(28 days)
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No
The device description explicitly states that the tests are performed "without the use of an instrument" and are based on lateral flow immunochromatographic assays, which are traditional biochemical methods. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is an in vitro diagnostic (IVD) device used to detect the presence of drugs and drug metabolites in human urine, not to treat a condition.
Yes
This device is described as an "in vitro diagnostics use" and "designed to qualitatively detect the presence of drugs and drug metabolites in human urine," which clearly indicates its purpose is to aid in diagnosis.
No
The device is a lateral flow chromatographic immunoassay, which is a physical test strip/cup, not a software-only device. It is performed "without the use of an instrument."
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states, "These tests are intended for in vitro diagnostics use."
- Device Description: It describes a "lateral flow immunochromatographic assay for the qualitative detection of Barbiturate, Benzodiazepine, Amphetamine, Methadone, Oxycodone, Phencyclidine at or above the cut-off levels as indicated." This is a common type of in vitro diagnostic test.
- Anatomical Site: The test is performed on "human urine," which is a biological sample tested outside the body.
- Performance Studies: The document details performance studies conducted on clinical urine samples to evaluate the device's accuracy and precision in detecting the target analytes. This is a standard requirement for IVD devices.
- Predicate Device: A predicate device (K122809) is listed, which is also a multi-drug screen test, further indicating that this device falls within the category of IVDs.
The description clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / 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:
Test Barbiturates (BAR) - Calibrator Secobarbital - Cut-off level 300 ng/mL
Test Benzodiazepines (BZO) - Calibrator Oxazepam - Cut-off level 300 ng/mL
Test Amphetamine (AMP) - Calibrator D-Amphetamine - Cut-off level 1000 ng/mL
Test Methadone (MTD) - Calibrator Methadone - Cut-off level 300 ng/mL
Test Oxycodone (OXY) - Calibrator Oxycodone - Cut-off level 100 ng/mL
Test Phencyclidine (PCP) - Calibrator Phencyclidine - Cut-off level 25 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.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DIS, JXM, DJR, DJG, LCM
Device Description
Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are competitive binding, lateral flow immunochromatographic assays for the qualitative detection of Barbiturate, Benzodiazepine, Amphetamine, Methadone, Oxycodone, Phencyclidine at or above the cut-off levels as indicated. The tests are performed without the use of an instrument.
The test cup and test dipcard formats use identical test strips made with the same chemical formulation and manufacturing procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data:
- Cross-reactivity: Tested with drug metabolites and structurally similar compounds in urine. Samples were tested in 5 replicates. Substances with the lowest concentration that produced a positive result were identified.
- Interference: Clinical urine samples were spiked with various compounds at 100 µg/mL (confirmed by GC/MS) in drug-free or drug-positive urine (50% below and 50% above cutoff). Tested with two lots of Single/Multi-drug Test Cup and Test Dipcard. None of the listed compounds interfered.
- Effect of Urinary pH: pH of drug-free urine adjusted to 3-9 in 1 pH unit increments and spiked with each drug at 50% below and 50% above cutoff levels (confirmed by GC/MS). Tested by two lots of Xenta Drug Screen Cup and Xenta Drug Screen Dipcard. Results showed varying pH ranges do not interfere.
- Effect of Urinary specific gravity: Specific gravity studies conducted on specimens with specific gravities 1.002, 1.010, 1.020, 1.030, 1.040, containing drug-free urine or drugs at 50% below and 50% above cutoff level (confirmed by GC/MS). Tested by two lots of Xenta Drug Screen Cup and Xenta Drug Screen Dipcard. Results showed varying specific gravity does not affect the test result.
- Precision:
- Study type: Precision studies performed using single drug and multi-drug test formats.
- Sample size: Each concentration of urine specimen was divided into aliquots. 1620 observations by 3 sites at 9 concentrations.
- Data source: Drug free specimens spiked with analytes at 0, +/-75% cutoff, +/-25% cutoff, and +100% cutoff. Concentrations confirmed by GC/MS.
- Annotation protocol: Aliquots were blindly labeled by a nonparticipant. Separate sets of blinded coded samples were assigned and randomized prior to testing.
