Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel

• K Number: K191099
• Device Name: Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
• Manufacturer: Atlas Medical
• Date Cleared: 2019-10-03 ( 161 days)
• Product Code: DKZ , DIO , DIS , DJC , DJG , DJR , DNK , JXM , JXN , LCM , LDJ , LFG
• Regulation Number: 862.3100
• Type: Traditional
• Panel: Toxicology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Atlas Multi-Drugs Screening Test Cup and Atlas Multi-Drugs Screening Test Panel are lateral flow chromatographic in vitro diagnostics immunoassays for the qualitative detection of following drugs in urine without the need of instruments: Amphetamine (AMP), Methylenedioxymethamphetamine (MDMA), Morphine (MOP), Oxycodone (OXY), Cocaine (COC), Nortriptyline, Methamphetamine (MET), Phencyclidine (PCP), Marijuana (THC), Secobarbital, Oxazepam, Methadone (MTD), Propoxyphene (PPX), Buprenorphine(BUP). The tests are intended for professional use only. The tests will yield preliminary positive results when the prescription drugs Secobarbital, oxazepam, Buprenorphine, Oxycodone, Propoxyphene, and Nortriptyline are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital, oxazepam, Buprenorphine, Oxycodone, Propoxyphene, and Nortriptyline in urine. The multi-drugs screening tests (Cup and Panel formats) show the drug was or was not present at the cutoff level. The tests provide only preliminary test results, which must be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring the drug levels.

Device Description

Atlas Multi-Drugs Screening Test cup format is single use device. The user collects urine in the cup to the recommended volume. The reaction is initiated by movement the sample to the strip. The strips are incorporated into the sides of sample cup. Atlas Multi-Drugs Screening Test panel format is single use dip card device. The user inserts the absorbent end of the device in the urine sample to the maximum level indicated by the line on the device label. The test reaction is initiated by movement of the sample through the strip. Atlas Multi-Drugs Screening Tests (Cup and Panel Formats) detect up to 14 drugs.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Atlas Multi-Drugs Screening Test Cup and Panel, extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the precision and analytical sensitivity studies, which show the device consistently performs around its cut-off values. The clinical study indicates a high percentage of agreement with GC/MS or LC/MS.

Drug / Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Precision (for each drug, across 3 lots and 3 users, at various concentrations relative to cut-off)	100% agreement between device result and expected result (negative for -100%, -75%, -50%, -25% cut-off; positive for cut-off, +25%, +50%, +75%, +100% cut-off)	100% agreement (45-/0+ or 45+/0-) across all lots and concentrations tested for all drugs listed (AMP, Secobarbital, Oxazepam, Buprenorphine, THC, MTD, MET, MDMA, Morphine 300 & 2000, Oxycodone, PCP, Propoxyphene, Nortriptyline, Cocaine) for both Panel and Cup formats.
Analytical Sensitivity (for each drug, n=25 samples per concentration)	Minimal misclassification at -25% and +25% cut-off; 100% agreement at -50% and +50% cut-off.	Panel: Minimal misclassifications at -25% cut-off (e.g., 1 out of 25 for BAR, THC, COC, MTD, MET, PPX) and +25% cut-off (e.g., 1 out of 25 for COC). 100% agreement at -50% and +50% cut-off for all drugs. Cup: Similar results to Panel, with minimal misclassifications at -25% cut-off (e.g., 1 out of 25 for BAR, THC, COC, MTD, MET, PPX) and +25% cut-off (e.g., 1 out of 25 for COC). 100% agreement at -50% and +50% cut-off for all drugs.
Cross-Reactivity	Specific detection of the target drug; minimal to no cross-reactivity with structurally similar compounds at specified concentrations.	Detailed tables provided showing specific percentages of cross-reactivity for various compounds with each drug target. For substances showing no cross-reactivity, results are reported as ">100000 ng/ml" or ">0.3% / >0.01% / >1%" at very high concentrations.
Interference	No interference at 100 ug/ml (albumin at 20 mg/mL) for listed substances.	The study concluded that "no interference" was observed for a comprehensive list of common ingestible or physiological substances.
Effect of pH	No effect on test results across pH range 4.5-9.	The study demonstrated that "the PH does not affect the results."
Effect of Specific Gravity	No effect on test results across specific gravity range 1.005-1.030.	The study demonstrated that "the specific gravity do not affect the results."
Clinical Study (% Agreement with GC/MS or LC/MS)	High percentage agreement for both positive and negative results.	Panel & Cup (similar results for both): - % Agreement Among positive: 95%-100% (e.g., AMP 100%, THC 95%, PCP 100%). - % Agreement Among negative: 95%-100% (e.g., AMP 98%, THC 100%, PCP 95%).
Real-Time Stability	Stable for 24 months at 2-30°C.	The device was found stable for 24 months at 2-30°C.
Accelerated Stability	Stable for at least 24 months based on accelerated testing.	Based on accelerated testing, the device is expected to be stable for at least 24 months.

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

• Precision Study:
  • Sample Size: For each drug, 9 different concentrations (ranging from -100% cut-off to +100% cut-off) were tested. Each concentration was tested with 15 tests (5 tests from each of 3 lots) for a total of 135 tests per drug. Across 14 drugs, this would be a total of 1890 tests per format (Cup and Panel).
  • Data Provenance: Not explicitly stated, but the sample preparation involved spiking drugs into "prepared samples." This suggests laboratory-controlled samples rather than purely clinical, patient-derived samples for the precision study.
• Analytical Sensitivity Study:
  • Sample Size: For each drug, 5 different concentrations (Drug free, Cut-off-50%, Cut-off-25%, Cut-off+25%, Cut-off+50%) were tested. 25 samples were used for each concentration. Therefore, for each drug, 125 tests were performed. For 14 drugs, this amounts to 1750 tests per format (Cup and Panel).
  • Data Provenance: "Drug-free urine pool was spiked with drugs." This indicates laboratory-prepared samples.
• Analytical Specificity and Cross Reactivity Study:
  • Sample Size: Not explicitly stated as a fixed number of samples, but implied to be a series of tests to determine the concentration at which cross-reacting substances are detected or not detected.
  • Data Provenance: Laboratory-prepared samples with specific compounds and target drugs.
• Interference Study:
  • Sample Size: "Drug-free urine samples were collected." Each sample was spiked with drugs at cut-off-25%, cut-off, and cut-off+25%. These samples were then spiked with 100 ug/ml of various interfering substances (albumin at 20 mg/mL). The number of individual tests per interfering substance or per concentration is not specified, but the number of interfering substances is extensive (over 70 listed).
  • Data Provenance: "Drug-free urine samples were collected," which could be clinical or laboratory-sourced. The spiking process makes them laboratory-controlled for interference testing.
• Effect of pH Study:
  • Sample Size: Samples spiked with drugs at cut-off-25%, cut-off, and cut-off+25% at 5 different pH values (4.5, 5, 6, 7, 8, 9).
  • Data Provenance: "Drug-free urine samples were collected... spiked with drugs." Laboratory-controlled.
• Effect of Specific Gravity Study:
  • Sample Size: Samples spiked with drugs at cut-off-25%, cut-off, and cut-off+25% at 4 different specific gravity values (1.005, 1.015, 1.025, 1.030).
  • Data Provenance: "Drug-free urine samples were collected... spiked with drugs." Laboratory-controlled.
• Clinical Study (Method Comparison):
  • Sample Size: 80 clinical specimens were tested for each drug.
  • Data Provenance: Clinical specimens. "All samples used in this study belong to adults (males and females) with ages 18+." "PCP samples which were diluted as per the table mentioned below in the study due to difficulty in sourcing PCP real samples." The cohort also uses 27 other negative urine samples confirmed by GC/MS or LC/MS methods. This indicates a mix of prospectively collected general clinical samples and some retrospectively sourced/modified samples for specific drugs (PCP). The country of origin is not explicitly stated.

