Evidence MultiSTAT DOA Urine MultiPlex
Device Facts
| Record ID | K250741 |
|---|---|
| Device Name | Evidence MultiSTAT DOA Urine MultiPlex |
| Applicant | Randox Laboratories Limited |
| Product Code | DJG · Clinical Toxicology |
| Decision Date | Jan 23, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
Indications for Use
The Evidence MultiSTAT DOA Urine Multiplex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyser intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cut offs. The Evidence MultiSTAT DOA Urine Multiplex detects the following drugs at the following cut offs: [Table of analytes and cut-offs omitted for brevity]. The Evidence MultiSTAT DOA Urine Multiplex provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and/or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS) and the preferred confirmatory methods. Other chemical confirmation methods are available. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
Device Story
The Evidence MultiSTAT DOA Urine Multiplex is a benchtop, fully automated Biochip Array System used in laboratory settings. It processes human urine samples to detect multiple drugs of abuse simultaneously. The system utilizes a self-contained, sealed biochip cartridge containing immobilized antibodies for specific drug classes. Operation involves a competitive chemiluminescent immunoassay where drug in the specimen competes with horseradish peroxidase (HRP)-labeled drug for antibody binding sites. Increased drug concentration reduces chemiluminescence. A Charge Coupled Device (CCD) camera captures the light signal from the biochip; analyzer software quantifies this signal against a known cut-off material to provide a qualitative result. Results are preliminary and require confirmation via GC/MS or LC/MS/MS. The device assists clinicians in identifying potential drug use or misuse, supporting clinical decision-making when combined with professional judgment.
Clinical Evidence
Bench testing only. Precision/reproducibility studies were conducted using 40 replicates per lot across three lots. Analytical specificity and cross-reactivity were evaluated against structurally related and unrelated compounds. Method comparison studies were performed using clinical urine samples compared against quantitative reference methods (GC/MS or LC-MS/MS). No clinical studies were required.
Technological Characteristics
Benchtop fully automated Biochip Array System. Technology: Competitive chemiluminescent immunoassay. Components: Sealed urine test cartridge, biochip with immobilized antibodies, HRP-labeled drug derivatives, luminol/peroxide signal reagent. Connectivity: Evidence MultiSTAT analyzer. Software: Automated signal quantification via CCD camera. Sterilization: Not specified.
Indications for Use
Indicated for the qualitative screening of drugs of abuse and their metabolites in human urine. Target population includes individuals undergoing drug testing in a laboratory setting. Analytes include Methamphetamine, Noroxycodone, Benzodiazepines, Methadone, Phenobarbital, Tramadol, Phencyclidine, Buprenorphine, 6-Acetylmorphine, Fentanyl, Opiates, Cocaine/Benzoylecgonine, and Cannabinoids (THC). Prescription use only.
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
- Evidence MultiSTAT DOA Urine Multiplex (k220451)
Related Devices
- K221550 — Evidence MultiSTAT DOA Urine MultiPlex · Randox Laboratories Limited · Oct 5, 2023
- K220451 — Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT · Randox Laboratories Limited · Oct 5, 2023
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
K250741
B Applicant
Randox Laboratories Limited
C Proprietary and Established Names
Evidence MultiSTAT DOA Urine Multiplex
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DJG | Class II | 21 CFR 862.3650 - Opiate Test System | TX - Clinical Toxicology |
| DIO | Class II | 21 CFR 862.3250 - Cocaine and cocaine metabolite test system | TX - Clinical Toxicology |
| LDJ | Class II | 21 CFR 862.3870 - Cannabinoid test system | TX - Clinical Toxicology |
| DKZ | Class II | 21 CFR 862.3100 - Amphetamine test system | TX - Clinical Toxicology |
| JXM | Class II | 21 CFR 862.3170 - Benzodiazepine test system | TX - Clinical Toxicology |
| DJC | Class II | 21 CFR 862.3610 - Methamphetamine test system | TX - Clinical Toxicology |
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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K250741 - Page 2 of 25
| DJR | Class II | 21 CFR 862.3620 - Methadone test system | TX - Clinical Toxicology |
| --- | --- | --- | --- |
| DIS | Class II | 21 CFR 862.3150 - Barbiturate test system | TX - Clinical Toxicology |
| LCM | Unclassified | | |
## II Submission/Device Overview:
### A Purpose for Submission:
New device
### B Measurand:
Fentanyl, Opiates, Benzoylecgonine/Cocaine, Cannabinoids (THC), Amphetamine, Benzodiazepines 2
### C Type of Test:
Chemiluminescent immunoassay
## III Intended Use/Indications for Use:
### A Intended Use(s):
See Indications for Use below.
### B Indication(s) for Use:
The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyser intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cut offs.
The Evidence MultiSTAT DOA Urine MultiPlex detects the following drugs at the following cut offs:
| Analyte | Analyte in Cut Off Material | Cut Off |
| --- | --- | --- |
| Methamphetamine | S-(+)-Methamphetamine | 500ng/ml |
| Noroxycodone | Noroxycodone | 100ng/ml |
| Benzodiazepines 1 | Oxazepam | 200ng/ml |
| Methadone | (+)-Methadone | 300ng/ml |
| Phenobarbital | Phenobarbital | 200ng/ml |
| Tramadol | Tramadol | 200ng/ml |
| Phencyclidine | Phencyclidine | 25ng/ml |
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K250741 - Page 3 of 25
| Buprenorphine | Norbuprenorphine | 5ng/ml |
| --- | --- | --- |
| 6-Acetylmorphine | 6-Acetylmorphine | 10ng/ml |
| Fentanyl | Fentanyl | 1ng/ml |
| Benzodiazepines 2 | Lorazepam | 200ng/ml |
| Opiates | Morphine | 300ng/ml |
| Benzoylecgonine/Cocaine | Benzoylecgonine | 150ng/ml |
| Cannabinoids (THC) | (-)-11-nor-9-Carboxy-Δ9-THC | 50ng/ml |
| Amphetamine | S-(+)-Amphetamine | 500ng/ml |
The Evidence MultiSTAT DOA Urine MultiPlex provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and/or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS) are the preferred confirmatory methods. Other chemical confirmation methods are available. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
For In Vitro Diagnostic use only.
## C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
## D Special Instrument Requirements:
Evidence MultiSTAT
## IV Device/System Characteristics:
## A Device Description:
The Evidence MultiSTAT is a benchtop fully automated Biochip Array System analyzer. The Evidence MultiSTAT DOA Urine MultiPlex test kit components include a sealed urine test cartridge which contains materials for the determination of the claimed analytes at the associated cut-off. This submission represents the following claimed analytes and associated cut off concentrations; Fentanyl at 1ng/ml, Opiates at 300ng/ml, Benzoylecgonine/Cocaine at 150ng/ml, Cannabinoids (THC) at 50ng/ml, Amphetamine at 500ng/ml, and Benzodiazepines 2 at 200ng/ml.
The Evidence MultiSTAT DOA Urine MultiPlex test kit will comprise of:
- 12 x Urine Test Cartridges
- 6 x 1mL Urine Cut Off Material (lyophilized)
- 4 x 1mL Urine Positive Control Material (lyophilized)
- 2 x 10mL Reconstitution Buffer
- 1 x Batch Barcodes
Each kit is supplied with the Evidence MutliSTAT Accessory Kit which contains:
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• 12 x MultiSTAT Tip Cartridges
• 1 x Tip/Waste Cartridge
• 6 x 1000 µl Pipette Tip
• 1 x Liquid Absorber
The Reagent Composition of the test kit will comprise:
• MultiSTAT DOA Urine MultiPlex Assay Diluent - 20 mM phosphate buffer, pH 7.0 containing protein, detergents, and preservatives. This is contained within the cartridge.
