(132 days)
Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:
| Test | Calibrator | Cut-off level |
|---|---|---|
| Marijuana (THC) | Delta-9-THC-COOH | 50 ng/mL |
| Cocaine (COC) | Benzoylecgonine | 300 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 3,4-Methylenedioxymethamphetamine | 500 ng/mL |
| Methamphetamine (MET) | D-Methamphetamine | 1000 ng/mL |
| Morphine 300 (MOP) | Morphine | 300 ng/mL |
The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use.
The assays provide only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are competitive binding, lateral flow immunochromatographic assays for the qualitative detection of Cocaine, Marijuana, Methamphetamine, Morphine, Methylenedioxymethamphetamine 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.
This document describes the validation of the Xenta Drug Screen Cup and Xenta Drug Screen Dipcard. The devices are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine.
1. Table of Acceptance Criteria and Reported Device Performance & 7. Type of Ground Truth Used
The acceptance criteria for qualitative drug tests typically involve demonstrating acceptable performance around the specified cut-off concentrations. The provided document shows performance data at various concentrations relative to the cut-off, including drug-free, below cut-off, near cut-off, and above cut-off concentrations. Gas Chromatography/Mass spectrometry (GC/MS) is explicitly stated as the preferred confirmatory method and was used to confirm drug concentrations in the accuracy studies, thus serving as the ground truth.
Here's a summary of the reported device performance for each drug at the cut-off concentration from the precision study, which serves as a key measure of performance around the acceptance threshold. For precision, a high percentage of correct results (positive for samples at or above cut-off, negative for samples below cut-off) is expected.
Xenta Drug Screen Cup and Dipcard Performance at Cut-off Concentration (across 3 lots, 60 determinations per lot):
| Drug Test | Cut-off Level | Format | Lot 1 Positive (%) | Lot 1 Negative (%) | Lot 2 Positive (%) | Lot 2 Negative (%) | Lot 3 Positive (%) | Lot 3 Negative (%) |
|---|---|---|---|---|---|---|---|---|
| COC | 300 ng/mL | Single Cup | 36 (60%) | 24 (40%) | 34 (57%) | 26 (43%) | 38 (63%) | 22 (37%) |
| COC | 300 ng/mL | Multi Cup | 34 (57%) | 26 (43%) | 36 (60%) | 24 (40%) | 32 (53%) | 28 (47%) |
| COC | 300 ng/mL | Single Dipcard | 34 (57%) | 26 (43%) | 36 (60%) | 24 (40%) | 34 (57%) | 26 (43%) |
| COC | 300 ng/mL | Multi Dipcard | 34 (57%) | 26 (43%) | 36 (60%) | 24 (40%) | 32 (53%) | 28 (47%) |
| MET | 1000 ng/mL | Single Cup | 34 (57%) | 26 (43%) | 36 (60%) | 24 (40%) | 38 (63%) | 22 (37%) |
| MET | 1000 ng/mL | Multi Cup | 34 (57%) | 26 (43%) | 38 (63%) | 22 (37%) | 36 (60%) | 24 (40%) |
| MET | 1000 ng/mL | Single Dipcard | 36 (60%) | 24 (40%) | 34 (57%) | 26 (43%) | 34 (57%) | 26 (43%) |
| MET | 1000 ng/mL | Multi Dipcard | 38 (63%) | 22 (37%) | 36 (60%) | 24 (40%) | 36 (60%) | 24 (40%) |
| MOP300 | 300 ng/mL | Single Cup | 42 (70%) | 18 (30%) | 44 (73%) | 16 (27%) | 44 (73%) | 16 (27%) |
| MOP300 | 300 ng/mL | Multi Cup | 42 (70%) | 18 (30%) | 40 (67%) | 20 (33%) | 44 (73%) | 16 (27%) |
| MOP300 | 2000 ng/mL* | Single Dipcard | 44 (73%) | 16 (27%) | 42 (70%) | 18 (30%) | 40 (67%) | 20 (33%) |
| MOP300 | 2000 ng/mL* | Multi Dipcard | 42 (70%) | 18 (30%) | 40 (67%) | 20 (33%) | 44 (73%) | 16 (27%) |
| THC | 50 ng/mL | Single Cup | 36 (60%) | 24 (40%) | 38 (63%) | 22 (37%) | 36 (60%) | 24 (40%) |
