QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k130213 B. Purpose for Submission: New Device C. Measurand: Amphetamine, Secobarbital, Oxazepam, Benzoylecgonine, Methadone, Methamphetamine, Opiates, Phencyclidine, Cannabinoid (THC) D. Type of Test: Qualitative chromatographic immunoassay E. Applicant: LumiQuick Diagnostics Inc. F. Proprietary and Established Names: QuickProfile Single Drugs of Abuse Screen Device QuickProfile Multi-Drugs of Abuse Screen Device G. Regulatory Information: | Product Code | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | DKZ | Class II | 21 CFR part 862.3100 Amphetamine test system | Toxicology (91) | | DIS | Class II | 21 CFR part 862.3150 Barbiturate test system | Toxicology (91) | | JXM | Class II | 21 CFR part 862.3170 Benzodiazepine test system | Toxicology (91) | | DIO | Class II | 21 CFR part 862.3250 Cocaine and cocaine metabolite test system | Toxicology (91) | | DJR | Class II | 21 CFR part 862.3620 Methadone test system | Toxicology (91) | {1} 2 | DJC | Class II | 21 CFR part 862.3610 Methamphetamine test system | Toxicology (91) | | --- | --- | --- | --- | | DJG | Class II | 21 CFR part 862.3650 Opiate test system | Toxicology (91) | | LCM | Unclassified | Phencyclidine | Toxicology (91) | | LDJ | Class II | 21 CFR part 862.3870 Cannabinoid test system. | Toxicology (91) | ## H. Intended Use: 1. Intended use(s): Please see indications for use below. 2. Indication(s) for use: LumiQuick’s QuickProfile Single Drugs of Abuse and QuickProfile Multi-Drugs of Abuse Screen Devices are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to nine of the following drugs in a variety of combinations in human urine. Both devices are available in test strip, dip panel, cassette panel and cup formats. The designed cutoff concentrations and direct calibrator for these drugs are as follows: | AMP | Amphetamine | 1000 ng/ml | | --- | --- | --- | | BAR | Secobarbital | 300 ng/ml | | BZO | Oxazepam | 300 ng/ml | | COC | Benzoylecgonine | 300 ng/ml | | MTD | Methadone | 300 ng/ml | | MAMP | Methamphetamine | 1000 ng/ml | | OPI | Morphine | 300 ng/ml | | PCP | Phencyclidine | 25 ng/ml | | THC | THC 11-nor-Δ⁹-THC-9-COOH | 50 ng/ml | These devices are intended for prescription use only. These assays provide only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. 3. Special conditions for use statement(s): For Prescription Use. {2} 4. Special instrument requirements: Not applicable; these are visually read single use devices I. Device Description: The QuickProfile Single Drugs of Abuse Device and Quick Profile Multi-Drugs of Abuse Screen Device are one-step, colloidal gold based chromatographic immunoassays for the rapid, qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Methadone, Methamphetamine, Opiates, Phencyclidine, and Marijuana in human urine. The single and multi-test devices contain one or more than one test strip. Both devices are available in test strip, dip panel, cassette panel and cup formats. J. Substantial Equivalence Information: 1. Predicate device name(s): Innovacon Spectrum II Test Card 2. Predicate 510(k) number(s): k061718 3. Comparison with predicate: | Item | QuickProfile Single Drugs of Abuse and QuickProfile Multi-Drugs of Abuse Screen Devices (Candidate Device) | Innovacon Spectrum II Test Card (Predicate-k061718) | | --- | --- | --- | | Intended Use | Rapid chromatographic immunoassays for the qualitative and simultaneous detection of one or more drugs of abuse in a variety of combinations in human urine. The devices are intended for prescription use only. | Same | | Method of Measurement | Test strip, Dip panel, Cassette panel, and Cup | Test card; Cup | | Test Principle | Enzyme Immunoassay (EIA) | Same | | Sample Matrix | Urine | Same | | Time | 5 Minutes | Same | | Cutoff Levels | Amphetamine 1000 ng/ml | Same | {3} | | Secobarbital 300 ng/ml | | --- | --- | | | Oxazepam 