• MultiSTAT DOA Urine MultiPlex Conjugate - 20 mM Tris based buffer, pH 7.0 containing protein, preservatives, and horseradish peroxidase - labelled drug derivatives. This is contained within the cartridge.
• MultiSTAT DOA Urine MultiPlex Biochip - Solid substrate containing immobilized antibody discrete test regions. This is contained within the cartridge.
• MultiSTAT DOA Urine MultiPlex Wash Buffer - 20 mM Tris buffered saline, pH 7.4, containing surfactant and preservatives. This is contained within the cartridge.
• LUM-EV934/PX - Luminol-EV934 and Peroxide are contained within the cartridge and are mixed in a ratio of 1:1 by the analyser to give the working signal reagent
• MultiSTAT DOA Urine MultiPlex Cut Off - Lyophilised, 20 mM phosphate buffer, pH 7.2 containing stabilizers, preservatives and drug concentrations at the assay cut off values.
• MultiSTAT DOA Urine MultiPlex Positive Control - Lyophilised, 20 mM phosphate buffer, pH 7.2 containing stabilizers, preservatives, and drug concentrations at 50% higher than the cutoff values.
• MultiSTAT Reconstitution Buffer – A solution at a neutral pH containing preservatives.
B Principle of Operation:
The candidate device performs simultaneous detection of multiple analytes from a single sample. The core technology is the Randox Biochip, a solid-state device containing an array of discrete test regions containing immobilized antibodies specific to different Drugs of Abuse (DOA) compound classes. A competitive chemiluminescent immunoassay is used for the DOA assays with the drug in the specimen and drug labelled with horseradish peroxidase (HRP) being in direct competition for the antibody binding sites. Increased levels of drug in a specimen will lead to reduced binding of drug labelled with HRP and thus a reduction in chemiluminescence being emitted. The light signal generated from each of the test regions on the biochip is detected by a Charge Coupled Device (CCD) camera in the Evidence MultiSTAT analyzer which, together with the analyzer software, is used to quantify the light output and produce results. The tests employ a qualitative reporting method. Each test sample is assayed against the provided Cut Off material of known concentration, which is used to determine the classification of the samples based on the comparison of the signal output.
The immunoassay processes are performed automatically in a self-contained and sealed biochip cartridge, which holds the biochips, the reagents, wash buffer and other fluids required for the test to be conducted.
V Substantial Equivalence Information:
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A Predicate Device Name(s):
Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
B Predicate 510(k) Number(s):
K220451
C Comparison with Predicate(s):
| Device & Predicate Device(s): | Candidate Device K250741 | K220451 |
| --- | --- | --- |
| Device Trade Name | Evidence MultiSTAT Urine DOA MultiPlex | Evidence MultiSTAT Urine DOA MultiPlex, Evidence MultiSTAT |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Same | For qualitative determination of parent drug molecule and metabolites of drugs in human urine |
| Sample Matrix | Same | Urine |
| General Device Characteristic Differences | | |
| Specific Analytes | Fentanyl, Opiates, Benzoylecgonine/Cocaine, Cannabinoids (THC), Amphetamine, Benzodiazepines 2, Phenobarbital, Tramadol, Phencyclidine, Buprenorphine, 6-Acetylmorphine, Methamphetamine, Noroxycodone, Benzodiazepines 1 and Methadone. | Same except no Fentanyl, Opiates, Benzoylecgonine/Cocaine, Cannabinoids (THC), Amphetamine, Benzodiazepines 2, Phenobarbital, Tramadol, Phencyclidine, Buprenorphine and 6-Acetylmorphine. |
VI Standards/Guidance Documents Referenced:
CLSI EP12 – A2 – User Protocol for Evaluation of Qualitative Test Performance.
CLSI EP25 – A – Evaluation of Stability of In Vitro Diagnostic Reagents.
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
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# 1. Precision/Reproducibility:
A precision study was conducted using drug free negative urine that was spiked with the appropriate analyte at; -100%, -75%, -50%, -25%, +25%, +50%, +75%, +100%, of the cut off as well as at the cut off. The test was performed by at least two (2) operators on 3 instruments (1 instrument for Benzodiazepine 2), with 40 replicates per lot. Data for each analyte is represented below. Data for Methamphetamine at 500 ng/ml, Noroxycodone at 100 ng/ml, Benzodiazepines I at 200 ng/ml, and Methadone at 300 ng/ml was reported in K220451 while data for Phenobarbital at 200 ng/ml, Tramadol at 200 ng/ml, Phencyclidine at 25 ng/ml, Buprenorphine at 5 ng/ml, 6-Acetylmorphine at 10 ng/ml was reported in K221550.
| Fentanyl | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Concentration (ng/ml) | % of Cut Off | Number of determinations | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | Negative | Positive | Negative | Positive | Negative | Positive |
| 0.00 | -100% | 40 | 40 | 0 | 40 | 0 | 40 | 0 |
| 0.25 | -75% | 40 | 40 | 0 | 40 | 0 | 40 | 0 |
| 0.50 | -50% | 40 | 40 | 0 | 40 | 0 | 40 | 0 |
| 0.75 | -25% | 40 | 14 | 26 | 23 | 17 | 22 | 18 |
| 1.00 | Cut Off | 40 | 0 | 40 | 6 | 34 | 3 | 37 |
| 1.25 | +25% | 40 | 0 | 40 | 0 | 40 | 0 | 40 |
| 1.50 | +50% | 40 | 0 | 40 | 0 | 40 | 0 | 40 |
| 1.75 | +75% | 40 | 0 | 40 | 0 | 40 | 0 | 40 |
| 2.00 | +100% | 40 | 0 | 40 | 0 | 40 | 0 | 40 |
| Opiates | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Concentration (ng/ml) | % of Cut Off | Number of determinations | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | Negative | Positive | Negative | Positive | Negative | Positive |
| 0 | -100% | 40 | 40 | 0 | 40 | 0 | 40 | 0 |
| 75 | -75% | 40 | 40 | 0 | 40 | 0 | 40 | 0 |
| 150 | -50% | 40 | 40 | 0 | 40 | 0 | 40 | 0 |
| 225 | -25% | 40 | 39 | 1 | 39 | 1 | 39 | 1 |
| 300 | Cut Off | 40 | 30 | 10 | 22 | 18 | 21 | 19 |
| 375 | +25% | 40 | 5 | 35 | 1 | 39 | 3 | 37 |
| 450 | +50% | 40 | 0 | 40 | 0 | 40 | 0 | 40 |
| 525 | +75% | 40 | 0 | 40 | 0 | 40 | 0 | 40 |
| 600 | +100% | 40 | 0 | 40 | 0 | 40 | 0 | 40 |
| Benzoylecgonine/Cocaine | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Concentration (ng/ml) | % of Cut Off | Number of determinations | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | Negative | Positive | Negative | Positive | Negative | Positive |
| 0.0 | -100% | 40 | 40 | 0 | 40 | 0 | 40 | 0 |
K250741 - Page 6 of 25
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| Cannabinoids (THC) | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Concentration (ng/ml) | % of Cut Off | Number of determinations | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | Negative | Positive | Negative | Positive | Negative | Positive |
| 0.0 | -100% | 40 | 40 | 0 | 40 | 0 | 40 | 0 |
| 12.5 | -75% | 40 | 40 | 0 | 40 | 0 | 40 | 0 |
| 25.0 | -50% | 40 | 40 | 0 | 40 | 0 | 40 | 0 |
| 37.5 | -25% | 40 | 39 | 1 | 40 | 0 | 40 | 0 |
| 50.0 | Cut Off | 40 | 34 | 6 | 38 | 2 | 33 | 7 |
| 62.5 | +25% | 40 | 10 | 30 | 11 | 29 | 6 | 34 |
| 75.0 | +50% | 40 | 0 | 40 | 0 | 40 | 0 | 40 |
| 87.5 | +75% | 40 | 0 | 40 | 0 | 40 | 0 | 40 |
| 100.0 | +100% | 40 | 0 | 40 | 0 | 40 | 0 | 40 |
| Amphetamine | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Concentration (ng/ml) | % of Cut Off | Number of determinations | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | Negative | Positive | Negative | Positive | Negative | Positive |
| 0 | -100% | 40 | 40 | 0 | 40 | 0 | 40 | 0 |
| 125 | -75% | 40 | 40 | 0 | 40 | 0 | 40 | 0 |
| 250 | -50% | 40 | 40 | 0 | 40 | 0 | 40 | 0 |
| 375 | -25% | 40 | 36 | 4 | 37 | 3 | 34 | 6 |
| 500 | Cut Off | 40 | 5 | 35 | 6 | 34 | 2 | 38 |
| 625 | +25% | 40 | 0 | 40 | 0 | 40 | 1 | 39 |
| 750 | +50% | 40 | 0 | 40 | 0 | 40 | 0 | 40 |
| 875 | +75% | 40 | 0 | 40 | 0 | 40 | 0 | 40 |
| 1000 | +100% | 40 | 0 | 40 | 0 | 40 | 0 | 40 |
| Benzodiazepines 2 | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Concentration (ng/ml) | % of Cut Off | Number of determinations | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | Negative | Positive | Negative | Positive | Negative | Positive |
| 0 | -100% | 40 | 40 | 0 | 40 | 0 | 40 | 0 |
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| 50 | -75% | 40 | 40 | 0 | 40 | 0 | 40 | 0 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 100 | -50% | 40 | 40 | 0 | 40 | 0 | 40 | 0 |
| 150 | -25% | 40 | 40 | 0 | 39 | 1 | 38 | 2 |
| 200 | Cut Off | 40 | 6 | 34 | 6 | 34 | 7 | 33 |
| 250 | +25% | 40 | 0 | 40 | 0 | 40 | 0 | 40 |
| 300 | +50% | 40 | 0 | 40 | 0 | 40 | 0 | 40 |
| 350 | +75% | 40 | 0 | 40 | 0 | 40 | 0 | 40 |
| 400 | +100% | 40 | 0 | 40 | 0 | 40 | 0 | 40 |
2. **Linearity:**
Not applicable. These devices are intended for qualitative use only.