| THC | 50 ng/mL | Multi Cup | 38 (63%) | 22 (37%) | 36 (60%) | 24 (40%) | 36 (60%) | 24 (40%) |
| THC | 50 ng/mL | Single Dipcard | 34 (57%) | 26 (43%) | 38 (63%) | 22 (37%) | 36 (60%) | 24 (40%) |
| THC | 50 ng/mL | Multi Dipcard | 36 (60%) | 24 (40%) | 34 (57%) | 26 (43%) | 38 (63%) | 22 (37%) |
| MDMA | 500 ng/mL | Single Cup | 36 (60%) | 24 (40%) | 34 (57%) | 26 (43%) | 36 (60%) | 24 (40%) |
| MDMA | 500 ng/mL | Multi Cup | 32 (53%) | 28 (47%) | 34 (57%) | 26 (43%) | 36 (60%) | 24 (40%) |
| MDMA | 500 ng/mL | Single Dipcard | 34 (57%) | 26 (43%) | 36 (60%) | 24 (40%) | 32 (53%) | 28 (47%) |
| MDMA | 500 ng/mL | Multi Dipcard | 36 (60%) | 24 (40%) | 34 (57%) | 26 (43%) | 34 (57%) | 26 (43%) |
*Note: There seems to be a discrepancy in the MOP cut-off reported in the product description (300 ng/mL) and the concentrations used in the precision study table for the Dipcard (e.g., 2000 ng/mL for cut-off). For the purpose of reporting the precision study results, I've used the "cutoff" row as indicated in the tables, assuming that concentration represents the cut-off for the study.
2. Sample Size Used for the Test Set and Data Provenance
-
Precision Study Test Set:
- For each drug: 9 concentrations (0, -75% cut-off, -50% cut-off, -25% cut-off, cut-off, +25% cut-off, +50% cut-off, +75% cut-off, +100% cut-off).
- 3 replicates at each concentration per day for 10 non-consecutive days.
- 2 operators per location.
- One device lot per location, across 3 locations (implying 3 lots tested in total).
- Total determinations: 9 concentrations * 3 replicates * 10 days * 2 operators * 3 lots = 1620 observations for each device format (Single Cup, Multi Cup, Single Dipcard, Multi Dipcard).
- Data Provenance: The document states 3 Point-of-Care sites and refers to "clinical urine samples" in the accuracy section, suggesting the data is derived from clinical settings, likely prospective or collected for the purpose of the study. The country of origin is not explicitly mentioned for the clinical samples.
-
Accuracy Study Test Set:
- Sample Size: 80 clinical urine specimens for each drug.
- Data Provenance: "Clinical urine specimens" were used. The document does not specify the country of origin of these samples. The study involved nurses at two Point-of-Care sites, implying these were real-world clinical samples rather than simulated ones. The samples were collected and analyzed for the purpose of this study (implied prospective within the study design).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Precision Study: The ground truth for the precision study's spiked samples was established by the precise "spiking" of analytes at known concentrations, with confirmation by GC/MS. No human experts were judging the presence/absence of drugs for these known-concentration samples.
- Accuracy Study: For the 80 clinical urine specimens "analyzed by GC/MS," GC/MS itself served as the gold standard ground truth. While GC/MS is operated by trained laboratory personnel, the document does not specify the number of "experts" (e.g., medical toxicologists, clinical chemists) who reviewed or confirmed the GC/MS results, nor their specific qualifications. It simply states the samples were "analyzed by GC/MS".
4. Adjudication Method for the Test Set
- Precision Study: For the spiked samples, results (positive/negative) were compared against the known spiked concentrations relative to the cut-off. Discordant results are not explicitly adjudicated by a separate panel but are inherent in the calculation of positive/negative agreement at various concentrations.
