Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
Device Facts
| Record ID | K222955 |
|---|---|
| Device Name | Xenta Drug Screen Cup, Xenta Drug Screen Dipcard |
| Applicant | Xenta Biomedical Science Co., Ltd. |
| Product Code | DJG · Clinical Toxicology |
| Decision Date | Feb 6, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
Indications for Use
Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations: Marijuana (THC) 50 ng/mL, Cocaine (COC) 300 ng/mL, Methylenedioxymethamphetamine (MDMA) 500 ng/mL, Methamphetamine (MET) 1000 ng/mL, Morphine 300 (MOP) 300 ng/mL. The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use. The assays provide only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
Device Story
Xenta Drug Screen Cup and Dipcard are lateral flow immunochromatographic assays for qualitative detection of drugs of abuse in human urine. Device uses competitive binding principle; urine sample migrates across test strip containing specific drug-antibody conjugates. Absence of colored line at test region indicates positive result (drug concentration above cutoff); presence of line indicates negative result. Performed manually without instrumentation; results read visually at 5 minutes. Used in clinical/point-of-care settings by healthcare professionals. Provides preliminary results; requires GC/MS confirmation. Assists clinicians in identifying potential drug use, supporting clinical decision-making.
Clinical Evidence
Clinical accuracy study compared Xenta devices against GC/MS reference method using 80 clinical urine specimens per drug. Samples spanned drug-free to high-positive concentrations. Results showed high concordance with GC/MS. Discordant results were analyzed and attributed to concentrations near the cutoff. No clinical data beyond this performance evaluation.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Formats: Test Cup and Test Dipcard. Qualitative visual readout. No instrumentation required. Analyte cutoffs: THC 50 ng/mL, COC 300 ng/mL, MDMA 500 ng/mL, MET 1000 ng/mL, MOP 300 ng/mL.
Indications for Use
Indicated for qualitative detection of drugs and drug metabolites (THC, COC, MDMA, MET, MOP) in human urine for prescription use. Intended for professional clinical use to provide preliminary analytical results.
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
- Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard (K153050)
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
K222955
B Applicant
Xenta Biomedical Science Co., Ltd.
C Proprietary and Established Names
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
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 |
| DJC | Class II | 21 CFR 862.3610 - Methamphetamine test system | TX - Clinical Toxicology |
## II Submission/Device Overview:
A Purpose for Submission:
New Device
B Measurand:
Cocaine, Marijuana, Methamphetamine, Morphine, Methylenedioxymethamphetamine
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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K222955 - Page 2 of 13
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:
Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:
| Test | Calibrator | Cut-off level |
| --- | --- | --- |
| Marijuana (THC) | Delta-9-THC-COOH | 50 ng/mL |
| Cocaine (COC) | Benzoylecgonine | 300 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 3,4-Methylenedioxymethamphetamine | 500 ng/mL |
| Methamphetamine (MET) | D-Methamphetamine | 1000 ng/mL |
| Morphine 300 (MOP) | Morphine | 300 ng/mL |
The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use.
The assays provide only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
D Special Instrument Requirements:
Not applicable; this is a visually read single use device
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K222955 - Page 3 of 13
## IV Device/System Characteristics:
### A Device Description:
Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are competitive binding, lateral flow immunochromatographic assays.
Kit Contents for Xenta Drug Screen Cup:
- One Xenta Drug Screen Cup with integrated test card.
- Desiccant Pouch.
Kit Contents for Xenta Drug Screen Dipcard:
- One pouch containing a test panel and desiccant.
- Urine Cups
The Xenta Drug Screen Cup and Xenta Drug Screen Dipcard formats use identical test strips made with the same chemical formulation and manufacturing procedures.
### B Principle of Operation:
The candidate device is a competitive immunoassay. It is a chromatographic absorbent device in which drugs within a urine sample competitively bind 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 at a level below the detection level of the test, the 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, that, regardless of its intensity, indicates a negative test result. When sample drug levels are at or above the detection level of the test, the free drug in the sample binds to the respective drug monoclonal antibody conjugate, preventing the respective drug monoclonal antibody conjugate from binding to the respective drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result.
To serve as a procedure control, a colored line will appear at the Control Region (C) of each strip (if the test has been performed properly).
