Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard
Device Facts
| Record ID | K240698 |
|---|---|
| Device Name | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard |
| Applicant | Guangzhou Decheng Biotechnology Co., Ltd. |
| Product Code | DJG · Clinical Toxicology |
| Decision Date | May 10, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
Indications for Use
Dochek® Multi-Drug Urine Test Dipcard Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations: [Table of drugs/cutoffs]. Dochek® Multi-Drug Urine Test Dipcard 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. 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 Dipcard is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations: [Table of drugs/cutoffs]. Dochek® Multi-Drug Urine Test Dipcard 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. Device consists of test strips integrated into plastic dipcard; absorbent end contacts urine sample. Principle: competitive immunoassay; drug in sample competes with drug-protein conjugate for limited monoclonal antibody binding sites. Negative result: colored line in Test Region (T) indicates drug below detection level. Positive result: absence of line in Test Region (T) indicates drug at or above detection level. Control line (C) confirms proper test performance. Used in clinical or home settings; operated by healthcare professionals or lay users. Provides preliminary results; requires professional judgment and confirmatory testing (GC/MS or LC/MS) for clinical decision-making.
Clinical Evidence
Bench testing only. Precision/reproducibility studies performed across 25 days using three lots. Analytical specificity/cross-reactivity evaluated against numerous compounds. Method comparison study performed with 80 clinical samples per drug compared to LC/MS. Lay user study conducted with 280 participants across three sites using various drug concentrations confirmed by LC/MS, demonstrating high accuracy.
Technological Characteristics
Lateral flow immunochromatographic assay. Materials: plastic dipcard with integrated test strips. Principle: competitive binding. Energy source: none (capillary action). Connectivity: none. Sterilization: not stated. Software: none.
Indications for Use
Indicated for qualitative detection of single or multiple drugs of abuse in human urine. Intended for prescription (Rx) or over-the-counter (OTC) use. Provides preliminary results; requires confirmatory testing (GC/MS or LC/MS).
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
- Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup (K232659)
Related Devices
- K250067 — Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro · Guangzhou Decheng Biotechnology Co., Ltd. · Feb 20, 2025
- K244043 — AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup · Hangzhou AllTest Biotech Co., Ltd. · Feb 27, 2025
- K253567 — Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card · Healgen Scientific,, LLC · Dec 23, 2025
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
K240698
B Applicant
Guangzhou Decheng Biotechnology Co., Ltd.
C Proprietary and Established Names
Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard
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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K240698 - Page 2 of 45
| 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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K240698 - Page 3 of 45
## 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 Dipcard Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations:
| Drug (Identifier) | Cut-off level |
| --- | --- |
| Amphetamine (AMP) | 1000 or 500 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Methamphetamine (MET) | 1000 or 500 ng/mL |
| Morphine (MOP300/OPI2000) | 2000 or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
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K240698 - Page 4 of 45
Oxycodone (OXY) 100 ng/mL
Phencyclidine (PCP) 25 ng/mL
Propoxyphene (PPX) 300 ng/mL
Nortriptyline (TCA) 1000 ng/mL
Cannabinoids (THC) 50 ng/mL
6-Monoacetylmorphine (6-MAM) 10 ng/mL
Dochek® Multi-Drug Urine Test Dipcard 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. 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 Dipcard is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations:
| Drug (Identifier) | Cut-off level |
| --- | --- |
| Amphetamine (AMP) | 1000 or 500 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Methamphetamine (MET) | 1000 or 500 ng/mL |
| Morphine (MOP300/OPI2000) | 2000 or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
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K240698 - Page 5 of 45
Nortriptyline (TCA) 1000 ng/mL
Cannabinoids (THC) 50 ng/mL
6-Monoacetylmorphine (6-MAM) 10 ng/mL
Dochek® Multi-Drug Urine Test Dipcard 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
## D Special Instrument Requirements:
Not applicable.
## IV Device/System Characteristics:
## A Device Description:
Dochek® Multi-Drug Urine Test Dipcard Rx and Dochek® Multi-Drug Urine Test Dipcard are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
This device is a dipcard format in which the test strips are integrated into the plastic dipcard. After removing the cap of the dipcard, the absorbent end of the test strips is exposed and can be in direct contact with the urine sample. The device is in a ready-to-use format and no longer requires assembly before use. The products are single-use in vitro diagnostic devices.
## 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.
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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):
Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
B Predicate 510(k) Number(s):
K232659
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K240698 | K232659 |
| --- | --- | --- |
| Device Trade Name | Dochek® Multi-Drug Urine Test Dipcard Rx and Dochek® Multi-Drug Urine Test Dipcard | Dochek® Multi-Drug Urine Test Cup Rx Dochek® Multi-Drug Urine Test Cup |
| 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 |
| Intended Users | Over the Counter (OTC) Use and Prescription Use | Same |
| General Device Characteristic Differences | | |
| Format | Test dipcard | Test cup |
VI Standards/Guidance Documents Referenced:
None referenced.
K240698 - Page 6 of 45
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VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
Precision studies were performed 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. Samples were prepared by spiking target drug into drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. Two configurations of samples were tested, as listed below. For each configuration, testing was performed over two runs per day for 25 days using three lots with one operator per lot.
