | 500 | 60% |
| Nordazepam | 1,000 | 30% |
| Delorazepam | 2,000 | 15% |
| Demoxepam | 5,000 | 6% |
| Flurazepam | 500 | 60% |
| COC 150 | Result
Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| Benzoylecgonine | 150 | 100% |
| Cocaine HCl | 500 | 30% |
| Cocaethylene | 5,000 | 3% |
| Ecgonine | 15,000 | 1% |
| COC 300 | Result
Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| Benzoylecgonine | 300 | 100% |
| Cocaine HCl | 750 | 40% |
| Cocaethylene | 12,500 | 2.4% |
| Ecgonine | 30,000 | 1% |
| EDDP 300 | Result
Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 | 100% |
| MDMA 500 | Result
Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| (+/-)3,4-Methylenedioxymethamphetamine HCl (MDMA) | 500 | 100% |
| (+/-)3,4-Methylenedioxyamphetamine HCl (MDA) | 3000 | 17% |
| (+/-)3,4-Methylenedioxyethylamphetamine (MDEA) | 300 | 167% |
| MET 500 | Result
Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| d-Methamphetamine | 500 | 100% |
| d-Amphetamine | 25,000 | 2% |
| Chloroquine | 25,000 | 2% |
| (1R,2S)-(-)-Ephedrine | 25,000 | 2% |
| (-)-Methamphetamine | 12,500 | 4% |
| (+/-)3,4-methylenedioxymethamphetamine | 2,000 | 25% |
K232659 - Page 14 of 38
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K232659 - Page 15 of 38
| (MDMA) | | |
| --- | --- | --- |
| β-Phenylethylamine | 25,000 | 2% |
| Trimethobenzamide | 5,000 | 10% |
| l-Amphetamine | 50,000 | 1% |
| (+/-)3,4-Methylenedioxyethylamphetamine (MDEA) | 15,000 | 3.3% |
| Mephentermine | 25,000 | 2% |
| Methoxyphenamine | 25,000 | 2% |
| Fenfluramine | 37,500 | 1.3% |
| d/l-Amphetamine | 75,000 | 0.7% |
| p-Hydroxymethamphetamine | 15,000 | 3.3% |
| d/l-Methamphetamine | 500 | 100% |
| (+/-) 3,4-Methylenedioxyamphetamine (MDA) | 75,000 | 0.7% |
| MET 1000 | Result Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| d-Methamphetamine | 1,000 | 100% |
| d-Amphetamine | 50,000 | 2% |
| Chloroquine | 50,000 | 2% |
| (1R,2S)-(-)-Ephedrine | 50,000 | 2% |
| (-)-Methamphetamine | 25,000 | 4% |
| (+/-)3,4-methylenedioxumethamphetamine (MDMA) | 4000 | 25% |
| β-Phenylethylamine | 50,000 | 2% |
| Trimethobenzamide | 10,000 | 10% |
| l-Amphetamine | 75,000 | 1.3% |
| (+/-)3,4-Methylenedioxyethylamphetamine (MDEA) | 30,000 | 3.3% |
| Mephentermine | 50,000 | 2% |
| Methoxyphenamine | 50,000 | 2% |
| Fenfluramine | 75,000 | 1.3% |
| p-Hydroxymethamphetamine | 30,000 | 3.3% |
| d/l-Methamphetamine | 1,000 | 100% |
| MOP 300 | Result Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| Morphine | 300 | 100% |
| Codeine | 300 | 100% |
| Hydrocodone | 5,000 | 6% |
| Hydromorphone | 1,000 | 30% |
| 6-Monoacetylmorphine | 150 | 200% |
| Morphine 3-β-D-glucuronide | 1,000 | 30% |
| Ethylmorphine | 100 | 300% |
{15}
K232659 - Page 16 of 38
| Diacetylmorphine (heroin) | 300 | 100% |
| --- | --- | --- |
| Levorphanol | 10,000 | 3% |
| Norcodeine | 5,000 | 6% |
| Oxycodone | 75,000 | 0.4% |
| Thebaine | 3,000 | 10% |
| Normorphine | 3,000 | 10% |
| Oxymorphone | 25,000 | 1.2% |