- Accuracy Study: The ground truth was established by GC/MS. The document then presents "Analysis of Discordant Results" where the test result is compared against the GC/MS confirmed drug concentration in urine. This implies a direct comparison rather than a separate adjudication panel for discrepant cases. For example, for the Single Drug Test Cup, a MET sample with GC/MS concentration of 867 ng/mL (below cut-off of 1000 ng/mL) was classified as "Positive" by the Xenta device. Similarly, an MDMA sample with GC/MS concentration of 715 ng/mL (above cut-off of 500 ng/mL) was classified as "Negative" by the device. These are reported as discordant results without further human adjudication in the document.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. The Xenta Drug Screen Cup and Dipcard are point-of-care immunoassay devices, which are typically read visually or by simple optical readers, not by complex AI algorithms that assist human readers in interpretation. The performance data presented is for the device's standalone accuracy against a gold standard (GC/MS).
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Yes, the studies described (Precision and Accuracy) represent the standalone performance of the Xenta Drug Screen Cup and Dipcard. These devices are designed to provide a direct positive/negative result without human interpretation beyond visually inspecting the test line. Therefore, the reported accuracy and precision data reflect the algorithm-only performance, as applied to these types of lateral flow immunoassays.
8. The Sample Size for the Training Set
The document does not provide details on a specific "training set" in the context of an algorithmic or AI device. Since the device is a lateral flow immunoassay, its "training" would typically involve optimization of chemical reagents and manufacturing processes during its development, rather than an algorithmic training phase with a distinct dataset. The performance data presented here are for validation testing.
9. How the Ground Truth for the Training Set Was Established
As indicated in point 8, a traditional "training set" with established ground truth, as would be used for AI/ML model development, is not applicable to these types of immunoassay devices. The inherent "ground truth" during device development would be established through careful analytical studies using known concentrations of analytes and cross-reactants to optimize the device's sensitivity and specificity to meet the specified cut-offs.
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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.
February 6, 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: K222955
Trade/Device Name: Xenta Drug Screen Cup, Xenta Drug Screen Dipcard Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG, DIO, LDJ, DJC Dated: September 27, 2022 Received: September 27, 2022
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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 medical devices and radiation-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 Caposino Digitally signed by Paula
Caposino Caposino -S Caposimo -3
Date: 2023.02.06 13:24:53
-05'00' -5
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
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Indications for Use
510(k) Number (if known) K222955
Device Name Xenta Drug Screen Cup Xenta Drug Screen Dipcard
Indications for Use (Describe)
Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:
| Test | Calibrator | Cut-off level |
|---|---|---|
| Marijuana (THC) | Delta-9-THC-COOH | 50 ng/mL |
| Cocaine (COC) | Benzoylecgonine | 300 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 3,4-Methylenedioxymethamphetamine | 500 ng/mL |
| Methamphetamine (MET) | D-Methamphetamine | 1000 ng/mL |
| Morphine 300 (MOP) | Morphine | 300 ng/mL |
The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use.
The assays provide only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
| 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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Section 5 - 510(k) Summary
Date of Summary Preparation: 2/2/2023 510(k) Number: K222955
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@gq.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@gq.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 862.3250 Cocaine test system 21 CFR 862.3650 Morphine test system 21 CFR 862.3870 Cannabinoid test system 21 CFR 862.3610 Methamphetamine test system
Device class: Class II Panel: Toxicology Product code: DIO,DJG,LDJ,DJC
4. The Predicate Devices
- K153050 Rapid Single/Multi-drug Test Cup Rapid Single/Multi-drug Test Dipcard
5. Device Description
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Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are competitive binding, lateral flow immunochromatographic assays for the qualitative detection of Cocaine, Marijuana, Methamphetamine, Morphine, Methylenedioxymethamphetamine 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 |
|---|---|---|
| Marijuana (THC) | Delta-9-THC-COOH | 50 ng/mL |
| Cocaine (COC) | Benzoylecgonine | 300 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 3,4-Methylenedioxymethamphetamine | 500 ng/mL |
| Methamphetamine (MET) | D-Methamphetamine | 1000 ng/mL |
| Morphine 300 (MOP) | Morphine | 300 ng/mL |
The tests contain two formats:1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use.