3. **Analytical Specificity/Interference:**
Potential interference from various compounds were tested by spiking the potentially interfering compound into drug-free urine containing the target drug concentrations at 50% below and 50% above the threshold cut off level. If interference was observed, the interferent was titrated down and the concentration at which no interference is observed quoted. The following compounds were found not to interfere with test results when tested up to the concentrations identified in the table below. Data for Methamphetamine at 500 ng/ml, Noroxycodone at 100 ng/ml, Benzodiazepines I at 200 ng/ml, and Methadone at 300 ng/ml was reported in K220451 while data for Phenobarbital at 200 ng/ml, Tramadol at 200 ng/ml, Phencyclidine at 25 ng/ml, Buprenorphine at 5 ng/ml, 6-Acetylmorphine at 10 ng/ml was reported in K221550.
| Interference: Fentanyl Assay | |
| --- | --- |
| Compound | Concentration Tested |
| Acetaminophen | 1mg/ml |
| Acetylsalicylic Acid | 1mg/ml |
| Albuterol (salbutamol) | 100,000ng/ml |
| Amitriptyline | 10,000ng/ml |
| Amobarbital | 100,000ng/ml |
| d,l-Amphetamine-D5 | 500,000ng/ml |
| Benzoylecgonine | 500,000ng/ml |
| Bupropion | 500,000ng/ml |
| Caffeine | 1mg/ml |
| Carbamazepine 10,11 epoxide | 100,000ng/ml |
| Carbamazepine | 100,000ng/ml |
| Chlorpromazine | 10,000ng/ml |
| Clomipramine | 100,000ng/ml |
| Cyclobenzaprine | 25,000ng/ml |
| Desipramine | 10,000ng/ml |
| Doxepin | 10,000ng/ml |
| Ecgonine | 100,000ng/ml |
| Ephedrine | 75,000ng/ml |
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| Fluoxetine | 100,000ng/ml |
| --- | --- |
| Fluphenazine | 100,000ng/ml |
| Ibuprofen | 500,000ng/ml |
| Imipramine | 10,000ng/ml |
| Ketamine | 100,000ng/ml |
| Lidocaine | 500,000ng/ml |
| Maprotiline | 50,000ng/ml |
| Methaqualone | 500,000ng/ml |
| Metronidazole | 300,000ng/ml |
| (-)-Nicotine | 100,000ng/ml |
| (±)-Norketamine | 100,000ng/ml |
| Nortriptyline | 100,000ng/ml |
| Oxazepam | 75,000ng/ml |
| Phenobarbital | 500,000ng/ml |
| Dextropropoxyphene | 100,000ng/ml |
| D-Norpropoxyphene | 10,000ng/ml |
| Ranitidine | 0.5mg/ml |
| Secobarbital | 500,000ng/ml |
| Valproic acid | 500,000ng/ml |
| Venlafaxine | 100,000ng/ml |
| Acetone | 1000mg/dL (10mg/ml) |
| L-Ascorbic Acid | 1500mg/dL (15mg/ml) |
| Bilirubin | 15mg/dL (0.15mg/ml) |
| Creatinine | 500mg/dL (5mg/ml) |
| Ethanol | 1000mg/dL (10mg/ml) |
| D-(+)-Galactose | 10mg/dL (0.1mg/ml) |
| Gamma globulin | 500mg/dL (5mg/ml) |
| D-(+)-Glucose | 3000mg/dL (30mg/ml) |
| Hemoglobin | 500mg/dL (5mg/ml) |
| Human Serum Allbumin | 500mg/dL (5mg/ml) |
| Oxalic Acid | 200mg/dL (2mg/ml) |
| (-)-Riboflavin | 7.5mg/dL (0.075mg/ml) |
| Sodium Chloride | 6000mg/dL (60mg/ml) |
| Urea | 60mg/ml |
| Boric acid | 1% w/v (10mg/ml) |
| Codeine | 100,000ng/ml |
| Morphine | 500,000ng/ml |
| Naloxone | 100,000ng/ml |
| Naltrexone | 100,000ng/ml |
| *Methapyrilene | 10,000ng/ml |
| *Phencyclidine (PCP) | 10,000ng/ml |
*Methapyrilene and Phencyclidine (PCP) elicited interference at 10,000ng/ml with the Fentanyl Assay. Cross reactivity was therefore assessed. Assessment of cross reactivity was conducted
K250741 - Page 9 of 25
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using approximate concentrations of 50,000ng/ml (for both compounds) diluted into drug free negative urine. Both compounds generated an approximate % cross reactivity of 0.002.