Configuration 1 consisted of:
| Target Drug | Cutoff value |
| --- | --- |
| Amphetamine (AMP) | 1000 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Morphine (OPI) | 2000 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| 6-Monoacetylmorphine (6-MAM) | 10 ng/mL |
Configuration 2 consisted of:
| Target Drug | Cutoff value |
| --- | --- |
| Amphetamine (AMP) | 500 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL |
K240698 - Page 7 of 45
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| Target Drug | Cutoff value |
| --- | --- |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Methamphetamine (MET) | 500 ng/mL |
| Morphine (MOP) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| 6-Monoacetylmorphine (6-MAM) | 10 ng/mL |
The results obtained are summarized in the following tables:
| Analyte | % 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 | 37 | 13 | 36 | 14 | 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 |
K240698 - Page 8 of 45
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| Analyte | % of cutoff | Number of Determinations per lot | Result | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | + | - | + | - | + | - |
| 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 | 36 | 14 | 38 | 12 | 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 | 36 | 16 | 35 | 15 | 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 |
| 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 | 39 | 11 | 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 |
K240698 - Page 9 of 45
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| Analyte | % of cutoff | Number of Determinations per lot | Result | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | + | - | + | - | + | - |
| 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 | 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 |
| 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 | 38 | 12 | 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 |
| 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 | 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 |
K240698 - Page 10 of 45
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| Analyte | % of cutoff | Number of Determinations per lot | Result | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | + | - | + | - | + | - |
| 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 | 10 | 10 | 40 | 10 | 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 |
| 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 |
| | Cutoff | 50 | 38 | 12 | 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 |
| 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 | 39 | 11 | 40 | 10 | 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 |
K240698 - Page 11 of 45
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| Analyte | % of cutoff | Number of Determinations per lot | Result | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | + | - | + | - | + | - |
| 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 | 36 | 14 | 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 |
| 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 | 40 | 10 | 41 | 9 | 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 |
| 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 | 36 | 14 | 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 |
K240698 - Page 12 of 45
{12}
| Analyte | % of cutoff | Number of Determinations per lot | Result | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | + | - | + | - | + | - |
| 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 |
| | -25% cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | Cutoff | 50 | 37 | 13 | 35 | 15 | 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 |
| 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 | 35 | 15 | 34 | 16 | 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 |
| 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 |
K240698 - Page 13 of 45
{13}
| Analyte | % of cutoff | Number of Determinations per lot | Result | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | + | - | + | - | + | - |
| 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 | 38 | 12 | 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 |
| 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 | 36 | 14 | 37 | 13 | 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 |
| | -50% cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25% cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | Cutoff | 50 | 36 | 14 | 35 | 15 | 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 |
| | | | | | | | | |
2. Linearity:
Not Applicable.
3. Analytical Specificity/Interference:
Cross-Reactivity:
K240698 - Page 14 of 45
{14}
To test cross-reactivity, drug metabolites and other structurally related compounds that are likely to cross-react 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 along with the corresponding % cross-reactivity. If no cross-reactivity was observed, the highest concentration tested is listed below along with the cross-reactivity as a “<” concentration.