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

• Clinical Study (Method Comparison): The ground truth for the clinical study was established by GC/MS (Gas Chromatography/Mass Spectrometry) or LC/MS (Liquid Chromatography/Mass Spectrometry). These are established analytical laboratory methods, not human expert consensus for this type of test. Therefore, human experts were not used to establish the ground truth in the traditional sense of medical image interpretation. The "experts" would be the laboratory personnel performing and interpreting the GC/MS or LC/MS results, who are usually highly qualified with specialized training and certifications in analytical chemistry and toxicology (e.g., clinical chemists, toxicologists). Their specific number or detailed qualifications are not provided in this document.

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4. Adjudication Method for the Test Set

• For the clinical study, the reference method (ground truth) was GC/MS or LC/MS. Discordant results between the device and the reference method were analyzed, but there is no mention of an independent adjudication process involving human readers. The GC/MS/LC/MS results are considered the definitive ground truth.

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5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a "Multi-Reader Multi-Case (MRMC) comparative effectiveness study" comparing human readers with and without AI assistance was not mentioned, nor is it typically applicable to a rapid in-vitro diagnostic immunoassay like this, which is read visually by a single user. The device's performance is determined by its analytical accuracy against a gold standard (GC/MS/LC/MS) and its visual interpretability by a single user.

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6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, the entire performance evaluation presented for the Atlas Multi-Drugs Screening Test Cup and Panel is a standalone performance study. The device itself (the immunoassay) is the 'algorithm' in this context, and its performance is evaluated directly against known concentrations and against reference laboratory methods (GC/MS/LC/MS). Human operators are involved in running the tests and reading the visual results, but the performance metrics (precision, sensitivity, specificity, agreement with GC/MS/LC/MS) are attributed to the device's inherent capability, not as an aid to human interpretation.

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7. Type of Ground Truth Used

• Precision, Analytical Sensitivity, Cross-Reactivity, Interference, pH, Specific Gravity Studies: Laboratory-prepared samples with known concentrations of drugs and interfering substances.
• Clinical Study (Method Comparison): GC/MS or LC/MS (Gas Chromatography/Mass Spectrometry or Liquid Chromatography/Mass Spectrometry) results are used as the ground truth. These are considered the gold standard analytical methods for drug detection and quantification in urine.

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8. Sample Size for the Training Set

• This is a lateral flow immunoassay device, not an AI/Machine Learning algorithm that typically requires a distinct "training set." Therefore, there is no explicit training set sample size described in the context of an AI algorithm. The device's design and manufacturing process would be informed by prior research and development, but not in the sense of an algorithmic training data set.

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

• As there is no explicit "training set" for an AI/ML algorithm in this context, this question is not applicable. The device's inherent performance is based on its biochemical design and manufacturing, which is validated through the studies described above.

Summary

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October 3, 2019

Atlas Medical Amani Al-Habahbeh Registration and RA Manager P.O Box 204 King Abdullah Industrial Estate, Sahab free zone Area Amman Jordan

Re: K191099

Trade/Device Name: Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Code: DKZ, DIS, JXM, JXN, DIO, DJC, DJR, DJG, LCM, LDJ, LFG, DNK Dated: May 9, 2019 Received: May 13, 2019

Dear Amani Al-Habahbeh:

We have reviewed vour 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

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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 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 [phone] or 301-796-7100).

Sincerely,

Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

See PRA Statement below.

510(k) Number (if known) K191099

Device Name

Atlas Multi-Drugs Screening Test Cup Atlas Multi-Drugs Screening Test Panel

Indications for Use (Describe)

Atlas Multi-Drugs Screening Test Cup and Atlas Multi-Drugs Screening Test Panel are lateral flow chromatographic in vitro diagnostics immunoassays for the qualitative detection of following drugs in urine without the need of instruments:

Drug Name	Calibrator	Cut-off
Amphetamine (AMP)	D-Amphetamine	1000
Methylenedioxymethamphetamine (MDMA)	D,L Methylenedioxymethamphetamine	500
Morphine (MOP)	Morphine	300
Morphine (MOP)	Morphine	2000
Oxycodone (OXY)	Oxycodone	100
Cocaine (COC)	Benzoylecgonine	300
Nortriptyline	Nortriptyline	1000
Methamphetamine (MET)	D-Methamphetamine	1000
Phencyclidine (PCP)	Phencyclidine	25
Marijuana (THC)	11-nor-Δ 9-THC-9 COOH	50
Secobarbital	Secobarbital	300
Oxazepam	Oxazepam	300
Methadone (MTD)	Methadone	300
Propoxyphene (PPX)	Propoxyphene	300
Buprenorphine(BUP)	Buprenorphine	10

The tests are intended for professional use only. The tests will yield preliminary positive results when the prescription drugs Secobarbital, oxazepam, Buprenorphine, Oxycodone, Propoxyphene, and Nortriptyline are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital, oxazepam, Buprenorphine, Oxycodone, Propoxyphene, and Nortriptyline in urine. The multi-drugs screening tests (Cup and Panel formats) show the drug was or was not present at the cutoff level. The tests provide only preliminary test results, which must be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring the drug levels.

Type of Use (Select one or both, as applicable)

• Prescription Use (Part 21 CFR 801 Subpart D)
  _ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

1- Submitter name, Address, telephone number, contact person, and the date of the summary prepared:

The submitter's name:	Atlas Medical.
Address:	Atlas Medical, P.O. Box 204,Sahab Free Zone Area, King Abdullah II Industrial CityAmman 11512 Jordan.Tel: [phone]Fax: [phone]Email: [e-mail] person: Amani AL-Habahbeh(Registration and RA Manager)

510 K number: K191099.

This 510(k) summary was prepared on October 01th, 2019.

2- The name of the device

Trade Name:	Atlas Multi-Drugs Screening Test PanelAtlas Multi-Drugs Screening Test Cup
Common Name:	Drug of Abuse screening Tests
Classification Name:	Immunoassay for the detection of drugs of abuse
Regulatory Information:

Classificatic Regulatory Information:

Product Code	Classification	Regulation Section	Panel
DKZ	Class II	21 CRF 862.3100Amphetamine Test System	91 (Toxicology)
DIS	Class II	21 CFR 862.3150Barbiturate test system	91 (Toxicology)
JXM	Class II	21 CFR 862.3170Benzodiazepine test system	91 (Toxicology)
JXN	Class II	21 CFR 862.3700Propoxyphene Test System	91 (Toxicology)
DIO	Class II	21 CFR 862.3250 Cocaineand cocainemetabolite test system	91 (Toxicology)
DJC	Class II	21 CFR 862.3610Methamphetamine testsystem	91 (Toxicology)
DJR	Class II	21 CFR 862.3620Methadone test system	91 (Toxicology)
DJG	Class II	21 CFR 862.3650 Opiatetest system	91 (Toxicology)

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LCM	Unclassified, Enzyme immunoassay, phencyclidine test system	91 (Toxicology)
LDJ	Class II	21 CFR 862.3870 Cannabinoid test system	91 (Toxicology)
LFG	Class II	21 CFR 862.3910 Tricyclic antidepressant drugs test system	91 (Toxicology)
DNK	Class II	21 CFR 862.3640 Morphine test system	91 (Toxicology)

Cup and Panel Formats. Format:

3- Equivalence legally marketed device:

Atlas Multi-Drugs Screening Tests (Cup and Panel Formats) has been determined to be substantially equivalent (Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard) (K 153050) currently in commercial distribution and manufactured by Co-innovation Biotech Co., ltd. (K153050).

4- Device description:

• 1. Atlas Multi-Drugs Screening Test cup format is single use device. The user collects urine in the cup to the recommended volume. The reaction is initiated by movement the sample to the strip. The strips are incorporated into the sides of sample cup.
• 2. Atlas Multi-Drugs Screening Test panel format is single use dip card device. The user inserts the absorbent end of the device in the urine sample to the maximum level indicated by the line on the device label. The test reaction is initiated by movement of the sample through the strip.