### V Substantial Equivalence Information:
#### A Predicate Device Name(s):
Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard
#### B Predicate 510(k) Number(s):
K153050
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K222955 - Page 4 of 13
# C Comparison with Predicate(s):
| Device & Predicate Device(s): | K222955 | K153050 |
| --- | --- | --- |
| Device Trade Name | Xenta Drug Screen Cup and Xenta Drug Screen Dipcard | Rapid Single/Multi-drug Test Cup
Rapid Single/Multi-drug Test Dipcard |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Qualitative detection of drugs-of-abuse in urine | Same |
| Specimen | Urine | Same |
| Read Time | 5 minutes | Same |
| Methodology | Competitive binding, Lateral flow immunochromatographic assay based on the principle of antigen antibody immunochemistry | Same |
| Cutoff | Cocaine:300 ng/mL
Methamphetamine:1000 ng/mL
Morphine:300 ng/mL
Marijuana:50 ng/mL
Methylenedioxy-methamphetamine:500 ng/mL | Same |
| General Device Characteristic Differences | | |
| Configuration | Dipcard and Cup | Cassette, Dipcard and Cup |
| Intended Users | Prescription Use Only | Over the Counter (OTC)
Use and Prescription Use |
# VI Standards/Guidance Documents Referenced:
None.
# VII Performance Characteristics (if/when applicable):
# A Analytical Performance:
1. Precision/Reproducibility:
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Precision studies were performed for the Xenta Drug Screen Dipcard and Xenta Drug Screen Cup formats. Drug free specimens were spiked with analytes at 0, ±75% cutoff, ±50% cutoff, ±25% cutoff, the cutoff, and +100% cutoff of each drug. The concentrations of the target drugs were confirmed with GC/MS. Each urine specimen was divided into aliquots. Testing was performed by an operator blinded to the sample concentration. Separate sets of blind-coded samples were assigned and randomized prior to testing. The study was conducted by 6 operators at 3 Point-of-Care sites. Two operators per location tested 3 aliquots at each concentration for each lot per day (3 runs/day) for 10 non-consecutive days using one device lot per location. One operator tested the Xenta Drug Screen Dipcard format and the second operator tested the Xenta Drug Screen Cup format. Precision studies were performed using the single drug and multi-drug test formats and results were similar. Only the results from the multi-drug test format for both the screen cup and screen dipcard are provided in the tables below:
Multi-Drug Xenta Drug Screen Cup Precision Results:
| Drug test | Approximate concentration | % of cutoff | Number of Determinations per lot | Result | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | | + | - | + | - | + | - |
| COC | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 225ng/ml | -25%cutoff | 60 | 8 | 52 | 6 | 54 | 4 | 56 |
| | 300ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 32 | 28 |
| | 375ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 52 | 8 |
| | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| MET | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 250ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 750ng/ml | -25%cutoff | 60 | 4 | 56 | 6 | 54 | 6 | 54 |
| | 1000ng/ml | cutoff | 60 | 34 | 26 | 38 | 22 | 36 | 24 |
| | 1250ng/ml | +25%cutoff | 60 | 56 | 4 | 58 | 2 | 58 | 2 |
| | 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| MOP 300 | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 225ng/ml | -25%cutoff | 60 | 8 | 52 | 10 | 50 | 8 | 52 |
| | 300ng/ml | cutoff | 60 | 42 | 18 | 40 | 20 | 44 | 16 |
| | 375ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 56 | 4 |
| | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
K222955 - Page 5 of 13
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Multi-Drug Xenta Drug Screen Dipcard Precision Results:
| Drug test | Approximate concentration of sample | % of cutoff | Number of Determinations per lot | Result | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | | + | - | + | - | + | - |
| COC | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 225ng/ml | -25%cutoff | 60 | 8 | 52 | 6 | 54 | 4 | 56 |
| | 300ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 32 | 28 |
| | 375ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 52 | 8 |
| | 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| MET | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 250ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 750ng/ml | -25%cutoff | 60 | 6 | 54 | 8 | 52 | 4 | 56 |
| | 1000ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 36 | 24 |
| | 1250ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 56 | 4 |
| | 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
K222955 - Page 6 of 13
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| Drug test | Approximate concentration of sample | % of cutoff | Number of determinations per lot | Result | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | | + | - | + | - | + | - |
| | 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| MOP 300 | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 500ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 1000ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 1500ng/ml | -25%cutoff | 60 | 8 | 52 | 10 | 50 | 8 | 52 |
| | 2000ng/ml | cutoff | 60 | 42 | 18 | 40 | 20 | 44 | 16 |
| | 2500ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 56 | 4 |
| | 3000ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 3500ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 4000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| THC | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 12.5ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 25ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 37.5ng/ml | -25%cutoff | 60 | 8 | 52 | 4 | 56 | 6 | 54 |
| | 50ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 38 | 22 |
| | 62.5ng/ml | +25%cutoff | 60 | 50 | 10 | 52 | 8 | 54 | 6 |
| | 75ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 87.5ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 100ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| MDMA | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 125ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 250ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 375ng/ml | -25%cutoff | 60 | 10 | 50 | 6 | 54 | 8 | 52 |
| | 500ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 34 | 26 |
| | 625ng/ml | +25%cutoff | 60 | 52 | 8 | 56 | 4 | 54 | 6 |
| | 750ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 875ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 1000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
2. Linearity:
Not Applicable.