| Codeine-6-β-D-glucuronide | 500 | 60% |
| d-Norpropoxyphene hydrochloride | 300 | 100% |
| OPI 2000 | Result Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| Morphine | 2,000 | 100% |
| Codeine | 2,000 | 100% |
| Hydrocodone | 12,500 | 16% |
| Hydromorphone | 5,000 | 40% |
| 6-Monoacetylmorphine | 1,500 | 133% |
| Morphine 3-β-D-glucuronide | 2000 | 100% |
| Ethylmorphine | 1,500 | 133% |
| Diacetylmorphine (heroin) | 2,000 | 100% |
| Levorphanol | 75,000 | 2.7% |
| Norcodeine | 12,500 | 16% |
| Thebaine | 5,000 | 40% |
| Normorphine | 50,000 | 4% |
| Codeine-6-β-D-glucuronide | 3,000 | 67% |
| d-Norpropoxyphene hydrochloride | 5,000 | 40% |
| MTD 300 | Result Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| Methadone | 300 | 100% |
| Doxylamine | 50,000 | 0.6% |
| OXY 100 | Result Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| Oxycodone | 100 | 100% |
| Hydrocodone | 5,000 | 2% |
| Hydromorphone | 50,000 | 0% |
| Oxymorphone | 1,000 | 10% |
| Dihydrocodeine | 20,000 | 0.5% |
| Oxymorphone-3β-D-glucuronide | 5,000 | 2% |
| PCP 25 | Result Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| Phencyclidine | 25 | 100% |
| 4-Hydroxy Phencyclidine | 1,500 | 1.7% |
{16}
K232659 - Page 17 of 38
| PPX 300 | Result
Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| d-Propoxyphene | 300 | 100% |
| d-Norpropoxyphene | 300 | 100% |
| TCA 1000 | Result
Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| Notriptyline | 1,000 | 100% |
| Nordoxepin | 1,000 | 100% |
| Trimipramine | 3,000 | 33.3% |
| Promazine | 1,500 | 66.7% |
| Desipramine | 200 | 500% |
| Imipramine | 750 | 133% |
| Clomipramine | 10,000 | 10% |
| Doxepin | 1,250 | 80% |
| Maprotiline | 2,000 | 50% |
| Amitriptyline | 1,500 | 66.7% |
| Promethazine | 25,000 | 4% |
| Cyclobenzaprine | 1,000 | 100% |
| Norclomipramine | 12,500 | 8% |
| THC 50 | Result
Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| 11-nor-Δ9-THC-9-COOH | 50 | 100% |
| 11-nor-Δ8-THC-9-COOH | 30 | 167% |
| (±)-11-Hydroxy-Δ9-THC | 2,500 | 2% |
| Δ8-Tetrahydrocannabinol | 2,000 | 2.5% |
| Δ9-Tetrahydrocannabinol | 5,000 | 1% |
| Cannabinol | 10,000 | 0.5% |
| Cannabidiol (CBD) | 100,000 | 0.05% |
| (±)-11-nor-9-carboxy-Δ 9-THC | 100 | 50% |
| 11-nor-Δ9-THC-carboxy glucuronide | 100 | 50% |
| 6-AM 10 | Result
Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| 6-Monoacetylmorphine | 10 | 100% |
| Hydrocodone | 50,000 | 0.02% |
| Hydromorphone | 10,000 | 0.1% |
| Morphine | 100,000 | 0.01% |
| 6-Monoacetylmorphine | 10 | 100% |
| Oxymorphone | 10,000 | 0.1% |
| Procaine | 50,000 | 0.02% |
| Thebaine | 10,000 | 0.1% |
| Diacetylmorphine (heroin) | 25 | 40% |
| Acetylcodeine | 100,000 | <0.1% |
{17}
Interfering substances:
To evaluate potential interference, non-structurally related compounds were added to drug-free urine and to urine samples containing the target drugs at 25% below and 25% above each corresponding cutoff. Compounds that show no interference at a concentration of 100µg/mL are summarized in the following table.
