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

K191099 · Atlas Medical · DKZ · Oct 3, 2019 · Clinical Toxicology

Device Facts

• Record ID: K191099
• Device Name: Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
• Applicant: Atlas Medical
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Oct 3, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for 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: 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.

Device Story

Device uses lateral flow chromatographic immunoassay to detect drugs of abuse in urine. Principle: competitive binding; drug in urine competes with drug-protein conjugate for antibody binding sites. If drug concentration is below cutoff, antibody binds conjugate, forming visible colored line (negative result). If drug concentration is above cutoff, binding sites are saturated, preventing line formation (positive result). Control line confirms proper wicking. Used in professional settings; no instrumentation required. Output is visual qualitative result (line/no line). Assists clinicians in preliminary drug screening; requires GC/MS confirmation for positive results.

Clinical Evidence

Clinical study compared device results against GC/MS or LC/MS reference methods using 80 clinical specimens. Results demonstrated high sensitivity, specificity, and accuracy. Agreement among positive/negative samples ranged from 95% to 100% across all 14 drug analytes. Bench testing confirmed precision, analytical sensitivity, specificity, cross-reactivity, and stability (24 months).

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Formats: Test Cup and Dipcard. No instrumentation required. Qualitative visual readout. Materials: membrane-based particle assay. Storage: 2-30°C.

Indications for Use

Indicated for professional use only for the qualitative detection of drugs of abuse in human urine. Target population includes individuals undergoing drug screening. Contraindications: Not for monitoring drug levels; preliminary results require GC/MS confirmation.

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Predicate Devices

• Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard (k153050)

Submission Summary (Full Text)

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Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number
k191099

B Applicant
Atlas Medical

C Proprietary and Established Names
Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel

## D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DKZ | Class II | 21 CRF 862.3100
Amphetamine Test System | 91 (Toxicology) |
| DIS | Class II | 21 CFR 862.3150
Barbiturate test system | 91 (Toxicology) |
| JXM | Class II | 21 CFR 862.3170
Benzodiazepine test system | 91 (Toxicology) |
| JXN | Class II | 21 CFR 862.3700
Propoxyphene Test System | 91 (Toxicology) |
| DIO | Class II | 21 CFR 862.3250 Cocaine and cocaine metabolite test system | 91 (Toxicology) |
| DJC | Class II | 21 CFR 862.3610
Methamphetamine test system | 91 (Toxicology) |
| DJR | Class II | 21 CFR 862.3620
Methadone test system | 91 (Toxicology) |
| DJG | Class II | 21 CFR 862.3650 Opiate test system | 91 (Toxicology) |
| LCM | Unclassified, Enzyme immunoassay, phencyclidine test system | | 91 (Toxicology) |
| LDJ | Class II | 21 CFR 862.3870
Cannabinoid test system | 91 (Toxicology) |

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| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| 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) |

## II Submission/Device Overview:

### A Purpose for Submission:
New device

### B Measurand:
Amphetamine, Methylenedioxymethamphetamine, Morphine, Oxycodone, Cocaine, Nortriptyline, Methamphetamine, Phencyclidine, Marijuana, Secobarbital, Oxazepam, Methadone, Propoxyphene, and Buprenorphine.

### C Type of Test:
Lateral flow chromatographic immunoassay

## III Intended Use/Indications for Use:

### A Intended Use(s):
See Indications for Use below.

### B Indication(s) for 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:

| Drug Name | Calibrator | Cut-off (ng/mL) |
| --- | --- | --- |
| Amphetamine (AMP) | D-Amphetamine | 1000 |
| Methylenedioxymethamphetamine (MDMA) | D,LMethylenedioxymethamphetamine | 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-Δ9-THC-9 COOH | 50 |
| Secobarbital | Secobarbital | 300 |
| Oxazepam | Oxazepam | 300 |
| Methadone (MTD) | Methadone | 300 |
| Propoxyphene (PPX) | Propoxyphene | 300 |
| Buprenorphine (BUP) | Buprenorphine | 10 |

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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.