The assays provide only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
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 (K153050) |
|---|---|---|
| Indication for use | Qualitative detection ofdrugs-of-abuse in urine(Cocaine ,Morphine,Methamphetamine, Marijuana,Methylenedioxymethamphetamine) | Same (but the number of drugsdetected different) |
| Intended Users | Prescription Use | Over the Counter (OTC) Use and |
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| Prescription Use | ||
|---|---|---|
| Specimen | Urine | Same |
| Cutoff | Cocaine:300 ng/mLMethamphetamine:1000 ng/mLMorphine:300 ng/mLMarijuana:50 ng/mLMethylenedioxymethamphetamine:500 ng/mL | Cocaine:300 ng/mLMethamphetamine:1000 ng/mLMorphine:300 ng/mLMarijuana:50 ng/mLMethylenedioxymethamphetamine: 500 ng/mL |
| Read time | 5 minutes | Same |
| Results | Qualitative | Same |
| Methodology | Competitive binding, Lateral flowimmunochromatographic assaybased on the principle of antigenantibody 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, 2 lots of test Dipcard and one lot of 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 3 lots of 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. If no cross reactivity was observed the highest concentration tested is shown.
| Cannabinoids (THC) | LowestConcentration(ng/mL) | %Cross-reactivity | Methylenedioxymethamphetamine (MDMA) | LowestConcentration(ng/mL) | %Cross-reactivity |
|---|---|---|---|---|---|
| 11-nor-Δ9-THC-9-COOH | 50 | 100% | (+/-)3,4-Methylenedioxymethamphetamine (MDMA) | 500 | 100% |
| 11-nor-Δ8-THC-9-COOH | 50 | 100% | 3,4-methylenedioxyamphetamine (MDA) | 2200 | 22.7% |
| Δ 9-THC | 15000 | 0.3% | 3,4-Methylenedioxyethylamphetamine (MDEA) | 240 | 208.3% |
| Δ 8-THC | 10000 | 0.5% | D-methamphetamine(MAMP) | 100000 | 0.5% |
| Cannabidiol | 20000 | 0.3% | D-Amphetamine | >100000 | <0.5% |
| Cannabinol | >100000 | <0.05% | L-Amphetamine | >100000 | <0.5% |
| (+/-)11-hydroxy-Δ9-THC | 5000 | 1% | L-Methamphetamine | >100000 | <0.5% |
| Methamphetamine (MET) | Morphine 300 (MOP) |
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| d-Methamphetamine | 1000 | 100% | Morphine | 300 | 100.0% |
|---|---|---|---|---|---|
| l-Methamphetamine | 8000 | 12.5% | Codeine | 300 | 100.0% |
| p-hydroxymethamphetamine | 30000 | 3.3% | Hydrocodone | 1500 | 20.0% |
| 3,4-methylenedioxumethamphetamine (MDMA) | 2000 | 50% | 6-Monoacetylmorphine (6-MAN) | 750 | 40.0% |
| 3,4-Methylenedioxyethylamphetamine (MDEA) | 50000 | 2% | Morphine 3- β-D-glucuronide | 300 | 100.0% |
| Mephentermine | 75000 | 1.3% | Ethylmorphine | 100 | 300.0% |
| d-Amphetamine | 50000 | 2% | Heroine | 800 | 37.5% |
| L-Amphetamine | 50000 | 2% | Levophenol | 50000 | 0.6% |
| Ephedrine | 100000 | 1% | Morphine3-glucuronide | 400 | 75% |
| 3,4-methylenedioxyampheta mine (MDA) | 100000 | 10% | Norcodeine | 16000 | 1.9% |
| Cocaine (COC) | Oxycodone | >75000 | <0.4% | ||
| Benzoylecgonine | 300 | 100% | Thebaine | >90000 | <0.3% |
| Cocaine | 800 | 37.5% | |||
| Cocaethylene | 12500 | 2.4% | |||
| Ecgonine HCl | 35000 | 0.9% | |||
| Ecgonine | >50000 | <0.6% |
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 THC, COC, MET, MOP, MDMA 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 100ug/mL (All concentrations of the drugs were confirmed with GC/MS). The urine specimens were tested with two lots of the corresponding Rapid 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 |
| 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 |
| Ephedrine | Norethindrone | |
| β-Estradiol | Noscapine | |
| Acetone | Acetylsalicylic acid | Albumin |
| Ascorbic Acid | Aspartame | Ascorbic Acid |
| Atropine | Benzocaine | Benzoylecgonine |
| Chlorquine | (±) Chlolrpheniramine | Creatine |
| Dexbrompheniramine | Dophenhydramine | Dopamine, |
| (±)-Isoproterenol | ||
| 1R,2S(+)-Ephedrine | Ethanol | Glucose |
| Guaiacol glyceryl ether | Levorphanol | Lidocaine |