| 3-Hydroxytyramine | Diflunisal | Oxolinic Acid |
| --- | --- | --- |
| Acetaminophen | Digoxin | Oxymetazoline |
| Acetylsalicylic Acid | Diphenhydramine | Paliperidone |
| Acyclovir | Dopamine HCl | Papaverine |
| Albumin (100mg/dL) | D-Pseudoephedrine | Penicillin-G |
| Albuterol sulfate(Proair HFA) | Duloxetine | Penicillin V Potassium |
| Aminophylline | Erythromycin | Phenacetin (Acetophenetidin) |
| Aminopyrine | Esomeprazole Magnesium | Phenelzine |
| Amoxicillin | Ethanol (1%) | Prednisone |
| Ampicillin | Fenoprofen | Pregablin |
| Apomorphine | Fluoxetine Hydrochloride | Quinine |
| Aripiprazole | Furosemide | Ranitidine |
| Aspartame | Gabapentin | Rifampicin |
| Atomoxetine | Gentisic Acid | Risperidone |
| Atorvastatin Calcium | Glucose | Salicylic Acid |
| Atropine | Hemoglobin | Serotonin |
| Azithromycin | Hydralazine | Sertraline Hydrochloride |
| Benzilic acid | Hydrochlorothiazide | Sildenafil Citrate |
| Benzocaine | Hydrocortisone | Simvastatin |
| Benzoic acid | Ibuprofen | Sulfamethazine |
| Bilirubin | Isoxsuprine | Sulindac |
| Bupropion | Ketamine | Tetrahydrozoline |
| Captopril | Ketoprofen | Theophylline |
| Carbamazepine | Labetalol | Thiamine |
| Cefradine | Levofloxacin Hydrochloride | Thioridazine |
| Cephalexin | Levonorgestrel | Tramadol Hydrochloride |
| Chloral Hydrate | Levothyroxine Sodium | Trazodone Hydrochloride |
| Chloramphenicol | Lidocaine Hydrochloride | Triamterene |
| Chlorothiazide | Lisinopril | Trifluoperazine |
| chlorpheniramine | Loperamide | Trimethoprim |
| Cholesterol | Loratadine | Uric Acid |
K232659 - Page 18 of 38
{18}
| Ciprofloxacin Hydrochloride | Magnesium | Venlafaxine HCl |
| --- | --- | --- |
| Citalopram | Meperidine | Verapamil |
| Clarithromycin | Meprobamate | Vitamin B2 |
| Clonidine | Metoprolol Tartrate | Vitamin C (Ascorbic acid) |
| Clozapine | Mifepristone | Zomepirac |
| Conjugated Estrogens | N-Acetylprocainamide | β-Estradiol |
| Cortisone | Nalidixic Acid | Chlorpromazine |
| Cotinine | Naproxen | Perphenazine |
| Creatinine | Niacinamide | Tetrahydrocortisone 3-(β-D-glucuronide) |
| D, L- Isoproterenol | Nicotine | Tetrahydrocortisone 3-acetate |
| D, L-Octopamine | Nifedipine | Ecgonine methyl ester |
| D, L-Propranolol | Nitroglycerin | Methoxyphenamine (except MET test) |
| D, L-Tryptophan | Norethindrone | Naloxone |
| D, L-Tyrosine | Noscapine | Naltrexone |
| Deoxycorticosterone | O-Hydroxyhippuric Acid | Tyramine (except AMP test) |
| Dextromethorphan | Omeprazole | |
| Diclofenac | Oxalic Acid | |
## Effect of Urinary Specific Gravity and pH:
To investigate the effect of urine specific gravity and urine pH, urine samples, with specific gravity ranging from 1.000 to 1.035 or urine samples with pH ranging from 4 to 9 were spiked with the target drugs to concentrations at 25% below and 25% above Cutoff levels. These samples were tested using three lots with two configurations. 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):
The device is traceable to commercially available reference materials.
6. Detection Limit:
Not applicable.