## C Special Conditions for Use Statement(s):
Rx - For Prescription Use

## D. Special Conditions for Use Statement(s):
None

## IV Device/System Characteristics:

### A Device Description:
The Atlas Multi-Drugs Screening Test Cup and the Atlas Multi-Drugs Screening Test Panel are competitive binding, lateral flow immunochromatographic assays for the qualitative detection of the drugs of abuse, at the indicated cutoffs, stated in the indications for use. The tests can be performed without the use of an instrument. The devices are available in one of two formats: Test Cup and Dipcard. The test configurations consist of single drug screening tests or any combinations of multiple drug screening tests.

### B Principle of Operation:
The Atlas Multi-Drugs Screening Test Cup and the Atlas Multi-Drugs Screening Test Panel are immunoassays based on the principle of competitive binding. Drugs 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 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.

### V Substantial Equivalence Information:

### A Predicate Device Name(s):
Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard

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B Predicate 510(k) Number(s):

k153050

C Comparison with Predicate(s):

| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device (k191099)Atlas Multi-Drugs Screening Test panelAtlas Multi-Drugs Screening Test Cup | Predicate Device (k153050)Rapid Single/Multi-drug Test CupRapid Single/Multi-drug Test Dipcard |
| Intended use | For the qualitative detection of drugs of abuse | Same |
| Specimen type (Matrix) | Urine | Same |
| Methodology | Colloidal Gold Immunoassay (Membrane particle assay) | Same |
| Test Time | 5 minutes | Same |
| Cut-off (ng/mL) | AMP 1000 | Same |
| | MDMA 500 | Same |
| | Oxazepam 300 | Same |
| | BUP 10 | Same |
| | COC 300 | Same |
| | MET 1000 | Same |
| | MTD 300 | Same |
| | MOP 300 | Same |
| | MOP 2000 | Same |
| | OXY 100 | Same |
| | PCP 25 | Same |
| | PPX 300 | Same |
| | Nortriptyline 1000 | Same |
| | THC 50 | Same |
| | Secobarbital 300 | Same |
| Differences | | |
| --- | --- | --- |
| Item | Candidate Device (k191099)Atlas Multi-Drugs Screening Test panelAtlas Multi-Drugs Screening Test Cup | Predicate Device (k153050)Rapid Single/Multi-drug Test CupRapid Single/Multi-drug Test Dipcard |
| Intended User | Prescription Use | Prescription and OTC use |
| Storage | 2-30°C | 4-30°C |

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VI Standards/Guidance Documents Referenced:
None referenced.

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:
A precision study was conducted where three operators tested drug concentrations around the cutoff, using spiked urine samples that were provided blind to the operators. Each operator used devices from 3 different lots of the Atlas Multi-Drugs Screening Test Cup and the Atlas Multi-Drugs Screening Test Panel, and the study was conducted over 2 weeks. For each sample, 45 results were generated for each device. Results are provided in the table below.

Atlas Multi-Drugs Screening Test Panel 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- |
| 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

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| 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+/− | 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+/− | 45+/0- |
| Lot C | 45-/0+ | 45-/0+ | 45-/0+ | 45-/0+ | 45+/0- | 45+/0- | 45+/0- | 45+/− | 45+/0- |
| Morphine (MOP 300) 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+/− | 45+/0- |
| Lot C | 45-/0+ | 45-/0+ | 45-/0+ | 45-/0+ | 45+/0- | 45+/0- | 45+/− | 45+/− | 45+/0- |
| Morphine (MOP 2000) 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+/− | 45+/− | 45+/0- |
| Lot C | 45-/0+ | 45-/0+ | 45-/0+ | 45-/0+ | 45+/0- | 45+/− | 45+/− | 45+/− | 45+/− |
| 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+/− | 45+/− | 45+/− | 45+/− |
| Lot C | 45-/0+ | 45-/0+ | 45-/0+ | 45-/0+ | 45+/− | 45+/− | 45+/− | 45+/− | 45+/− |

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| 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+ | 45+ | 45+ | 45+ |