| Lysergic acid | Methadone | Methanol |
| Methaqualone | Morphine | (1R,2S)-(-)-n-Methyl-ephe |
| drine | ||
| (+)-Naproxen | (±)-Norephedrine | Nortriptyline |
| Nordiazepam | ||
| Pheniramine | Phenothiazine | L-Phenylephrine |
| B-Phenylethylamin | Phencyclidine | Procaine |
| Propoxyphene | Ranitidine | Riboflavin |
| Salicylic acid | Secobarbital | Sodium Chloride |
| Theophylline | Tyramine | Uric acid |
| Vitamin(L-Ascorbic Acid) | 4-Dimethylaminoantipyrine | d-Amphetamine |
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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.
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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 THC, COC, MET, MOP, MDMA at 50% below and 50% above cutoff level (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 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, ±50% 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.
| Drugtest | Approximateconcentrationof sample | % of cutoff | Number ofdeterminations per lot | Result | Lot 1 | Lot 2 | Lot 3 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 0ng/ml | Negative | 60 | Positive | Negative | Positive | Negative | Positive | Negative | 0 | 60 | |
| 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |||
| 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |||
| 225ng/ml | -25%cutoff | 60 | 8 | 52 | 6 | 54 | 4 | 56 | |||
| COC | 300ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 38 | 22 | ||
| 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 | |||
| 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |||
| 250ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |||
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |||
| 750ng/ml | -25%cutoff | 60 | 4 | 56 | 8 | 52 | 6 | 54 | |||
| MET | 1000ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 38 | 22 |
Single drug Test Cup:
{9}------------------------------------------------
| 1250ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 58 | 2 | |
|---|---|---|---|---|---|---|---|---|---|
| 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 225ng/ml | -25%cutoff | 60 | 8 | 52 | 10 | 50 | 8 | 52 | |
| MOP | 300ng/ml | cutoff | 60 | 42 | 18 | 44 | 16 | 44 | 16 |
| 300 | 375ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 56 | 4 |
| 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 12.5ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 25ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 37.5ng/ml | -25%cutoff | 60 | 8 | 52 | 6 | 54 | 6 | 54 | |
| THC | 50ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 36 | 24 |
| 62.5ng/ml | +25%cutoff | 60 | 52 | 8 | 56 | 4 | 54 | 6 | |
| 75ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 87.5ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 100ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 125ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| MDMA | 250ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 375ng/ml | -25%cutoff | 60 | 8 | 52 | 6 | 54 | 6 | 54 | |
| 500ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 36 | 24 | |
| 625ng/ml | +25%cutoff | 60 | 52 | 8 | 54 | 6 | 56 | 4 | |
| 750ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 875ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 1000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
Multi-drug Test Cup:
| Drugtest | Approximateconcentrationof sample | % of cutoff | Number ofdeterminationsper lot | Result | |||||
|---|---|---|---|---|---|---|---|---|---|
| Lot 1 | Lot 2 | Lot 3 | |||||||
| Positive | Negative | Positive | Negative | Positive | Negative | ||||
| COC | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 225ng/ml | -25%cutoff | 60 | 8 | 52 | 6 | 54 | 4 | 56 | |
| 300ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 32 | 28 | |
| 375ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 52 | 8 | |