- Key results: 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 test dipcard format and the second operator tested the test cup format. Detailed results for each drug (AMP, BAR, BZO, MTD, OXY, PCP) at various concentrations across 3 lots are provided, showing positive/negative counts for each.
- Accuracy:
- Study type: Accuracy study using clinical urine samples.
- Sample size: 80 clinical urine samples for each drug.
- Data source: Clinical urine specimens collected from sample place several hospitals and drug relief reformatory. All analyzed by GC/MS.
- Annotation protocol: Samples blindly labeled by a nonparticipant. Separate sets of blind coded assigned. Samples randomized prior to testing.
- Key results: Samples divided into five categories: drug free, less than half the cutoff negative, near cutoff negative, near cutoff positive, and high positive. Tested by two lots of the corresponding Single/Multi-drug Test Cup and Test Dipcard. Conducted by 4 nurses at two Point-of-Care sites. Results show concordance with GC/MS analysis, with some discordant results observed for BZO, MTD, and PCP near the cutoff for both single and multi-drug test formats (Cup and Dipcard).
- Stability of the test line studies:
- Study type: Stability study of test line.
- Data source: Drug free specimens spiked with analytes at different concentrations (+/- 50% cutoff and +100% cutoff). Each sample contained all eleven drugs, and concentrations were confirmed by GC/MS. Five drug-free specimens were also tested.
- Key results: The color T line of Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are stable from 3 to 50 minutes. Suggested read time is 5 to 30 minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not explicitly stated as Sensitivity, Specificity, PPV, NPV values in a summary table, but raw data is provided in the Accuracy section tables.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 19, 2023
Xenta Biomedical Science Co., Ltd. Huang Ling Product Manager Building C5, 9th Floor, Rm 901, No. 11 Kaiyuan Avenue Huangpu District Guangzhou, Guangdong 510535 China
Re: K231137
Trade/Device Name: Xenta Drug Screen Cup, Xenta Drug Screen Dipcard Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DIS, JXM, DJR, DJG, LCM Dated: April 21, 2023 Received: April 21, 2023
Dear Huang Ling:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Paula V. Caposino -S
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231137
Device Name Xenta Drug Screen Cup Xenta Drug Screen Dipcard
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 Barbiturates (BAR) Benzodiazepines (BZO) Amphetamine (AMP) Methadone (MTD) Oxycodone (OXY) Phencyclidine (PCP)
- Calibrator Secobarbital Oxazepam D-Amphetamine Methadone Oxycodone Phencyclidine
Cut-off level 300 ng/mL 300 ng/mL 1000 ng/mL 300 ng/mL 100 ng/mL 25 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Section 5 - 510(k) Summary
Date of Summary Preparation: 5/17/2023
510(k) Number: K231137
1. Submitter's Identifications
Submitter: Xenta Biomedical Science Co., Ltd. Address: Building C5, 9th Floor, Rm 901, No. 11 Kaiyuan Avenue, Huangpu District, Guangzhou, 510535, P.R. China Contact Person: Huang Ling Contact Email Address: 1433969171@qq.com Telephone: +86-20-31707187 Fax: +86-20-31707187
2. Correspondent's Identifications
Correspondent's Name: Xenta Biomedical Science Co., Ltd. Address: Building C5, 9th Floor, Rm 901, No. 11 Kaiyuan Avenue, Huangpu District, Guangzhou, 510535, P.R. China Contact Person: Huang Ling Contact Email Address: 1433969171@qq.com Telephone: 86-20-31707187 Fax: 86-20-31707187
3. Name of the Device
Proprietary names:
Xenta Drug Screen Cup Xenta Drug Screen Dipcard
Recommended classification regulation:
21 CFR 862.3150 Barbiturate test system
21 CFR 862.3170 Benzodiazepine test system
21 CFR 862.3100 Amphetamine test system
21 CFR 862.3620 Methadone test system
21 CFR 862.3650 Opiate test system
Unclassified Enzyme Immunoassay Phencyclidine
Device class: Class II Panel: Toxicology Product code: DIS,JXM,DKZ,DJR,DJG,LCM
4. The Predicate Devices
- K122809 Advin Multi-Drug Screen Test Dip Card Advin Multi-Drug Screen Test Cup Advin Multi-Drug Screen Test Cassette
4
5. Device Description
Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are competitive binding, lateral flow immunochromatographic assays for the qualitative detection of Barbiturate, Benzodiazepine, Amphetamine, Methadone, Oxycodone, Phencyclidine at or above the cut-off levels as indicated. The tests are performed without the use of an instrument.