Atlas Multi-Drugs 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+ | 45+ | 45+ | 45+ | 45+ |
| 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+ | 45+ | 45+ | 45+ | 45+ |
| 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+ | 45+ | 45+ | 45+ | 45+ |
| 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+ | 45+ | 45+ | 45+ | 45+ |
| 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+ |
| Lot C | 45-/0+ | 45-/0+ | 45-/0+ | 45-/0+ | 45+ | 45+ | 45+ | 45+ | 45+ |

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| 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+ | 45+ |
| Lot C | 45-/0+ | 45-/0+ | 45-/0+ | 45-/0+ | 45+/0- | 45+/0- | 45+/0- | 45+/0- | 45+ |
| 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+ | 45+ | 45+ |
| Lot C | 45-/0+ | 45-/0+ | 45-/0+ | 45-/0+ | 45+/0- | 45+ | 45+ | 45+ | 45+ |
| Morphine (MOP 300) 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+ | 45+ | 45+ | 45+ |
| Lot C | 45-/0+ | 45-/0+ | 45-/0+ | 45-/0+ | 45+ | 45+ | 45+ | 45+ | 45+ |
| Morphine (MOP 2000) 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+ | 45+ | 45+ | 45+ | 45+ |
| Lot C | 45-/0+ | 45-/0+ | 45-/0+ | 45-/0+ | 45+ | 45+ | 45+ | 45+ | 45+ |
| 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+ | 45+ | 45+ | 45+ | 45+ |
| Lot C | 45-/0+ | 45-/0+ | 45-/0+ | 45-/0+ | 45+ | 45+ | 45+ | 45+ | 45+ |
| 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+ | 45+ | 45+ | 45+ | 45+ |
| Lot C | 45-/0+ | 45-/0+ | 45-/0+ | 45-/0+ | 45+ | 45+ | 45+ | 45+ | 45+ |

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K191099 - Page 9 of 19

| 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+ | 45+/0- | 45+/0- | 45+/0- | 45+/0- |

2. **Linearity:**
Not applicable.

3. **Analytical Specificity/Interference:**

**Cross-reactivity:**
Cross reactivity with structurally similar compounds was tested for each device, and the results for both devices were identical, as provided in the table below. The table below lists the concentrations at which various compounds produced a positive result, or the maximum concentration detected, and these concentrations were used to calculate the percent (%) cross-reactivity.

| Drug Name | | |
| --- | --- | --- |
| AMPHETAMINE 1000 | ng/mL | % of cross reactivity |
| 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 | % of cross reactivity |
| --- | --- | --- |
| Secobarbital | 300 | 100% |
| Phenobarbital | 2500 | 12% |
| Butalbital | 500 | 60% |
| Pentobarbital | 1500 | 20% |
| Amobarbital | 2500 | 12% |

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| SECOBARBITAL 300 | ng/mL | % of cross reactivity |
| --- | --- | --- |
| Cyclopentobarbital | 500 | 60% |
| Butethal | 800 | 37.5% |
| Barbital | 300 | 100% |
| Butabarbital | 1500 | 20% |
| Buprenorphine 10 | ng/mL | % of cross 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 | % of cross reactivity |
| --- | --- | --- |
| 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% |

K191099 - Page 10 of 19

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| COCAINE 300 | ng/mL | % of cross reactivity |
| --- | --- | --- |
| Cocaine | >100000 | >0.3% |
| Benzoylecgonine | 300 | 100% |
| EcgonineHCl | 35000 | 0.86% |
| Coaethylene | 14000 | 2.14% |
| Norcocaine | >100000 | >0.3% |
| METHADONE 300 | ng/mL | % of cross reactivity |
| --- | --- | --- |
| 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% |
| METHAMPHETAMINES 1000 | ng/mL | % of cross reactivity |
| --- | --- | --- |
| (+/-)- 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) 500 | ng/mL | % of cross reactivity |
| --- | --- | --- |
| (+/-) 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% |