3. Analytical Specificity/Interference:
K222955 - Page 7 of 13
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# Cross-Reactivity
To determine cross-reactivity, drug metabolites and structurally similar compounds were tested. All the components were added to drug-free normal human urine. Each sample was tested in 5 replicates using two lots of Xenta Drug Screen Dipcard and one lot of Xenta Drug Screen Cup. If any positive result was observed, the compounds were further diluted with known drug-free urine specimen sequentially to different concentrations and tested in quintuplicate, until the highest concentration that generated a negative result was reached. The cross-reacting substances with the lowest concentration that produced a positive result was identified and is listed in the table below. If no cross-reactivity was observed the highest concentration tested is shown.
| Compounds Tested | Lowest Concen. (ng/mL) | % Cross-reactivity | Compounds Tested | Lowest Concen. (ng/mL) | % Cross-reactivity |
| --- | --- | --- | --- | --- | --- |
| Cannabinoids (THC) | | | Methylenedioxy-methamphetamine (MDMA) | | |
| 11-nor-Δ9-THC-9-COOH | 50 | 100% | (+/-)3,4-Methylenedioxy-methamphetamine (MDMA) | 500 | 100% |
| 11-nor-Δ8-THC-9-COOH | 50 | 100% | 3,4-methylenedioxyamphetamine (MDA) | 2200 | 22.7% |
| Δ9-THC | 15000 | 0.3% | 3,4-Methylenedioxy-ethylamphetamine (MDEA) | 240 | 208.3% |
| Δ8-THC | 10000 | 0.5% | D-methamphetamine (MAMP) | 100000 | 0.5% |
| Cannabidiol | 20000 | 0.3% | D-Amphetamine | >100000 | <0.5% |
| Cannabinol | >100000 | <0.05% | L-Amphetamine | >100000 | <0.5% |
| (+/-)11-hydroxy-Δ9-THC | 5000 | 1% | L-Methamphetamine | >100000 | <0.5% |
| Methamphetamine (MET) | | | Morphine 300 (MOP) | | |
| d-Methamphetamine | 1000 | 100% | Morphine | 300 | 100.0% |
| l-Methamphetamine | 8000 | 12.5% | Codeine | 300 | 100.0% |
| p-hydroxymethamphetamine | 30000 | 3.3% | Hydrocodone | 1500 | 20.0% |
| 3,4-methylenedioxumethamphetamine (MDMA) | 2000 | 50% | 6-Monoacetylmorphine (6-MAN) | 750 | 40.0% |
| 3,4-Methylenedioxyethylamphetamine (MDEA) | 50000 | 2% | Morphine 3-β-D-glucuronide | 300 | 100.0% |
| Mephentermine | 75000 | 1.3% | Ethylmorphine | 100 | 300.0% |
| d-Amphetamine | 50000 | 2% | Heroine | 800 | 37.5% |
| L-Amphetamine | 50000 | 2% | Levophenol | 50000 | 0.6% |
| Ephedrine | 100000 | 1% | Morphine3-glucuronide | 400 | 75% |
| 3,4-methylenedioxyamphetamine (MDA) | 100000 | 10% | Norcodeine | 16000 | 1.9% |
K222955 - Page 8 of 13
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| Compounds Tested | Lowest Concen. (ng/mL) | % Cross-reactivity | Compounds Tested | Lowest Concen. (ng/mL) | % Cross-reactivity |
| --- | --- | --- | --- | --- | --- |
| Cocaine (COC) | | | Oxycodone | >75000 | <0.4% |
| Benzoylecgonine | 300 | 100% | Thebaine | >90000 | <0.3% |
| Cocaine | 800 | 37.5% | | | |
| Cocaethylene | 12500 | 2.4% | | | |
| Ecgonine HCl | 35000 | 0.9% | | | |
| Ecgonine | >50000 | <0.6% | | | |
| Benzoylecgonine | 300 | 100% | | | |
| Cocaine | 800 | 37.5% | | | |
## Interfering substances
To determine interference, potentially interfering compounds (listed below) were added to drug-free urine or drug positive urine containing MDMA, THC, COC, MET, and MOP concentrations 50% below the cutoff and 50% above the cutoff, respectively. All potential interfering substances were added at a concentration of 100μg/mL. All concentrations of the drugs were confirmed with GC/MS. The urine specimens were tested in 3 replicates with two lots of the rapid single/multi-drug Xenta Drug Screen Dipcard and one lot of the rapid single/multi-drug Xenta Drug Screen Cup. None of the urine samples showed any deviation from the expected results.