300 ng/ml | | | Benzoylecgonine 300 ng/ml | | | Methadone 300 ng/ml | | | Methamphetamine 1000 ng/ml | | | Opiates 300 ng/ml | | | Phencyclidine 25 ng/ml | | | THC 50 ng/ml | K. Standard/Guidance Document Referenced (if applicable): None were referenced. L. Test Principle: The QuickProfile Single Drugs of Abuse and QuickProfile Multi-Drugs of Abuse Screen Device are one-step immunoassays in which chemically labeled drugs (drug-protein conjugates) compete for limited antibody binding sites with drugs that may be present in urine. The single and multi-test devices contain one or more than one test strips (single drug or 2 drugs per test strip) in the dip panel, cassette panel and cup formats. The drug-protein conjugates are pre-coated on the test band of the membrane and the drug mouse antibody-colloidal gold conjugate pads are placed at one end of the membrane. In the absence of drugs in the urine, the solution of the colored antibody-colloidal gold conjugates move along with the sample solution by capillary action to the immobilized drug-protein conjugate zones on the test band region. The colored antibody-gold conjugates then attach to the drug-protein conjugates to form visible lines as the antibodies complex with the drug conjugates. Therefore, the formation of the visible precipitant in the test band occurs when the test urine is negative for the drug. When drug is present in the urine, the drug/metabolite antigen competes with drug-protein conjugates on the test band region for the limited antibody on the colored drug antibody-colloidal gold conjugate pad. When a sufficient concentration of the drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored antibody (drug-protein conjugate)-colloidal gold conjugate to the drug-protein conjugate zone on the test band region. Therefore, absence of the color band on the test region indicates a positive result. A control band is added to the immunochromatographic membrane strip at the control region (C) to indicate that the test has performed properly. This control line should always appear regardless of the presence of drug or metabolite. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: 1. Intra-assay precision around the cutoff {4} A commercially available panel (blinded) of GC/MS confirmed urine-based control samples containing multiple drugs were used for the study. These samples contained the following concentrations: Negative, 50%, 75%, 100%, 125%, 150%, and 200% of the cutoff level of drug analytes. Two additional concentrations were prepared using these controls to generate samples at 25% and 175% of the cut off level. Test Strip, Dip Panel, Cassette Panel and Cup formats, for 9 target drugs were tested. Each control level was tested in duplicates for ten consecutive days, 3 lots per format, one device lot per professional (3 professionals). Results were consistent between lots. Representative lot results are presented in the tables below: ## Amphetamine (AMP): ### Test Strip | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 250 | 25% | 20 | 20 | | 100 | | 500 | 50% | 20 | 20 | | 100 | | 750 | 75% | 20 | 20 | | 100 | | 1000 | 100% | 20 | | 20 | 100 | | 1250 | 125% | 20 | | 20 | 100 | | 1500 | 150% | 20 | | 20 | 100 | | 1750 | 175% | 20 | | 20 | 100 | | 2000 | 200% | 20 | | 20 | 100 | ### Dip Panel | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 250 | 25% | 20 | 20 | | 100 | | 500 | 50% | 20 | 20 | | 100 | | 750 | 75% | 20 | 20 | | 100 | | 1000 | 100% | 20 | | 20 | 100 | | 1250 | 125% | 20 | | 20 | 100 | | 1500 | 150% | 20 | | 20 | 100 | | 1750 | 175% | 20 | | 20 | 100 | | 2000 | 200% | 20 | | 20 | 100 | ### Cassette Panel | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 250 | 25% | 20 | 20 | | 100 | | 500 | 50% | 20 | 20 | | 100 | | 750 | 75% | 20 | 20 | | 100 | {5} 6 | 1000 | 100% | 20 | | 20 | 100 | | --- | --- | --- | --- | --- | --- | | 1250 | 