7. Assay Cut-Off:
Refer to Section VII.A.1
K232659 - Page 19 of 38
{19}
B Comparison Studies:
1. Method Comparison with Predicate Device:
Method comparison studies were performed in-house by three operators. Eighty (80) unaltered clinical samples were run for each target drug. The samples were tested in a blinded fashion and compared to LC/MS results. The results are presented in the tables below:
AMP 1000:
| Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 6 | 31 |
| | Negative | 15 | 8 | 17 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 6 | 31 |
| | Negative | 15 | 8 | 17 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 7 | 31 |
| | Negative | 15 | 8 | 17 | 2 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 0955 | 1014.625 | Negative |
| Viewer B | 0955 | 1014.625 | Negative |
| Viewer C | 0955 | 1014.625 | Negative |
| Viewer A | 0936 | 1056.71 | Negative |
| Viewer B | 0936 | 1056.71 | Negative |
| Viewer C | 0936 | 1056.71 | Negative |
| Viewer A | 0903 | 1141.794 | Negative |
| Viewer B | 0903 | 1141.794 | Negative |
AMP 500:
| Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 8 | 30 |
| | Negative | 15 | 12 | 13 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 8 | 30 |
K232659 - Page 20 of 38
{20}
| | Negative | 15 | 12 | 13 | 2 | 0 |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer C | Positive | 0 | 0 | 0 | 8 | 30 |
| | Negative | 15 | 12 | 13 | 2 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 1345 | 512.815 | Negative |
| Viewer B | 1345 | 512.815 | Negative |
| Viewer C | 1345 | 512.815 | Negative |
| Viewer A | 1297 | 545.751 | Negative |
| Viewer B | 1297 | 545.751 | Negative |
| Viewer C | 1297 | 545.751 | Negative |
BAR 300:
| Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 16 | 22 |
| | Negative | 15 | 18 | 7 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 15 | 22 |
| | Negative | 15 | 18 | 7 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 16 | 22 |
| | Negative | 15 | 18 | 7 | 2 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 0221 | 302.963 | Negative |
| Viewer B | 0221 | 302.963 | Negative |
| Viewer C | 0221 | 302.963 | Negative |
| Viewer B | 0238 | 304.207 | Negative |
| Viewer A | 0173 | 312.828 | Negative |
| Viewer B | 0173 | 312.828 | Negative |
| Viewer C | 0173 | 312.828 | Negative |
BUP 10:
K232659 - Page 21 of 38
{21}
| Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 2 | 29 | 10 |
| | Negative | 15 | 13 | 10 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 29 | 10 |
| | Negative | 15 | 13 | 11 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 29 | 10 |
| | Negative | 15 | 13 | 10 | 1 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 0136 | 8.76 | Positive |
| Viewer B | 0136 | 8.76 | Positive |
| Viewer C | 0136 | 8.76 | Positive |
| Viewer A | 0137 | 8.785 | Positive |
| Viewer C | 0137 | 8.785 | Positive |
| Viewer A | 0141 | 10.761 | Negative |
| Viewer B | 0141 | 10.761 | Negative |
| Viewer C | 0141 | 10.761 | Negative |
BZO 300:
| Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 2 | 7 | 31 |
| | Negative | 15 | 11 | 12 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 7 | 31 |
| | Negative | 15 | 11 | 13 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 8 | 31 |
| | Negative | 15 | 11 | 13 | 1 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 0405 | 269.424 | Positive |
| Viewer A | 0428 | 290.449 | Positive |
K232659 - Page 22 of 38
{22}
K232659 - Page 23 of 38
COC 300:
| Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 11 | 27 |
| | Negative | 15 | 13 | 11 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 11 | 27 |
| | Negative | 15 | 13 | 10 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 11 | 27 |
| | Negative | 15 | 13 | 10 | 2 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 0632 | 284.614 | Positive |
| Viewer B | 0632 | 284.614 | Positive |
| Viewer C | 0632 | 284.614 | Positive |
| Viewer B | 0602 | 295.071 | Positive |
| Viewer C | 0602 | 295.071 | Positive |
| Viewer A | 0620 | 307.773 | Negative |
| Viewer B | 0620 | 307.773 | Negative |
| Viewer C | 0620 | 307.773 | Negative |
| Viewer A | 0630 | 308.012 | Negative |
| Viewer B | 0630 | 308.012 | Negative |
| Viewer C | 0630 | 308.012 | Negative |
COC 150:
| Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
{23}
| Viewer A | Positive | 0 | 0 | 1 | 13 | 25 |
| --- | --- | --- | --- | --- | --- | --- |
| | Negative | 15 | 12 | 12 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 13 | 25 |
| | Negative | 15 | 12 | 12 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 13 | 25 |
| | Negative | 15 | 12 | 12 | 2 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 1446 | 138.861 | Positive |
| Viewer B | 1446 | 138.861 | Positive |
| Viewer C | 1446 | 138.861 | Positive |
| Viewer A | 1512 | 156.470 | Negative |