Acetaminophen, Acetophenetidin, Amoxicillin, Ampicillin, Aspirin, Atenolol, Atorvastatin, Azlocillin, Benzilic acid, Benzylpenicillin, Benzoic acid, Bilirubin, Benzydamine, Caffeine, Carbamazepine, Cephalexin, Chloralhydrate, Chloramphenicol, Chlorothiazide, Chlorpheniramine, d,l-Chlorpromazine, Cholesterol, Clonidine, Cimetidine, Citalopram, Cortisone, Creatinine, Deoxycorticosterone, Dexamethasone, Dextromethorphan, Diclofenac, Diflunisal, Digoxin, Diphenhydramine, β-Estradiol, Estrone-3-sulfate, Ethyl-p-aminobenzoate, Erythromycin, Fenoprofen, Flucloxacillin, Fluoxetine, Furosemide, Gentisic acid, Hemoglobin, Hydralazine, Hydrochlorothiazide, Hydrocortisone, o-Hydroxyhippuric acid, Ibuprofen, Indomethacin, Iproniazid, Isoxsuprine, Ketamine, Ketoprofen, Labetalol, Lisinopril, Loperamide, Meperidine, Meprobamate, Methoxyphenamine, Nadolol, Nalidixic acid, Naproxen, Niacinamide, Nicotine, Nifedipine, Norethindrone, Noscapine, d,l-Octopamine, Oxalic acid, Oxolinic acid, Oxymetazoline, Oxytetracycline, Papaverine, Penicillin-G, Pentazocine, Perphenazine, Phenelzine, Prednisolone, Prednisone, d,l-Propanolol, Quinacrine, Quinine, Quindine, Salicylic acid, Serotonin, Sulfamethazine, Sulindac, Tetracycline, Tetrahydrozoline, Thiamine, Thioridazine, d,l-Thyroxine, Tolbutamine, Tolbutamide, Trifluoperazine, Tryptamine, Uric acid, Verapamil, Zomepirac, Acetone, Acetylsalicylic acid, Albumin, Ascorbic Acid, Aspartame, Ascorbic Acid, Atropine, Benzocaine, Benzoylecgonine, Chlorquine, (±) Chlortheniramine, Creatine, Dexbrompheniramine, Dophenhydramine, Dopamine, (+/-)-Isoproterenol, 1R,2S(+)-Ephedrine, Ethanol, Glucose, Guaiacol glyceryl ether, Levorphanol, Lidocaine, Lysergic acid, Methadone, Methanol, Methaqualone, Morphine, (1R,2S)-(-)-n-Methyl-ephedrine, (+)-Naproxen, (+/-)-Norephedrine, Nortriptyline, Nordiazepam, Pheniramine, Phenothiazine, L-Phenylephrine, B-Phenylethylamin, Phencyclidine, Procaine, Propoxyphene, Ranitidine, Riboflavin, Salicylic acid, Secobarbital, Sodium Chloride, Theophyline, Tyramine, Uric acid, Vitamin(L-Ascorbic Acid), 4-Dimethylaminoantipyrine, d-Amphetamine
K222955 - Page 9 of 13
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# Effect of Urinary Specific Gravity
The specific gravity studies were conducted on drug-free urine specimens with varying specific gravity conditions including 1.002, 1.010, 1.020, 1.030, 1.040 spiked with MDMA, THC, COC, MET, or MOP at 50% below and 50% above cutoff levels. All concentrations were confirmed with GC/MS. Each sample was tested using two lots of the corresponding multi-drug Xenta Drug Screen Cup and Xenta Drug Screen Dipcard. The results demonstrate that the tested range of specific gravity does not affect the test result.
# Effect of Urinary pH
The pH of an aliquot of negative urine pool was adjusted to a pH range of 3 to 9 in 1 pH unit increments and spiked with each drug at 50% below and 50% above cutoff levels (all concentrations were confirmed with GC/MS). Each sample was tested using two lots of the corresponding multi-drug Xenta Drug Screen Cup and Xenta Drug Screen Dipcard. The result demonstrate that the tested pH range does not interfere with the performance of the test.