The test cup and test dipcard formats use identical test strips made with the same chemical formulation and manufacturing procedures.
6. 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:
| Test | Calibrator | Cut-off level |
|---|---|---|
| Barbiturates (BAR) | Secobarbital | 300 ng/mL |
| Benzodiazepines (BZO) | Oxazepam | 300 ng/mL |
| Amphetamine (AMP) | D-Amphetamine | 1000 ng/mL |
| Methadone (MTD) | Methadone | 300 ng/mL |
| Oxycodone (OXY) | Oxycodone | 100 ng/mL |
| Phencyclidine (PCP) | Phencyclidine | 25 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. The 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.
7. Comparison to Predicate Devices:
A summary comparison of features of the Xenta Drug Screen Cup and Xenta Drug Screen Dipcard and the predicate devices is provided in the following Table:
| Item | Device | Predicate (K122809) |
|---|---|---|
| Indication for use | Qualitative detection of | Same (but the number of |
5
| drugs-of-abuse in urine | drugs detected different) | |
|---|---|---|
| Intended Users | Prescription Use | Over the Counter (OTC) Use |
| and Prescription Use | ||
| Specimen | Urine | Same |
| Cutoff | Barbiturates:300 ng/mL | |
| Benzodiazepines:300 ng/mL | ||
| Amphetamine:1000 ng/mL | ||
| Methadone:300 ng/mL | ||
| Oxycodone:100 ng/mL | ||
| Phencyclidine: 25 ng/mL | Barbiturate:300 ng/mL | |
| Benzodiazepine:300 ng/mL | ||
| Amphetamine:500 ng/mL | ||
| Methadone:300 ng/mL | ||
| Oxycodone:100 ng/mL | ||
| Phencyclidine: 25 ng/mL | ||
| Read time | 5 minutes | Same |
| Results | Qualitative | Same |
| Methodology | Competitive binding, Lateral flow | |
| immunochromatographic assay based | ||
| on the principle of antigen antibody | ||
| immunochemistry | Same | |
| Configuration | Dipcard and Cup | Cassette,Dip Card and Cup |
8. Performance Data:
8.1 Cross-reactivity with structurally similar compounds
To test the cross reactivity of the test, test Dipcard and test Cup was used to test with drug metabolites and drug structurally similar compounds in urine. All the components were added to drug-free normal human urine. Each sample was tested in 5 replicates using Test Cup and Test Dipcard. 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 generates a negative result was identified.
The cross reacting substances with the lowest concentration that produced a positive result was identified and is listed in the table below.
| Amphetamine (AMP) | Lowest
Concentrat
ion
(ng/mL) | %
Cross-react
ivity | Methadone (MTD) | Lowest
Concentrat
ion
(ng/mL) | %
Cross-react
ivity |
|-------------------------|----------------------------------------|---------------------------|-----------------------------------------------------|----------------------------------------|---------------------------|
| d-Amphetamine | 1000 | 100% | Methadone | 300 | 100% |
| L-Amphetamine | 50000 | 2% | (±)2-Ethyl-1,5-dimethyl-3,
3-diphenylpyrrolinium | 50000 | 0.6% |
| MDA | 2000 | 50% | Doxylamine | 50000 | 0.6% |
| Phentermine | 45000 | 2.2% | Oxycodone (OXY) | | |
| Benzodiazepines (BZO) | | | Oxycodone | 100 | 100% |
| Oxazepam | 300 | 100% | Hydrocodone | 3000 | 3.3% |
| Alpha-hydroxyalprazolam | 1900 | 15.8% | Hydromorphone | 75000 | 0.1% |
6
| Alprazolam | 200 | 150% | Oxymorphone | 1000 | 10% |
|---|---|---|---|---|---|
| Bromazepam | 1000 | 30% | Ethymorphine | 50000 | 0.2% |
| Clobazam | 100 | 300% | Codeine | 50000 | 0.2% |
| Clonazepam | 800 | 37.5% | Barbiturates (BAR) | ||
| Desalkylflurazepam | 400 | 75% | Secobarbital | 300 | 100% |
| Diazepam | 200 | 150% | Amobarbital | 500 | 60% |
| Flunitrazepam | 350 | 85.7% | Aprobarbital | 200 | 150% |
| Lorazepam | 1200 | 25% | Butabarbital | 75 | 400% |