| Interference: Opiates Assay | |
| --- | --- |
| Compound | Concentration Tested |
| Oxazepam | 500,000ng/ml |
| (±)-Lorazepam | 500,000ng/ml |
| Temazepam | 500,000ng/ml |
| Nordiazepam (desmethyldiazepam) | 500,000ng/ml |
| Nitrazepam | 500,000ng/ml |
| Flunitrazepam | 500,000ng/ml |
| -nor-9-Carboxy- Δ9-THC | 100,000ng/ml |
| Barbital | 500,000ng/ml |
| Benzoylecgonine | 500,000ng/ml |
| Butalbital | 100,000ng/ml |
| d,l-Amphetamine-D5 | 500,000ng/ml |
| d(+)-Amphetamine | 300,000ng/ml |
| (±)-MDA | 500,000ng/ml |
| 3,4-MDEA | 500,000ng/ml |
| MDMA | 500,000ng/ml |
| (-)- Methamphetamine | 500,000ng/ml |
| Pentobarbital | 500,000ng/ml |
| Phencyclidine | 500,000ng/ml |
| Phenobarbital | 500,000ng/ml |
| Secobarbital | 500,000ng/ml |
| Acetaminophen | 1mg/ml |
| Acetone | 1000mg/dL (10mg/ml) |
| Acetylsalicylic Acid | 1mg/ml |
| L-Ascorbic Acid | 1500mg/dL (15mg/ml) |
| Caffeine | 1mg/ml |
| Creatinine | 500mg/dL (5mg/ml) |
| Ethanol | 1000mg/dL (10mg/ml) |
| D-(+)-Galactose | 10mg/dL (0.1mg/ml) |
| Gamma globulin | 500mg/dL (5mg/ml) |
| D-(+)-Glucose | 3000mg/dL (30mg/ml) |
| Hemoglobin | 500mg/dL (5mg/ml) |
| Human Serum Allbumin | 500mg/dL (5mg/ml) |
| Ibuprofen | 500,000ng/ml |
| Oxalic Acid | 200mg/dL (2mg/ml) |
| Ranitidine | 0.5mg/ml |
| (-)-Riboflavin | 7.5mg/dL (0.075mg/ml) |
| Sodium Chloride | 6000mg/dL (60mg/ml) |
| Urea | 60mg/ml |
| Naloxone | 100,000ng/ml |
| Naltrexone | 100,000ng/ml |
| Imipramine | 100,000ng/ml |
K250741 - Page 10 of 25
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| Interference: Benzoylecgonine/Cocaine Assay | |
| --- | --- |
| Compound | Concentration Tested |
| Acetaminophen | 1mg/ml |
| Acetone | 1000mg/dL (10mg/ml) |
| L-Ascorbic Acid | 1500mg/dL (15mg/ml) |
| Acetylsalicylic Acid | 1mg/ml |
| Caffeine | 1mg/ml |
| Creatinine | 500mg/dL (5mg/ml) |
| Ethanol | 1000mg/dL (10mg/ml) |
| D-(+)-Galactose | 10mg/dL (0.1mg/ml) |
| Gamma globulin | 500mg/dL (5mg/ml) |
| D-(+)-Glucose | 3000mg/dL (30mg/ml) |
| Hemoglobin | 500mg/dL (5mg/ml) |
| Human Serum Allbumin | 500mg/dL (5mg/ml) |
| Ibuprofen | 500,000ng/ml |
| Oxalic Acid | 200mg/dL (2mg/ml) |
| (-)-Riboflavin | 7.5mg/dL (0.075mg/ml) |
| Sodium Chloride | 6000mg/dL (60mg/ml) |
| Urea | 60mg/ml |
| d,l-Amphetamine-D5 | 500,000ng/ml |
| Bupropion | 500,000ng/ml |
| Chlorpheniramine | 500,000ng/ml |
| Fluoxetine | 100,000ng/ml |
| Meperidine (Pethidine) | 500,000ng/ml |
| (±)-Methadone | 500,000ng/ml |
| (-)- Methamphetamine | 500,000ng/ml |
| Methaqualone | 500,000ng/ml |
| Morphine | 500,000ng/ml |
| Nifedipine | 100,000ng/ml |
| Oxazepam | 500,000ng/ml |
| Phencyclidine | 500,000ng/ml |
| Phenobarbital | 500,000ng/ml |
| Dextropropoxyphene | 500,000ng/ml |
| Ranitidine | 0.5mg/ml |
| Secobarbital | 500,000ng/ml |
| Valproic acid | 500,000ng/ml |
| Interference: Cannabinoids (THC) Assay | |
| --- | --- |
| Compound | Concentration Tested |
| Acetaminophen | 1mg/ml |
| Acetylsalicylic acid | 500,000ng/ml |
| Amitriptyline | 500,000ng/ml |
| Amobarbital | 500,000ng/ml |
K250741 - Page 11 of 25
{11}
K250741 - Page 12 of 25
| d,l-Amphetamine-D5 | 500,000ng/ml |
| --- | --- |
| d(+)-Amphetamine | 300,000ng/ml |
| Benzoylecgonine | 500,000ng/ml |
| Bupropion | 500,000ng/ml |
| Caffeine | 1mg/ml |
| Chlorpheniramine | 500,000ng/ml |
| Chlorpromazine | 500,000ng/ml |
| Cocaine | 500,000ng/ml |
| Codeine | 500,000ng/ml |
| Dextromethorphan | 100,000ng/ml |
| Ecgonine Methyl Ester | 500,000ng/ml |
| (1S,2R)-(+)-Ephedrine | 500,000ng/ml |
| Imipramine | 500,000ng/ml |
| JWH-018 | 500,000ng/ml |
| JWH-073 | 500,000ng/ml |
| Lidocaine | 500,000ng/ml |
| Meperidine (Pethidine) | 500,000ng/ml |
| (±)-Methadone | 500,000ng/ml |
| (-)- Methamphetamine | 500,000ng/ml |
| Methaqualone | 500,000ng/ml |
| Morphine | 500,000ng/ml |
| Nortriptyline | 500,000ng/ml |
| Oxazepam | 500,000ng/ml |
| Phencyclidine | 500,000ng/ml |
| Pentobarbital | 500,000ng/ml |
| Promethazine | 100,000ng/ml |
| Dextropropoxyphene | 500,000ng/ml |
| D-Norpropoxyphene | 500,000ng/ml |
| Ranitidine | 0.5mg/ml |
| Secobarbital | 500,000ng/ml |
| Valproic acid | 500,000ng/ml |
| Acetone | 1000mg/dL (10mg/ml) |
| L-Ascorbic Acid | 500mg/dL (5mg/ml) |
| Creatinine | 500mg/dL (5mg/ml) |
| Ethanol | 1000mg/dL (10mg/ml) |
| D-(+)-Galactose | 10mg/dL (0.1mg/ml) |
| Gamma globulin | 500mg/dL (5mg/ml) |
| D-(+)-Glucose | 3000mg/dL (30mg/ml) |
| Hemoglobin | 500mg/dL (5mg/ml) |
| Human Serum Allbumin | 500mg/dL (5mg/ml) |
| Oxalic Acid | 100mg/dL (1mg/ml) |
| (-)-Riboflavin | 7.5mg/dL (0.075mg/ml) |
| Sodium Chloride | 6000mg/dL (60mg/ml) |
| Urea | 60mg/ml |
| Interference: Amphetamine Assay | |
| --- | --- |
| Compound | Concentration Tested |
{12}
K250741 - Page 13 of 25
| Creatinine | 500mg/dL (5mg/ml) |
| --- | --- |
| D-(+)-Glucose | 3000mg/dL (30mg/ml) |
| Human Serum Allbumin | 500mg/dL (5mg/ml) |
| Sodium Chloride | 6000mg/dL (60mg/ml) |
| Oxalic Acid | 200mg/dL (2mg/ml) |
| Urea | 60mg/ml |
| Acetone | 1000mg/dL (10mg/ml) |
| L-Ascorbic Acid | 1500mg/dL (15mg/ml) |
| Ethanol | 1000mg/dL (10mg/ml) |