| Drug/Cutoff | Cross-reacting compound | Lowest concentration causing a positive result (ng/mL) | % Cross- Reactivity |
| --- | --- | --- | --- |
| AMP 1000 | d-Amphetamine | 1,000 | 100% |
| | d/l-Amphetamine | 3,000 | 33.3% |
| | l-Amphetamine | 50,000 | 2% |
| | (+/-) 3,4-methylenedioxyamphetamine (MDA) | 5,000 | 20% |
| | Phentermine | 3,000 | 33.3% |
| | Hydroxyamphetamine | 10,000 | 10% |
| | d-Methamphetamine | 100,000 | <1% |
| | l-Methamphetamine | 100,000 | <1% |
| | (+/-)3,4-Methylenedioxyethylamphetamine (MDEA) | 100,000 | <1% |
| | (+/-)3,4-Methylenedioxymethamphetamine (MDMA) | 100,000 | <1% |
| | (1R,2S)-(-)-Ephedrine | 100,000 | <1% |
| | β-Phenylethylamine | 100,000 | 1% |
| | Tyramine | 100,000 | 1% |
| | p-Hydroxynorephedrine | 100,000 | 1% |
| | Phenylpropanolamine | 100,000 | <1% |
| | (±)Phenylpropanolamine | 100,000 | <1% |
| | p-Hydroxyamphetamine | 100,000 | 1% |
| | d/l-Norephedrine | 100,000 | 1% |
K240698 - Page 15 of 45
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K240698 - Page 16 of 45
| Drug/Cutoff | Cross-reacting compound | Lowest concentration causing a positive result (ng/mL) | % Cross- Reactivity |
| --- | --- | --- | --- |
| | Benzphetamine | 100,000 | <1% |
| | l-Epinephrine | 100,000 | <1% |
| | d/l-Epinephrine | 100,000 | <1% |
| BAR 300 | Secobarbital | 300 | 100% |
| | Amobarbital | 1,000 | 30% |
| | 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 | Buprenorphine | 10 | 100% |
| | Norbuprenorphine | 50 | 20% |
| | Buprenorphine 3-D-glucuronide | 10 | 100% |
| | Norbuprenorphine 3-D-glucuronide | 10 | 100% |
| | Morphine | 100,000 | <0.1% |
| | Oxymorphone | 100,000 | <0.1% |
| | Hydromorphone | 100,000 | <0.1% |
| | 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% |
{16}
K240698 - Page 17 of 45
| Drug/Cutoff | Cross-reacting compound | Lowest concentration causing a positive result (ng/mL) | % Cross- Reactivity |
| --- | --- | --- | --- |
| BZO 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% |
| Lorazepam | 5,000 | 6% |
| Norchlordiazepoxide | 500 | 60% |
| Nordazepam | 1,000 | 30% |
| Delorazepam | 2,000 | 15% |
| Demoxepam | 5,000 | 6% |
| Flurazepam | 500 | 60% |
| COC 300 | Benzoylecgonine | 300 | 100% |
| Cocaine HCl | 750 | 40% |
| Cocaethylene | 12,500 | 2.4% |
| Ecgonine | 30,000 | 1% |
| Ecgonine methyl ester | 100,000 | <0.3% |
| Norcocaine | 100,000 | <0.3% |
| EDDP 300 | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 | 100% |
| Methadone | 100,000 | <0.3% |
| EMDP | 100,000 | <0.3% |
| Doxylamine | 100,000 | <0.3% |
| Levacetylmethadol (LAAM) | 100,000 | <0.3% |
| Disopyramide | 100,000 | <0.3% |
| Alpha Methadol | 100,000 | <0.3% |
{17}
K240698 - Page 18 of 45
| Drug/Cutoff | Cross-reacting compound | Lowest concentration causing a positive result (ng/mL) | % Cross- Reactivity |
| --- | --- | --- | --- |
| MDMA 500 | (+/-) 3,4-
Methylenedioxymethamphetamine
HCl (MDMA) | 500 | 100% |
| | (+/-) 3,4-
Methylenedioxyamphetamine HCl
(MDA) | 3,000 | 17% |
| | (+/-) 3,4-
Methylenedioxyethylamphetamine
(MDEA) | 300 | 167% |
| | d-Methamphetamine | 100,000 | <0.5% |
| | d-Amphetamine | 100,000 | <0.5% |
| | l-Methamphetamine | 100,000 | <0.5% |
| | l-Amphetamine | 100,000 | <0.5% |
| MET 1000 | 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-
methylenedioxymethamphetamine
(MDMA) | 4,000 | 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% |
{18}
K240698 - Page 19 of 45
| Drug/Cutoff | Cross-reacting compound | Lowest concentration causing a positive result (ng/mL) | % Cross- Reactivity |
| --- | --- | --- | --- |
| | Procaine | 100,000 | <1% |
| | d/l-Amphetamine | 100,000 | <1% |
| | p-Hydroxymethamphetamine | 30,000 | 3.3% |
| | l-Phenylephrine | 100,000 | <1% |
| | d/l-Methamphetamine | 1,000 | 100% |
| | (+/-) 3,4-Methylenedioxyamphetamine (MDA) | 100,000 | <1% |
| OPI 2000 | 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 | 2,000 | 100% |
| | Ethylmorphine | 1,500 | 133% |
| | Diacetylmorphine (heroin) | 2,000 | 100% |
| | Levorphanol | 75,000 | 2.7% |
| | Norcodeine | 12,500 | 16% |
| | Oxycodone | 100,000 | <2% |
| | Thebaine | 5,000 | 40% |
| | Normorphine | 50,000 | 4% |
| | Oxymorphone | 100,000 | <2% |
| | Procaine | 100,000 | <2% |
| | Codeine-6-β-D-glucuronide | 3,000 | 67% |
| | d-Norpropoxyphene hydrochloride | 5,000 | 40% |
| MTD 300 | Methadone | 300 | 100% |
| | EDDP | 100,000 | <0.3% |
| | Doxylamine | 50,000 | 0.6% |
| | Levacetylmethadol (LAAM) | 100,000 | <0.3% |
{19}
K240698 - Page 20 of 45
| Drug/Cutoff | Cross-reacting compound | Lowest concentration causing a positive result (ng/mL) | % Cross- Reactivity |
| --- | --- | --- | --- |
| | EMDP | 100,000 | <0.3% |
| | Alpha Methadol | 100,000 | <0.3% |
| OXY 100 | Oxycodone | 100 | 100% |
| | Hydrocodone | 5,000 | 2% |
| | Hydromorphone | 50,000 | 0.2% |
| | Oxymorphone | 1,000 | 10% |
| | Codeine | 100,000 | <0.1% |
| | Ethylmorphine | 100,000 | <0.1% |
| | Dihydrocodeine | 20,000 | 0.5% |
