IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL

{0} 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE ONLY TEMPLATE A. 510(k) Number: k080057 B. Purpose for Submission: New device C. Measurands: Oxycodone, amphetamines, phencyclidine (PCP), and cannabinoids (THC) D. Type of Test: Qualitative and semi-quantitative immunoassay E. Applicant: NOVX Systems, Inc. F. Proprietary and Established Names: iMDx Prep Reagent Plate iMDx Prep Calibration Plate iMDx Prep Control G. Regulatory Information: 1. Regulation section: 21 CFR § 862.3200 Clinical toxicology calibrator 21 CFR § 862.3280 Clinical toxicology control material 21 CFR § 862.3100 Amphetamine test system 21 CFR § 862.3870 Cannabinoid test system 21 CFR § 862.3650 Opiate test system Unclassified (PCP) 2. Classification: All Class II except for 862.3280 Clinical toxicology control material which is Class I (reserved) {1} Page 2 of 23 3. Product Code: DLJ, DIF, DKZ, LDJ, DJG, LCM respectively 4. Panel: Toxicology (91) H. Intended Use: 1. Intended use(s): Refer to indications for use below. 2. Indication(s) for use: The iMDx™ System is an in vitro diagnostic device consisting of the iMDx™ Analyzer and iMDxPrep™ Assays. The system is an expandable, closed system. All assays are designed for use with automated iMDx™ Analyzer. The system has been designed to be used by practitioners in drug rehabilitation clinics, physician offices, and clinical laboratories. The Amphetamines (Methamphetamine), Oxycodone (Oxycodone), Phencyclidine (Phencyclidine), and Cannabinoids (Δ⁹-THC-COOH) assays are enzyme immunoassays with cutoffs of 1000 ng/mL, 100 ng/mL, 25 ng/mL, and 50 ng/mL, respectively. These assays are intended for use in the qualitative and semi-quantitative analysis of Amphetamines, Oxycodone, Phencyclidine, and Cannabinoids in human urine. Semi-quantitative analysis is only for estimation of dilution for confirmation testing. All assays provide only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) analysis is performed. FOR USE BY TRAINED PERSONNEL ONLY. Only operators trained in the use of the iMDx™ System by NOVX personnel should perform these procedures. 3. Special condition for use statement(s): All assays provide only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) analysis is preferred. {2} Page 3 of 23 For prescription use. The assay is intended for use in point-of-care settings. Tests for oxycodone cannot distinguish between abused drugs and certain prescribed medications. Certain foods or medications may interfere with tests for amphetamines and opiates and cause false positive results. 4. Special instrument Requirements: iMDx™ Analyzer I. Device Description: The device consists of anti-drug monoclonal/polyclonal antibody coated plates and other reagents including enzyme-drug conjugate and substrate solution, stop solution, wash buffer, and calibrators. The specific antibodies are mouse monoclonal against oxycodone, amphetamine/methamphetamine, PCP, and THC. The iMDx System contains the following items: - iMDx Analyzer - iMDxPrep MMT-1 Reagent plate is a sealed ready to use microplate that contains the reagents to perform testing for oxycodone, amphetamines, PCP, and cannabinoids. - iMDxPrep MMT-1 Calibration Plate is a sealed ready to use microplate that contains calibrator solutions to perform a calibration for each of the analytes contained on the reagent plate. - iMDxPrep MMT-1 Control is a ready to use human urine based liquid control containing oxycodone, methamphetamine, PCP, and cannabinoids. J. Substantial Equivalence Information: 1. Predicate device name(s): Microgenics CEDIA® Amphetamine Assay Microgenics CEDIA® Cannabinoids Assay Microgenics DRI® Oxycodone Assay Microgenics CEDIA® Phencyclidine Assay 2. Predicate k number(s): k951154, k942337, k040411, k935650 {3} # 3. Comparison with predicate: The devices are for measurement of the same analytes in the same matrix, and utilize the same test methodology and cutoff concentrations. The predicate devices are for use on open automated chemistry analyzers, while the new device is a proprietary system that includes calibrators, controls, and reagents. The reagent formulations vary between the two devices. | Similarities | | | | --- | --- | --- | | Item | Predicate