Xenta Drug Screen Cup, Xenta Drug Screen Dipcard

• K Number: K231137
• Device Name: Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
• Manufacturer: Xenta Biomedical Science Co., Ltd.
• Date Cleared: 2023-05-19 ( 28 days)
• Product Code: DKZ , DIS , DJG , DJR , JXM , LCM
• Regulation Number: 862.3100
• Type: Traditional
• Panel: Toxicology
• Reference & Predicate Devices: K122809
• Predicate For: N/A

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 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.

AI/ML Overview

The provided document describes the performance of the Xenta Drug Screen Cup and Xenta Drug Screen Dipcard for detecting various drugs in human urine. The study evaluates cross-reactivity, interference, effect of pH and specific gravity, precision, and accuracy.

Here's an breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

The document does not explicitly state "acceptance criteria" but rather presents a rigorous set of performance data that would generally be used to support claims of substantial equivalence. For immunoassays of this type, key performance indicators are typically precision (agreement at different concentrations, especially near the cutoff) and accuracy (agreement with a gold-standard confirmatory method like GC/MS).

Implicit Acceptance Criteria (based on common standards for such devices):

• Precision: High percentage of agreement (positive/negative results) for samples spiked at various concentrations, especially those near the cutoff (e.g., -25% and +25% of cutoff). For negative and very high positive concentrations, 100% agreement would generally be expected.
• Accuracy: High concordance with a confirmatory method (GC/MS) for clinical samples, particularly for drug-free, high positive, and discordant samples.
• Specificity (Cross-reactivity): Low or no cross-reactivity with structurally similar compounds and other common substances, or clearly defined cross-reactivity profiles.
• Robustness (Interference, pH, Specific Gravity): The device's performance should not be significantly affected by common interfering substances, varying urine pH, or specific gravity within physiological and expected ranges.

Reported Device Performance:

The document provides extensive data demonstrating the device's performance across these parameters. For brevity, here's a summary derived from the tables provided in section 8:

Performance Parameter	Reported Performance (Summary from tables)
Precision (Agreement at cutoff)	Amphetamine (AMP) at 1000 ng/mL cutoff: Single Test Cup/Dipcard: 32-38 positive out of 60 (53-63%). Multi Test Cup/Dipcard: 32-38 positive out of 60 (53-63%).Barbiturates (BAR) at 300 ng/mL cutoff: Single Test Cup/Dipcard: 34-38 positive out of 60 (57-63%). Multi Test Cup/Dipcard: 34-38 positive out of 60 (57-63%).Benzodiazepines (BZO) at 300 ng/mL cutoff: Single Test Cup/Dipcard: 34-38 positive out of 60 (57-63%). Multi Test Cup/Dipcard: 34-38 positive out of 60 (57-63%).Methadone (MTD) at 300 ng/mL cutoff: Single Test Cup/Dipcard: 32-38 positive out of 60 (53-63%). Multi Test Cup/Dipcard: 34-38 positive out of 60 (57-63%).Oxycodone (OXY) at 100 ng/mL cutoff: Single Test Cup/Dipcard: 34-38 positive out of 60 (57-63%). Multi Test Cup/Dipcard: 34-38 positive out of 60 (57-63%).Phencyclidine (PCP) at 25 ng/mL cutoff: Single Test Cup/Dipcard: 34-38 positive out of 60 (57-63%). Multi Test Cup/Dipcard: 34-38 positive out of 60 (57-63%).Note: Agreement is nearly 100% for samples significantly below (-75%, -50% cutoff) and significantly above (+50%, +75%, +100% cutoff) the cutoff.
Accuracy (Concordance with GC/MS)	For all drugs (AMP, BAR, BZO, MTD, OXY, PCP) and both device formats (Single/Multi Drug Test Cup and Dipcard), the device consistently showed: - 0 false positives in drug-free samples. - 0 false positives in samples less than half the cutoff. - Very few false positives (0-1) and some false negatives (4-8) in the "Near Cutoff Negative" (between 50% below cutoff and cutoff concentration) category. - Very few false positives (0) and some false negatives/positives (range varies, but generally consistent with expected +/- 25% cutoff performance) in the "Near Cutoff Positive" (between cutoff and 50% above cutoff concentration) category.- 0 false negatives in "High Positive" samples (greater than 50% above the cutoff).Specific discordant results are minimal and generally at concentrations very close to the cutoff.In total, for each drug, 80 clinical samples were tested, with very high overall agreement for clearly negative or clearly positive samples.
Cross-reactivity	Detailed tables show the lowest concentration of various related compounds that produced a positive result. Percent cross-reactivity is calculated. E.g., L-Amphetamine: 2%, MDA: 50%, Hydrocodone: 3.3%. This is a comprehensive evaluation common for immunoassays.
Interference	"None of the compounds listed below were shown to interfere." (List includes numerous common medications and physiological substances at 100 µg/mL).
Effect of pH	"The results demonstrate that varying ranges of pH do not interfere with the performance of the test." (Tested pH range 3-9).
Effect of Specific Gravity	"The results demonstrate that varying ranges of urinary specific gravity do not affect the test result." (Tested SG 1.002 to 1.040).
Stability of Test Line	"The results show that the color T line... are stable from 3 to 50 minutes." (Suggested read time: 5 to 30 minutes).