| | Oxymorphone-3β-D- glucuronide | 5,000 | 2% |
| | Morphine | 100,000 | <0.1% |
| | 6-Monoacetylmorphine | 100,000 | <0.1% |
| | Buprenorphine | 100,000 | <0.1% |
| | Thebaine | 100,000 | <0.1% |
| PCP 25 | Phencyclidine | 25 | 100% |
| | 4-Hydroxy Phencyclidine | 1500 | 1.7% |
| PPX 300 | d-Propoxyphene | 300 | 100% |
| | d-Norpropoxyphene | 300 | 100% |
| TCA 1000 | 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% |
{20}
K240698 - Page 21 of 45
| Drug/Cutoff | Cross-reacting compound | Lowest concentration causing a positive result (ng/mL) | % Cross- Reactivity |
| --- | --- | --- | --- |
| | Cyclobenzaprine | 1,000 | 100% |
| | Norclomipramine | 12,500 | 8% |
| THC 50 | 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-MAM 10 | 6-Monoacetylmorphine | 10 | 100% |
| | Codeine | 100,000 | <0.01% |
| | Ethylmorphine | 100,000 | <0.01% |
| | Hydrocodone | 50,000 | 0.02% |
| | Hydromorphone | 10,000 | 0.1% |
| | Levorphanol | 100,000 | <0.01% |
| | Morphine 3-β-D-glucuronide | 100,000 | <0.01% |
| | Morphine | 100,000 | 0.01% |
| | Norcodeine | 100,000 | <0.01% |
| | Normorphine | 100,000 | <0.01% |
| | Oxycodone | 100,000 | <0.01% |
| | Oxymorphone | 10,000 | 0.1% |
| | Procaine | 50,000 | 0.02% |
| | Thebaine | 10,000 | 0.1% |
| | Diacetylmorphine (heroin) | 25 | 40% |
| | Acetylcodeine | 10,000 | <0.1% |
| | Buprenorphine | 10,000 | <0.1% |
{21}
K240698 - Page 22 of 45
| Drug/Cutoff | Cross-reacting compound | Lowest concentration causing a positive result (ng/mL) | % Cross- Reactivity |
| --- | --- | --- | --- |
| 6-MAM 10 (cont) | Dihydrocodeine | 10,000 | <0.1% |
| Nalorphine | 5,000 | 0.02% |
| Dextromethorphan | 100,000 | <0.01% |
| Imipramine | 100,000 | <0.01% |
| Levacetylmethadol (LAAM) | 100,000 | <0.01% |
| Meperidine | 100,000 | <0.01% |
| Methadone | 100,000 | <0.01% |
| Mitragynine (kratom) | 20,000 | <0.05% |
| Morphine 6-D-glucuronide | 100,000 | <0.01% |
| Naloxone | 100,000 | <0.01% |
| Naltrexone | 100,000 | <0.01% |
| Naproxen | 100,000 | <0.01% |
| Norbuprenorphine | 10,000 | <0.1% |
| Norbuprenorphine glucuronide | 100,000 | <0.01% |
| Norhydrocodone | 100,000 | <0.01% |
| Noroxycodone | 100,000 | <0.01% |
| Noroxymorphone | 100,000 | <0.01% |
| Norpropoxyphene | 100,000 | <0.01% |
| Oxymorphone-3β-D-glucuronide | 100,000 | <0.01% |
| Tapentadol HCl | 100,000 | <0.01% |
| Tramadol | 100,000 | <0.01% |
| | 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% |
{22}
K240698 - Page 23 of 45
| Drug/Cutoff | Cross-reacting compound | Lowest concentration causing a positive result (ng/mL) | % Cross- Reactivity |
| --- | --- | --- | --- |
| AMP 500 | d-Methamphetamine | 100,000 | <0.5% |
| | l-Methamphetamine | 100,000 | <0.5% |
| | (+/-)3,4-
Methylenedioxyethylamphetamine
(MDEA) | 100,000 | <0.5% |
| | (+/-)3,4-
Methylenedioxymethamphetamine
(MDMA) | 100,000 | <0.5% |
| | (1R,2S)-(-)-Ephedrine | 100,000 | <0.5% |
| | β-Phenylethylamine | 100,000 | 0.5% |
| | Tyramine | 100,000 | 0.5% |
| | p-Hydroxynorephedrine | 100,000 | 0.5% |
| | Phenylpropanolamine | 100,000 | <0.5% |
| | (±)Phenylpropanolamine | 100,000 | <0.5% |
| | p-Hydroxyamphetamine | 100,000 | 0.5% |
| | d/l-Norephedrine | 100,000 | 0.5% |
| | Benzphetamine | 100,000 | <0.5% |
| | l-Epinephrine | 100,000 | <0.5% |
| | d/l-Epinephrine | 100,000 | <0.5% |
| COC 150 | Benzoylecgonine | 150 | 100% |
| | Cocaine HCl | 500 | 30% |
| | Cocaethylene | 5,000 | 3% |
| | Ecgonine | 15,000 | 1% |
| | Ecgonine methyl ester | 100,000 | <0.15% |
| | Norcocaine | 100,000 | <0.15% |
| | d-Methamphetamine | 500 | 100% |
| | d-Amphetamine | 25,000 | 2% |
| | Chloroquine | 25,000 | 2% |
| | (1R,2S)-(-)-Ephedrine | 25,000 | 2% |
| | (-)-Methamphetamine | 12,500 | 4% |
{23}
K240698 - Page 24 of 45
| Drug/Cutoff | Cross-reacting compound | Lowest concentration causing a positive result (ng/mL) | % Cross- Reactivity |
| --- | --- | --- | --- |
| MET 500 | (+/-)3,4-
methylenedioxumethamphetamine
(MDMA) | 2,000 | 25% |
| 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% |
| Procaine | 100,000 | <0.5% |
| d/l-Amphetamine | 75,000 | 0.7% |
| p-Hydroxymethamphetamine | 15,000 | 3.3% |
| l-Phenylephrine | 100,000 | <0.5% |
| d/l-Methamphetamine | 500 | 100% |
| (+/-) 3,4-
Methylenedioxyamphetamine
(MDA) | 75,000 | 0.7% |
| MOP 300 | 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% |
| Diacetylmorphine (heroin) | 300 | 100% |
| Levorphanol | 10,000 | 3% |
| Norcodeine | 5,000 | 6% |
{24}
K240698 - Page 25 of 45
| Drug/Cutoff | Cross-reacting compound | Lowest concentration causing a positive result (ng/mL) | % Cross- Reactivity |
| --- | --- | --- | --- |
| | Oxycodone | 75,000 | 0.4% |
| | Thebaine | 3,000 | 10% |
| | Normorphine | 3,000 | 10% |
| | Oxymorphone | 25,000 | 1.2% |
| | Procaine | 100,000 | <0.3% |
| | Codeine-6-β-D-glucuronide | 500 | 60% |
| | d-Norpropoxyphene hydrochloride | 300 | 100% |
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 showed no interference at a concentration of 100 µg/mL are summarized in the following table.