| Lorazepam-glucuronide | 5000 | 6% | Butalbital | 1500 | 20% |
| Nitrazepam | 100 | 300% | Cyclopentobarbital | 600 | 50% |
| Nordiazepam | 400 | 75% | Pentobarbital | 700 | 42.9% |
| Norchlordiazepapoxide | 500 | 60% | Phenobarbital | 300 | 100% |
| Nordiazepoxide | 400 | 75% | Phencyclidine (PCP) | ||
| Temazepam | 120 | 250% | Phencyclidine | 25 | 100% |
| Triazolam | 1000 | 30% | 4-Hydroxy-PCP | 15000 | 0.2% |
8.2 Interference
Clinical urine samples may contain substances that could potentially interfere with the test. The following compounds were added to drug-free urine or drug positive urine containing AMP, BAR, BZO, MTD, OXY, PCP with the concentration 50% below the cutoff and the concentration 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 with two lots of the corresponding Single/Multi-drug Test Cup and Test Dipcard. None of the compounds listed below were shown to interfere.
| Acetaminophen | Estrone-3-sulfate | d,l-Octopamine |
|---|---|---|
| Acetophenetidin | Ethyl-p-aminobenzoate | Oxalic acid |
| Amoxicillin | Erythromycin | Oxolinic acid |
| Ampicillin | Fenoprofen | Oxymetazoline |
| Aspirin | Flucloxacillin | Oxytetracycline |
| Atenolol | Fluoxetine | Papaverine |
| Atorvastatin | Furosemide | Penicillin-G |
| Azlocillin | Gentisic acid | Pentazocine |
| Benzilic acid | Hemoglobin | Perphenazine |
| Benzylpenicillin | Hydralazine | Phenelzine |
| Benzoic acid | Hydrochlorothiazide | Prednisolone |
| Bilirubin | Hydrocortisone | Prednisone |
| Benzydamine | o-Hydroxyhippuric acid | d,l-Propanolol |
| Caffeine | p-Hydroxytyramine | d-Pseudoephedrine |
| Carbamazepine | Ibuprofen | Quinacrine |
| Cephalexin | Indomethacin | Quinine |
| Chloralhydrate | Iproniazid | Quindine |
| Chloramphenicol | d,l-Isoproterenol | Ranitidine |
| Chlorothiazide | Isoxsuprine | Salicylic acid |
| Chlorpheniramine | Ketamine | Serotonin |
| d,l-Chlorpromazine | Ketoprofen | Sulfamethazine |
| Cholesterol | Labetalol | Sulindac |
| Clonidine | Lisinopril | Tetracycline |
7
| Cimetidine | Loperamide | Tetrahydrozoline |
|---|---|---|
| Citalopram | Meperidine | Thiamine |
| Cortisone | Meprobamate | Thioridazine |
| Creatinine | Methoxyphenamine | d, l-Thyroxine |
| Deoxycorticosterone | Methylphenidate | Tolbutamine |
| Dexamethasone | Nadolol | Tolbutamide |
| Dextromethorphan | Nalidixic acid | Trifluoperazine |
| Diclofenac | Naproxen | Tryptamine |
| Diflunisal | Niacinamide | Uric acid |
| Digoxin | Nicotine | Verapamil |
| Diphenhydramine | Nifedipine | Zomepirac |
| ẞ-Estradiol | Norethindrone | |
| Acetone | Noscapine | |
| Ascorbic Acid | Acetylsalicylic acid | Albumin |
| Atropine | Aspartame | Ascorbic Acid |
| Chlorquine | Benzocaine | Benzoylecgonine |
| Dexbrompheniramine | (±) Chlolrpheniramine | Creatine |
| 1R,2S(+)-Ephedrine | Dophenhydramine | Dopamine, |
| Guaiacol glyceryl ether | Ethanol | (+/-)-Isoproterenol |
| Lysergic acid | Levorphanol | Glucose |
| Methaqualone | Methadone | Lidocaine |
| (+)-Naproxen | Morphine | Methanol |
| Nordiazepam | (+/-)-Norephedrine | (1R,2S)-(-)-n-Methyl-ephedrine |
| Pheniramine | Phenothiazine | Nortriptyline |
| B-Phenylethylamin | Phencyclidine | L-Phenylephrine |
| Propoxyphene | Ranitidine | Procaine |
| Salicylic acid | Secobarbital | Riboflavin |
| Theophyline | Tyramine | Sodium Chloride |
| Vitamin(L-Ascorbic Acid) | 4-Dimethylaminoantipyrine | Uric acid |
| d-Amphetamine |
8.3 Effect of urinary pH
The pH of an aliquot negative urine pool is 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 by two lots of the corresponding Xenta Drug Screen Cup and Xenta Drug Screen Dipcard. The results demonstrate that varying ranges of pH do not interfere with the performance of the test.