Atlas Multi-Drugs Screening Tests (Cup and Panel Formats) detect up to 14 drugs. The table presented below lists of detected drugs:

Drug Name	Calibrator	Cut-off
Amphetamine (AMP)	D-Amphetamine	1000 ng/ml
Methylenedioxymethamphetamine(MDMA)	D,LMethylenedioxymethamphetamine	500 ng/ml
Morphine (MOP)	Morphine	300 ng/ml
Morphine (MOP)	Morphine	2000 ng/ml
Oxycodone (OXY)	Oxycodone	100 ng/ml
Cocaine (COC)	Benzoylecgonine	300 ng/ml
Nortriptyline	Nortriptyline	1000 ng/ml
Methamphetamine (MET)	D-Methamphetamine	1000 ng/ml
Phencyclidine (PCP)	Phencyclidine	25 ng/ml
Marijuana (THC)	11-nor-Δ9-THC-9 COOH	50 ng/ml
Secobarbital	Secobarbital	300 ng/ml
Oxazepam	Oxazepam	300 ng/ml
Methadone (MTD)	Methadone	300 ng/ml

King Abdullah The Second Industrial Estate, Street 19, Sahab Free Zone Area, P.O. Box: 201 Amman 11512 Jordan.

Tel: [phone], Fax: [phone]

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Propoxyphene (PPX)	Propoxyphene	300 ng/ml
Buprenorphine(BUP)	Buprenorphine	10 ng/ml

5- Intended use (Indication for use):

Atlas Multi-Screening Tests (Cup and panel formats) are lateral flow chromatographic in vitro diagnostics immunoassays for the qualitative detection of following drugs in urine without the need of instruments:

Drug Name	Calibrator	Cut-off
Amphetamine (AMP)	D-Amphetamine	1000 ng/ml
Methylenedioxymethamphetamine (MDMA)	D,L Methylenedioxymethamphetamine	500 ng/ml
Morphine (MOP)	Morphine	300 ng/ml
Morphine (MOP)	Morphine	2000 ng/ml
Oxycodone (OXY)	Oxycodone	100 ng/ml
Cocaine (COC)	Benzoylecgonine	300 ng/ml
Nortriptyline	Nortriptyline	1000 ng/ml
Methamphetamine (MET)	D-Methamphetamine	1000 ng/ml
Phencyclidine (PCP)	Phencyclidine	25 ng/ml
Marijuana (THC)	11-nor-Δ9-THC-9 COOH	50 ng/ml
Secobarbital	Secobarbital	300 ng/ml
Oxazepam	Oxazepam	300 ng/ml
Methadone (MTD)	Methadone	300 ng/ml
Propoxyphene (PPX)	Propoxyphene	300 ng/ml
Buprenorphine(BUP)	Buprenorphine	10 ng/ml

The tests are intended for professional use only. The tests will yield preliminary positive results when the prescription drugs Secobarbital. oxazepam. Buprenorphine. Oxycodone, Propoxyphene, and Nortriptyline are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital, oxazepam, Buprenorphine, Oxycodone, Propoxyphene, and Nortriptyline in urine. The multi-drugs screening tests (Cup and Panel formats) show the drug was or was not present at the cutoff level. The tests provide only preliminary test results, which must be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring the drug levels.

6- Test Format:

Atlas Multi-Drugs Screening Tests formats are Cup and panel.

7- Test Principle:

Atlas Multi-Drugs Screening Tests (Cup and panel formats) (Urine) are an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen Compete against the drug conjugate for binding sites on the antibody. During testing, a urine specimen migrates upward by capillary action. A drug, if present in the urine specimen below its cut-off concentration, will not saturate the binding sites of its specific

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antibody. The antibody will then react with the drug-protein conjugate and a visible colored line will show up in the test line region of the specific drug strip. The presence of drug above the cut-off concentration will saturate all the binding sites of the antibody. Therefore, the colored line will not form in the test line region. A drug-positive urine specimen will not generate a colored line in the specific test line region of the strip because of drug competition, while a drug-negative urine specimen will generate a line in the test line region because of the absence of drug competition. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

Image /page/7/Figure/1 description: This image is a diagram titled "Figure 1: Test Principle". The diagram shows a horizontal line with five arrows pointing down to it, labeled A, B, C, D, and E. There are three colored blocks on top of the line, colored green, red, and purple.

As shown in Figure 1 above, the specimen (A) migrates via capillary action along the membrane to react with the colored conjugate (B). Drugs present in the specimen below cutoff, will not saturate the binding sites of the gold-conjugated specific antibodies and not form a colored antibody-antigen complex(C). The gold-conjugated antibodies will then be captured by immobilized specific drug conjugate and a visible red band will form indicating a negative result (D). The absence of line formation in the test line region indicates a positive reading and that the drugs level of the test specimen is above the detection sensitivity of the test. In the control line region of the membrane, immobilized reagents capture colored conjugate regardless of the presence of the test specimen composition. The resulting visible red band (E) confirms that the assay is functioning correctly.

8- Major ingredients of Atlas Multi-Drugs Screening Tests (Cup and Panel formats):

• -Goat antibody.
• Specific Drug antibody. -
• Specific Drug conjugate. -
• -Adhesive plastic backing.
• Absorbant pad. -

9- Comparison with predicate device

Feature Comparison of Atlas Multi-Drugs Screening Tests (Cup and Panel formats) with Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard currently in commercial distribution and manufactured by Co-innovation Biotech Co., Itd. (K153050).

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Similarities
Item	Device (Atlas Multi-Drugs Screening Test panel and Atlas Multi-Drugs Screening Test Cup)	Predicate (Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard ) (K 153050)
Intended use	For the qualitative detection of drugs of abuse.	For the qualitative detection of drugs of abuse.
Specimen type (Matrix)	Urine	Urine
Indication for Use	Screening test for rapid detection of the drugs of abuse in urine.	Screening test for rapid detection of the drugs of abuse in urine.
Methodology	Colloidal Gold Immunoassay (Membrane particle assay)	Colloidal Gold Immunoassay (Membrane particle assay)
Test Time	5 minutes.	5 minutes.
Cut-off	AMP 1000 ng/ml	AMP 1000 ng/ml
	MDMA 500 ng/ml	MDMA 500 ng/ml
	Oxazepam 300 ng/ml	Oxazepam 300 ng/ml
	BUP 10 ng/ml	BUP 10 ng/ml
	COC 300 ng/ml	COC 300 ng/ml
	MET 1000 ng/ml	MET 1000 ng/ml
	MTD 300 ng/ml	MTD 300 ng/ml
	MOP 300 ng/ml	MOP 300 ng/ml
	MOP 2000 ng/ml	MOP 2000 ng/ml
	OXY 100 ng/ml	OXY 100 ng/ml
	PCP 25 ng/ml	PCP 25 ng/ml
	PPX 300 ng/ml	PPX 300 ng/ml
	Nortriptyline 1000 ng/ml	Nortriptyline 1000 ng/ml
	THC 50 ng/ml	THC 50 ng/ml
	Secobarbital 300 ng/ml	Secobarbital 300 ng/ml
Intender user	Professional users	Professional users

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Differences
Item	Device (Atlas Multi-Drugs Screening Test panel and Atlas Multi-Drugs Screening Test Cup).	Predicate (Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard ).(K 153050).
Storage	2-30 °C	4-30 °C

10. Performance Characteristics:

1. Analytical performance:

a) Precision:

The study involved three users, each were given part of the prepared samples. Users were also given adequate number of Atlas Multi-Drugs Screening Tests (Cup and panel formats) from three different lots. Users were asked to test each sample with 15 tests from each format (Cup and panel formats); 5 tests on each lot and record the results in the designated table. The test was conducted as per the respective package inserts.