125% | 20 | | 20 | 100 | | 1500 | 150% | 20 | | 20 | 100 | | 1750 | 175% | 20 | | 20 | 100 | | 2000 | 200% | 20 | | 20 | 100 | Cup | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 250 | 25% | 20 | 20 | | 100 | | 500 | 50% | 20 | 20 | | 100 | | 750 | 75% | 20 | 20 | | 100 | | 1000 | 100% | 20 | | 20 | 100 | | 1250 | 125% | 20 | | 20 | 100 | | 1500 | 150% | 20 | | 20 | 100 | | 1750 | 175% | 20 | | 20 | 100 | | 2000 | 200% | 20 | | 20 | 100 | Opiates 300 (OPI): Test Strip | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 75 | 25% | 20 | 20 | | 100 | | 150 | 50% | 20 | 20 | | 100 | | 225 | 75% | 20 | 20 | | 100 | | 300 | 100% | 20 | | 20 | 100 | | 375 | 125% | 20 | | 20 | 100 | | 450 | 150% | 20 | | 20 | 100 | | 525 | 175% | 20 | | 20 | 100 | | 600 | 200% | 20 | | 20 | 100 | Dip Panel | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 75 | 25% | 20 | 20 | | 100 | | 150 | 50% | 20 | 20 | | 100 | | 225 | 75% | 20 | 20 | | 100 | | 300 | 100% | 20 | | 20 | 100 | | 375 | 125% | 20 | | 20 | 100 | | 450 | 150% | 20 | | 20 | 100 | | 525 | 175% | 20 | | 20 | 100 | | 600 | 200% | 20 | | 20 | 100 | {6} Cassette Panel | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 75 | 25% | 20 | 20 | | 100 | | 150 | 50% | 20 | 20 | | 100 | | 225 | 75% | 20 | 20 | | 100 | | 300 | 100% | 20 | | 20 | 100 | | 375 | 125% | 20 | | 20 | 100 | | 450 | 150% | 20 | | 20 | 100 | | 525 | 175% | 20 | | 20 | 100 | | 600 | 200% | 20 | | 20 | 100 | Cup | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 75 | 25% | 20 | 20 | | 100 | | 150 | 50% | 20 | 20 | | 100 | | 225 | 75% | 20 | 20 | | 100 | | 300 | 100% | 20 | | 20 | 100 | | 375 | 125% | 20 | | 20 | 100 | | 450 | 150% | 20 | | 20 | 100 | | 525 | 175% | 20 | | 20 | 100 | | 600 | 200% | 20 | | 20 | 100 | Benzodiazepines (BZO): Test Strip | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 75 | 25% | 20 | 20 | | 100 | | 150 | 50% | 20 | 20 | | 100 | | 225 | 75% | 20 | 20 | | 100 | | 300 | 100% | 20 | | 20 | 100 | | 375 | 125% | 20 | | 20 | 100 | | 450 | 150% | 20 | | 20 | 100 | | 525 | 175% | 20 | | 20 | 100 | | 600 | 200% | 20 | | 20 | 100 | Dip Panel | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | {7} 8 | 75 | 25% | 20 | 20 | | 100 | | --- | --- | --- | --- | --- | --- | | 150 | 50% | 20 | 20 | | 100 | | 225 | 75% | 20 | 20 | | 100 | | 300 | 100% | 20 | | 20 | 100 | | 375 | 125% | 20 | | 20 | 100 | | 450 | 150% | 20 | | 20 | 100 | | 525 | 175% | 20 | | 20 | 100 | | 600 | 200% | 20 | | 20 | 100 | Cassette Panel | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 75 | 25% | 20 | 20 | | 100 | | 150 | 50% | 20 | 20 | | 100 | | 225 | 75% | 20 | 20 | | 100 | | 300 | 100% | 20 | | 20 | 100 | | 375 | 125% | 20 | | 20 | 100 | | 450 | 150% | 20 | | 20 | 100 | | 525 | 175% | 20 | | 20 | 100 | | 600 | 200% | 20 | | 20 | 100 | Cup | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 75 | 25% | 20 | 20 | | 100 | | 150 | 50% | 20 | 20 | | 100 | | 225 | 75% | 20 | 20 | | 100 | | 300 | 100% | 20 | | 20 | 100 | | 375 | 125% | 20 | | 20 | 100 | | 450 | 150% | 20 | | 20 | 100 | | 525 | 175% | 20 | | 20 | 100 | | 600 | 200% | 20 | | 20 | 100 | Cocaine (COC): Test Strip | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 75 | 25% | 20 | 20 | | 100 | | 150 | 50% | 20 | 20 | | 100 | | 225 | 75% | 20 | 20 | | 100 | | 300 | 100% | 20 | | 20 | 100 | | 375 | 125% | 20 | | 20 | 100 | {8} 9 | 450 | 150% | 20 | | 20 | 100 | | --- | --- | --- | --- | --- | --- | | 525 | 175% | 20 | | 20 | 100 | | 600 | 200% | 20 | | 20 | 100 | ## Dip Panel | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 75 | 25% | 20 | 20 | | 100 | | 150 | 50% | 20 | 20 | | 100 | | 225 | 75% | 20 | 20 | | 100 | | 300 | 100% | 20 | | 20 | 100 | | 375 | 125% | 20 | | 20 | 100 | | 450 | 150% | 20 | | 20 | 100 | | 525 | 175% | 20 | | 20 | 100 | | 600 | 200% | 20 | | 20 | 100 | ## Cassette Panel | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 