| 3-Hydroxytyramine | Diflunisal | Oxalic Acid |
| --- | --- | --- |
| Acetaminophen | Digoxin | Oxolinic Acid |
| Acetylsalicylic Acid | Diphenhydramine | Oxymetazoline |
| Acyclovir | Dopamine HCl | Paliperidone |
| Albumin (100 mg/dL) | D-Pseudoephedrine | Papaverine |
| Albuterol sulfate (Proair HFA) | Duloxetine | Penicillin-G |
| Aminophylline | Erythromycin | PenicillinV Potassium |
| Aminopyrine | Esomeprazole Magnesium | Phenacetin (Acetophenetidin) |
| Amoxicillin | Ethanol (1%) | Phenelzine |
| Ampicillin | Fenoprofen | Prednisone |
| Apomorphine | Fluoxetine Hydrochloride | Pregablin |
{25}
K240698 - Page 26 of 45
| Aripiprazole | Furosemide | Quinine |
| --- | --- | --- |
| Aspartame | Gabapentin | Ranitidine |
| Atomoxetine | Gentisic Acid | Rifampicin |
| Atorvastatin Calcium | Glucose | Risperidone |
| Atropine | Hemoglobin | Salicylic Acid |
| Azithromycin | Hydralazine | Serotonin |
| Benzilic acid | Hydrochlorothiazide | Sertraline Hydrochloride |
| Benzocaine | Hydrocortisone | Sildenafil Citrate |
| Benzoic acid | Ibuprofen | Simvastatin |
| Bilirubin | Isoxsuprine | Sulfamethazine |
| Bupropion | Ketamine | Sulindac |
| Captopril | Ketoprofen | Tetrahydrozoline |
| Carbamazepine | Labetalol | Theophylline |
| Cefradine | Levofloxacin Hydrochloride | Thiamine |
| Cephalexin | Levonorgestrel | Thioridazine |
| Chloral Hydrate | Levothyroxine Sodium | Tramadol Hydrochloride |
| Chloramphenicol | Lidocaine Hydrochloride | Trazodone Hydrochloride |
| Chlorothiazide | Lisinopril | Triamterene |
| chlorpheniramine | Loperamide | Trifluoperazine |
| Cholesterol | Loratadine | Trimethoprim |
| Ciprofloxacin Hydrochloride | Magnesium | Uric Acid |
| Citalopram | Meperidine | Venlafaxine HCl |
{26}
| Clarithromycin | Meprobamate | Verapamil |
| --- | --- | --- |
| Clonidine | Metoprolol Tartrate | Vitamin B2 |
| Clozapine | Mifepristone | Vitamin C (Ascorbic acid) |
| Conjugated Estrogens | N-Acetylprocainamide | Zomepirac |
| Cortisone | Nalidixic Acid | β-Estradiol |
| Cotinine | Naproxen | Chlorpromazine |
| Creatinine | Niacinamide | Perphenazine |
| D,L- Isoproterenol | Nicotine | Tetrahydrocortisone 3-(β-D-glucuronide) |
| D,L-Octopamine | Nifedipine | Tetrahydrocortisone 3-acetate |
| D,L-Propranolol | Nitroglycerin | Ecgonine methyl ester |
| D,L-Tryptophan | Norethindrone | Methoxyphenamine (except MET test) |
| D,L-Tyrosine | Noscapine | Naloxone |
| Deoxycorticosterone | O-Hydroxyhippuric Acid | Naltrexone |
| Dextromethorphan | Omeprazole | Tyramine (except AMP test) |
| Diclofenac | | |
## Effect of Urinary Specific Gravity and pH:
To investigate the effect of urine specific gravity and urine pH, urine samples with specific gravity at 1.000, 1.005, 1.010, 1.015, 1.020, 1.025, 1.030, and 1.035 and urine samples with pH at 4, 5, 6, 7, 8, and 9 were spiked with the target drugs to concentrations at 25% below and 25% above the cutoff level for each drug. 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):
K240698 - Page 27 of 45
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The device is traceable to commercially available materials.