Amphetamine (AMP) 1,000 ng/ml
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Secobarbital 300 ng/mL
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Oxazepam 300 ng/mL
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Buprenorphine (BUP) 10 ng/ml
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Marijuana (THC) 50 ng/ml
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Methadone (MTD) 300 ng/mL
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Methamphetamine (MET) 1,000 ng/mL
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Methylenedioxymethamphetamine (MDMA) 500 ng/mL
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Morphine (MOP) 300 ng/mL
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Morphine (MOP) 2000 ng/mL
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Oxycodone (OXY) 100ng/mL
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Phencyclidine (PCP) 25 ng/mL
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Propoxyphene (PPX) 300ng/mL
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Nortriptyline 1,000 ng/mL
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Cocaine (COC) 300 ng/mL
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-

1.1 Atlas Multi-Drug Screening Test Panel Test Result:

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King Abdullah The Second Industrial Estate, Street 19, Sahab Free Zone Area, P.O. Box: 201
King Abdullah The Second Industrial Estate, Street 19, Sahab Free Zone Area, P.O. B

Amman 11512 Jordan.

Tel: [phone], Fax: [phone]

{11}------------------------------------------------

1.2 Atlas Multi-Drug Screening Test Cup Test Result:

Amphetamine (AMP) 1,000 ng/ml
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Secobarbital 300 ng/mL
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Oxazepam 300 ng/mL
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-

King Abdullah The Second Industrial Estate, Street 19, Sahab Free Zone Area, P.O. Box: 201

Amman 11512 Jordan.

Tel: [phone], Fax: [phone]

{12}------------------------------------------------

Buprenorphine (BUP) 10 ng/ml
Lot No.	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%
	cut off	cut off	cut off	cutoff		cut off	cut off	cut off	cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Marijuana (THC) 50 ng/ml										Lot No.	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%		cut off	cut off	cut off	cutoff		cut off	cut off	cut off	cut off	Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Methadone (MTD) 300 ng/mL										Lot No.	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%		cut off	cut off	cut off	cutoff		cut off	cut off	cut off	cut off	Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Methamphetamine (MET) 1,000 ng/mL										Lot No.	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%		cut off	cut off	cut off	cutoff		cut off	cut off	cut off	cut off	Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Methylenedioxymethamphetamine (MDMA) 500 ng/mL										Lot No.	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%		cut off	cut off	cut off	cutoff		cut off	cut off	cut off	cut off	Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Morphine (MOP ) 300 ng/mL										Lot No.	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%		cut off	cut off	cut off	cutoff		cut off	cut off	cut off	cut off	Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Morphine (MOP) 2000 ng/mL										Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Oxycodone (OXY) 100ng/mL										Lot No.	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%		cut off	cut off	cut off	cutoff		cut off	cut off	cut off	cut off	Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Marijuana (THC) 50 ng/ml
Lot No.	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%
	cut off	cut off	cut off	cutoff		cut off	cut off	cut off	cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Methadone (MTD) 300 ng/mL
Lot No.	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%
	cut off	cut off	cut off	cutoff		cut off	cut off	cut off	cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Methamphetamine (MET) 1,000 ng/mL										Lot No.	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%		cut off	cut off	cut off	cutoff		cut off	cut off	cut off	cut off	Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Methylenedioxymethamphetamine (MDMA) 500 ng/mL										Lot No.	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%		cut off	cut off	cut off	cutoff		cut off	cut off	cut off	cut off	Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Morphine (MOP ) 300 ng/mL										Lot No.	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%		cut off	cut off	cut off	cutoff		cut off	cut off	cut off	cut off	Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Morphine (MOP) 2000 ng/mL										Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Oxycodone (OXY) 100ng/mL										Lot No.	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%		cut off	cut off	cut off	cutoff		cut off	cut off	cut off	cut off	Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Methamphetamine (MET) 1,000 ng/mL
Lot No.	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%
	cut off	cut off	cut off	cutoff		cut off	cut off	cut off	cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Methylenedioxymethamphetamine (MDMA) 500 ng/mL
Lot No.	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%
	cut off	cut off	cut off	cutoff		cut off	cut off	cut off	cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Morphine (MOP ) 300 ng/mL										Lot No.	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%		cut off	cut off	cut off	cutoff		cut off	cut off	cut off	cut off	Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Morphine (MOP) 2000 ng/mL										Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Oxycodone (OXY) 100ng/mL										Lot No.	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%		cut off	cut off	cut off	cutoff		cut off	cut off	cut off	cut off	Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Morphine (MOP ) 300 ng/mL
Lot No.	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%
	cut off	cut off	cut off	cutoff		cut off	cut off	cut off	cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Morphine (MOP) 2000 ng/mL										Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-	Oxycodone (OXY) 100ng/mL										Lot No.	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%		cut off	cut off	cut off	cutoff		cut off	cut off	cut off	cut off	Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Morphine (MOP) 2000 ng/mL
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Oxycodone (OXY) 100ng/mL										Lot No.	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%		cut off	cut off	cut off	cutoff		cut off	cut off	cut off	cut off	Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Oxycodone (OXY) 100ng/mL
Lot No.	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%
	cut off	cut off	cut off	cutoff		cut off	cut off	cut off	cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-

{13}------------------------------------------------

Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Phencyclidine (PCP) 25 ng/mL
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Propoxyphene (PPX) 300ng/mL
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Nortriptyline 1,000 ng/mL
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Cocaine (COC) 300 ng/mL
Lot No.	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot A	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot B	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-
Lot C	45-/0+	45-/0+	45-/0+	45-/0+	45+/0-	45+/0-	45+/0-	45+/0-	45+/0-

Conclusion: The results above show that Atlas Multi-Drugs Screening Tests (Cup and Panel) formats are reproducible within lots, cross lots and cross users.

b) Analytical Sensitivity:

A drug-free urine pool was spiked with drugs to the concentrations at ± 50% cut-off and ± 25% cut-off. The samples were tested using Atlas Multi-Drugs Screening Tests (Cup and Panel). The results are summarized below.

{14}------------------------------------------------

1) Atlas Multi-Drug Screening Test Panel Test Result:

Drug conc.(Cut-off range)	n	AMP		BAR		BZO		BUP
		-	+	-	+	-	+	-	+
Drug free	25	25	0	25	0	25	0	25	0
Cut-off-50%	25	25	0	25	0	25	0	25	0
Cut-off-25%	25	25	0	24	1	25	0	25	0
Cut-off+25%	25	0	25	0	25	0	25	0	25
Cut-off+50%	25	0	25	0	25	0	25	0	25

Drug conc.(Cut-off range)	n	COC		THC		MTD		MET
		-	+	-	+	-	+	-	+
Drug free	25	25	0	25	0	25	0	25	0
Cut-off-50%	25	25	0	25	0	25	0	25	0
Cut-off-25%	25	25	0	24	1	25	0	25	0
Cut-off+25%	25	1	24	0	25	0	25	0	25
Cut-off+50%	25	0	25	0	25	0	25	0	25

Drug conc.(Cut-off range)	n	PCP		PPX		Nortriptyline
		-	+	-	+	-	+
Drug free	25	25	0	25	0	25	0
Cut-off-50%	25	25	0	25	0	25	0
Cut-off-25%	25	25	0	24	1	25	0
Cut-off+25%	25	0	25	0	25	0	25
Cut-off+50%	25	0	25	0	25	0	25

Drug conc.(Cut-off range)	n	MDMA		MOP 300		MOP 2000		OXY
		-	+	-	+	-	+	-	+
Drug free	25	25	0	25	0	25	0	25	0
Cut-off-50%	25	25	0	25	0	25	0	25	0
Cut-off-25%	25	25	0	25	0	25	0	25	0
Cut-off+25%	25	0	25	0	25	0	25	0	25
Cut-off+50%	25	0	25	0	25	0	25	0	25