8.4 Effect of Urinary specific gravity
The specific gravity studies were conducted on different specific gravity including 1.002,1.010, 1.020, 1.030, 1.040 specimens with drug free urine containing AMP, BAR, BZO, MTD, OXY, PCP at 50% below and 50% above cutoff level (All concentrations were confirmed with GC/MS).
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Each sample was tested by two lots of the corresponding Xenta Drug Screen Cup and Xenta Drug Screen Dipcard. The results demonstrate that varying ranges of urinary specific gravity do not affect the test result.
8.5 Precision
Precision studies were performed using the single drug and multi-drug test formats. Drug free specimens were spiked with analytes at 0, ±75% cutoff, ±25% cutoff, ±25% cutoff and +100% cutoff of drug. The concentrations of the target drugs were confirmed with GC/MS. In both the single drug test and multi-drug test precision studies each concentration of the urine specimen was divided into aliquots. Each aliquot was blindly labeled by a nonparticipant. Separate sets of blinded 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 test dipcard format and the second operator tested the test cup format. There were 1620 observations by 3 sites at 9 concentrations.
| Drug
test | Approximate
concentration
of sample | % of cutoff | Number of
determinations per lot | Lot 1 | | Lot 2 | | Lot 3 | |
|--------------|-------------------------------------------|-------------|-------------------------------------|----------|----------|----------|----------|----------|----------|
| | | | | Positive | Negative | Positive | Negative | Positive | Negative |
| AMP | 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 | 8 | 52 |
| | 1000ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 32 | 28 |
| | 1250ng/ml | +25%cutoff | 60 | 52 | 8 | 52 | 8 | 54 | 6 |
| | 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 |
| BAR | 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 | 4 | 56 | 6 | 54 | 4 | 56 |
| | 300ng/ml | cutoff | 60 | 38 | 22 | 38 | 22 | 36 | 24 |
| | 375ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 58 | 2 |
| | 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 |
| BZO | 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 | 6 | 54 | 4 | 56 | 6 | 54 |
| | 300ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 34 | 26 |
| | 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 |
| MTD | 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 | 6 | 54 | 4 | 56 | 4 | 56 |
| | 300ng/ml | cutoff | 60 | 34 | 26 | 38 | 22 | 36 | 24 |
| | 375ng/ml | +25%cutoff | 60 | 54 | 6 | 58 | 2 | 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 |
| OXY | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 25ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 50ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 75ng/ml | -25%cutoff | 60 | 6 | 54 | 4 | 56 | 8 | 52 |
| | 100ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 34 | 26 |
| | 125ng/ml | +25%cutoff | 60 | 56 | 4 | 56 | 4 | 58 | 2 |
| | 150ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 175ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 200ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| PCP | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 6.3ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 12.5ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 18.8ng/ml | -25%cutoff | 60 | 4 | 56 | 4 | 56 | 6 | 54 |
| | 25ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 34 | 26 |
| | 31.3ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 56 | 4 |
| | 37.5ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 43.8ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 50ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
Single drug Test Cup:
9
Multi-drug Test Cup:
| Drug
test | Approximate
concentration
of sample | % of cutoff | Number of
determinations
per lot | Result | | | | | |
|--------------|-------------------------------------------|-------------|----------------------------------------|----------|----------|----------|----------|----------|----------|
| | | | | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | | Positive | Negative | Positive | Negative | Positive | Negative |