| Hemoglobin | 500mg/dL (5mg/ml) |
| Bilirubin | 15mg/dL (0.15mg/ml) |
| Acetaminophen | 1mg/ml |
| Acetylsalicylic Acid | 1mg/ml |
| Amitriptyline | 100,000ng/ml |
| Aspartame | 100,000ng/ml |
| Benzocaine | 100,000ng/ml |
| Benzoylecgonine | 500,000ng/ml |
| Caffeine | 1mg/ml |
| Cannabidiol | 100,000ng/ml |
| Cocaine | 100,000ng/ml |
| Codeine | 100,000ng/ml |
| Desipramine | 100,000ng/ml |
| Dextromethorphan | 100,000ng/ml |
| Dextropropoxyphene | 500,000ng/ml |
| Diazepam | 100,000ng/ml |
| Digoxin | 100,000ng/ml |
| Diphenhydramine | 100,000ng/ml |
| Diphenylhydantoin (Phenytoin) | 100,000ng/ml |
| Doxepin | 100,000ng/ml |
| Ecgonine | 100,000ng/ml |
| Ecgonine Methyl Ester | 500,000ng/ml |
| Erythromycin | 100,000ng/ml |
| Furosemide | 100,000ng/ml |
| Guaiacol glyceryl ether | 100,000ng/ml |
| Hydrochlorothiazide | 100,000ng/ml |
| Ibuprofen | 500,000ng/ml |
| Ketamine | 100,000ng/ml |
| L-Thyroxine | 100,000ng/ml |
| LSD | 100,000ng/ml |
| Meperidine (Pethidine) | 500,000ng/ml |
| (±)-Methadone | 500,000ng/ml |
| Methaqualone | 500,000ng/ml |
| Morphine | 500,000ng/ml |
| Naloxone | 100,000ng/ml |
| Naltrexone | 100,000ng/ml |
| Naproxen | 100,000ng/ml |
| Niacinamide (Nicotinamide) | 100,000ng/ml |
{13}
K250741 - Page 14 of 25
| (-)-Nicotine | 100,000ng/ml |
| --- | --- |
| Nifedipine | 100,000ng/ml |
| Nordiazepam (desmethyldiazepam) | 500,000ng/ml |
| Omeprazole | 100,000ng/ml |
| Oxazepam | 500,000ng/ml |
| Penicillin G | 100,000ng/ml |
| Phencyclidine | 500,000ng/ml |
| Phenobarbital | 500,000ng/ml |
| Quinine | 100,000ng/ml |
| Secobarbital | 500,000ng/ml |
| Tetracycline | 100,000ng/ml |
| Delta-9-THC | 100,000ng/ml |
| (1S,2R)-(+)-Ephedrine | 500,000ng/ml |
| Interference: Benzodiazepines 2 Assay | |
| --- | --- |
| Compound | Concentration Tested |
| Acetone | 1000mg/dL |
| Ethanol | 1000mg/dL |
| Glucose | 3000mg/dL |
| Oxalic Acid | 100mg/dL |
| Sodium Chloride | 6000mg/dL |
| Caffeine | 1mg/mL |
| Ascorbic Acid | 1500mg/dL |
| Galactose | 10mg/dL |
| Haemoglobin | 300mg/dL |
| Riboflavin | 7.5mg/dL |
| Acetaminophen | 1mg/mL |
| Ibuprofen | 1mg/mL |
| Creatinine | 5mg/mL |
| Gamma Globulin | 500mg/dL |
| Human Serum Albumin | 500mg/dL |
| Urea | 3500mg/dL |
| Acetylsalicylic Acid | 1mg/mL |
| Ranitidine | 0.9mg/ml |
| Sodium Fluoride | 10g/L |
| Procaine HCL | 100,000ng/ml |
| Furosemide | 100,000ng/ml |
| Sodium Azide | 10mg/ml |
| Boric Acid | 10mg/ml |
| (1S,2R)-(+)-Ephedrine | 500,000ng/ml |
| (1R,2R)-(-)- Pseudoephedrine | 100,000ng/ml |
| (1S, 2S)-(+)- Pseudoephedrine | 100,000ng/ml |
| (-)-alpha- Acetylmethadol HCL | 100,000ng/ml |
| Chloramphenicol | 100,000ng/ml |
| Labetalol HCL | 100,000ng/ml |
| Atropine Sulfate | 100,000ng/ml |
| (±)-Methadone Hydrochloride | 500,000ng/ml |
{14}
| (+)-Methamphetamine Hydrochloride | 500,000ng/ml |
| --- | --- |
| Bilirubin | 0.15mg/ml |
| Codeine Monohydrate | 500,000ng/ml |
| MDEA HCL | 500,000ng/ml |
| Quinidine | 100,000ng/ml |
| (-)-isoproterenol HCl | 100,000ng/ml |
| (-)-Cotinine | 100,000ng/ml |
| Cocaine Hydrochloride | 500,000ng/ml |
| Benzoylecgonine Tetrahydrate | 500,000ng/ml |
| Morphine Sulfate Salt Pentahydrate | 500,000ng/ml |
| (-)-11-Nor-Δ9-THC Carboxylic Acid | 500,000ng/ml |
| Aspartame | 100,000ng/ml |
| Benzilic Acid | 100,000ng/ml |
| Estrone | 100,000ng/ml |
| Chlorpheniramine | 500,000ng/ml |
| EDDP Perchlorate | 100,000ng/ml |
| Loperamide Hydrochloride | 100,000ng/ml |
| Pentobarbital | 500,000ng/ml |
| Oxycodone Hydrochloride | 100,000ng/ml |
| Heroin | 100,000ng/ml |
| Chloroquine | 100,000ng/ml |
| Ecgonine Methyl Ester | 500,000ng/ml |
| Ketamine HCl | 100,000ng/ml |
| (-)-11-Hydroxy- delta9-THC | 100,000ng/ml |
| (±)-MDMA | 100,000ng/ml |
| Phencyclidine | 100,000ng/ml |
| 6-Acetylmorphine | 100,000ng/ml |
| (±)-MDA | 100,000ng/ml |
| Amitriptyline HCl | 125,000ng/ml |
| (±) MBDB | 100,000ng/ml |
| Cannabidiol | 100,000ng/ml |
| EMDP | 100,000ng/ml |
| Secobarbital | 100,000 ng/ml |
| d,l-Amphetamine-D5 HCl | 100,000 ng/ml |
| Amobarbital | 100,000ng/ml |
| (-)-Δ9-THC | 100,000ng/ml |
| Dihydrocodeine | 100,000ng/ml |
| Cocaethylene (Benzoylecgonine ethyl ester) | 100,000ng/ml |
| Perphenazine | 100,000ng/ml |
| Phenethylamine (β- Phenylethylamine) | 100,000ng/ml |
**Analytical Specificity:**
To test cross-reactivity, drug metabolites and other compounds that may be present in human urine samples were tested using the candidate device. The sponsor identified the
K250741 - Page 15 of 25
{15}
concentration of each compound prepared in drug free negative urine that would produce a positive response for each assay when analyzed against the cut off material. The following is a summary of the cross-reactivity study. Data for Methamphetamine at 500 ng/ml, Noroxycodone at 100 ng/ml, Benzodiazepines I at 200 ng/ml, and Methadone at 300 ng/ml was reported in K220451 while data for Phenobarbital at 200 ng/ml, Tramadol at 200 ng/ml, Phencyclidine at 25 ng/ml, Buprenorphine at 5 ng/ml, 6-Acetylmorphine at 10 ng/ml was reported in K221550.