{15}------------------------------------------------

	Drug conc.(Cut-off range)	n	AMP	BAR	BZO	BUP
			-	+	-	+	-	+	-	+
	Drug free	25	25	0	25	0	25	0	25	0
	Cut-off-50%	25	25	0	25	0	25	0	25	0
	Cut-off-25%	25	25	0	24	1	25	0	25	0
	Cut-off+25%	25	0	25	0	25	0	25	0	25
	Cut-off+50%	25	0	25	0	25	0	25	0	25
	Drug conc.(Cut-off range)	n	COC	THC	MTD	MET
			-	+	-	+	-	+	-	+
	Drug free	25	25	0	25	0	25	0	25	0
	Cut-off-50%	25	25	0	25	0	25	0	25	0
	Cut-off-25%	25	25	0	24	1	25	0	25	0
	Cut-off+25%	25	1	24	0	25	0	25	0	25
	Cut-off+50%	25	0	25	0	25	0	25	0	25
	Drug conc.(Cut-off range)	n	PCP	PPX	Nortriptyline

2) Atlas Multi-Drug Screening Test Cup:

Drug conc.(Cut-off range)	n	PCP		PPX		Nortriptyline
		-	+	-	+	-	+
Drug free	25	25	0	25	0	25	0
Cut-off-50%	25	25	0	25	0	25	0
Cut-off-25%	25	25	0	24	1	25	0
Cut-off+25%	25	0	25	0	25	0	25
Cut-off+50%	25	0	25	0	25	0	25

Drug conc.(Cut-off range)		n	MDMA		MOP300		MOP2000		OXY
			-	+	-	+	-	+	-	+
Drug free		25	25	0	25	0	25	0	25	0
Cut-off-50%		25	25	0	25	0	25	0	25	0
Cut-off-25%		25	25	0	25	0	25	0	25	0
Cut-off+25%		25	0	25	0	25	0	25	0	25
Cut-off+50%		25	0	25	0	25	0	25	0	25

Conclusion: As indicated in the table above: The Atlas Multi-Screening drugs tests (Cup and Panel) behave within their normal conditions as expected around their cut off values.

c) Analytical Specificity and Cross Reactivity:

Table below lists the compounds that are positively detected in urine by Atlas Drug of Abuse Rapid Tests (Cup and panel formats) (Urine) at 5 minutes and the concentrations at which they are detected.

{16}------------------------------------------------

Drug Name	ng/mL	% of cross reactivity
AMPHETAMINE 1000 ng/mL
D-Amphetamine	1000	100%
D,L-Amphetamine	2500	40%
L-Amphetamine	50000	2%
(+/-)3,4-Methylenedioxy-amphetamine (MDA)	2000	50%
Ephedrine	> 100000	>1%
3,4-Methylenedioxythylamphetamine (MDEA) +	> 100000	>1%
MDMA	1000	100%
D-Methamphetamine	1500	66.7%
L- Methamphetamine	3500	28.5%
Secobarbital 300 ng/mL
Secobarbital	300	100%
Phenobarbital	2500	12%
Butalbital	500	60%
Pentobarbital	1500	20%
Amobarbital	2500	12%
Cyclopentobarbital	500	60%
Butethal	800	37.5%
Barbital	300	100%
Butabarbital	1500	20%

		1) Atlas Multi-Drug Screening Test Panel:

		% of cross
Buprenorphine 10 ng/mL	ng/mL	reactivity
Buprenorphine	10	100%
Norbuprenorphine	15	66.7%
Buprenorphine 3-D-Glucuronide	12.5	80%
Norbuprenorphine 3-D-Glucuronide	175	5.7%
Morphine-3-D-glucoronide	100000	0.01%
Morphine	> 100000	>0.01%
Oxymorphone	> 100000	>0.01%
Hydromorphone	> 100000	>0.01%

Oxazepam 300 ng/mL	ng/mL	% of crossreactivity
Oxazepam	300	100%
Alprazolam	200	150%
α-Hydroxyalprazolam	1000	30%

King Abdullah The Second Industrial Estate, Street 19, Sahab Free Zone Area, P.O. Box: 201

Amman 11512 Jordan.

Tel: [phone], Fax: [phone]

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

Bromazepam	250	120%
Chlordiazepoxide	2500	12%
Clobazam	100	300%
Clonazepam	850	35.3%
Clorazepate	250	120%
Delorazepam	1600	18.75%
Diazepam	200	150%
Estazolam	200	150%
Flunitrazepam	300	100%
Lorazepam	1000	30%
Midazolam	1500	20%
Nitrazepam	100	300%
Nordiazepam	400	75%
Temazepam	150	200%
Triazolam	500	60%

COCAINE 300 ng/mL	ng/mL	% of crossreactivity
Cocaine	> 100000	>0.3%
Benzoylecgonine	300	100%
EcgonineHCl	35000	0.86%
Coaethylene	14000	2.14%
Norcocaine	> 100000	>0.3%
METHADONE 300 ng/mL	ng/mL	% of crossreactivity
Methadone	300	100%
(+)2-Ethyl-1,5-dimethyl-3,3-diphenylpyrrolinium	50000	0.6%
Doxylamine	50000	0.6%
EMDP (2-Ethyl-5-methyl-3,3-diphenylpyrroline)	> 100000	>0.3%
LAAM (1-Alpha-acetylmethadol)	5000	6%
a- Methadol	2000	15%
Disopyramide	8000	3.75%

METHAMPHETAMINE 1000 ng/mL	ng/mL	% of crossreactivity
(+/-)- Methamphetamine	2000	50%
(+)-Methamphetamine	1000	100%
3,4-Methylenedioxythylamphetamine (MDEA)	35000	2.85%
(+/-) 3,4-Methylenedioxymethamphetamine (MDMA)	2000	50%
Ranitidine (Zantac)	> 100000	>1%

King Abdullah The Second Industrial Estate, Street 19, Sahab Free Zone Area, P.O. Box: 201

Amman 11512 Jordan.

Tel: [phone], Fax: [phone]

{18}------------------------------------------------

3,4-Methylenedioxyamphetamine (MDA)	> 100000	>1%
D-Amphetamine	> 100000	>1%
L-Amphetamine	> 100000	>1%
Ephedrine	> 100000	>1%
L-Methamphetamine	5000	20%

METHYLENEDIOXYMETHAMPHETAMINE (MDMA) 500 ng/mL	ng/mL	% of crossreactivity
(+/-) 3,4-Methylenedioxymethamphetamine (MDMA)	500	100%
D-Amphetamine	> 100000	> 0.5%
L-Methamphetamine	100000	0.5%
3,4-Methylenedioxythylamphetamine (MDEA)	200	250%
3,4-Methylenedioxyamphetamine (MDA)	2000	25%
L-Amphetamine	> 100000	> 0.5%
D-Methamphetamine	> 100000	> 0.5%

MARIJUANA 50 ng/mL	ng/mL	% of crossreactivity
11-nor-D9-THC-9 COOH	50	100%
11-nor-D8-THC-9 COOH	50	100%
D8-THC	8000	0.6%
D9-THC	10000	0.5%
Cannabinol	100000	0.05%

		% of cross
MORPHINE 2000 ng/mL	ng/mL	reactivity
Morphine	2000	100%
Codeine	2000	100%
Hydrocodone	10000	20%
Hydromorphone	7000	28.5%
Morphine 3-b-D-glucuronide	2000	100%
6-Monoacetylmorphine	5000	40%
Normorphone	100000	2%
Oxycodone	20000	10%
Oxymorphone	100000	2%
Thebaine	70000	2.8%
Heroin	2500	80%
Ethylmorphine	5000	40%

{19}------------------------------------------------

MORPHINE 300 ng/mL	ng/mL	% of crossreactivity
Morphine	300	100%
Codeine	300	100%
Hydrocodone	2000	15%
Hydromorphone	3500	8.5%
Morphine 3-b-D-glucuronide	300	100%
6-Monoacetylmorphine	600	50%
Normorphone	100000	0.3%
Oxycodone	10000	3%
Oxymorphone	50000	0.6%
Thebaine	7000	4.3%
Heroin	350	85.7%
Ethylmorphine	6000	5%