75 | 25% | 20 | 20 | | 100 | | 150 | 50% | 20 | 20 | | 100 | | 225 | 75% | 20 | 20 | | 100 | | 300 | 100% | 20 | | 20 | 100 | | 375 | 125% | 20 | | 20 | 100 | | 450 | 150% | 20 | | 20 | 100 | | 525 | 175% | 20 | | 20 | 100 | | 600 | 200% | 20 | | 20 | 100 | ## Cup | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 75 | 25% | 20 | 20 | | 100 | | 150 | 50% | 20 | 20 | | 100 | | 225 | 75% | 20 | 20 | | 100 | | 300 | 100% | 20 | | 20 | 100 | | 375 | 125% | 20 | | 20 | 100 | | 450 | 150% | 20 | | 20 | 100 | | 525 | 175% | 20 | | 20 | 100 | | 600 | 200% | 20 | | 20 | 100 | {9} Methamphetamine (MAMP): Test Strip | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 250 | 25% | 20 | 20 | | 100 | | 500 | 50% | 20 | 20 | | 100 | | 750 | 75% | 20 | 20 | | 100 | | 1000 | 100% | 20 | | 20 | 100 | | 1250 | 125% | 20 | | 20 | 100 | | 1500 | 150% | 20 | | 20 | 100 | | 1750 | 175% | 20 | | 20 | 100 | | 2000 | 200% | 20 | | 20 | 100 | Dip Panel | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 250 | 25% | 20 | 20 | | 100 | | 500 | 50% | 20 | 20 | | 100 | | 750 | 75% | 20 | 20 | | 100 | | 1000 | 100% | 20 | | 20 | 100 | | 1250 | 125% | 20 | | 20 | 100 | | 1500 | 150% | 20 | | 20 | 100 | | 1750 | 175% | 20 | | 20 | 100 | | 2000 | 200% | 20 | | 20 | 100 | Cassette Panel | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 250 | 25% | 20 | 20 | | 100 | | 500 | 50% | 20 | 20 | | 100 | | 750 | 75% | 20 | 20 | | 100 | | 1000 | 100% | 20 | | 20 | 100 | | 1250 | 125% | 20 | | 20 | 100 | | 1500 | 150% | 20 | | 20 | 100 | | 1750 | 175% | 20 | | 20 | 100 | | 2000 | 200% | 20 | | 20 | 100 | Cup | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 250 | 25% | 20 | 20 | | 100 | {10} Marijuana (THC): Test Strip | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 12.5 | 25% | 20 | 20 | | 100 | | 25 | 50% | 20 | 20 | | 100 | | 37.5 | 75% | 20 | 20 | | 100 | | 50 | 100% | 20 | | 20 | 100 | | 62.5 | 125% | 20 | | 20 | 100 | | 75 | 150% | 20 | | 20 | 100 | | 87.5 | 175% | 20 | | 20 | 100 | | 100 | 200% | 20 | | 20 | 100 | Dip Panel | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 12.5 | 25% | 20 | 20 | | 100 | | 25 | 50% | 20 | 20 | | 100 | | 37.5 | 75% | 20 | 20 | | 100 | | 50 | 100% | 20 | | 20 | 100 | | 62.5 | 125% | 20 | | 20 | 100 | | 75 | 150% | 20 | | 20 | 100 | | 87.5 | 175% | 20 | | 20 | 100 | Cassette Panel | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 12.5 | 25% | 20 | 20 | | 100 | | 25 | 50% | 20 | 20 | | 100 | | 37.5 | 75% | 20 | 20 | | 100 | | 50 | 100% | 20 | | 20 | 100 | | 62.5 | 125% | 20 | | 20 | 100 | | 75 | 150% | 20 | | 20 | 100 | {11} 12 | 87.5 | 175% | 20 | | 20 | 100 | | --- | --- | --- | --- | --- | --- | | 100 | 200% | 20 | | 20 | 100 | ## Cup | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 12.5 | 25% | 20 | 20 | | 100 | | 25 | 50% | 20 | 20 | | 100 | | 37.5 | 75% | 20 | 20 | | 100 | | 50 | 100% | 20 | | 20 | 100 | | 62.5 | 125% | 20 | | 20 | 100 | | 75 | 150% | 20 | | 20 | 100 | | 87.5 | 175% | 20 | | 20 | 100 | | 100 | 200% | 20 | | 20 | 100 | ## Barbiturate (BAR): ### Test Strip | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 75 | 25% | 20 | 20 | | 100 | | 150 | 50% | 20 | 20 | | 100 | | 225 | 75% | 20 | 20 | | 100 | | 300 | 100% | 20 | | 20 | 100 | | 375 | 125% | 20 | | 20 | 100 | | 450 | 150% | 20 | | 20 | 100 | | 525 | 175% | 20 | | 20 | 100 | | 600 | 200% | 20 | | 20 | 100 | ## Dip Panel | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 75 | 25% | 20 | 20 | | 100 | | 150 | 50% | 20 | 20 | | 100 | | 225 | 75% | 20 | 20 | | 100 | | 300 | 100% | 20 | | 20 | 100 | | 375 | 125% | 20 | | 20 | 100 | | 450 | 150% | 20 | | 20 | 100 | | 525 | 175% | 20 | | 20 | 100 | | 600 | 200% | 20 | | 20 | 100 | {12} Cassette Panel | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 75 | 25% | 20 | 20 | | 100 | | 150 | 50% | 20 | 20 | | 100 | | 225 | 75% | 20 | 20 | | 100 | | 300 | 100% | 20 | | 20 | 