6. Detection Limit:
Not applicable.
7. Assay Cut-Off:
Refer to Section VII.A.1
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 | Candidate Device Result | 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 | 7 | 31 |
| | Negative | 15 | 8 | 17 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 6 | 31 |
| | Negative | 15 | 8 | 17 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 6 | 31 |
| | Negative | 15 | 8 | 17 | 3 | 0 |
Discordant Results
| Viewer | Sample number | LC-MS result (ng/mL) | Candidate device result |
| --- | --- | --- | --- |
| A, B, C | 0955 | 1014.625 | Negative |
| A, B, C | 0936 | 1056.71 | Negative |
| B, C | 0903 | 1141.794 | Negative |
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| AMP 500 | Candidate Device Result | 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 |
| | 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 (ng/mL) | Candidate device result |
| --- | --- | --- | --- |
| A, B, C | 1345 | 513 | Negative |
| A, B, C | 1297 | 546 | Negative |
| BAR | Candidate Device Result | 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 | 16 | 22 |
| | Negative | 15 | 18 | 7 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 15 | 22 |
| | Negative | 15 | 18 | 7 | 3 | 0 |
Discordant Results
| Viewer | Sample number | LC-MS result (ng/mL) | Candidate device result |
| --- | --- | --- | --- |
| A, B, C | 0221 | 302.963 | Negative |
| C | 0238 | 304.207 | Negative |
| A, B, C | 0173 | 312.828 | Negative |
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| BUP | Candidate Device Result | 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 | 2 | 29 | 10 |
| | Negative | 15 | 13 | 10 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 29 | 10 |
| | Negative | 15 | 13 | 11 | 1 | 0 |
Discordant Results
| Viewer | Sample number | LC-MS result (ng/mL) | Candidate device result |
| --- | --- | --- | --- |
| A, B, C | 0136 | 8.76 | Positive |
| A, B | 0137 | 8.785 | Positive |
| A, B, C | 0141 | 10.761 | Negative |
| BZO | Candidate Device Result | 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 | 8 | 31 |
| | Negative | 15 | 11 | 13 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 7 | 31 |
| | Negative | 15 | 11 | 12 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 7 | 31 |
| | Negative | 15 | 11 | 13 | 2 | 0 |
Discordant Results
| Viewer | Sample number | LC-MS result (ng/mL) | Candidate device result |
| --- | --- | --- | --- |
| B | 0405 | 269.424 | Positive |
| A, B, C | 0428 | 290.449 | Positive |
| B, C | 0422 | 301.512 | Negative |
| A, B, C | 0409 | 301.586 | Negative |
K240698 - Page 30 of 45
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| COC 300 | Candidate Device Result | 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 | 11 | 27 |
| | Negative | 15 | 13 | 10 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 11 | 27 |
| | Negative | 15 | 13 | 11 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 11 | 27 |
| | Negative | 15 | 13 | 10 | 2 | 0 |
Discordant Results
| Viewer | Sample number | LC-MS result (ng/mL) | Candidate device result |
| --- | --- | --- | --- |
| A, B, C | 0632 | 284.614 | Positive |
| A, C | 0602 | 295.071 | Positive |
| A, B, C | 0620 | 307.773 | Negative |
| A, B, C | 0630 | 308.012 | Negative |
| COC 150 | Candidate Device Result | 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 | 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 (ng/mL) | Candidate device result |
| --- | --- | --- | --- |
| A, B, C | 1446 | 138.9 | Positive |
| A, B, C | 1512 | 156.5 | Negative |
| A, B, C | 1505 | 162.1 | Negative |
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| EDDP | Candidate Device Result | 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 | 29 |
| | Negative | 15 | 6 | 18 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 11 | 29 |
| | Negative | 15 | 6 | 19 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 11 | 29 |
| | Negative | 15 | 6 | 18 | 0 | 0 |
Discordant Results
| Viewer | Sample number | LC-MS result (ng/mL) | Candidate device result |
| --- | --- | --- | --- |
| A, C | 1591 | 296.944 | Positive |
| MDMA | Candidate Device Result | 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 | 14 | 10 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 9 | 30 |
| | Negative | 15 | 14 | 11 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 9 | 30 |
| | Negative | 15 | 14 | 10 | 1 | 0 |
Discordant Results
| Viewer | Sample number | LC-MS result (ng/mL) | Candidate device result |
| --- | --- | --- | --- |
| A, C | 0762 | 458.975 | Positive |
| A, B, C | 0750 | 565.340 | Negative |
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| MET 1000 | Candidate Device Result | 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 (ng/mL) | Candidate device result |
| --- | --- | --- | --- |
| A, B, C | 0972 | 1002.105 | Negative |
| A, B, C | 1025 | 1026.596 | Negative |
| MET 500 | Candidate Device Result | 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 | 10 | 30 |
| | Negative | 15 | 14 | 11 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 9 | 30 |
| | Negative | 15 | 14 | 11 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 9 | 30 |
| | Negative | 15 | 14 | 11 | 1 | 0 |
Discordant Results
| Viewer | Sample number | LC-MS result (ng/mL) | Candidate device result |
| --- | --- | --- | --- |