| AMP | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| AMP | 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 | 6 | 54 | 8 | 52 |
| | 1000ng/ml | cutoff | 60 | 34 | 26 | 38 | 22 | 36 | 24 |
| | 1250ng/ml | +25%cutoff | 60 | 54 | 6 | 58 | 2 | 56 | 4 |
| | 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 |
| | 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 | 6 | 54 | 2 | 58 | 4 | 56 |
| BAR | 300ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 34 | 26 |
| | 375ng/ml | +25%cutoff | 60 | 58 | 2 | 54 | 6 | 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 |
| | 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 | 4 | 56 | 6 | 54 |
| BZO | 300ng/ml | cutoff | 60 | 36 | 24 | 36 | 24 | 38 | 22 |
| | 375ng/ml | +25%cutoff | 60 | 52 | 8 | 54 | 6 | 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 |
| | 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 | 2 | 58 | 4 | 56 | 4 | 56 |
| MTD | 300ng/ml | cutoff | 60 | 38 | 22 | 34 | 26 | 36 | 24 |
| | 375ng/ml | +25%cutoff | 60 | 58 | 2 | 54 | 6 | 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 |
| OXY | 25ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 50ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 75ng/ml | -25%cutoff | 60 | 6 | 54 | 8 | 52 | 4 | 56 |
| | 100ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 38 | 22 |
| | 125ng/ml | +25%cutoff | 60 | 54 | 6 | 58 | 2 | 56 | 4 |
| | 150ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 175ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 200ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| PCP | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 6.3ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 12.5ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| | 18.8ng/ml | -25%cutoff | 60 | 4 | 56 | 4 | 56 | 6 | 54 |
| | 25ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 34 | 26 |
| | 31.3ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 52 | 8 |
| | 37.5ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 43.8ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| | 50ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
10
11
Single drug Test Dipcard:
| Approximate | Number of | Result | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug | concentration | % of cutoff | determinations | Lot 1 | Lot 2 | Lot 3 | |||
| test | of sample | per lot | Positive | Negative | Positive | Negative | Positive | Negative | |
| 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 | 8 | 52 | 6 | 54 | 10 | 50 | |
| AMP | 1000ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 36 | 24 |
| 1250ng/ml | +25%cutoff | 60 | 50 | 10 | 52 | 8 | 54 | 6 | |
| 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 | |
| 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 | 6 | 54 | 4 | 56 | 4 | 56 | |
| BAR | 300ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 34 | 26 |
| 375ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 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 | |
| BZO | 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
12
| 225ng/ml | -25%cutoff | 60 | 8 | 52 | 6 | 54 | 4 | 56 | |
|---|---|---|---|---|---|---|---|---|---|
| 300ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 36 | 24 | |
| 375ng/ml | +25%cutoff | 60 | 54 | 6 | 54 | 6 | 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 | |
| 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 | 4 | 56 | 2 | 58 | 6 | 54 | |
| 300ng/ml | cutoff | 60 | 32 | 28 | 36 | 24 | 34 | 26 | |
| MTD | 375ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 58 | 2 |
| 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 | |
| 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 25ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 50ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 75ng/ml | -25%cutoff | 60 | 2 | 58 | 6 | 54 | 4 | 56 | |
| OXY | 100ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 34 | 26 |
| 125ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 58 | 2 | |
| 150ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 175ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 200ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 6.3ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 12.5ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 18.8ng/ml | -25%cutoff | 60 | 6 | 54 | 6 | 54 | 4 | 56 | |