100 | | 375 | 125% | 20 | | 20 | 100 | | 450 | 150% | 20 | | 20 | 100 | | 525 | 175% | 20 | | 20 | 100 | | 600 | 200% | 20 | | 20 | 100 | Cup | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 75 | 25% | 20 | 20 | | 100 | | 150 | 50% | 20 | 20 | | 100 | | 225 | 75% | 20 | 20 | | 100 | | 300 | 100% | 20 | | 20 | 100 | | 375 | 125% | 20 | | 20 | 100 | | 450 | 150% | 20 | | 20 | 100 | | 525 | 175% | 20 | | 20 | 100 | | 600 | 200% | 20 | | 20 | 100 | Phencyclidine (PCP): Test Strip | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 6.25 | 25% | 20 | 20 | | 100 | | 12.5 | 50% | 20 | 20 | | 100 | | 18.75 | 75% | 20 | 20 | | 100 | | 25 | 100% | 20 | | 20 | 100 | | 31.25 | 125% | 20 | | 20 | 100 | | 37.5 | 150% | 20 | | 20 | 100 | | 43.75 | 175% | 20 | | 20 | 100 | | 50 | 200% | 20 | | 20 | 100 | Dip Panel | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 6.25 | 25% | 20 | 20 | | 100 | {13} 14 | 12.5 | 50% | 20 | 20 | | 100 | | --- | --- | --- | --- | --- | --- | | 18.75 | 75% | 20 | 20 | | 100 | | 25 | 100% | 20 | | 20 | 100 | | 31.25 | 125% | 20 | | 20 | 100 | | 37.5 | 150% | 20 | | 20 | 100 | | 43.75 | 175% | 20 | | 20 | 100 | | 50 | 200% | 20 | | 20 | 100 | Cassette Panel | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 6.25 | 25% | 20 | 20 | | 100 | | 12.5 | 50% | 20 | 20 | | 100 | | 18.75 | 75% | 20 | 20 | | 100 | | 25 | 100% | 20 | | 20 | 100 | | 31.25 | 125% | 20 | | 20 | 100 | | 37.5 | 150% | 20 | | 20 | 100 | | 43.75 | 175% | 20 | | 20 | 100 | | 50 | 200% | 20 | | 20 | 100 | Cup | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 6.25 | 25% | 20 | 20 | | 100 | | 12.5 | 50% | 20 | 20 | | 100 | | 18.75 | 75% | 20 | 20 | | 100 | | 25 | 100% | 20 | | 20 | 100 | | 31.25 | 125% | 20 | | 20 | 100 | | 37.5 | 150% | 20 | | 20 | 100 | | 43.75 | 175% | 20 | | 20 | 100 | | 50 | 200% | 20 | | 20 | 100 | Methadone (MTD): Test Strip | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 75 | 25% | 20 | 20 | | 100 | | 150 | 50% | 20 | 20 | | 100 | | 225 | 75% | 20 | 20 | | 100 | | 300 | 100% | 20 | | 20 | 100 | | 375 | 125% | 20 | | 20 | 100 | | 450 | 150% | 20 | | 20 | 100 | {14} | 525 | 175% | 20 | | 20 | 100 | | --- | --- | --- | --- | --- | --- | | 600 | 200% | 20 | | 20 | 100 | Dip Panel | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 75 | 25% | 20 | 20 | | 100 | | 150 | 50% | 20 | 20 | | 100 | | 225 | 75% | 20 | 20 | | 100 | | 300 | 100% | 20 | | 20 | 100 | | 375 | 125% | 20 | | 20 | 100 | | 450 | 150% | 20 | | 20 | 100 | | 525 | 175% | 20 | | 20 | 100 | | 600 | 200% | 20 | | 20 | 100 | Cassette Panel | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 75 | 25% | 20 | 20 | | 100 | | 150 | 50% | 20 | 20 | | 100 | | 225 | 75% | 20 | 20 | | 100 | | 300 | 100% | 20 | | 20 | 100 | | 375 | 125% | 20 | | 20 | 100 | | 450 | 150% | 20 | | 20 | 100 | | 525 | 175% | 20 | | 20 | 100 | | 600 | 200% | 20 | | 20 | 100 | Cup | Conc (ng/ml) | Cut-off % | No. of Tested | No. of Negative | No. of Preliminary | % Agreement | | --- | --- | --- | --- | --- | --- | | 0 | Negative | 20 | 20 | | 100 | | 75 | 25% | 20 | 20 | | 100 | | 150 | 50% | 20 | 20 | | 100 | | 225 | 75% | 20 | 20 | | 100 | | 300 | 100% | 20 | | 20 | 100 | | 375 | 125% | 20 | | 20 | 100 | | 450 | 150% | 20 | | 20 | 100 | | 525 | 175% | 20 | | 20 | 100 | | 600 | 200% | 20 | | 20 | 100 | b. Linearity/assay reportable range: Not Applicable. {15} c. Traceability, Stability, Expected values (controls, , calibrators, or methods): External controls are not supplied with this device. The labeling states that users should follow the appropriate federal, state, and local guidelines concerning the running of external quality controls. ## Stability Accelerated and real time studies have been conducted for the QuickProfile Single Drug of Abuse and QuickProfile Multi-Drugs of Abuse Screen Devices. Protocols and acceptance criteria were reviewed and found to be acceptable. The