| Fentanyl Assay Specificity- Unrelated Compounds | | |
| --- | --- | --- |
| Compound | Approximate Concentration to Read Positive (ng/ml) | Approximate % Cross Reactivity |
| S(+)-Methamphetamine | Negative at 50,000ng/ml | <0.002 |
| Noroxycodone | Negative at 100,000ng/ml | <0.001 |
| Oxazepam | Negative at 50,000ng/ml | <0.002 |
| (±)-Methadone | Negative at 50,000ng/ml | <0.002 |
| Phenobarbital | Negative at 50,000ng/ml | <0.002 |
| Tramadol | Negative at 100,000ng/ml | <0.001 |
| Norbuprenorphine | Negative at 100,000ng/ml | <0.001 |
| 6-Acetylmorphine | Negative at 100,000ng/ml | <0.001 |
| Lorazepam | Negative at 50,000ng/ml | <0.002 |
| Morphine | Negative at 50,000ng/ml | <0.002 |
| Benzoylecgonine | Negative at 100,000ng/ml | <0.001 |
| (-)-11-nor-9-Carboxy-Δ⁹-THC | Negative at 100,000ng/ml | <0.001 |
| S(+)-Amphetamine | Negative at 50,000ng/ml | <0.002 |
| Opiates Assay Specificity- Unrelated Compounds | | |
| --- | --- | --- |
| Compound | Approximate Concentration to Read Positive (ng/ml) | Approximate % Cross Reactivity |
| S(+)-Methamphetamine | Negative at 50,000ng/ml | <0.6 |
| Noroxycodone | Negative at 100,000ng/ml | <0.3 |
| Oxazepam | Negative at 50,000ng/ml | <0.6 |
| (±)-Methadone | Negative at 50,000ng/ml | <0.6 |
| Phenobarbital | Negative at 50,000ng/ml | <0.6 |
| Tramadol | Negative at 100,000ng/ml | <0.3 |
| Phencyclidine | Negative at 50,000ng/ml | <0.6 |
| Norbuprenorphine | Negative at 100,000ng/ml | <0.3 |
| Fentanyl | Negative at 50,000ng/ml | <0.6 |
| Lorazepam | Negative at 50,000ng/ml | <0.6 |
| Benzoylecgonine | Negative at 100,000ng/ml | <0.3 |
| (-)-11-nor-9-Carboxy-Δ⁹-THC | Negative at 100,000ng/ml | <0.3 |
| S(+)-Amphetamine | Negative at 50,000ng/ml | <0.6 |
| Benzoylecgonine/Cocaine Assay Specificity- Unrelated Compounds | | |
| --- | --- | --- |
| Compound | Approximate Concentration to Read Positive (ng/ml) | Approximate % Cross Reactivity |
| S(+)-Methamphetamine | Negative at 50,000ng/ml | <0.3 |
| Noroxycodone | Negative at 100,000ng/ml | <0.15 |
K250741 - Page 16 of 25
{16}
| Cannabinoids (THC) Assay Specificity- Unrelated Compounds | | |
| --- | --- | --- |
| Compound | Approximate Concentration to Read Positive (ng/ml) | Approximate % Cross Reactivity |
| S(+)-Methamphetamine | Negative at 50,000ng/ml | <0.1 |
| Noroxycodone | Negative at 100,000ng/ml | <0.05 |
| Oxazepam | Negative at 50,000ng/ml | <0.1 |
| (±)-Methadone | Negative at 50,000ng/ml | <0.1 |
| Phenobarbital | Negative at 50,000ng/ml | <0.1 |
| Tramadol | Negative at 100,000ng/ml | <0.05 |
| Phencyclidine | Negative at 50,000ng/ml | <0.1 |
| Norbuprenorphine | Negative at 100,000ng/ml | <0.05 |
| 6-Acetylmorphine | Negative at 100,000ng/ml | <0.05 |
| Fentanyl | Negative at 50,000ng/ml | <0.1 |
| Lorazepam | Negative at 50,000ng/ml | <0.1 |
| Morphine | Negative at 50,000ng/ml | <0.1 |
| Benzoylecgonine | Negative at 100,000ng/ml | <0.05 |
| S(+)-Amphetamine | Negative at 50,000ng/ml | <0.1 |
| Amphetamine Assay Specificity- Unrelated Compounds | | |
| --- | --- | --- |
| Compound | Approximate Concentration to Read Positive (ng/ml) | Approximate % Cross Reactivity |
| S(+)-Methamphetamine | Negative at 50,000ng/ml | <1 |
| Noroxycodone | Negative at 100,000ng/ml | <0.5 |
| Oxazepam | Negative at 50,000ng/ml | <1 |
| (±)-Methadone | Negative at 50,000ng/ml | <1 |
| Phenobarbital | Negative at 50,000ng/ml | <1 |
| Tramadol | Negative at 100,000ng/ml | <0.5 |
| Phencyclidine | Negative at 50,000ng/ml | <1 |
| Norbuprenorphine | Negative at 100,000ng/ml | <0.5 |
| 6-Acetylmorphine | Negative at 100,000ng/ml | <0.5 |
| Fentanyl | Negative at 50,000ng/ml | <1 |
K250741 - Page 17 of 25
{17}
K250741 - Page 18 of 25
| Benzodiazepines 2 Assay Specificity- Unrelated Compounds | | |
| --- | --- | --- |
| Compound | Approximate Concentration to Read Positive (ng/ml) | Approximate % Cross Reactivity |
| S(+)-Methamphetamine | Negative at 50,000ng/ml | <0.4 |
| S(+)-Amphetamine | Negative at 50,000ng/ml | <0.4 |
| Phenobarbital | Negative at 50,000ng/ml | <0.4 |
| (-)-11-nor-9-Carboxy-Δ9-THC | Negative at 50,000ng/ml | <0.4 |
| Benzoylecgonine | Negative at 50,000ng/ml | <0.4 |
| (±)-Methadone | Negative at 50,000ng/ml | <0.4 |
| Morphine | Negative at 50,000ng/ml | <0.4 |
| Fentanyl | Negative at 50,000ng/ml | <0.4 |
| Noroxycodone | Negative at 50,000ng/ml | <0.4 |
| Tramadol | Negative at 50,000ng/ml | <0.4 |
| Norbuprenorphine | Negative at 50,000ng/ml | <0.4 |
| 6-Acetylmorphine | Negative at 50,000ng/ml | <0.4 |
| Phencyclidine (PCP) | Negative at100,000ng/ml | <0.2 |
Specificity of Structurally Related Compounds:
The following structurally unrelated compounds were tested and were found not to be detected when measuring any of the claimed drugs (Fentanyl, Opiates, Benzoylecgonine/Cocaine, Cannabinoids (THC), Amphetamine, and Benzodiazepines 2). Data for Methamphetamine at 500 ng/ml, Noroxycodone at 100 ng/ml, Benzodiazepines I at 200 ng/ml, and Methadone at 300 ng/ml was reported in K220451 while data for Phenobarbital at 200 ng/ml, Tramadol at 200 ng/ml, Phencyclidine at 25 ng/ml, Buprenorphine at 5 ng/ml, 6-Acetylmorphine at 10 ng/ml was reported in K221550.