| PCP | 25ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 38 | 22 |
| 31.3ng/ml | +25%cutoff | 60 | 56 | 4 | 56 | 4 | 58 | 2 | |
| 37.5ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 43.8ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 50ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
Multi-drug Test Dipcard:
| Drug
| test | Approximate | Number of | Result | ||||||
|---|---|---|---|---|---|---|---|---|---|
| concentration | |||||||||
| of sample | % of cutoff | determinations | |||||||
| per lot | Lot 1 | Lot 2 | Lot 3 | ||||||
| AMP | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| AMP | 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 | 10 | 50 | 8 | 52 | 6 | 54 | |
| 1000ng/ml | cutoff | 60 | 36 | 24 | 32 | 28 | 34 | 26 | |
| 1250ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 54 | 6 | |
| 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 | |
| 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 | 4 | 56 | 6 | 54 | 8 | 52 | |
| BAR | 300ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 38 | 22 |
| 375ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 54 | 6 | |
| 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 | |
| 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 | 6 | 54 | 4 | 56 | 6 | 54 | |
| BZO | 300ng/ml | cutoff | 60 | 38 | 22 | 34 | 26 | 36 | 24 |
| 375ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 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 | |
| 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 | 6 | 54 | 4 | 56 | 2 | 58 | |
| MTD | 300ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 36 | 24 |
| 375ng/ml | +25%cutoff | 60 | 56 | 4 | 58 | 2 | 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 | |
| 25ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| OXY | 50ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/ml | -25%cutoff | 60 | 8 | 52 | 4 | 56 | 6 | 54 | |
| 100ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 34 | 26 | |
| 125ng/ml | +25%cutoff | 60 | 56 | 4 | 58 | 2 | 54 | 6 | |
| 150ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 175ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 200ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| PCP | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 6.3ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 12.5ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 18.8ng/ml | -25%cutoff | 60 | 2 | 58 | 4 | 56 | 6 | 54 | |
| 25ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 34 | 26 | |
| 31.3ng/ml | +25%cutoff | 60 | 58 | 2 | 56 | 4 | 54 | 6 | |
| 37.5ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 43.8ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 50ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
13
14
8.6 Accuracy
80 clinical urine samples collected all from sample place several hospitals and drug relief reformatory. All clinical urine specimens for each drug were analyzed by GC/MS and by two lots of the corresponding Single/Multi-drug Test Cup and Test Dipcard. Samples were divided by concentration into five categories: drug free, less than half the cutoff negative, near cutoff positive, and high positive. All samples were blindly labeled by a nonparticipant. Separate sets of the blind coded were assigned. Samples were also randomized prior to testing. The study was conducted by 4 nurses at two Point-of-Care sites. The test dipcard format was performed at one site and the test cup format at the second site. Each operator only performed one test format and different nurses tested each format. Results were as follows:
Single drug Test Cup:
| 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 |
|--------------|-----------------|-----------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------|
| AMP | + | 0 | 0 | 0 | 6 | 34 | 80 |
| AMP | - | 33 | 2 | 5 | 0 | 0 | 80 |
| BAR | + | 0 | 0 | 0 | 6 | 34 | 80 |
| BAR | - | 33 | 0 | 7 | 0 | 0 | 80 |
| BZO | + | 0 | 0 | 1 | 7 | 33 | 80 |
| BZO | - | 31 | 0 | 8 | 0 | 0 | 80 |
| MTD | + | 0 | 0 | 1 | 5 | 35 | 80 |
| MTD | - | 32 | 2 | 5 | 0 | 0 | 80 |
| OXY | + | 0 | 0 | 0 | 6 | 34 | 80 |
| OXY | - | 35 | 0 | 5 | 0 | 0 | 80 |
| PCP | + | 0 | 0 | 1 | 5 | 35 | 80 |
| PCP | - | 35 | 0 | 4 | 0 | 0 | 80 |
15