manufacturer claims the following expiration date for the unopened (shelf-life) stability: 18 months for all formats (test strip, cassette panel, cup and dip panel). For open pouch stability the user is instructed in the labeling as follows: “Do not open pouches until ready to perform the assay.” ## d. Detection limit: Not applicable. ## e. Analytical specificity: Interference was evaluated by spiking various concentrations of each substance into GC/MS confirmed urine-based control material at the following levels: Negative, 50% and 150% of cutoff. Compounds chemically related to each drug were tested to determine possible interference. Each compound was tested in three replicates. The highest concentration at which each substance does not interfere is presented below for each substance: | Compound | Concentration (μg/mL) | | --- | --- | | Acetaminophen | 100 | | Acetone | 200 | | Albumin | 50,000 | | Amitriptyline | 100 | | Ampicillin | 100 | | Aspartame | 100 | | Aspirin | 100 | | Atropine | 100 | | Benzocaine | 100 | | Bilirubin | 150 | | Caffeine | 100 | | Chloroquine | 100 | | Chlorpheniramine | 100 | | Creatinine | 100 | | Dextromethorphan | 100 | | Dextrorphan tartrate | 100 | | 4-Dimethyllaminoantiyrine | 100 | {16} Cross-reactivity was tested by adding various drugs, drug metabolites, and other structure-similar compounds that are likely to be present in the urine. All compounds were prepared in a drug-free pool of human urine. Each compound that indicated positive results was diluted until negative results were observed and the minimum level of cross reactivity was identified. Each compound was tested in replicates of three. Results are provided below: | Amphetamine related compounds | Concentration (ng/ml) | % Cross Reactivity | | --- | --- | --- | | d-Amphetamine | 1000 | 100 | | l-Amphetamine | 30,000 | 3.33 | | d-Methamphetamine | >100,000 | < 1 | | l-Methamphetamine | >100,000 | < 1 | | 3,4-Methylenedioxyamphetamine (MDA) | 2,500 | 40 | | 3,4-Methylenedioxy-methamphetamine (MDMA) | >100,000 | < 1 | {17} 18 3,4-Methylenedioxyethylamphetamine (MDEA) &gt;100,000 &lt; 1 Opiates 300 related compounds | Concentration (ng/ml) | % Cross Reactivity | | --- | --- | | Morphine | 300 | | Codeine | 300 | | Diacetyl Morphin (Heroin) | 1,250 | | Ethylmorphine | 300 | | Hydromorphone | 1,000 | | Hydrocodone | 1,250 | | Oxymorphon | 10,000 | | Oxycodone | >100,000 | | Merperidine | >100,000 | | 6-Acetylmorphine | 100 | | Morphine-3-glucuronid | 300 | | Nalbupine | >100,000 | | Nalorphine | 750 | | Naloxone | 25,000 | | Natrexone | 100,000 | | Normorphone | 2,000 | | Procaine | >100,000 | Benzodiazepines related compounds | Concentration (ng/ml) | % Cross Reactivity | | --- | --- | | Oxazepam | 300 | | Alprazolam | 300 | | Bromazepam | 1,000 | | Chlordiazepoxide | 300 | | Clobazam | 300 | | Clonazepam | 2,000 | | Diazepam | 300 | | Estazolam | 500 | | Fentanyl | >100,000 | | Flunitrazepam | 300 | | Flurazepam | >100,000 | | Lorazepam | 1,000 | | Lormetazepam | 1,000 | | Midazolam | >100,000 | | Nitrazepam | 100 | | Nordiazepam | 500 | | Prazepam | >100,000 | | Temazepam | 300 | | Triazolam | 1,000 | {18} | Cocaine related compounds | Concentration (ng/ml) | % Cross Reactivity | | --- | --- | --- | | Benzoylecgonine | 300 | 100 | | Cocaine | 300 | 100 | | Ecgonine | >100,000 | < 0.3 | | Ecgonine Methyl Ester | >100,000 | < 0.3 | | Methamphetamine related compounds | Concentration (ng/ml) | % Cross Reactivity | | --- | --- | --- | | (+)-Methamphetamine | 1,000 | 100 | | d-Amphetamine | 100,000 | 1.00 | | Chloroquine | >100,000 | < 1 | | (+/-) Ephedrine | >100,000 | < 1 | | (-)-Methamphetamine | 10,000 | 10 | | 3,4-Methylenedioxy-methamphetamine (MDMA) | 1,000 | < 1 | | 3,4-Methylenedioxyamphetamine (MDA) | >100,000 | 100 | | 3,4-Methylenedioxyethylamphetamine (MDEA) | 10,000 | 10 | | (+/-) N-Methyl-1-(3,4-methylenedioxyphenyl)-2-butanamine (MBDB) | 50,000 | 2 | | THC related compounds | Concentration (ng/ml) | % Cross Reactivity | | --- | --- | --- | | 11-nor-Δ9-THC-9-COOH | 50 | 100 | | Δ8-tetrahydrocannabinol | 50,000 | 0.10 | | Δ9-tetrahydrocannabinol | 500 | 10 | | 11-hydroxy-Δ9-THC | 50,000 | 0.10 | | Cannabinol | >100,000 | < 0.05 | | Cannabidiol | >100,000 | < 0.05 | | Barbiturates related compounds | Concentration (ng/ml) | % Cross Reactivity | | --- | --- | --- | | Secobarbital | 300 | 100 | | Amobarbital | 150 | 200 | | Butalbital | 2,000 | 15 | | Pentobarbital | 300 | 100 | | Phenobarbital | 300 | 100 | | PCP related compounds | Concentration (ng/ml) | % Cross Reactivity | | --- | --- | --- | | Phencyclidine | 25 | 100 | | Cis-Tramadol | 10,000 | 0.25 | 19 {19} | Dextromethorphan | 50,000 | 0.05 | | --- | --- | --- | | N-Desmethyl-cis-tramadol | 10,000 | 0.25 | | Methadone related compounds | Concentration (ng/ml) | % Cross Reactivity | | Methadone | 300 | 100 | | Doxylamine | >100,000 | < 0.3 | | EDDP | >100,000 | < 0.3 | pH and Specific Gravity To test for possible positive and/or negative interference from pH, urine samples containing drug concentrations of $0\%$ , $75\%$ , $125\%$ and $150\%$ of cutoff and with a $\mathrm{pH}$ of 3.0, 5.0, 6.5, 7.5 and 8.5 were used. Three replicates per sample were tested. No positive or negative interference due to $\mathrm{pH}$ was observed. To test for possible positive and/or negative interference from specific gravity, urine samples having specific gravity of 1.000-1.009, 1.010-1.020, 1.021-1.029 and $\geq 1.030$ were used. The samples were spiked to negative, $75\%$ , $125\%$ , and $150\%$ of cutoff of all drug analytes. No positive or negative interference due to specific gravity was observed. f. Assay cut-off: A separate cut-off study was conducted similarly to the precision study above, with similar results obtained. See precision studies above in section M.1.a. 2. Comparison studies: a. Method comparison with predicate device: The study was performed using commercially available blinded-level and unaltered clinical urine specimens confirmed by GC/MS or LC/MS methodology. Tests were performed by 3 lab technicians. A minimum of 41 negative urine and 43 positive urine samples for each analyte (drug) were tested in duplicate in the following formats: Cup, Dip Panel, Test Strip and Cassette Panel. The results are presented below: Amphetamine comparison with GC/MS value: | AMP | | Drug-Free Urine | < -50% of the cut-off | -50% of the cut-off to the cut-off | Cut-off to +50% of the cutoff | > +50% of the cut-off | % Agreement | | --- | --- | --- | --- | --- | --- | --- | --- | | Cup | + | 0 | 0 | 0 | 10 | 40 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | | Dip Panel | + | 0 | 0 | 0 | 10 | 40 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | {20} Barbiturates (BAR) comparison with GC/MS value: | BAR | | Drug-Free Urine | < -50% of the cut-off | -50% of the cut-off to the cut-off | Cut-off to +50% of the cutoff | > +50% of the cut-off | % Agreement | | --- | --- | --- | --- | --- | --- | --- | --- | | Cup | + | 0 | 0 | 0 | 5 | 41 | 100.0 | | | - | 34 | 16 | 6 | 0 | 0 | 100.0 | | Dip Panel | + | 0 | 0 | 0 | 5 | 41 | 100.0 | | | - | 34 | 16 | 6 | 0 | 0 | 100.0 | | Test Strip | + | 0 | 0 | 0 | 5 | 41 | 100.0 | | | - | 34 | 16 | 6 | 0 | 0 | 100.0 | | Cassette Panel | + | 0 | 0 | 0 | 5 | 41 | 100.0 | | | - | 34 | 16 | 6 | 0 | 0 | 100.0 | Benzodiazepines (BZO) comparison with GC/MS value: | BZO | | Drug-Free Urine | < -50% of the cut-off | -50% of the cut-off to the cut-off | Cut-off to +50% of the cutoff | > +50% of the cut-off | % Agreement | | --- | --- | --- | --- | --- | --- | --- | --- | | Cup | + | 0 | 0 | 0 | 10 | 59 | 100.0 | | | - | 34 | 8 | 12 | 0 | 0 | 100.0 | | Dip Panel | + | 0 | 0 | 0 | 10 | 59 | 100.0 | | | - | 34 | 8 | 12 | 0 | 0 | 100.0 | | Test Strip | + | 0 | 0 | 0 | 10 | 59 | 100.0 | | | - | 34 | 8 | 12 | 0 | 0 | 100.0 | | Cassette Panel | + | 0 | 0 | 0 | 10 | 59 | 100.0 | | | - | 34 | 8 | 12 | 0 | 0 | 100.0 | Cocaine (COC) comparison with GC/MS value: | COC | | Drug-Free Urine | < -50% of the cut-off | -50% of the cut-off to the cut-off | Cut-off to +50% of the cutoff | > +50% of the cut-off | % Agreement | | --- | --- | --- | --- | --- | --- | --- | --- | | Cup | + | 0 | 0 | 0 | 9 | 39 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | | Dip Panel | + | 0 | 0 | 0 | 9 | 39 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | | Test Strip | + | 0 | 0 | 0 | 9 | 39 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | | Cassette Panel | + | 0 | 0 | 0 | 9 | 39 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | {21} Methadone (MTD) comparison with GC/MS value: | MTD | | Drug-Free Urine | < -50% of the cut-off | -50% of the cut-off to the cut-off | Cut-off to +50% of the cutoff | > +50% of the cut-off | % Agreement | | --- | --- | --- | --- | --- | --- | --- | --- | | Cup | + | 0 | 0 | 0 | 8 | 35 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | | Dip Panel | + | 0 | 0 | 0 | 8 | 35 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | | Test Strip | + | 0 | 0 | 0 | 8 | 35 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | | Cassette Panel | + | 0 | 0 | 0 | 8 | 35 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | Methamphetamine (MAMP) comparison with GC/MS value: | MAMP | | Drug-Free Urine | < -50% of the cut-off | -50% of the cut-off to the cut-off | Cut-off to +50% of the cutoff | > +50% of the cut-off | % Agreement | | --- | --- | --- | --- | --- | --- | --- | --- | | Cup | + | 0 | 0 | 0 | 10 | 40 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | | Dip Panel | + | 0 | 0 | 0 | 10 | 40 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | | Test Strip | + | 0 | 0 | 0 | 10 | 40 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | | Cassette Panel | + | 0 | 0 | 0 | 10 | 40 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | Opiates 300 (OPI) comparison with GC/MS value: | OPI 300 | | Drug-Free Urine | < -50% of the cut-off | -50% of the cut-off to the cut-off | Cut-off to +50% of the cutoff | > +50% of the cut-off | % Agreement | | --- | --- | --- | --- | --- | --- | --- | --- | | Cup | + | 0 | 0 | 0 | 10 | 39 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | | Dip Panel | + | 0 | 0 | 0 | 10 | 39 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | | Test Strip | + | 0 | 0 | 0 | 10 | 39 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | | Cassette Panel | + | 0 | 0 | 0 | 10 | 39 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | Phencyclidine (PCP) comparison with GC/MS value: | PCP | | Drug-Free Urine | < -50% of the cut-off | -50% of the cut-off to the cut-off | Cut-off to +50% of the cutoff | > +50% of the cut-off | % Agreement | | --- | --- | --- | --- | --- | --- | --- | --- | | Cup | + | 0 | 0 | 0 | 4 | 42 | 100.0 | | | - | 34 | 2 | 5 | 0 | 0 | 100.0 | | Dip Panel | + | 0 | 0 | 0 | 4 | 42 | 100.0 | {22} Marijuana (THC) comparison with GC/MS value: | THC | | Drug-Free Urine | < -50% of the cut-off | -50% of the cut-off to the cut-off | Cut-off to +50% of the cutoff | > +50% of the cut-off | % Agreement | | --- | --- | --- | --- | --- | --- | --- | --- | | Cup | + | 0 | 0 | 0 | 10 | 37 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | | Dip Panel | + | 0 | 0 | 0 | 10 | 37 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | | Test Strip | + | 0 | 0 | 0 | 10 | 37 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | | Cassette Panel | + | 0 | 0 | 0 | 10 | 37 | 100.0 | | | - | 34 | 5 | 10 | 0 | 0 | 100.0 | b. Matrix comparison: Not applicable. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Not applicable. 4. Clinical cut-off: Not applicable. 5. Expected values/Reference range: Not applicable. {23} N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 24