| 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 250ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 750ng/ml | -25%cutoff | 60 | 4 | 56 | 6 | 54 | 6 | 54 | |
| MET | 1000ng/ml | cutoff | 60 | 34 | 26 | 38 | 22 | 36 | 24 |
| 1250ng/ml | +25%cutoff | 60 | 56 | 4 | 58 | 2 | 58 | 2 | |
| 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 1750ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 2000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 225ng/ml | -25%cutoff | 60 | 8 | 52 | 10 | 50 | 8 | 52 | |
| MOP | 300ng/ml | cutoff | 60 | 42 | 18 | 40 | 20 | 44 | 16 |
| 300 | 375ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 56 | 4 |
| 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 12.5ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 25ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 37.5ng/ml | -25%cutoff | 60 | 6 | 54 | 8 | 52 | 4 | 56 | |
| THC | 50ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 36 | 24 |
| 62.5ng/ml | +25%cutoff | 60 | 52 | 8 | 56 | 4 | 54 | 6 | |
| 75ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 87.5ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 100ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 125ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 250ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| MDMA | 375ng/ml | -25%cutoff | 60 | 8 | 52 | 10 | 50 | 6 | 54 |
| 500ng/ml | cutoff | 60 | 32 | 28 | 34 | 26 | 36 | 24 | |
| 625ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 52 | 8 | |
| 750ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 875ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 1000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
{10}------------------------------------------------
{11}------------------------------------------------
Single drug Test Dipcard:
| Drugtest | Approximateconcentrationof sample | % of cutoff | Number ofdeterminationsper lot | ResultLot 1 | ResultLot 2 | ResultLot 3 | |||
|---|---|---|---|---|---|---|---|---|---|
| 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 | 8 | 52 | |
| COC | 300ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 34 | 26 |
| 375ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 56 | 4 | |
| 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 250ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 750ng/ml | -25%cutoff | 60 | 4 | 56 | 4 | 56 | 6 | 54 | |
| MET | 1000ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 34 | 26 |
| 1250ng/ml | +25%cutoff | 60 | 56 | 4 | 56 | 4 | 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 | |
| 500ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 1000ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 1500ng/ml | -25%cutoff | 60 | 10 | 50 | 8 | 52 | 6 | 54 | |
| MOP | 2000ng/ml | cutoff | 60 | 44 | 16 | 42 | 18 | 40 | 20 |
| 2500ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 54 | 6 | |
| 3000ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 3500ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 4000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 12.5ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| THC | 25ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 37.5ng/ml | -25%cutoff | 60 | 6 | 54 | 4 | 56 | 8 | 52 | |
| 50ng/ml | cutoff | 60 | 34 | 26 | 38 | 22 | 36 | 24 | |
| 62.5ng/ml | +25%cutoff | 60 | 50 | 10 | 52 | 8 | 54 | 6 | |
| 75ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
{12}------------------------------------------------
| 87.5ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
|---|---|---|---|---|---|---|---|---|---|
| 100ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| MDMA | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 125ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 250ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 375ng/ml | -25%cutoff | 60 | 6 | 54 | 8 | 52 | 10 | 50 | |
| MDMA | 500ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 32 | 28 |