2. Sample Size Used for the Test Set and Data Provenance

• Precision Test Set Sample Size:
  • For each drug, for both single and multi-drug formats, and for both Test Cup and Test Dipcard:
    • 9 concentrations (0, -75%, -50%, -25%, Cutoff, +25%, +50%, +75%, +100% of cutoff).
    • 60 determinations per lot for each concentration (this is derived from 3 aliquots x 3 runs/day x 10 days x 2 operators/device type at each of the 3 sites, meaning 60 samples per lot, per concentration for each device type).
    • Tested with 3 lots.
    • Total precision observations for one drug and one device format (e.g., AMP on Single Test Cup) = 9 concentrations x 60 determinations/lot x 3 lots = 1620 observations.
    • Total observations for all 6 drugs and 2 device types (Single Test Cup, Multi Test Cup, Single Test Dipcard, Multi Test Dipcard) multiplied by 1620 observations per format.
• Accuracy Test Set Sample Size:
  • 80 clinical urine samples per drug (AMP, BAR, BZO, MTD, OXY, PCP) for each of the four device variants (Single Drug Test Cup, Multi Drug Test Cup, Single Drug Test Dipcard, Multi Drug Test Dipcard).
  • Total accuracy samples = 80 samples/drug x 6 drugs = 480 clinical samples (with GC/MS confirmation). These 480 samples are then tested across the 4 device variants.
• Data Provenance:
  • Clinical Urine Samples: "80 clinical urine samples collected all from sample place several hospitals and drug relief reformatory."
  • Retrospective/Prospective: The description does not explicitly state retrospective or prospective collection for the clinical samples. However, given they were "collected all from sample place," it implies they were likely existing samples (retrospective) or collected for the specific purpose of the study (prospective), but the exact method isn't specified. The emphasis on blind labeling and randomization for testing suggests a controlled prospective-like application in the study even if samples were retrospectively sourced.
  • Country of Origin: Not explicitly stated for specific samples, but the submitting company is "Xenta Biomedical Science Co., Ltd." located in Guangzhou, China.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• The ground truth for the clinical accuracy test set was established by Gas Chromatography/Mass spectrometry (GC/MS). GC/MS is considered the "preferred confirmatory method" and the gold standard for drug detection in urine.
• No human "experts" (e.g., radiologists) were used to establish the ground truth in this context; instead, a highly accurate analytical laboratory method (GC/MS) served as the gold standard. Therefore, the concept of "qualifications of those experts" does not directly apply in the way it would for image-based diagnostic devices. The expertise lies in the laboratory personnel performing and interpreting the GC/MS analysis.

4. Adjudication Method for the Test Set

• GC/MS was used as the confirmatory method to adjudicate the results of the rapid tests.
• For the precision study, samples were "blindly labeled by a nonparticipant" and "randomized prior to testing," indicating a blind comparison against the known spiked concentrations.
• For the accuracy study, clinical samples were also "blindly labeled by a nonparticipant" and "randomized prior to testing" against the GC/MS confirmed results.
• There's no mention of a traditional group adjudication method (e.g., 2+1, 3+1) involving multiple human readers of the rapid test, as the rapid test is interpreted visually by a single operator. Discordant results were analyzed by comparing the device result directly against the GC/MS result and the drug concentration.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not performed, nor would it be applicable for this type of device.
• This device is a qualitative lateral flow immunoassay for drug detection in urine, designed for visual interpretation. It is not an AI-assisted diagnostic imaging device for human interpretation like those typically evaluated in MRMC studies. Therefore, there's no AI component or human reader improvement analysis.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Yes, in essence. The device itself is a "standalone" test in the sense that its performance (how accurately it detects drugs based on chemical reactions) is tested directly against gold standard methods (GC/MS) or known spiked concentrations.
• The interpretation step is visual, performed by a human operator, but the core performance data (cross-reactivity, precision, accuracy) reflect the inherent capability of the immunoassay itself to produce a detectable signal at certain concentrations. The studies described are primarily focused on this standalone performance of the test strip.