| Fentanyl Assay Specificity- Related Compounds | | |
| --- | --- | --- |
| Compound | Approximate Concentration to Read Positive (ng/ml) | Approximate % Cross Reactivity |
| Fentanyl | 1 | 100 |
| Butyryl fentanyl | 1 | 100 |
| β-hydroxyfentanyl | 1.5 | 66.67 |
| Furanyl fentanyl | 2 | 50 |
| Acrylfentanyl | 2.5 | 40 |
| (±) β-hydroxythiofentanyl | 3 | 33.33 |
| Isobutyryl fentanyl | 4 | 25 |
| Para-fluorobutyryl fentanyl (p-FBF) | 4 | 25 |
| Norfentanyl | 5 | 20 |
| Para-fluoro fentanyl | 5 | 20 |
| 4-Fluoro-isobutyryl fentanyl | 10 | 10 |
| Valeryl fentanyl | 12 | 8.33 |
| Ocfentanil | 15 | 6.67 |
{18}
K250741 - Page 19 of 25
| (±)-3-cis-methyl fentanyl | 20 | 5 |
| --- | --- | --- |
| ω-1-Hydroxyfentanyl | 25 | 4 |
| Acetyl fentanyl | 75 | 1.33 |
| Acetyl norfentanyl | 110 | 0.91 |
| Remifentanil | 300 | 0.33 |
| Carfentanil | 750 | 0.13 |
| Norcarfentanil | 4,500 | 0.02 |
| Sufentanil | 5,000 | 0.02 |
| Alfentanil | 10,000 | 0.01 |
| Despropionyl fentanyl (4- ANPP) | 15,000 | 0.01 |
| Meperidine | 25,000 | 0.004 |
| Normeperidine | 40,000 | 0.003 |
| Tilidine | 50,000 | 0.002 |
| Methapyrilene | 50,000 | 0.002 |
| Phencyclidine (PCP) | 50,000 | 0.002 |
| 6-Acetyl morphine | Negative at 100,000ng/ml | Not Detected |
| Buprenorphine | Negative at 100,000ng/ml | Not Detected |
| Buprenorphine glucuronide | Negative at 100,000ng/ml | Not Detected |
| Dextromethorphan | Negative at 100,000ng/ml | Not Detected |
| Dihydrocodeine | Negative at 100,000ng/ml | Not Detected |
| EDDP | Negative at 100,000ng/ml | Not Detected |
| EMDP | Negative at 100,000ng/ml | Not Detected |
| Heroin | Negative at 100,000ng/ml | Not Detected |
| Hydrocodone | Negative at 100,000ng/ml | Not Detected |
| Hydromorphone | Negative at 100,000ng/ml | Not Detected |
| 9-Hydroxyrisperidone | Negative at 100,000ng/ml | Not Detected |
| Labetalol | Negative at 100,000ng/ml | Not Detected |
| Levorphanol | Negative at 100,000ng/ml | Not Detected |
| M-Chlorophenylpiperazine (m-CPP) | Negative at 100,000ng/ml | Not Detected |
| Methadone | Negative at 100,000ng/ml | Not Detected |
| Morphine-3-glucuronide | Negative at 100,000ng/ml | Not Detected |
| Norbuprenorphine | Negative at 100,000ng/ml | Not Detected |
| Norcodeine | Negative at 100,000ng/ml | Not Detected |
| Normorphine | Negative at 100,000ng/ml | Not Detected |
| Noroxycodone | Negative at 100,000ng/ml | Not Detected |
| Oxycodone | Negative at 100,000ng/ml | Not Detected |
| Oxymorphone | Negative at 100,000ng/ml | Not Detected |
| Pentazocine (Talwin) | Negative at 100,000ng/ml | Not Detected |
| Pipamperone | Negative at 100,000ng/ml | Not Detected |
| Quinine | Negative at 100,000ng/ml | Not Detected |
| Quinidine | Negative at 100,000ng/ml | Not Detected |
| Risperidone | Negative at 100,000ng/ml | Not Detected |
| Tapentadol | Negative at 100,000ng/ml | Not Detected |
| Thioridazine | Negative at 100,000ng/ml | Not Detected |
| Tramadol | Negative at 100,000ng/ml | Not Detected |
| Tramadol-O-Desmethyl | Negative at 100,000ng/ml | Not Detected |
| Tramadol-N-Desmethyl | Negative at 100,000ng/ml | Not Detected |
{19}
| Trazodone | Negative at 100,000ng/ml | Not Detected |
| --- | --- | --- |
| Opiates Assay Specificity- Related Compounds | | |
| --- | --- | --- |
| Compound | Approximate Concentration to Read Positive (ng/ml) | Approximate % Cross Reactivity |
| Morphine | 300 | 100 |
| 6-Monoacetylmorphine | 35 | 857.1 |
| 6-Acetylcodeine | 40 | 750.0 |
| Heroin | 85 | 352.9 |
| Ethylmorphine | 450 | 66.7 |
| Codeine | 480 | 62.5 |
| Desomorphine | 1,500 | 20.0 |
| Morphine-3-glucuronide | 1,700 | 17.6 |
| Levorphanol | 2,200 | 13.6 |
| Dihydrocodeine | 2,700 | 11.1 |
| Hydromorphone | 2,700 | 11.1 |
| Morphine-6-βD-glucuronide | 3,500 | 8.6 |
| Hydrocodone | 3,800 | 7.9 |
| Thebaine | 6,000 | 5.0 |
| HCl (Meperidine HCl) | 200,000 | 0.2 |
| Nalorphine | 220,000 | 0.1 |
| Dextromethorphan | 750,000 | 0.04 |
| Norcodeine | Negative at 100,000ng/ml | Not Detected |
| Normorphine | Negative at 100,000ng/ml | Not Detected |
| Noroxycodone | Negative at 100,000ng/ml | Not Detected |
| Oxycodone | Negative at 100,000ng/ml | Not Detected |
| Oxymorphone | Negative at 100,000ng/ml | Not Detected |
| Benzoylecgonine/Cocaine Assay Specificity- Related Compounds | | |
| --- | --- | --- |
| Compound | Approximate Concentration to Read Positive (ng/ml) | Approximate % Cross Reactivity |
| Benzoylecgonine | 150 | 100 |
| Cocaethylene | 50 | 300 |
| Cocaine | 80 | 187.5 |
| Ecgonine Methyl Ester | 15,000 | 1 |
| Ecgonine | 40,000 | 0.4 |
| Norcocaine | 45,000 | 0.3 |
| Amobarbital | Negative at 500,000ng/ml | Not Detected |
| Amoxicillin | Negative at 500,000ng/ml | Not Detected |
| Atropine | Negative at 500,000ng/ml | Not Detected |
| Captopril | Negative at 500,000ng/ml | Not Detected |
| Chlordiazepoxide | Negative at 500,000ng/ml | Not Detected |
| Chlorpromazine | Negative at 500,000ng/ml | Not Detected |
| Codeine | Negative at 500,000ng/ml | Not Detected |
| Dextromethorphan | Negative at 500,000ng/ml | Not Detected |
| Diazepam | Negative at 500,000ng/ml | Not Detected |
| Digoxin | Negative at 500,000ng/ml | Not Detected |
K250741 - Page 20 of 25
{20}
| Enalapril | Negative at 500,000ng/ml | Not Detected |
| --- | --- | --- |
| Glyburide | Negative at 500,000ng/ml | Not Detected |
| Lidocaine | Negative at 500,000ng/ml | Not Detected |
| Nicotine | Negative at 500,000ng/ml | Not Detected |
| Salicyluric acid | Negative at 500,000ng/ml | Not Detected |
| 11-nor- THC-COOH | Negative at 500,000ng/ml | Not Detected |
| Verapamil | Negative at 500,000ng/ml | Not Detected |
| Cannabinoids (THC) Assay Specificity- Related Compounds | | |
| --- | --- | --- |
| Compound | Approximate Concentration to Read Positive (ng/ml) | Approximate % Cross Reactivity |
| (-)-11-nor-9-Carboxy-Δ⁹-THC | 50 | 100 |
| 8-β-hydroxy-Δ⁹-THC | 100 | 50 |
| (+)-11-Nor-Δ⁹-THC-Carboxylic Acid | 100 | 50 |
| l-11-Hydroxy-Δ⁸-THC | 200 | 25 |
| l-11-Hydroxy-Δ⁹-THC | 250 | 20 |
| exo - THC | 350 | 14.3 |
| (-)-Δ⁸-THC | 800 | 6.3 |
| Cannabinol | 1200 | 4.2 |
| Nor-Δ⁹-THC-Carboxylic Acid-glucuronide | 14,000 | 0.4 |
| Δ⁹-THC | 20,000 | 0.3 |
| Cannabidiol | Negative at 100,000ng/ml | Not Detected |
| Amphetamine Assay Specificity- Related Compounds | | |
| --- | --- | --- |
| Compound | Approximate Concentration to Read Positive (ng/ml) | Approximate % Cross Reactivity |
| S(+)-Amphetamine | 500 | 100 |
| (±) MDA | 200 | 250 |
| BDB | 750 | 66.7 |
| Phentermine | 2,800 | 17.9 |
| (±) MDEA | 40,000 | 1.3 |
| l-Amphetamine | 50,000 | 1 |
| (±) MDMA | 100,000 | 0.5 |
| Tyramine | 100,000 | 0.5 |