OXYCODONE 100 ng/mL	ng/mL	% of crossreactivity
Oxycodone	100	100%
Morphine	50000	0.2%
Codeine	25000	0.4%
Morphine 3-b-D-glucuronide	50000	0.2%
Hydrocodone	1600	6.25%
Hydromorphone	15000	0.67%
Normorphone	100000	0.1%
Oxymorphone	1500	6.7%
6-Monoacetylmorphine	>100000	>0.1%
Ethylmorphine	5000	2%

PHENCYCLIDINE 25 ng/mL	ng/mL	% of crossreactivity
Phencyclidine	25	100%
4-Hydroxyphencyclidine	15000	0.17%

PROPOXYPHENE 300 ng/mL	ng/mL	% of crossreactivity
propoxyphene	300	100%
Norpropoxyphene	7500	4%
Methadone	> 100000	0.3%

{20}------------------------------------------------

Notriptyline 1000 ng/mL	ng/mL	% of crossreactivity
Notriptyline	1000	100%
Trimipramine	4500	22.2%
Amitriptyline	1000	100%
Promazine	3000	33.3%
Desipramine	1000	100%
Imipramine	1000	100%
Clomipramine	7500	13.3%
Doxepine	3000	33.3%
Maprotiline	50000	2%

2) Atlas Multi-Drug Screening Test Cup:

Drug Name	ng/mL	% of crossreactivity
AMPHETAMINE 1000 ng/mL
D-Amphetamine	1000	100%
D,L-Amphetamine	2500	40%
L-Amphetamine	50000	2%
(+/-)3,4-Methylenedioxy-amphetamine (MDA)	2000	50%
Ephedrine	> 100000	>1%
3,4-Methylenedioxythylamphetamine (MDEA) +	> 100000	>1%
MDMA	1000	100%
D-Methamphetamine	1500	66.7%
L- Methamphetamine	3500	28.5%

Secobarbital 300 ng/mL	ng/mL	% of crossreactivity
Secobarbital	300	100%
Phenobarbital	2500	12%
Butalbital	500	60%
Pentobarbital	1500	20%
Amobarbital	2500	12%
Cyclopentobarbital	500	60%
Butethal	800	37.5%
Barbital	300	100%
Butabarbital	1500	20%

{21}------------------------------------------------

Buprenorphine 10 ng/mL	ng/mL	% of crossreactivity
Buprenorphine	10	100%
Norbuprenorphine	15	66.7%
Buprenorphine 3-D-Glucuronide	12.5	80%
Norbuprenorphine 3-D-Glucuronide	175	5.7%
Morphine-3-D-glucoronide	100000	0.01%
Morphine	> 100000	>0.01%
Oxymorphone	> 100000	>0.01%
Hydromorphone	> 100000	>0.01%

Oxazepam 300 ng/mL	ng/mL	% of crossreactivity
Oxazepam	300	100%
Alprazolam	200	150%
α-Hydroxyalprazolam	1000	30%
Bromazepam	250	120%
Chlordiazepoxide	2500	12%
Clobazam	100	300%
Clonazepam	850	35.3%
Clorazepate	250	120%
Delorazepam	1600	18.75%
Diazepam	200	150%
Estazolam	200	150%
Flunitrazepam	300	100%
Lorazepam	1000	30%
Midazolam	1500	20%
Nitrazepam	100	300%
Nordiazepam	400	75%
Temazepam	150	200%
Triazolam	500	60%

		% of cross
COCAINE 300 ng/mL	ng/mL	reactivity
Cocaine	> 100000	>0.3%
Benzoylecgonine	300	100%
EcgonineHCl	35000	0.86%
Coaethylene	14000	2.14%
Norcocaine	> 100000	>0.3%

{22}------------------------------------------------

METHADONE 300 ng/mL	ng/mL	% of crossreactivity
Methadone	300	100%
(+)2-Ethyl-1,5-dimethyl-3,3-diphenylpyrrolinium	50000	0.6%
Doxylamine	50000	0.6%
EMDP (2-Ethyl-5-methyl-3,3-diphenylpyrroline)	> 100000	>0.3%
LAAM (1-Alpha-acetylmethadol)	5000	6%
α- Methadol	2000	15%
Disopyramide	8000	3.75%

METHAMPHETAMINE 1000 ng/mL	ng/mL	% of crossreactivity
(+/-)- Methamphetamine	2000	50%
(+)-Methamphetamine	1000	100%
3,4-Methylenedioxythylamphetamine (MDEA)	35000	2.85%
(+/-) 3,4-Methylenedioxymethamphetamine (MDMA)	2000	50%
Ranitidine (Zantac)	> 100000	>1%
3,4-Methylenedioxyamphetamine (MDA)	> 100000	>1%
D-Amphetamine	> 100000	>1%
L-Amphetamine	> 100000	>1%
Ephedrine	> 100000	>1%
L-Methamphetamine	5000	20%

METHYLENEDIOXYMETHAMPHETAMINE (MDMA)	ng/mL	% of cross reactivity
500 ng/mL
(+/-) 3,4-Methylenedioxymethamphetamine (MDMA)	500	100%
D-Amphetamine	> 100000	> 0.5%
L-Methamphetamine	100000	0.5%
3,4-Methylenedioxythylamphetamine (MDEA)	200	250%
3,4-Methylenedioxyamphetamine (MDA)	2000	25%
L-Amphetamine	> 100000	> 0.5%
D-Methamphetamine	> 100000	> 0.5%

MARIJUANA 50 ng/mL	ng/mL	% of crossreactivity
11-nor-D9 -THC-9 COOH	50	100%
11-nor-D8-THC-9 COOH	50	100%
D8 -THC	8000	0.6%

{23}------------------------------------------------

D9 -THC	100000	0.5%
Cannabinol	100000	0.05%

		% of cross
MORPHINE 2000 ng/mL	ng/mL	reactivity
Morphine	2000	100%
Codeine	2000	100%
Hydrocodone	10000	20%
Hydromorphone	7000	28.5%
Morphine 3-b-D-glucuronide	2000	100%
6-Monoacetylmorphine	5000	40%
Normorphone	100000	2%
Oxycodone	20000	10%
Oxymorphone	100000	2%
Thebaine	70000	2.8%
Heroin	2500	80%
Ethylmorphine	5000	40%

MORPHINE 300 ng/mL	ng/mL	% of crossreactivity
Morphine	300	100%
Codeine	300	100%
Hydrocodone	2000	15%
Hydromorphone	3500	8.5%
Morphine 3-b-D-glucuronide	300	100%
6-Monoacetylmorphine	600	50%
Normorphone	100000	0.3%
Oxycodone	10000	3%
Oxymorphone	50000	0.6%
Thebaine	7000	4.3%
Heroin	350	85.7%
Ethylmorphine	6000	5%

OXYCODONE 100 ng/mL	ng/mL	% of crossreactivity
Oxycodone	100	100%
Morphine	50000	0.2%
Codeine	25000	0.4%
Morphine 3-b-D-glucuronide	50000	0.2%

{24}------------------------------------------------

Hydrocodone	1600	6.25%
Hydromorphone	15000	0.67%
Normorphone	100000	0.1%
Oxymorphone	1500	6.7%
6-Monoacetylmorphine	>100000	>0.1%
Ethylmorphine	5000	2%

PHENCYCLIDINE 25 ng/mL	ng/mL	% of crossreactivity
Phencyclidine	25	100%
4-Hydroxyphencyclidine	15000	0.17%

PROPOXYPHENE 300 ng/mL	ng/mL	% of crossreactivity
propoxyphene	300	100%
Norpropoxyphene	7500	4%
Methadone	> 100000	0.3%

Nortriptyline 1000 ng/mL	ng/mL	% of crossreactivity
Notriptyline	1000	100%
Trimipramine	4500	22.2%
Amitriptyline	1000	100%
Promazine	3000	33.3%
Desipramine	1000	100%
Imipramine	1000	100%
Clomipramine	7500	13.3%
Doxepine	3000	33.3%
Maprotiline	50000	2%

Conclusion: Atlas Multi-Drugs screening Tests (Cup and Panel formats) gave similar result behavior to positive results when tested with the previous mentioned substances at their corresponding concentration in the table. Where results found to be negative even at high concentrations, the above table reports the concentrations as >100,000ng/ml.

d) Interference (Interfering Substances):

The Drug-free urine samples were collected. Each sample had been spiked with drugs to the concentrations cut-off-25%, cut-off and cut-off+25%. These urine samples had been spiked with 100ug/ml of the various ingestible or physiological substances (albumin was evaluated at 20 mg/mL) using Atlas Multi-Drugs screening tests ((Cup and Panel formats).