| Viewer B | 1512 | 156.470 | Negative |
| Viewer C | 1512 | 156.470 | Negative |
| Viewer A | 1505 | 162.099 | Negative |
| Viewer B | 1505 | 162.099 | Negative |
| Viewer C | 1505 | 162.099 | Negative |
EDDP 300:
| Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 11 | 29 |
| | Negative | 15 | 6 | 19 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 11 | 29 |
| | Negative | 15 | 6 | 18 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 11 | 29 |
| | Negative | 15 | 6 | 18 | 0 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer B | 1591 | 296.944 | Positive |
| Viewer C | 1591 | 296.944 | Positive |
MDMA 500:
K232659 - Page 24 of 38
{24}
| Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 9 | 30 |
| | Negative | 15 | 14 | 11 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 9 | 30 |
| | Negative | 15 | 14 | 10 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 9 | 30 |
| | Negative | 15 | 14 | 10 | 1 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer B | 0762 | 458.975 | Positive |
| Viewer C | 0762 | 458.975 | Positive |
| Viewer A | 0750 | 565.340 | Negative |
| Viewer B | 0750 | 565.340 | Negative |
| Viewer C | 0750 | 565.340 | Negative |
MET 1000:
| Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 8 | 30 |
| | Negative | 15 | 8 | 17 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 8 | 30 |
| | Negative | 15 | 8 | 17 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 8 | 30 |
| | Negative | 15 | 8 | 17 | 2 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 972 | 1002.105 | Negative |
| Viewer B | 972 | 1002.105 | Negative |
| Viewer C | 972 | 1002.105 | Negative |
| Viewer A | 1025 | 1026.596 | Negative |
| Viewer B | 1025 | 1026.596 | Negative |
K232659 - Page 25 of 38
{25}
MET 500:
| Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 9 | 30 |
| | Negative | 15 | 14 | 11 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 9 | 30 |
| | Negative | 15 | 14 | 11 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 10 | 30 |
| | Negative | 15 | 14 | 11 | 0 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 1403 | 507.553 | Negative |
| Viewer B | 1403 | 507.553 | Negative |
OPI 2000:
| Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 2 | 9 | 29 |
| | Negative | 15 | 9 | 14 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 9 | 29 |
| | Negative | 15 | 9 | 14 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 9 | 29 |
| | Negative | 15 | 9 | 14 | 2 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 0817 | 1872.771 | Positive |
| Viewer B | 0817 | 1872.771 | Positive |
| Viewer C | 0817 | 1872.771 | Positive |
| Viewer A | 0855 | 1996.034 | Positive |
| Viewer B | 0855 | 1996.034 | Positive |
K232659 - Page 26 of 38
{26}
MOP 300:
| Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 2 | 19 | 21 |
| | Negative | 15 | 12 | 11 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 18 | 21 |
| | Negative | 15 | 12 | 11 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 18 | 21 |
| | Negative | 15 | 12 | 11 | 1 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 1279 | 248.796 | Positive |
| Viewer B | 1279 | 248.796 | Positive |
| Viewer C | 1279 | 248.796 | Positive |
| Viewer A | 1259 | 249.557 | Positive |
| Viewer B | 1259 | 249.557 | Positive |
| Viewer C | 1259 | 249.557 | Positive |
| Viewer B | 1264 | 308.896 | Negative |
| Viewer C | 1264 | 308.896 | Negative |
MTD 300:
| Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 2 | 8 | 30 |
| | Negative | 15 | 12 | 11 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 9 | 30 |
K232659 - Page 27 of 38
{27}
| | Negative | 15 | 12 | 11 | 1 | 0 |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer C | Positive | 0 | 0 | 2 | 9 | 30 |
| | Negative | 15 | 12 | 11 | 1 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 1159 | 271.186 | Positive |
| Viewer B | 1159 | 271.186 | Positive |
| Viewer C | 1159 | 271.186 | Positive |
| Viewer A | 1185 | 273.035 | Positive |
| Viewer B | 1185 | 273.035 | Positive |
| Viewer C | 1185 | 273.035 | Positive |
| Viewer A | 1129 | 308.556 | Negative |
| Viewer B | 1129 | 308.556 | Negative |
| Viewer C | 1129 | 308.556 | Negative |
| Viewer A | 1123 | 324.733 | Negative |
OXY 100:
| Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 2 | 9 | 29 |
| | Negative | 15 | 12 | 11 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 10 | 29 |
| | Negative | 15 | 12 | 11 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 10 | 29 |
| | Negative | 15 | 12 | 11 | 1 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 0379 | 85.212 | Positive |
| Viewer B | 0379 | 85.212 | Positive |
| Viewer C | 0379 | 85.212 | Positive |
| Viewer A | 0375 | 87.649 | Positive |
| Viewer B | 0375 | 87.649 | Positive |
| Viewer C | 0375 | 87.649 | Positive |
| Viewer A | 0397 | 106.706 | Negative |
K232659 - Page 28 of 38
{28}