| S(+)-Methamphetamine | Negative at 50,000ng/ml | Not Detected |
| l-Methamphetamine | Negative at 50,000ng/ml | Not Detected |
| MBDB | Negative at 100,000ng/ml | Not Detected |
| Phendimetrazine | Negative at 50,000ng/ml | Not Detected |
| (±) Phenylpropanolamine | Negative at 100,000ng/ml | Not Detected |
| d-Pseudoephedrine | Negative at 100,000ng/ml | Not Detected |
| Benzodiazepines 2 Assay Specificity- Related Compounds | | |
| --- | --- | --- |
| Compound | Approximate Concentration to Read Positive (ng/ml) | Approximate % Cross Reactivity |
| Lorazepam | 200 | 100.0 |
| Phenazepam | 180 | 111.1 |
| Delorazepam | 220 | 90.9 |
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| Meclonazepam | 300 | 66.7 |
| --- | --- | --- |
| Clonazepam | 650 | 30.8 |
| Desalkylflurazepam | 750 | 26.7 |
| Flubromazepam | 800 | 25.0 |
| Nordiazepam | 3,000 | 6.7 |
| Oxazepam | 4,000 | 5.0 |
| Nitrazepam | 15,000 | 1.3 |
| Bromazepam | 20,000 | 1.0 |
| 7-Aminoclonazepam | 26,000 | 0.8 |
| Diclazepam | 25,000 | 0.8 |
| Estazolam | 50,000 | 0.4 |
| Benzphetamine | 90,000 | 0.2 |
| Alprazolam | Negative at 20,000ng/ml | Not Detected |
| alpha-OH-Alprazolam | Negative at 20,000ng/ml | Not Detected |
| 8-Aminoclonazolam | Negative at 20,000ng/ml | Not Detected |
| Carbamazepine | Negative at 300,000ng/ml | Not Detected |
| Chlordiazepoxide | Negative at 20,000ng/ml | Not Detected |
| Clonazolam | Negative at 20,000ng/ml | Not Detected |
| Clobazam | Negative at 100,000ng/ml | Not Detected |
| Diazepam | Negative at 20,000ng/ml | Not Detected |
| Etizolam | Negative at 20,000ng/ml | Not Detected |
| Flualprazolam | Negative at 20,000ng/ml | Not Detected |
| α-OH-Flualprazolam | Negative at 20,000ng/ml | Not Detected |
| Flubromazolam | Negative at 20,000ng/ml | Not Detected |
| Flunitrazepam | Negative at 20,000ng/ml | Not Detected |
| Flunitrazolam | Negative at 20,000ng/ml | Not Detected |
| Flurazepam | Negative at 250,000ng/ml | Not Detected |
| α-Hydroxytriazolam | Negative at 20,000ng/ml | Not Detected |
| 1' Hydroxy midazolam | Negative at 20,000ng/ml | Not Detected |
| 1' Hydroxy triazolam | Negative at 20,000ng/ml | Not Detected |
| Lormetazepam | Negative at 75,000ng/ml | Not Detected |
| Medazepam | Negative at 20,000ng/ml | Not Detected |
| Midazolam | Negative at 100,000ng/ml | Not Detected |
| Prazepam | Negative at 100,000ng/ml | Not Detected |
| Pyrazolam | Negative at 20,000ng/ml | Not Detected |
| Temazepam | Negative at 20,000ng/ml | Not Detected |
| Triazolam | Negative at 100,000ng/ml | Not Detected |
## Specific gravity and pH:
The effect of specific gravity for each analyte was evaluated by testing positive (50% above cutoff) and negative samples (50% below cutoff) at specific gravities ranging from 1.000 to 1.030. No interference was observed for all specific gravities tested.
The sponsor performed a study to evaluate whether low or high pH causes negative or positive interference with the candidate device. Samples containing the claimed drugs at concentrations corresponding to -50% and +50% of the cutoff were adjusted to pH levels
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ranging from 3 to 11. Results for Fentanyl, Opiates and Cannabinoids (THC) showed no discrepant results at pH levels from 4-11. Results for Benzoylecgonine /Cocaine showed no discrepant results at pH levels from 3-10. Results Benzodiazepines 2 and Amphetamine showed no discrepant results at pH levels from 3-11. Data for Methamphetamine at 500 ng/ml, Noroxycodone at 100 ng/ml, Benzodiazepines I at 200 ng/ml, and Methadone at 300 ng/ml was reported in K220451 while data for Phenobarbital at 200 ng/ml, Tramadol at 200 ng/ml, Phencyclidine at 25 ng/ml, Buprenorphine at 5 ng/ml, 6-Acetylmorphine at 10 ng/ml was reported in K221550.
4. Assay Reportable Range:
Not applicable.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The assays are traceable to commercially available standards.
6. Detection Limit:
Not applicable.
7. Assay Cut-Off:
Not applicable.
## B Comparison Studies:
1. Method Comparison with Predicate Device:
A method comparison study was conducted using clinical samples obtained from two sites and tested on the candidate device. Candidate device results were compared to results from a quantitative comparator method (e.g. LC-MS/MS, LC/MS or GC/MS). Results are summarized below. Data for Methamphetamine at 500 ng/ml, Noroxycodone at 100 ng/ml, Benzodiazepines I at 200 ng/ml, and Methadone at 300 ng/ml was reported in K220451 while data for Phenobarbital at 200 ng/ml, Tramadol at 200 ng/ml, Phencyclidine at 25 ng/ml, Buprenorphine at 5 ng/ml, 6-Acetylmorphine at 10 ng/ml was reported in K221550.
| Analyte | N | Cut-Off (ng/ml) | Evidence MultSTAT Urine MultiPlex Result | Reference Method Results by GC/MS or LC-MS/MS Value | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | Low Negative Less than 50% below the Cut Off | Near Cut Off Negative Between 50% below the Cut Off | Near Cut Off Positive Between 50% above the Cut Off | High Positive Greater than 50% above the Cut Off |
| Fentanyl | 98 | 1 | Positive | 0 | 20 | 8 | 43 |
| | | | Negative | 24 | 2 | 1 | 0 |
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| Opiates | 84 | 300 | Positive | 2* | 5 | 4 | 39 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Negative | 28 | 6 | 0 | 0 |
| Benzoylecogonine/Cocaine) | 87 | 150 | Positive | 0 | 4 | 4 | 39 |
| | | | Negative | 37 | 2 | 1 | 0 |
| Cannabinoids (THC) | 93 | 50 | Positive | 0 | 2 | 11 | 36 |
| | | | Negative | 25 | 13 | 6 | 0 |
| Amphetamine | 105 | 500 | Positive | 0 | 1 | 6 | 46 |
| | | | Negative | 42 | 7 | 3 | 0 |
| Benzodiazepines 2 | 151 | 200 | Positive | 1** | 4 | 7 | 31 |
| | | | Negative | 99 | 6 | 3 | 0 |
**Discordant Sample Results:**
*These samples contained hydromorphone, hydrocodone and/or codeine at levels shown to cause positive interference in Opiates testing,*
**This sample contained oxazepam at levels expected to yield positive results when measured by Benzodiazepines 1, which is always run concurrently with Benzodiazepines 2.**
2. **Matrix Comparison:**
Not applicable.
**C Clinical Studies:**
1. **Clinical Sensitivity:**
Not applicable.
2. **Clinical Specificity:**
Not applicable.
3. **Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):**
Not applicable.
**D Clinical Cut-Off:**
Not applicable.
**E Expected Values/Reference Range:**
Not applicable.
**VIII Proposed Labeling:**
The labeling supports the finding of substantial equivalence for this device.
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IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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