{25}------------------------------------------------

The obtained results showed that the following list of substances showed no interference at the concentration 100 ug/ml(albumin was evaluated at 20 mg/mL) when tested with Atlas Multi-Drugs Screening Test Panel and Atlas Multi-Drugs Screening Test cup.

Acetophenetidin	Estrone-3-sulfate	Penicillin-G
Acetone	Ethyl alcohol	Perphenazine
N-Acetylprocainamide	L-ψ-Ephedrine	Phenelzine
Acetylsalicylic acid	Fenoprofen	L-Phenylephrine
Acetaminophen	Furosemide	b-Phenylethylamine
Albumin	Gentisic acid	Pheniramine
Aminopyrine	d-Glucose	Phenothiazine
Amoxicillin	Guaiacol Glyceryl Ether	Prednisolone
Ampicillin	Hemoglobin	Prednisone
L-Ascorbic acid	Hydralazine	Procaine
Apomorphine	Hydrochlorothiazide	DL-Propranolol
Aspartame	Hydrocortisone	D-Pseudoephedrine
Atropine	O-Hydroxyhippuric acid	Quinidine
Benzilic acid	Ibuprofen	Quinine
Benzoic acid	D,L--Isoproterenol	Ranitidine
Bilirubin	Isoxsuprine	Riboflavin
Caffeine	Ketamine	Salicylic acid
Cannabidiol	Ketoprofen	Serotonin
Chloralhydrate	Labetalol	Sodium chloride
Chloramphenicol	Lidocaine	Sulfamethazine
Chlorothiazide	Loperamide	Sulindac
(+)Chlorpheniramine	Meperidine	Tetracycline
Chlorprothixene	Meprobamate	Tetrahydrocortisone, 3-acetate
Chloroquine	Methoxyphenamine	Tetrahydrozoline
Cholesterol	Methylphenidate	Thiamine
Clonidine	Nalidixic acid	Theophylline
Cortisone	Naloxone	Tolbutamide
L- Cotinine	Naltrexone	Triamterene
Creatinine	Naproxen	Trifluoperazine
Deoxycorticosterone	Niacinamide	Trimethoprim
Dextromethorphan	Nifedipine	DL-Tryptophan
Dexbrompheniramine	Nicotine	Verapamil
Diclofenac	Norethindrone	Zomepirac
Diflunisal	Noscapine	(R,2S)-(-)-N-Methyl-Ephedrine
Digoxin	Norephedrine
4-Dimethylaminoantipyrine	d,L-Octopamine
Diphenhydramine	Oxalic acid

{26}------------------------------------------------

Dopamine	Oxolinic acid
Erythromycin	Oxymetazoline
b-Estradiol	Papaverine

f) Effect of PH on Atlas Multi-Drugs Screening Tests (Cup and Panel):

The Drug-free urine samples were collected and tested by GC/MS or LC/MS to ensure they are drug free. These samples were spiked with drugs to the concentrations at ± 50% cut-off and ± 25% cut-off. The PH of these samples was adjusted to be 4.5. 5.6.7.8 and 9. respectively. The Cup and panel formats with all drug test strips were tested at each PH. The results demonstrated that the PH does not affect the results of Atlas Multi-Drugs screening tests (Cup and Panel) Formats.

g) Effect of specific gravity on Atlas Multi-Drugs Screening Tests (Cup and Panel):

The Drug-free urine samples were collected and tested by GC/MS or LC/MS to they are drug free. These samples were spiked with drugs to the concentrations at ± 50% cut-off and

± 25% cut-off. The specific gravity of these samples adjusted to be 1.005, 1.015, 1.025 and 1.030, respectively. The Cup and panel formats with all drug test strips were tested at each specific gravity. The results demonstrated that the specific gravity do not affect the results of Atlas Multi-Drugs screening tests (Cup and Panel) Formats.

h) Clinical Study (Method Comparison):

The comparison study was conducted to compare Atlas Multi-Drugs screening Tests (Cup and panel formats) (Urine) with the GC/MS or LC/MS methods. Testing was performed on 80 Clinical specimens All samples used in this study belong to adults (males and females) with ages 18+. Samples were used as is without any dilution or alteration (except PCP samples which were diluted as per the table mentioned below in the study due to difficulty in sourcing PCP real samples). The unaltered clinical samples had been confirmed with Gas Chromatography Method (GC/MS) and the unaltered clinical samples (less than -50% of the cutoff, near cutoff negative (between -50% and the cutoff), near cutoff positive (between cutoff and +50%) and high positive (greater than +50%) were tested using Atlas Multi-Drugs screening Tests (Cup and panel formats) (Urine). Test results per drug are summarized in the table below:

Tested Drug	CandidateDeviceResult	Negativesamples	Less than halfthe cutoffconcentrationBy GC/MS	Near cutoffnegative (between -50% below thecutoff and thecutoffconcentration	Near cutoffpositive(betweenthe cutoffand+50%Above thecutoffconcentration)	HighPositive(greater than+50% above thecutoffconcentration)
AMP1000 ng/ml	Positive	0	0	1	4	36
	Negative	16	20	3	0	0

1) Atlas Multi-Drugs screening Panel Test Result:

{27}------------------------------------------------

Secobarbital	Positive	0	0	1	2	37
300 ng/ml	Negative	18	17	4	1	0
Oxazepam	Positive	0	0	2	3	36
300 ng/ml	Negative	19	17	2	1	0
COC	Positive	0	0	1	3	37
300 ng/ml	Negative	20	15	4	0	0
THC	Positive	0	0	0	2	36
50 ng/ml	Negative	21	15	4	2	0
MTD	Positive	0	0	1	2	37
300 ng/ml	Negative	18	17	4	1	0
MET	Positive	0	0	2	3	36
1000 ng/ml	Negative	22	14	2	1	0
MDMA	Positive	0	0	1	4	36
500 ng/ml	Negative	25	11	3	0	0
MOP300 ng/ml	Positive	0	0	1	2	37
ng/ml	Negative	21	14	4	1	0
MOP2000 ng/ml	Positive	0	0	0	4	35
ng/ml	Negative	20	17	3	1	0
PPX300 ng/ml	Positive	0	0	1	2	36
ng/ml	Negative	25	11	3	2	0
OXY	Positive	0	0	1	3	37
100 ng/ml	Negative	21	14	4	0	0
Nortriptyline	Positive	0	0	0	2	36
1000 ng/ml	Negative	22	14	4	2	0
BUP10 ng/ml	Positive	0	0	0	2	36
ng/ml	Negative	21	15	4	2	0
PCP25 ng/ml	Positive	0	0	2	3	16
ng/ml	Negative	20	16	4	0	0

2) Atlas Multi-Drugs screening Cup Test Result:

Tested Drug	CandidateDeviceResult	Negativesamples	Less than halfthe cutoffconcentrationBy GC/MS	Nearcutoffnegative (between -50% below thecutoff and thecutoffconcentration)	Nearcutoffpositive(between thecutoffand+50%Above thecutoffconcentration)	HighPositive(greater than+50% above thecutoffconcentration)
AMP1000 ng/ml	Positive	0	0	1	4	36
AMP1000 ng/ml	Negative	16	20	3	0	0
Secobarbital300 ng/ml	Positive	0	0	1	2	37
Secobarbital300 ng/ml	Negative	18	17	4	1	0
Oxazepam300 ng/ml	Positive	0	0	2	3	36
Oxazepam300 ng/ml	Negative	19	17	2	1	0