PCP 25:
| Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 28 | 12 |
| | Negative | 15 | 13 | 12 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 27 | 12 |
| | Negative | 15 | 13 | 12 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 27 | 12 |
| | Negative | 15 | 13 | 12 | 1 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer B | 0053 | 25.901 | Negative |
| Viewer C | 0053 | 25.901 | Negative |
PPX 300:
| Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 12 | 28 |
| | Negative | 15 | 13 | 11 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 10 | 28 |
| | Negative | 15 | 13 | 11 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 11 | 28 |
| | Negative | 15 | 13 | 10 | 1 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 0504 | 285.846 | Positive |
| Viewer B | 0504 | 285.846 | Positive |
| Viewer C | 0504 | 285.846 | Positive |
K232659 - Page 29 of 38
{29}
TCA 1000:
| Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 6 | 32 |
| | Negative | 15 | 13 | 12 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 6 | 32 |
| | Negative | 15 | 13 | 12 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 6 | 32 |
| | Negative | 15 | 13 | 12 | 2 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 0688 | 1051.49 | Negative |
| Viewer B | 0688 | 1051.49 | Negative |
| Viewer C | 0688 | 1051.49 | Negative |
| Viewer A | 0653 | 1135.56 | Negative |
| Viewer B | 0653 | 1135.56 | Negative |
| Viewer C | 0653 | 1135.56 | Negative |
THC 50:
| Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 9 | 30 |
| | Negative | 15 | 13 | 11 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 9 | 30 |
| | Negative | 15 | 13 | 11 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 9 | 30 |
| | Negative | 15 | 13 | 10 | 1 | 0 |
Discordant Results
K232659 - Page 30 of 38
{30}
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer B | 0300 | 41.179 | Positive |
| Viewer C | 0300 | 41.179 | Positive |
| Viewer A | 0317 | 49.391 | Positive |
| Viewer C | 0317 | 49.391 | Positive |
| Viewer A | 0312 | 55.644 | Negative |
| Viewer B | 0312 | 55.644 | Negative |
| Viewer C | 0312 | 55.644 | Negative |
6-AM 10:
| Test Cup | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 3 | 28 | 10 |
| | Negative | 15 | 13 | 9 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 3 | 28 | 10 |
| | Negative | 15 | 13 | 9 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 3 | 28 | 10 |
| | Negative | 15 | 13 | 9 | 2 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 1091 | 9.006 | Positive |
| Viewer B | 1091 | 9.006 | Positive |
| Viewer C | 1091 | 9.006 | Positive |
| Viewer A | 1081 | 9.465 | Positive |
| Viewer B | 1081 | 9.465 | Positive |
| Viewer C | 1081 | 9.465 | Positive |
| Viewer A | 1053 | 9.967 | Positive |
| Viewer B | 1053 | 9.967 | Positive |
| Viewer C | 1053 | 9.967 | Positive |
| Viewer A | 1048 | 10.237 | Negative |
| Viewer B | 1048 | 10.237 | Negative |
| Viewer C | 1048 | 10.237 | Negative |
| Viewer A | 1052 | 10.257 | Negative |
| Viewer B | 1052 | 10.257 | Negative |
| Viewer C | 1052 | 10.257 | Negative |
K232659 - Page 31 of 38
{31}
2. Lay user study:
A lay user study was performed using two configurations of Dochek® Multi-Drug Urine Test Cup at three intended use sites with 280 lay persons. The lay users had diverse ages and educational and professional backgrounds. Urine samples were prepared at multiple concentrations (Negative (-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. Each sample was aliquoted into individual containers and tested in a blinded fashion. Each participant was provided with the package insert, one blind-labeled sample and a test cup device, and was not provided any other assistance. Summary results are shown below:
Result of Dochek® Multi-Drug Urine Test Cup Configuration 1 (included AMP1000, COC300, MET1000 and OPI2000):
| Drugs | % of Cut-off | Number of samples | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| AMP 1000 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 20 | 0 | 100 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| BAR 300 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 2 | 18 | 90 |
| | +25% Cut-off | 20 | 18 | 2 | 90 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| BUP 10 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 2 | 18 | 90 |
| | +25% Cut-off | 20 | 18 | 2 | 90 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| BZO 300 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 0 | 20 | 100 |
| | +25% Cut-off | 20 | 18 | 2 | 90 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| COC 300 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
K232659 - Page 32 of 38
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K232659 - Page 33 of 38
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| --- | --- | --- | --- | --- | --- |