7. The Type of Ground Truth Used

• Laboratory Confirmatory Method (GC/MS): This was the primary gold standard ground truth for the clinical accuracy studies.
• Known Spiked Concentrations: For the precision studies, the ground truth was established by spiking drug-free urine with precisely measured concentrations of analytes, confirmed by GC/MS. This allows for a very controlled evaluation of the device's consistency and ability to detect at specific thresholds.

8. The Sample Size for the Training Set

• The document describes performance studies for the device, implying a final validation of a developed product. It does not mention a "training set" in the context of an algorithm or machine learning model.
• For a traditional immunoassay, there isn't a "training set" in the computational sense. The "training" for such a device involves the biochemical development and optimization of the reagents and test strip design. The provided data are for verification and validation of the final product.

9. How the Ground Truth for the Training Set Was Established

• As there is no "training set" in the context of an AI/machine learning algorithm, this question is not applicable. The development of an immunoassay involves optimizing antibody-antigen reactions and signal generation, which is a biochemical engineering process, not a data-driven model training process.

Summary

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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.

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

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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 ([e-mail]) or phone [phone] 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

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Indications for Use

510(k) Number (if known) K231137

Device Name Xenta Drug Screen Cup Xenta Drug Screen Dipcard

Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:

Test Barbiturates (BAR) Benzodiazepines (BZO) Amphetamine (AMP) Methadone (MTD) Oxycodone (OXY) Phencyclidine (PCP)

• Calibrator Secobarbital Oxazepam D-Amphetamine Methadone Oxycodone Phencyclidine
  Cut-off level 300 ng/mL 300 ng/mL 1000 ng/mL 300 ng/mL 100 ng/mL 25 ng/mL

The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use.

The assays provide only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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: [e-mail] Telephone: [phone] Fax: [phone]

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: [e-mail] Telephone: [phone] Fax: [phone]

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

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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

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	drugs-of-abuse in urine	drugs detected different)
Intended Users	Prescription Use	Over the Counter (OTC) Useand Prescription Use
Specimen	Urine	Same
Cutoff	Barbiturates:300 ng/mLBenzodiazepines:300 ng/mLAmphetamine:1000 ng/mLMethadone:300 ng/mLOxycodone:100 ng/mLPhencyclidine: 25 ng/mL	Barbiturate:300 ng/mLBenzodiazepine:300 ng/mLAmphetamine:500 ng/mLMethadone:300 ng/mLOxycodone:100 ng/mLPhencyclidine: 25 ng/mL
Read time	5 minutes	Same
Results	Qualitative	Same
Methodology	Competitive binding, Lateral flowimmunochromatographic assay basedon the principle of antigen antibodyimmunochemistry	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)	LowestConcentration(ng/mL)	%Cross-reactivity	Methadone (MTD)	LowestConcentration(ng/mL)	%Cross-reactivity
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%

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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

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Cimetidine	Loperamide	Tetrahydrozoline
Citalopram	Meperidine	Thiamine
Cortisone	Meprobamate	Thioridazine
Creatinine	Methoxyphenamine	d, l-Thyroxine
Deoxycorticosterone	Methylphenidate	Tolbutamine
Dexamethasone	Nadolol	Tolbutamide
Dextromethorphan	Nalidixic acid	Trifluoperazine
Diclofenac	Naproxen	Tryptamine
Diflunisal	Niacinamide	Uric acid
Digoxin	Nicotine	Verapamil
Diphenhydramine	Nifedipine	Zomepirac
ẞ-Estradiol	Norethindrone
Acetone	Noscapine
Ascorbic Acid	Acetylsalicylic acid	Albumin
Atropine	Aspartame	Ascorbic Acid
Chlorquine	Benzocaine	Benzoylecgonine
Dexbrompheniramine	(±) Chlolrpheniramine	Creatine
1R,2S(+)-Ephedrine	Dophenhydramine	Dopamine,
Guaiacol glyceryl ether	Ethanol	(+/-)-Isoproterenol
Lysergic acid	Levorphanol	Glucose
Methaqualone	Methadone	Lidocaine
(+)-Naproxen	Morphine	Methanol
Nordiazepam	(+/-)-Norephedrine	(1R,2S)-(-)-n-Methyl-ephedrine
Pheniramine	Phenothiazine	Nortriptyline
B-Phenylethylamin	Phencyclidine	L-Phenylephrine
Propoxyphene	Ranitidine	Procaine
Salicylic acid	Secobarbital	Riboflavin
Theophyline	Tyramine	Sodium Chloride
Vitamin(L-Ascorbic Acid)	4-Dimethylaminoantipyrine	Uric acid
		d-Amphetamine