4. Assay Reportable Range:
Not applicable.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The device is traceable to commercially available reference materials.
6. Detection Limit:
Not Applicable.
7. Assay Cut-Off:
Refer to Section VII.A.1
# B Comparison Studies:
1. Method Comparison with Predicate Device:
Eighty (80) clinical urine specimens for each drug were analyzed by GC/MS and by two lots of the corresponding Xenta Drug Screen Cup and Xenta Drug Screen Dipcard. The study was conducted by 4 operators at two Point-of-Care sites in which the Xenta Drug Screen Cup or Xenta Drug Screen Dipcard format was tested. Comparison studies were performed using the single drug and multi-drug test formats and results were similar. Only the results from the multi-drug test format for both the Xenta Drug Screen cup and Xenta Drug Screen Dipcard are provided in the tables below:
Multi-Drug Xenta Drug Screen Cup Test Results
| Drug Test | Xenta Result | | Less than half the cutoff concentration | Near Cutoff Negative (Between) | Near Cutoff Positive (Between the | High Positive (greater than | Total |
| --- | --- | --- | --- | --- | --- | --- | --- |
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| | | Drug free by GC/MS analysis | by GC/MS analysis | 50% below the cutoff and the cutoff concentration) | cutoff and 50% above the cutoff concentration) | 50% above the cutoff concentration) | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| MDMA | + | 0 | 0 | 0 | 5 | 34 | 80 |
| | - | 32 | 3 | 5 | 1 | 0 | |
| COC | + | 0 | 0 | 0 | 5 | 35 | 80 |
| | - | 33 | 1 | 6 | 0 | 0 | |
| THC | + | 0 | 0 | 0 | 6 | 33 | 80 |
| | - | 34 | 1 | 5 | 1 | 0 | |
| MET | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 30 | 3 | 6 | 0 | 0 | |
| MOP 300 | + | 0 | 0 | 1 | 6 | 34 | 80 |
| | - | 30 | 4 | 5 | 0 | 0 | |
Analysis of Discordant Results with Multi-drug Xenta Drug Screen Cup
| Multi-drug Xenta Drug Screen Cup | | | GC/MS Analysis | |
| --- | --- | --- | --- | --- |
| Drug Test | Cutoff (ng/mL) | Test Result | Drug Concentration (ng/mL) | Drug in Urine |
| MET | 1000 | Positive | 867 | Methamphetamine |
| MDMA | 500 | Negative | 715 | 3,4-Methylenedioxy-methamphetamine |
| MOP | 300 | Positive | 275 | Morphine |
| THC | 50 | Negative | 61 | 11-nor-Δ9--THC-9-COOH |
Multi-Drug Xenta Drug Screen Dipcard Test Results
| Drug Test | Xenta Result | Drug free by GC/MS analysis | Less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) | Total |
| --- | --- | --- | --- | --- | --- | --- | --- |
| MDMA | + | 0 | 0 | 0 | 5 | 34 | 80 |
| | - | 32 | 3 | 5 | 1 | 0 | |
| COC | + | 0 | 0 | 0 | 5 | 35 | 80 |
| | - | 33 | 1 | 6 | 0 | 0 | |
| THC | + | 0 | 0 | 0 | 6 | 33 | 80 |
| | - | 34 | 1 | 5 | 1 | 0 | |
| MET | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 30 | 3 | 6 | 0 | 0 | |
| MOP 300 | + | 0 | 0 | 1 | 6 | 34 | 80 |
| | - | 30 | 4 | 5 | 0 | 0 | |
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Analysis of Discordant Results with Multi-drug Xenta Drug Screen Dipcard
| Multi-drug Xenta Drug Screen Cup | | | GC/MS Analysis | |
| --- | --- | --- | --- | --- |
| Drug Test | Cutoff (ng/mL) | Test Result | Drug Concentration | Drug in Urine |
| MET | 1000 | Positive | 867 | Methamphetamine |
| MDMA | 500 | Negative | 715 | 3,4-Methylenedioxymethamphetamine |
| MOP | 300 | Positive | 275 | Morphine |
| THC | 50 | Negative | 61 | 11-nor-Δ9--THC-9-COOH |
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):
Read Time
Five drug free specimens were spiked with the respective drug to concentrations of 0, -50% and +50% cutoff levels. The samples were tested in replicates of 10 with one lot of Xenta Drug Screen Cup and one lot of Xenta Drug Screen Dipcard following the procedures described in the package inserts. The sponsor provided data to support the recommendation for read time. The sponsor recommends that the test results should be read 5-30 minutes after use.
## 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.
K222955 - Page 13 of 13