K191099 - Page 11 of 19

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| MARIJUANA 50 | ng/mL | % of cross reactivity |
| --- | --- | --- |
| 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% |
| MORPHINE 2000 | ng/mL | % of cross 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 | % of cross reactivity |
| --- | --- | --- |
| 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% |

K191099 - Page 12 of 19

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K191099 - Page 13 of 19

| OXYCODONE 100 | ng/mL | % of cross reactivity |
| --- | --- | --- |
| 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 | % of cross reactivity |
| --- | --- | --- |
| Phencyclidine | 25 | 100% |
| 4-Hydroxyphencyclidine | 15000 | 0.17% |
| PROPOXYPHENE 300 | ng/mL | % of cross reactivity |
| --- | --- | --- |
| propoxyphene | 300 | 100% |
| Norpropoxyphene | 7500 | 4% |
| Methadone | >100000 | 0.3% |
| NORTRIPTYLINE 1000 | ng/mL | % of cross reactivity |
| --- | --- | --- |
| Nortriptyline | 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% |

## Interference:

Interference from structurally similar and dissimilar compounds was evaluated by spiking these compounds into urine samples containing drugs of abuse at concentrations of $+/-25\%$ of the respective cut-offs. The following list of potentially interfering substances showed no interference at a test concentration of $100~\mathrm{ug / ml}$ (albumin was evaluated at $20~\mathrm{mg / mL}$) when tested with Atlas Multi-Drugs Screening Test Panel and Atlas Multi-Drugs Screening Test cup.

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K191099 - Page 14 of 19
| 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 | |
| Dopamine | Oxolinic acid | |
| Erythromycin | Oxymetazoline | |
| b-Estradiol | Papaverine | |

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K191099 - Page 15 of 19

# Effect of pH on the Atlas Multi-Drugs Screening Test Cup and the Atlas Multi-Drugs Screening Test Panel:

The pH of drug-free urine samples was adjusted to be pH 4.5, 5, 6, 7, 8 and 9, and the samples were spiked with drugs of abuse to +/-25% and +/-50% of the respective cutoffs. Each sample was tested using the Atlas Multi-Drugs Screening Test Cup and the Atlas Multi-Drugs Screening Test Panel. The results demonstrated that the pH does not affect the results of the Atlas Multi-Drugs Screening Test Cup and the Atlas Multi-Drugs Screening Test Panels.

# Effect of specific gravity on the Atlas Multi-Drugs Screening Test Cup and the Atlas Multi-Drugs Screening Test Panel:

The specific gravity of drug-free urine samples was adjusted to 1.005, 1.010, 1.015, 1.025 and 1.030 and spiked with drugs of abuse to +/-25% and +/-50% of the respective cutoffs. Each sample was tested using the Atlas Multi-Drugs Screening Test Cup and the Atlas Multi-Drugs Screening Test Panel. The results demonstrated that the specific gravity does not affect the results of the Atlas Multi-Drugs Screening Test Cup and the Atlas Multi-Drugs Screening Test Panel.

4. Assay Reportable Range:
Not applicable.

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Not applicable.

6. Detection Limit:
Not applicable.

7. Assay Cut-Off:
See section VII.A.1.

# B Comparison Studies:

1. Accuracy

A method comparison study was conducted to demonstrate the accuracy of the Atlas Multi-Drugs Screening Test Cup and the Atlas Multi-Drugs Screening Test Panel with the GC/MS or LC/MS methods. Testing was performed on 80 unaltered clinical specimens for each test analyte (except for PCP samples which were diluted as per the table mentioned below in the study due to difficulty in sourcing PCP native samples). The unaltered clinical samples were quantitated with GC/MS or LC/MS and were also tested using the Atlas Multi-Drugs Screening Test Cup and the Atlas Multi-Drugs Screening Test Panel. Test results per drug analyte are summarized in the table below:

{15}

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

| Tested Drug | Candidate Device Result | Negative samples | Less than half the cutoff concentration by GC/MS | Near cutoff negative (between -50% below the cutoff and the cutoff concentration) | Near cutoff positive (between the cutoff and+50% Above the cutoff concentration) | High Positive (greater than +50% above the cutoff concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| AMP 1000 | Positive | 0 | 0 | 1 | 4 | 36 |
| | Negative | 16 | 20 | 3 | 0 | 0 |
| Secobarbital 300 | Positive | 0 | 0 | 1 | 2 | 37 |
| | Negative | 18 | 17 | 4 | 1 | 0 |
| Oxazepam 300 | Positive | 0 | 0 | 2 | 3 | 36 |
| | Negative | 19 | 17 | 2 | 1 | 0 |
| COC 300 | Positive | 0 | 0 | 1 | 3 | 37 |
| | Negative | 20 | 15 | 4 | 0 | 0 |
| THC 50 | Positive | 0 | 0 | 0 | 2 | 36 |
| | Negative | 21 | 15 | 4 | 2 | 0 |
| MTD 300 | Positive | 0 | 0 | 1 | 2 | 37 |
| | Negative | 18 | 17 | 4 | 1 | 0 |
| MET 1000 | Positive | 0 | 0 | 2 | 3 | 36 |
| | Negative | 22 | 14 | 2 | 1 | 0 |
| MDMA 500 | Positive | 0 | 0 | 1 | 4 | 36 |
| | Negative | 25 | 11 | 3 | 0 | 0 |
| MOP 300 | Positive | 0 | 0 | 1 | 2 | 37 |
| | Negative | 21 | 14 | 4 | 1 | 0 |
| MOP 2000 | Positive | 0 | 0 | 0 | 4 | 35 |
| | Negative | 20 | 17 | 3 | 1 | 0 |
| PPX 300 | Positive | 0 | 0 | 1 | 2 | 36 |
| | Negative | 25 | 11 | 3 | 2 | 0 |
| OXY 100 | Positive | 0 | 0 | 1 | 3 | 37 |
| | Negative | 21 | 14 | 4 | 0 | 0 |
| Nortriptyline 1000 | Positive | 0 | 0 | 0 | 2 | 36 |
| | Negative | 22 | 14 | 4 | 2 | 0 |
| BUP 10 | Positive | 0 | 0 | 0 | 2 | 36 |
| | Negative | 21 | 15 | 4 | 2 | 0 |
| PCP 25 | Positive | 0 | 0 | 2 | 3 | 16 |
| | Negative | 20 | 16 | 4 | 0 | 0 |

2) Atlas Multi-Drugs Screening Test Cup Test Result:

| Tested Drug | Candidate Device Result | Negative samples | Less than half the cutoff concentration by GC/MS | Near cutoff negative (between -50% below the cutoff and the cutoff concentration) | Near cutoff positive (between the cutoff and+50% Above the cutoff concentration) | High Positive (greater than +50% above the cutoff concentration) |
| --- | --- | --- | --- | --- | --- | --- |

K191099 - Page 16 of 19

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| | | | | | cutoff concentration) | |
| --- | --- | --- | --- | --- | --- | --- |
| AMP 1000 | Positive | 0 | 0 | 1 | 4 | 36 |
| | Negative | 16 | 20 | 3 | 0 | 0 |
| Secobarbital 300 | Positive | 0 | 0 | 1 | 2 | 37 |
| | Negative | 18 | 17 | 4 | 1 | 0 |
| Oxazepam 300 | Positive | 0 | 0 | 2 | 3 | 36 |
| | Negative | 19 | 17 | 2 | 1 | 0 |
| COC 300 | Positive | 0 | 0 | 1 | 3 | 37 |
| | Negative | 20 | 15 | 4 | 0 | 0 |
| THC 50 | Positive | 0 | 0 | 0 | 2 | 36 |
| | Negative | 21 | 15 | 4 | 2 | 0 |
| MTD 300 | Positive | 0 | 0 | 1 | 2 | 37 |
| | Negative | 18 | 17 | 4 | 1 | 0 |
| MET 1000 | Positive | 0 | 0 | 2 | 3 | 36 |
| | Negative | 22 | 14 | 2 | 1 | 0 |
| MDMA 500 | Positive | 0 | 0 | 1 | 4 | 36 |
| | Negative | 25 | 11 | 3 | 0 | 0 |
| MOP 300 | Positive | 0 | 0 | 1 | 2 | 37 |
| | Negative | 21 | 14 | 4 | 1 | 0 |
| MOP 2000 | Positive | 0 | 0 | 0 | 4 | 35 |
| | Negative | 20 | 17 | 3 | 1 | 0 |
| PPX 300 | Positive | 0 | 0 | 1 | 2 | 36 |
| | Negative | 25 | 11 | 3 | 2 | 0 |
| OXY 100 | Positive | 0 | 0 | 1 | 3 | 37 |
| | Negative | 21 | 14 | 4 | 0 | 0 |
| Nortriptyline 1000 | Positive | 0 | 0 | 0 | 2 | 36 |
| | Negative | 23 | 13 | 4 | 2 | 0 |
| BUP 10 | Positive | 0 | 0 | 0 | 2 | 36 |
| | Negative | 21 | 15 | 4 | 2 | 0 |
| PCP 25 | Positive | 0 | 0 | 2 | 3 | 16 |
| | Negative | 20 | 16 | 4 | 0 | 0 |