| | -25% Cut-off | 20 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 18 | 2 | 90 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| EDDP 300 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 0 | 20 | 100 |
| | +25% Cut-off | 20 | 20 | 0 | 100 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| MDMA 500 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 2 | 18 | 90 |
| | +25% Cut-off | 20 | 19 | 1 | 95 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| MET 1000 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 0 | 20 | 100 |
| | +25% Cut-off | 20 | 19 | 1 | 95 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| OPI 2000 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 0 | 20 | 100 |
| | +25% Cut-off | 20 | 19 | 1 | 95 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| MTD 300 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 2 | 18 | 90 |
| | +25% Cut-off | 20 | 18 | 2 | 90 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| OXY 100 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
{33}
Result of Dochek® Multi-Drug Urine Test Cup Configuration 2 (included AMP500, COC150, MET500 and MOP300):
| Drugs | % of Cut-off | Number of samples | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| AMP 500 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
K232659 - Page 34 of 38
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K232659 - Page 35 of 38
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| --- | --- | --- | --- | --- | --- |
| | -25% Cut-off | 20 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 18 | 2 | 90 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| BAR 300 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 2 | 18 | 90 |
| | +25% Cut-off | 20 | 18 | 2 | 90 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| BUP 10 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 0 | 20 | 100 |
| | +25% Cut-off | 20 | 19 | 1 | 95 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| BZO 300 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 2 | 18 | 90 |
| | +25% Cut-off | 20 | 18 | 2 | 90 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| COC 150 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 2 | 18 | 90 |
| | +25% Cut-off | 20 | 20 | 0 | 100 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| EDDP 300 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 2 | 18 | 90 |
| | +25% Cut-off | 20 | 20 | 0 | 100 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| MDMA 500 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 2 | 18 | 90 |
| | +25% Cut-off | 20 | 20 | 0 | 100 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
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K232659 - Page 36 of 38
| | | | | | |
| --- | --- | --- | --- | --- | --- |
| MET 500 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 0 | 20 | 100 |
| | +25% Cut-off | 20 | 18 | 2 | 90 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| MOP 300 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 2 | 18 | 90 |
| | +25% Cut-off | 20 | 18 | 2 | 90 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| MTD 300 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 0 | 20 | 100 |
| | +25% Cut-off | 20 | 18 | 2 | 90 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| OXY 100 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 2 | 18 | 90 |
| | +25% Cut-off | 20 | 18 | 2 | 90 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| PCP 25 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 19 | 1 | 95 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| PPX 300 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 2 | 18 | 90 |
| | +25% Cut-off | 20 | 19 | 1 | 95 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| TCA 1000 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
{36}
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| --- | --- | --- | --- | --- | --- |
| | -25% Cut-off | 20 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 19 | 1 | 95 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| THC 50 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 2 | 18 | 90 |
| | +25% Cut-off | 20 | 18 | 2 | 90 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| 6-AM 10 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 20 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 20 | 0 | 100 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
3. **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):**
Read Time:
The sponsor provided data to support the recommendation for read time. The sponsor recommends that the results should be read 5-60 minutes after testing.
D **Clinical Cut-Off:**
Not Applicable.
K232659 - Page 37 of 38
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K232659 - Page 38 of 38
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.