8.3 Effect of urinary pH

The pH of an aliquot negative urine pool is adjusted to a pH range of 3 to 9 in 1 pH unit increments and spiked with each drug at 50% below and 50% above cutoff levels (All concentrations were confirmed with GC/MS). Each sample was tested by two lots of the corresponding Xenta Drug Screen Cup and Xenta Drug Screen Dipcard. The results demonstrate that varying ranges of pH do not interfere with the performance of the test.

8.4 Effect of Urinary specific gravity

The specific gravity studies were conducted on different specific gravity including 1.002,1.010, 1.020, 1.030, 1.040 specimens with drug free urine containing AMP, BAR, BZO, MTD, OXY, PCP at 50% below and 50% above cutoff level (All concentrations were confirmed with GC/MS).

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Each sample was tested by two lots of the corresponding Xenta Drug Screen Cup and Xenta Drug Screen Dipcard. The results demonstrate that varying ranges of urinary specific gravity do not affect the test result.

8.5 Precision

Precision studies were performed using the single drug and multi-drug test formats. Drug free specimens were spiked with analytes at 0, ±75% cutoff, ±25% cutoff, ±25% cutoff and +100% cutoff of drug. The concentrations of the target drugs were confirmed with GC/MS. In both the single drug test and multi-drug test precision studies each concentration of the urine specimen was divided into aliquots. Each aliquot was blindly labeled by a nonparticipant. Separate sets of blinded coded samples were assigned and randomized prior to testing. The study was conducted by 6 operators at 3 Point-of-Care sites. Two operators per location tested 3 aliquots at each concentration for each lot per day (3 runs/day) for 10 non-consecutive days using one device lot per location. One operator tested the test dipcard format and the second operator tested the test cup format. There were 1620 observations by 3 sites at 9 concentrations.

Drugtest	Approximateconcentrationof sample	% of cutoff	Number ofdeterminations 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:

Drugtest	Approximateconcentrationof sample	% of cutoff	Number ofdeterminationsper 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:

Drugtest	Approximate		Number of	Result
	concentrationof sample	% of cutoff	determinationsper 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:

DrugTest	XentaResult	Drug freeby GC/MSanalysis	Less than half thecutoff concentrationby GC/MS analysis	Near Cutoff Negative(Between 50% belowthe cutoff and the cutoffconcentration)	Near Cutoff Positive(Between the cutoff and50% above the cutoffconcentration)	High Positive(greater than 50%above the cutoffconcentration)	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:

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
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/mL)	Test Result	DrugConcentration(ng/mL)	Drug in Urine
BZO	300	Positive	188	Oxazepam
MTD	300	Positive	209	Methadone
PCP	25	Positive	23	Phencyclidine

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
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:

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
AMP	+	0	0	0	6	34	80
	-	33	2	5	0	0
BAR	+	0	0	0	6	34	80
	-	33	0	7	0	0
BZO	+	0	0	1	7	33	80
	-	31	0	8	0	0
MTD	+	0	0	1	5	35	80
	-	32	2	5	0	0
OXY	+	0	0	0	6	34	80
	-	35	0	5	0	0
PCP	+	0	0	1	5	35	80
	-	35	0	4	0	0

Analysis of Discordant Results with Rapid Multi-drug Test Dipcard

	Multi-drug Test Dipcard		GC/MS Analysis
Drug Test	Cutoff(ng/mL)	Test Result	Drug Concentration (ng/mL)	Drug in Urine
BZO	300	Positive	188	Oxazepam
MTD	300	Positive	209	Methadone
PCP	25	Positive	23	Phencyclidine

Stability of the test line studies:

Stability of the test line studies were performed using the single drug and multi-drug test formats. Drug free specimens were spiked with analytes at different concentration containing +/- 50% cutoff and +100% cutoff. Each sample contain all of eleven drugs and the concentrations of target drugs were confirmed with GC/MS. Spiked specimens and five drug free specimens were test.

{17}------------------------------------------------

The results show that the color T line of Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are stable from 3 to 50 minutes.

We suggest to read the test results within 5 to 30 minutes.

9. Conclusion:

The data collected in the performance and accuracy studies demonstrate that the Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are substantially equivalent to the predicate device.

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Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).