{28}------------------------------------------------

COC	Positive	0	0	1	3	37
300 ng/ml	Negative	20	15	4	0	0
THC	Positive	0	0	0	2	36
50 ng/ml	Negative	21	15	4	2	0
MTD	Positive	0	0	1	2	37
300 ng/ml	Negative	18	17	4	1	0
MET	Positive	0	0	2	3	36
1000 ng/ml	Negative	22	14	2	1	0
MDMA	Positive	0	0	1	4	36
500 ng/ml	Negative	25	11	3	0	0
MOP	Positive	0	0	1	2	37
300 ng/ml	Negative	21	14	4	1	0
MOP2000ng/ml	Positive	0	0	0	4	35
ng/ml	Negative	20	17	3	1	0
PPX300ng/ml	Positive	0	0	1	2	36
ng/ml	Negative	25	11	3	2	0
OXY	Positive	0	0	1	3	37
100 ng/ml	Negative	21	14	4	0	0
Nortriptyline1000 ng/ml	Positive	0	0	0	2	36
1000 ng/ml	Negative	23	13	4	2	0
BUP10ng/ml	Positive	0	0	0	2	36
ng/ml	Negative	21	15	4	2	0
PCP25ng/ml	Positive	0	0	2	3	16
ng/ml	Negative	20	16	4	0	0

The Summary of Discordant Results is listed in the table below:

Assay	Cut-off	Sample Number	LC/MS Result	Atlas Multi –Screening DOApanel TestResults	Atlas Multi –Screening DOACup TestResults
AMP	1000ng/ml	Sample 23	855 ng/ml	Positive	Positive
Secobarbital	300 ng/ml	Sample 51	287 ng/ml	Positive	Positive
Secobarbital	300 ng/ml	Sample 71	348 ng/ml	Negative	Negative
Oxazepam	300 ng/ml	Sample 16	330 ng/ml	Negative	Negative
Oxazepam	300 ng/ml	Sample 37	299 ng/ml	Positive	Positive
Oxazepam	300 ng/ml	Sample 78	198 ng/ml	Positive	Positive
COC	300 ng/ml	Sample 67	294 ng/ml	Positive	Positive
THC	50 ng/ml	Sample 43	55 ng/ml	Negative	Negative
THC	50 ng/ml	Sample 66	56 ng/ml	Negative	Negative
MTD	300 ng/ml	Sample 43	304 ng/ml	Negative	Negative
MTD	300 ng/ml	Sample 80	293 ng/ml	Positive	Positive
MET	1000 ng/ml	Sample 6	1006 ng/ml	Negative	Negative
MET	1000 ng/ml	Sample 34	992 ng/ml	Positive	Positive
MET	1000 ng/ml	Sample 63	989 ng/ml	Positive	Positive

King Abdullah The Second Industrial Estate, Street 19, Sahab Free Zone Area, P.O. Box: 201

Amman 11512 Jordan.

Tel: [phone], Fax: [phone]

{29}------------------------------------------------

MDMA	500 ng/ml	Sample 43	501 ng/ml	Positive	Positive
MOP	300 ng/ml	Sample 7	318 ng/ml	Negative	Negative
MOP	300 ng/ml	Sample 57	292 ng/ml	Positive	Positive
MOP	2000 ng/ml	Sample 4	2007 ng/ml	Negative	Negative
PCP	25 ng/ml	Sample 10	24 ng/ml	Positive	Positive
PCP	25 ng/ml	Sample 26	22 ng/ml	Positive	Positive
PPX	300 ng/ml	Sample 15	314 ng/ml	Negative	Negative
PPX	300 ng/ml	Sample 42	302 ng/ml	Negative	Negative
PPX	300 ng/ml	Sample 47	289 ng/ml	Positive	Positive
OXY	100 ng/ml	Sample 25	98 ng/ml	Positive	Positive
Nortriptyline	1000 ng/ml	Sample 61	1010 ng/ml	Negative	Negative
Nortriptyline	1000 ng/ml	Sample 78	1013 ng/ml	Negative	Negative
BUP	10 ng/ml	Sample 3	11 ng/ml	Negative	Negative
BUP	10 ng/ml	Sample 78	11 ng/ml	Negative	Negative

Note: Two Samples of high PCP concentration confirmed by GC/MS to be (192 ng/ml and 147 ng/ml) were collected; those samples were diluted with negative urine sample confirmed negative by GC/MS or LC/MS methods to make the following concentrations:

Table #1:
Sample #1	Sample #2
192 ng/ml	147 ng/ml
171 ng/ml	132 ng/ml
153 ng/ml	117 ng/ml
134 ng/ml	102 ng/ml
115 ng/ml	88 ng/ml
96 ng/ml	73 ng/ml
76 ng/ml	58 ng/ml
57 ng/ml	44 ng/ml
38 ng/ml	29 ng/ml
28 ng/ml	22 ng/ml
24 ng/ml	18 ng/ml
19 ng/ml	14 ng/ml
14 ng/ml	10 ng/ml
9 ng/ml	7 ng/ml
4 ng/ml	3 ng/ml
2 ng/ml	1 ng/ml
1 ng/ml	<1 ng/ml

High positive: 16

Near positive: 3

Near Negative: 6

Negative: 9

The cohort also uses 27 other negative urine samples confirmed by GC/MS or LC/MS methods.

{30}------------------------------------------------

Conclusion:

The Summary of % agreement of Atlas Multi-screening DOA Tests (Panel and Cup) formats with GC/MS method is listed in the table below:

Drugs	Cutoff	% Agreement Among positive	% Agreement Among negative
AMP	1000 ng/ml	100%	98%
Secobarbital	300 ng/ml	98%	98%
Oxazepam	300 ng/ml	98%	95%
COC	300 ng/ml	100%	98%
THC	50 ng/ml	95%	100%
MTD	300 ng/ml	98%	98%
MET	1000 ng/ml	98%	95%
MDMA	500 ng/ml	100%	98%
MOP	300 ng/ml	98%	98%
MOP	2000 ng/ml	98%	100%
PPX	300 ng/ml	95%	98%
OXY	100 ng/ml	100%	98%
Nortriptyline	1000 ng/ml	95%	100%
BUP	10 ng/ml	100%	95%
PCP	25 ng/ml	100%	95%

The obtained data from this study show that Atlas Multi-Drugs screening Tests (Cup and panel formats) (Urine) have relatively high sensitivity, Specificity and accuracy when compared to GS/MS or LC/MS methods.

I) Stability Study:

1) Real Time Stability

Real Time Stability of the Drug of abuse rapid test was evaluated using samples from three different lots. These samples were placed in an incubator with the temperature calibrated at 2±1 ℃ and 30±1 ℃ with relative humidity (RH) calibrated at 60±3%. A series of stability tests were performed each month from 0 to 24 months. Tests were assayed using urine specimens with the drugs concentrations of 0% Cut-off, -25% Cut-off, -50% Cut-off, +25% Cut-off, +50% Cut-off. Results are read at 5 minute. The tests were performed according to the package insert.

Conclusion: Atlas Drug of Abuse Test Panel (Urine) is stable at the temperature of 2-30°C for 24 months.

2) Accelerated Stability

Accelerated Stability of the Drug of abuse rapid test was evaluated using samples from three different lots. These samples were placed in an incubator with the temperature calibrated at 40±1 ℃ with relative humidity (RH) calibrated at 60±3%. A series of stability tests were performed each week from 0 to 3 weeks (4 weeks in total). Tests were assayed using urine specimens with drugs concentrations of 0% Cutoff, -25% Cut-off, -50% Cut-off, +25% Cut-off, +50% Cut-off. Results are read at 5 minute. The tests were performed according to the package insert.

Conclusion: Based on accelerated testing equations where one week represents one year of stability at room temperature Atlas Drug of abuse test is expected to be stable for at least 24 months.

L) Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CRF part 809.10.

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).