Analysis of Discordant Results with Single drug Test Cup
| Single drug Test Cup | GC/MS Analysis | ||||
|---|---|---|---|---|---|
| Drug Test | Cutoff(ng/mL) | Test Result | Drug Concentration (ng/mL) | Drug in Urine | |
| BZO | 300 | Positive | 188 | Oxazepam | |
| MTD | 300 | Positive | 209 | Methadone | |
| PCP | 25 | Positive | 23 | Phencyclidine |
Multi-drug Test Cup:
| 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 |
|--------------|-----------------|-----------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-------|
| AMP | + | 0 | 0 | 0 | 6 | 34 | 80 |
| | - | 33 | 2 | 5 | 0 | 0 | 80 |
| BAR | + | 0 | 0 | 0 | 6 | 34 | 80 |
| | - | 33 | 0 | 7 | 0 | 0 | 80 |
| BZO | + | 0 | 0 | 1 | 7 | 33 | 80 |
| | - | 31 | 0 | 8 | 0 | 0 | 80 |
| MTD | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 32 | 2 | 5 | 0 | 0 | 80 |
| OXY | + | 0 | 0 | 0 | 6 | 34 | 80 |
| | - | 35 | 0 | 5 | 0 | 0 | 80 |
| PCP | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 35 | 0 | 4 | 0 | 0 | 80 |
Analysis of Discordant Results with Multi-drug Test Cup
| Multi-drug Test Cup | GC/MS Analysis | |||
|---|---|---|---|---|
| Drug Test | Cutoff(ng/m | |||
| L) | Test Result | Drug | ||
| Concentration | ||||
| (ng/mL) | Drug in Urine | |||
| BZO | 300 | Positive | 188 | Oxazepam |
| MTD | 300 | Positive | 209 | Methadone |
| PCP | 25 | Positive | 23 | Phencyclidine |
Single drug Test Dipcard:
| Drug
Test | Co-Innovation
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 |
|--------------|-------------------------|--------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------|
| AMP | + | 0 | 0 | 0 | 6 | 34 | 80 |
| AMP | - | 33 | 2 | 5 | 0 | 0 | |
| BAR | + | 0 | 0 | 0 | 6 | 34 | 80 |
16
| - | 33 | 0 | 7 | 0 | 0 | ||
|---|---|---|---|---|---|---|---|
| BZO | + | 0 | 0 | 1 | 7 | 33 | 80 |
| - | 31 | 0 | 8 | 0 | 0 | 80 | |
| MTD | + | 0 | 0 | 1 | 5 | 35 | 80 |
| - | 32 | 2 | 5 | 0 | 0 | 80 | |
| OXY | + | 0 | 0 | 0 | 6 | 34 | 80 |
| - | 35 | 0 | 5 | 0 | 0 | 80 | |
| PCP | + | 0 | 0 | 1 | 5 | 35 | 80 |
| - | 35 | 0 | 4 | 0 | 0 | 80 |
Analysis of Discordant Results with Single drug Test Dipcard
| Single drug Test Dipcard | GC/MS Analysis | |||
|---|---|---|---|---|
| Drug Test | Cutoff(ng/mL) | Test Result | Drug Concentration (ng/mL) | Drug in Urine |
| BZO | 300 | Positive | 188 | Oxazepam |
| MTD | 300 | Positive | 209 | Methadone |
| PCP | 25 | Positive | 23 | Phencyclidine |
Multi-drug Test Dipcard:
| Drug
Test | Co-Innovation
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 |
|--------------|-------------------------|--------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------|
| AMP | + | 0 | 0 | 0 | 6 | 34 | 80 |
| | - | 33 | 2 | 5 | 0 | 0 | |
| BAR | + | 0 | 0 | 0 | 6 | 34 | 80 |
| | - | 33 | 0 | 7 | 0 | 0 | |
| BZO | + | 0 | 0 | 1 | 7 | 33 | 80 |
| | - | 31 | 0 | 8 | 0 | 0 | |
| MTD | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 32 | 2 | 5 | 0 | 0 | |
| OXY | + | 0 | 0 | 0 | 6 | 34 | 80 |
| | - | 35 | 0 | 5 | 0 | 0 | |
| PCP | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 35 | 0 | 4 | 0 | 0 | |
Analysis of Discordant Results with Rapid Multi-drug Test Dipcard
| Multi-drug Test Dipcard | GC/MS Analysis | |||
|---|---|---|---|---|
| Drug Test | Cutoff(ng/mL) | Test Result | Drug Concentration (ng/mL) | Drug in Urine |
| BZO | 300 | Positive | 188 | Oxazepam |
| MTD | 300 | Positive | 209 | Methadone |
| PCP | 25 | Positive | 23 | Phencyclidine |
Stability of the test line studies:
Stability of the test line studies were performed using the single drug and multi-drug test formats. Drug free specimens were spiked with analytes at different concentration containing +/- 50% cutoff and +100% cutoff. Each sample contain all of eleven drugs and the concentrations of target drugs were confirmed with GC/MS. Spiked specimens and five drug free specimens were test.
17
The results show that the color T line of Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are stable from 3 to 50 minutes.
We suggest to read the test results within 5 to 30 minutes.
9. Conclusion:
The data collected in the performance and accuracy studies demonstrate that the Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are substantially equivalent to the predicate device.
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