| B, C | 1403 | 508 | Negative |
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| OPI 2000 | Candidate Device Result | 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 (ng/mL) | Candidate device result |
| --- | --- | --- | --- |
| A, B, C | 0817 | 1872.771 | Positive |
| A, B, C | 0855 | 1996.034 | Positive |
| A, B, C | 0879 | 2022.484 | Negative |
| A, B, C | 0880 | 2137.854 | Negative |
| MOP 300 | Candidate Device Result | 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 | 18 | 21 |
| | Negative | 15 | 12 | 11 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 19 | 21 |
| | Negative | 15 | 12 | 11 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 18 | 21 |
| | Negative | 15 | 12 | 11 | 1 | 0 |
Discordant Results
| Viewer | Sample number | LC-MS result (ng/mL) | Candidate device result |
| --- | --- | --- | --- |
| A, B, C | 1279 | 249 | Positive |
| A, B, C | 1259 | 250 | Positive |
| A, C | 1264 | 309 | Negative |
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| MTD | Candidate Device Result | 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 | 30 |
| | Negative | 15 | 12 | 11 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 8 | 30 |
| | Negative | 15 | 12 | 11 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 9 | 30 |
| | Negative | 15 | 12 | 11 | 1 | 0 |
Discordant Results
| Viewer | Sample number | LC-MS result (ng/mL) | Candidate device result |
| --- | --- | --- | --- |
| A, B, C | 1159 | 271 | Positive |
| A, B, C | 1185 | 273 | Positive |
| A, B, C | 1129 | 309 | Negative |
| B | 1123 | 325 | Negative |
| OXY | Candidate Device Result | 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 | 10 | 29 |
| | Negative | 15 | 12 | 11 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 9 | 29 |
| | Negative | 15 | 12 | 11 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 10 | 29 |
| | Negative | 15 | 12 | 11 | 1 | 0 |
Discordant Results
| Viewer | Sample number | LC-MS result (ng/mL) | Candidate device result |
| --- | --- | --- | --- |
| A, B, C | 0379 | 85 | Positive |
| A, B, C | 0375 | 88 | Positive |
| B | 0397 | 107 | Negative |
| A, B, C | 0340 | 109 | Negative |
K240698 - Page 35 of 45
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| PCP | Candidate Device Result | 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 | 27 | 12 |
| | Negative | 15 | 13 | 12 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 28 | 12 |
| | Negative | 15 | 13 | 12 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 27 | 12 |
| | Negative | 15 | 13 | 12 | 1 | 0 |
Discordant Results
| Viewer | Sample number | LC-MS result (ng/mL) | Candidate device result |
| --- | --- | --- | --- |
| A, C | 0053 | 25.9 | Negative |
| PPX | Candidate Device Result | 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 | 11 | 28 |
| | Negative | 15 | 13 | 10 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 12 | 28 |
| | Negative | 15 | 13 | 11 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 10 | 28 |
| | Negative | 15 | 13 | 11 | 2 | 0 |
Discordant Results
| Viewer | Sample number | LC-MS result (ng/mL) | Candidate device result |
| --- | --- | --- | --- |
| A, B, C | 0504 | 286 | Positive |
| A | 0487 | 296 | Positive |
| A, C | 0536 | 347 | Negative |
| C | 0551 | 356 | Negative |
K240698 - Page 36 of 45
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| TCA | Candidate Device Result | 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 (ng/mL) | Candidate device result |
| --- | --- | --- | --- |
| A, B, C | 0688 | 1051 | Negative |
| A, B, C | 0653 | 1136 | Negative |
| THC | Candidate Device Result | 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 | 30 |
| | Negative | 15 | 13 | 10 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 9 | 30 |
| | Negative | 15 | 13 | 11 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 9 | 30 |
| | Negative | 15 | 13 | 11 | 1 | 0 |
Discordant Results
| Viewer | Sample number | LC-MS result (ng/mL) | Candidate device result |
| --- | --- | --- | --- |
| A, C | 0300 | 41.2 | Positive |
| A, B | 0317 | 49.4 | Positive |
| A, B, C | 0312 | 55.6 | Negative |
K240698 - Page 37 of 45
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| 6-MAM | Candidate Device Result | 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 (ng/mL) | Candidate device result |
| --- | --- | --- | --- |
| A, B, C | 1091 | 9.006 | Positive |
| A, B, C | 1081 | 9.465 | Positive |
| A, B, C | 1053 | 9.967 | Positive |
| A, B, C | 1048 | 10.237 | Negative |
| A, B, C | 1052 | 10.257 | Negative |
2. Lay user study:
A lay user study was performed using configuration 1 and configuration 2 at three intended use sites with the results read by 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 dipcard device, and with no assistance. Summary results are shown below:
Configuration 1
| Analyte | % of Cut-off | Number of samples | Lay person results | | 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 | 0 | 20 | 100 |
| | +25% Cut-off | 20 | 20 | 0 | 100 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
K240698 - Page 38 of 45
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K240698 - Page 39 of 45
| Analyte | % of Cut-off | Number of samples | Lay person results | | Percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| BAR 300 | +75% Cut-off | 20 | 20 | 0 | 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 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 20 | 0 | 100 |
