Who is the manufacturer of Xenta Drug Screen Cup, Xenta Drug Screen Dipcard?

Xenta Biomedical Science Co., Ltd. filed the 510(k) submission for Xenta Drug Screen Cup, Xenta Drug Screen Dipcard (K231137).

What is the FDA product code for Xenta Drug Screen Cup, Xenta Drug Screen Dipcard?

DKZ. It is classified under 21 CFR 862.3100 as a Class 2 device in the Clinical Toxicology panel.

What is the regulatory pathway for Xenta Drug Screen Cup, Xenta Drug Screen Dipcard?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Xenta Drug Screen Cup, Xenta Drug Screen Dipcard?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard

K231137 · Xenta Biomedical Science Co., Ltd. · DKZ · May 19, 2023 · Clinical Toxicology

Device Facts

Record ID	K231137
Device Name	Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
Applicant	Xenta Biomedical Science Co., Ltd.
Product Code	DKZ · Clinical Toxicology
Decision Date	May 19, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.3100
Device Class	Class 2

Intended 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) 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.

Device Story

Lateral flow chromatographic immunoassays for qualitative detection of drugs of abuse in human urine. Competitive binding principle; antigen-antibody immunochemistry. Device formats: Test Cup and Test Dipcard. Used at point-of-care by healthcare professionals. Input: human urine sample. Output: visual test line (qualitative). No instrumentation required. Results are preliminary; GC/MS recommended for confirmation. Clinical judgment required for interpretation. Benefits: rapid, on-site screening for drug presence.

Clinical Evidence

Clinical accuracy study using 80 urine samples per drug, analyzed by GC/MS and subject device. Samples categorized as drug-free, <50% cutoff, near-cutoff negative, near-cutoff positive, and high positive. Results showed high concordance with GC/MS. Discordant results observed near cutoff levels. Stability of test lines confirmed between 3-50 minutes.

Technological Characteristics

Lateral flow immunochromatographic assay. Competitive binding principle. Formats: Test Cup and Test Dipcard. Urine specimen. Visual readout. No energy source required. Non-instrumented. Software: None.

Indications for Use

Indicated for qualitative detection of drugs and drug metabolites (BAR, BZO, AMP, MTD, OXY, PCP) in human urine for prescription use. Intended for in vitro diagnostic use.

Regulatory Classification

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.

Special Controls

*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).

Related Devices

K091612 — UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; · Ucp Biosciences, Inc. · Feb 24, 2010
K140215 — ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD · Co-Innovation Biotech Co., Ltd. · Jun 16, 2014
K153050 — Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard · Co-Innovation Biotech Co., Ltd. · Apr 26, 2016
K180255 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup · Hangzhou Clongene Biotech Co., Ltd. · Feb 28, 2018
K031759 — ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD · ACON Laboratories, Inc. · Aug 4, 2003

Submission Summary (Full Text)

{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) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* {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). {8}------------------------------------------------ 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…