| 625ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 52 | 8 | |
| 750ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 875ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 1000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
Multi-drug Test Dipcard:
| Drugtest | Approximateconcentrationof sample | % of cutoff | Number ofdeterminationsper lot | Lot 1 | Lot 2 | Lot 3 | |||
|---|---|---|---|---|---|---|---|---|---|
| Positive | Negative | Positive | Negative | Positive | Negative | ||||
| 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 75ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 150ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 225ng/ml | -25%cutoff | 60 | 8 | 52 | 6 | 54 | 4 | 56 | |
| COC | 300ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 32 | 28 |
| 375ng/ml | +25%cutoff | 60 | 56 | 4 | 54 | 6 | 52 | 8 | |
| 450ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 525ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 600ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 250ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 500ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 750ng/ml | -25%cutoff | 60 | 6 | 54 | 8 | 52 | 4 | 56 | |
| MET | 1000ng/ml | cutoff | 60 | 38 | 22 | 36 | 24 | 36 | 24 |
| 1250ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 56 | 4 | |
| 1500ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 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 | |
| MOP300 | 500ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 1000ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 1500ng/ml | -25%cutoff | 60 | 8 | 52 | 10 | 50 | 8 | 52 |
{13}------------------------------------------------
| 2000ng/ml | cutoff | 60 | 42 | 18 | 40 | 20 | 44 | 16 | |
|---|---|---|---|---|---|---|---|---|---|
| 2500ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 56 | 4 | |
| 3000ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 3500ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 4000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 12.5ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 25ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 37.5ng/ml | -25%cutoff | 60 | 8 | 52 | 4 | 56 | 6 | 54 | |
| THC | 50ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 38 | 22 |
| 62.5ng/ml | +25%cutoff | 60 | 50 | 10 | 52 | 8 | 54 | 6 | |
| 75ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 87.5ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 100ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| 125ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | |
| MDMA | 250ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 375ng/ml | -25%cutoff | 60 | 10 | 50 | 6 | 54 | 8 | 52 | |
| 500ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 34 | 26 | |
| 625ng/ml | +25%cutoff | 60 | 52 | 8 | 56 | 4 | 54 | 6 | |
| 750ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 875ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | |
| 1000ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
8.6 Accuracy
80 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:
{14}------------------------------------------------
| DrugTest | XentaResult | Drug freeby GC/MSanalysis | Less than half thecutoffconcentration byGC/MS analysis | Near Cutoff Negative(Between 50% belowthe cutoff and the cutoffconcentration) | Near Cutoff Positive(Between the cutoffand 50% above thecutoff concentration) | High Positive(greater than 50%above the cutoffconcentration) | Total |
|---|---|---|---|---|---|---|---|
| COC | + | 0 | 0 | 0 | 5 | 35 | 80 |
| COC | - | 33 | 1 | 6 | 0 | 0 | 80 |
| MET | + | 0 | 0 | 1 | 5 | 35 | 80 |
| MET | - | 30 | 3 | 6 | 0 | 0 | 80 |
| MOP300 | + | 0 | 0 | 1 | 6 | 34 | 80 |
| MOP300 | - | 30 | 4 | 5 | 0 | 0 | 80 |
| THC | + | 0 | 0 | 0 | 6 | 33 | 80 |
| THC | - | 34 | 1 | 5 | 1 | 0 | 80 |
| MDMA | + | 0 | 0 | 0 | 5 | 34 | 80 |