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

| Tested Drug | Cut-off | Sample Number | LC/MS Result | Atlas Multi - Screening DOA panel Test Results | Atlas Multi - Screening DOA Cup Test Results |
| --- | --- | --- | --- | --- | --- |
| AMP | 1000 | Sample 23 | 855 | Positive | Positive |
| Secobarbital | 300 | Sample 51 | 287 | Positive | Positive |
| Secobarbital | 300 | Sample 71 | 348 | Negative | Negative |
| Oxazepam | 300 | Sample 16 | 330 | Negative | Negative |
| Oxazepam | 300 | Sample 37 | 299 | Positive | Positive |
| Oxazepam | 300 | Sample 78 | 198 | Positive | Positive |

K191099 - Page 17 of 19

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| COC | 300 | Sample 67 | 294 | Positive | Positive |
| --- | --- | --- | --- | --- | --- |
| THC | 50 | Sample 43 | 55 | Negative | Negative |
| THC | 50 | Sample 66 | 56 | Negative | Negative |
| MTD | 300 | Sample 43 | 304 | Negative | Negative |
| MTD | 300 | Sample 80 | 293 | Positive | Positive |
| MET | 1000 | Sample 6 | 1006 | Negative | Negative |
| MET | 1000 | Sample 34 | 992 | Positive | Positive |
| MET | 1000 | Sample 63 | 989 | Positive | Positive |
| MDMA | 500 | Sample 43 | 501 | Positive | Positive |
| MOP | 300 | Sample 7 | 318 | Negative | Negative |
| MOP | 300 | Sample 57 | 292 | Positive | Positive |
| MOP | 2000 | Sample 4 | 2007 | Negative | Negative |
| PCP | 25 | Sample 10 | 24 | Positive | Positive |
| PCP | 25 | Sample 26 | 22 | Positive | Positive |
| PPX | 300 | Sample 15 | 314 | Negative | Negative |
| PPX | 300 | Sample 42 | 302 | Negative | Negative |
| PPX | 300 | Sample 47 | 289 | Positive | Positive |
| OXY | 100 | Sample 25 | 98 | Positive | Positive |
| Nortriptyline | 1000 | Sample 61 | 1010 | Negative | Negative |
| Nortriptyline | 1000 | Sample 78 | 1013 | Negative | Negative |
| BUP | 10 | Sample 3 | 11 | Negative | Negative |
| BUP | 10 | Sample 78 | 11 | Negative | Negative |

2. Matrix Comparison:
Urine is the only matrix

C Clinical Studies:

1. Clinical Sensitivity:
Not Applicable

2. Clinical Specificity:
Not Applicable

3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
None

D Clinical Cut-Off:
Not Applicable

E Expected Values/Reference Range:
Not Applicable

VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.

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IX Conclusion:

The submitted information in this premarket notification is complete and support a substantial equivalence decision.

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