| | +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 | 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 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 20 | 0 | 100 |
| | +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 |
| | -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 |
| EDDP 300 | -100% Cut-off | 20 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 0 | 20 | 100 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
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K240698 - Page 40 of 45
| Analyte | % of Cut-off | Number of samples | Lay person results | | Percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| +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 | 0 | 20 | 100 |
| | +25% Cut-off | 20 | 20 | 0 | 100 |
| | +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 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 20 | 0 | 100 |
| | +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 | 20 | 0 | 100 |
| | +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 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 19 | 1 | 95 |
| | +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 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 20 | 0 | 100 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| PCP 25 | -100% Cut-off | 20 | 0 | 20 | 100 |
{40}
K240698 - Page 41 of 45
| Analyte | % of Cut-off | Number of samples | Lay person results | | Percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| Analyte | -75% Cut-off | 20 | 0 | 20 | 100 |
| -75% Cut-off | -50% Cut-off | 20 | 0 | 20 | 100 |
| -25% Cut-off | -25% Cut-off | 20 | 2 | 18 | 90 |
| +25% Cut-off | +25% Cut-off | 20 | 20 | 0 | 100 |
| +50% Cut-off | +50% Cut-off | 20 | 0 | 0 | 100 |
| +75% Cut-off | +75% Cut-off | 20 | 0 | 0 | 100 |
| PPX 300 | -100% Cut-off | 20 | 0 | 20 | 100 |
| -100% Cut-off | -75% Cut-off | 20 | 0 | 20 | 100 |
| -50% Cut-off | -50% Cut-off | 20 | 0 | 20 | 100 |
| -25% Cut-off | -25% Cut-off | 20 | 0 | 20 | 100 |
| +25% Cut-off | +25% Cut-off | 20 | 20 | 0 | 100 |
| +50% Cut-off | +50% Cut-off | 20 | 20 | 0 | 100 |
| +75% Cut-off | +75% Cut-off | 20 | 0 | 0 | 100 |
| TCA 1000 | -100% Cut-off | 20 | 0 | 20 | 100 |
| -100% Cut-off | -75% Cut-off | 20 | 0 | 20 | 100 |
| -50% Cut-off | -50% Cut-off | 20 | 0 | 20 | 100 |
| -25% Cut-off | -25% Cut-off | 20 | 0 | 20 | 100 |
| +25% Cut-off | +25% Cut-off | 20 | 20 | 0 | 100 |
| +50% Cut-off | +50% Cut-off | 20 | 20 | 0 | 100 |
| +75% Cut-off | +75% Cut-off | 20 | 0 | 0 | 100 |
| THC 50 | -100% Cut-off | 20 | 0 | 20 | 100 |
| -100% Cut-off | -75% Cut-off | 20 | 0 | 20 | 100 |
| -50% Cut-off | -50% Cut-off | 20 | 0 | 20 | 100 |
| -25% Cut-off | -25% Cut-off | 20 | 1 | 19 | 95 |
| +25% Cut-off | +25% Cut-off | 20 | 19 | 1 | 95 |
| +50% Cut-off | +50% Cut-off | 20 | 20 | 0 | 100 |
| +75% Cut-off | +75% Cut-off | 20 | 20 | 0 | 100 |
| 6-AM 10 | -100% Cut-off | 20 | 0 | 20 | 100 |
| -100% Cut-off | -75% Cut-off | 20 | 0 | 20 | 100 |
| -75% Cut-off | -50% Cut-off | 20 | 0 | 20 | 100 |
{41}
Configuration 2
| Analyte | % of Cut-off | Number of samples | Lay person results | | 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 |
| | -50% Cut-off | 20 | 0 | 20 | 100 |
| | -25% Cut-off | 19 | 1 | 20 | 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 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 20 | 0 | 100 |
| | +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 | 20 | 0 | 100 |
| | +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 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 19 | 1 | 95 |
| | +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 |
K240698 - Page 42 of 45
{42}
| Analyte | % of Cut-off | Number of samples | Lay person results | | Percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| | +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 | 1 | 19 | 95 |
| | +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 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 20 | 0 | 100 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
| | +75% Cut-off | 20 | 20 | 0 | 100 |
| 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 | 19 | 1 | 95 |
| | +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 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 20 | 0 | 100 |
| | +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 | 19 | 1 | 95 |
| | +50% Cut-off | 20 | 20 | 0 | 100 |
K240698 - Page 43 of 45
{43}
| Analyte | % of Cut-off | Number of samples | Lay person results | | Percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| | +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 | 20 | 0 | 100 |
| | +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 | 20 | 0 | 100 |
| | +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 |
| | -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 |
| 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 | 20 | 0 | 100 |
| | +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 |
K240698 - Page 44 of 45
{44}
| Analyte | % of Cut-off | Number of samples | Lay person results | | Percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| | -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.
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.
K240698 - Page 45 of 45