| MDMA | - | 32 | 3 | 5 | 1 | 0 | 80 |
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 |
| MET | 1000 | Positive | 867 | Methamphetamine |
| MOP300 | 300 | Positive | 275 | Morphine |
| THC | 50 | Negative | 61 | 11-nor-Δ9--THC-9-COOH |
| MDMA | 500 | Negative | 715 | 3,4-Methylenedioxymethamphetamine |
Multi-drug Test Cup:
| DrugTest | XentaResult | Drug free byGC/MSanalysis | Less than halfthe cutoffconcentrationby GC/MSanalysis | Near CutoffNegative(Between 50%below the cutoffand the cutoffconcentration) | Near CutoffPositive(Between thecutoff and 50%above the cutoffconcentration) | High Positive(greater than50% above thecutoffconcentration) | Total |
|---|---|---|---|---|---|---|---|
| MDMA | + | 0 | 0 | 0 | 5 | 34 | 80 |
| - | 32 | 3 | 5 | 1 | 0 | 80 | |
| COC | + | 0 | 0 | 0 | 5 | 35 | 80 |
| - | 33 | 1 | 6 | 0 | 0 | 80 | |
| THC | + | 0 | 0 | 0 | 6 | 33 | 80 |
| - | 34 | 1 | 5 | 1 | 0 | 80 | |
| MET | + | 0 | 0 | 1 | 5 | 35 | 80 |
| - | 30 | 3 | 6 | 0 | 0 | 80 | |
| MOP | + | 0 | 0 | 1 | 6 | 34 | 80 |
| 300 | - | 30 | 4 | 5 | 0 | 0 | 80 |
Analysis of Discordant Results with Multi-drug Test Cup
| Multi-drug Test Cup | GC/MS Analysis |
|---|---|
| --------------------- | ---------------- |
{15}------------------------------------------------
| Drug Test | Cutoff(ng/mL) | Test Result | Drug Concentration(ng/mL) | Drug in Urine |
|---|---|---|---|---|
| MET | 1000 | Positive | 867 | Methamphetamine |
| MDMA | 500 | Negative | 715 | 3,4-Methylenedioxymethamphetamine |
| MOP | 300 | Positive | 275 | Morphine |
| THC | 50 | Negative | 61 | 11-nor-Δ9--THC-9-COOH |
Single drug Test Dipcard:
| DrugTest | Co-InnovationResult | Drug freebyGC/MSanalysis | Less than half thecutoffconcentration byGC/MS analysis | Near Cutoff Negative(Between 50% belowthe cutoff and thecutoff concentration) | Near Cutoff Positive(Between the cutoffand 50% above thecutoff concentration) | High Positive(greater than 50%above the cutoffconcentration) | Total |
|---|---|---|---|---|---|---|---|
| COC | + | 0 | 0 | 0 | 5 | 35 | |
| COC | - | 33 | 1 | 6 | 0 | 0 | 80 |
| MET | + | 0 | 0 | 1 | 5 | 35 | |
| MET | - | 30 | 3 | 6 | 0 | 0 | 80 |
| MOP300 | + | 0 | 0 | 1 | 6 | 34 | |
| MOP300 | - | 30 | 4 | 5 | 0 | 0 | 80 |
| THC | + | 0 | 0 | 0 | 6 | 33 | |
| THC | - | 34 | 1 | 5 | 1 | 0 | 80 |
| MDMA | + | 0 | 0 | 0 | 5 | 34 | |
| MDMA | - | 32 | 3 | 5 | 1 | 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 |
| MET | 1000 | Positive | 867 | Methamphetamine |
| MOP300 | 300 | Positive | 275 | Morphine |
| THC | 50 | Negative | 61 | 11-nor-Δ9--THC-9-COOH |
| MDMA | 500 | Negative | 715 | 3,4-Methylenedioxymethamphetamine |
Multi-drug Test Dipcard:
| DrugTest | Co-InnovationResult | Drug freebyGC/MSanalysis | Less than half thecutoffconcentration byGC/MS analysis | Near Cutoff Negative(Between 50% belowthe cutoff and thecutoff concentration) | Near Cutoff Positive(Between the cutoffand 50% above thecutoff concentration) | High Positive(greater than 50%above the cutoffconcentration) | Total |
|---|---|---|---|---|---|---|---|
| COC | + | 0 | 0 | 0 | 5 | 35 | 80 |
| - | 33 | 1 | 6 | 0 | 0 | ||
| MET | + | 0 | 0 | 1 | 5 | 35 | 80 |
| - | 30 | 3 | 6 | 0 | 0 |
{16}------------------------------------------------
| MOP300 | + | 0 | 0 | 1 | 6 | 34 | 80 |
|---|---|---|---|---|---|---|---|
| - | 30 | 4 | 5 | 0 | 0 | ||
| THC | + | 0 | 0 | 0 | 6 | 33 | 80 |
| - | 34 | 1 | 5 | 1 | 0 | ||
| MDMA | + | 0 | 0 | 0 | 5 | 34 | |
| - | 32 | 3 | 5 | 1 | 0 | 80 | |
| + | 0 | 0 | 0 | 5 | 34 |
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 |
| MET | 1000 | Positive | 867 | Methamphetamine |
| MOP300 | 300 | Positive | 275 | Morphine |
| THC | 50 | Negative | 61 | 11-nor-Δ9--THC-9-COOH |
| MDMA | 500 | Negative | 715 | 3,4-Methylenedioxymethamphetamine |
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.
--- End of this section ---
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).