Devices | iMDx™ Analyzer | | Cutoffs | Oxycodone – 100 ng/mL Amphetamines –1000 ng/mL PCP – 25 ng/mL Cannabinoids – 50 ng/mL | Same | | Qualitative or semi-quantitative | Both | Same | | Method principle | Homogeneous enzyme immunoassay | Same | | Calibrator/control matrix | Human urine based | Same | | Differences | | | | Item | Predicate Devices | iMDx™ Analyzer | | Instrument type | Open | Closed | | Sample Type | Urine, plasma, serum | Urine | | Reagent Type | Lyophilized | Ready to use liquid | # K. Standard/Guidance Document Referenced (if applicable): The sponsor referenced the following guidance documents in their submission: {4} Page 5 of 23 - CLSI Evaluation Protocols: EP5-A Evaluation of precision performance of clinical chemistry devices - CLSI Evaluation Protocols: EP6-P Evaluation of the linearity of quantitative analytical methods - CLSI Evaluation Protocols: EP12-A User protocol for evaluation of qualitative test performance - Validation of Analytical Procedures: Methodology, Q2B, ICH Harmonized Tripartite Guideline (1996) - CSA C22.2: Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use ## L. Test Principle: The enzyme immunoassays (EIA) methods are intended for the qualitative and semi-quantitative determination of oxycodone, amphetamine, phencyclidine, and cannabinoids (THC). The EIA assays are based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, drug-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. When free drug is present in the sample, antibody binds to the free drug, and the unbound drug-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm on the iMDx Analyzer. ## M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: ### OXYCODONE Specimen description: human urine spiked with analyte Number of days: 5 Replicates per day: 4 Lots of product used: 1 Number of calibrations performed during the study: 2 {5} Note: the precision studies at the cutoff and $\pm 25\%$ of the cutoff were conducted over ten days, with 4 runs per day and 2 replicates per run, for a total of 80 measurements. The sponsor states that studies were conducted using CLSI Guidelines (EP5-A) for precision as a guide. Results of the studies are presented below. Oxycodone - Semi-Quantitative Results | Sample Concentration (ng/mL) | Mean ng/mL | Within-run | | Total | | | --- | --- | --- | --- | --- | --- | | | | SD | % CV | SD | % CV | | 0 | 0.00 | 0.00 | N/A | 0.00 | N/A | | 25 | 45.80 | 1.95 | 4.26 | 1.97 | 4.29 | | 50 | 59.05 | 1.12 | 1.89 | 1.76 | 2.97 | | 75 | 82.50 | 2.89 | 3.50 | 3.71 | 4.49 | | 100 | 101.61 | 5.99 | 5.89 | 7.71 | 7.59 | | 125 | 126.78 | 10.41 | 8.21 | 12.64 | 9.97 | | 150 | 121.45 | 2.01 | 1.66 | 3.52 | 2.90 | | 175 | 141.55 | 6.37 | 4.50 | 6.48 | 4.58 | | 200 | 222.00 | 28.52 | 12.85 | 28.56 | 12.87 | Oxycodone- Qualitative Results | Sample Concentration (ng/mL) | % of Cutoff | Number of Observations | Results #Neg/#Pos | | --- | --- | --- | --- | | 0 | -100 | 20 | 20/0 | | 25 | -75 | 20 | 20/0 | | 50 | -50 | 20 | 20/0 | | 75 | -25 | 80 | 80/0 | | 100 | cutoff | 80 | 31/49 | | 125 | 25 | 80 | 0/80 | | 150 | 50 | 20 | 0/20 | | 175 | 75 | 20 | 0/20 | | 200 | 100 | 20 | 0/20 | # AMPHETAMINES Specimen description: human urine spiked with analyte Number of days: 5 Replicates per day: 4 Lots of product used: 1 Number of calibrations performed during the study: two {6} Note: the precision studies at the cutoff and $\pm 25\%$ of the cutoff were conducted over ten days, with 4 runs per day and 2 replicates per run, for a total of 80 measurements. The sponsor states that studies were conducted using CLSI Guidelines (EP5-A) for precision as a guide. Results of the studies are presented below. Amphetamines Semi-Quantitative Results | Sample Conc. (ng/mL) | Mean ng/mL | Within-run | | Total | | | --- | --- | --- | --- | --- | --- | | | | SD | % CV | SD | % CV | | 0 | 0.00 | 0.00 | N/A | 0.00 | N/A | | 250 | 45.80 | 1.95 | 4.26 | 1.97 | 4.29 | | 500 | 59.05 | 1.12 | 1.89 | 1.76 | 2.97 | | 750 | 82.50 | 2.89 | 3.50 | 3.71 | 4.49 | | 1000 | 101.61 | 5.99 | 5.89 | 7.71 | 7.59 | | 1250 | 126.78 | 10.41 | 8.21 | 12.64 | 9.97 | | 1500 | 121.45 | 2.01 | 1.66 | 3.52 | 2.90 | | 1750 | 141.55 | 6.37 | 4.50 | 6.48 | 4.58 | | 2000 | 222.00 | 28.52 | 12.85 | 28.56 | 12.87 | Amphetamines - Qualitative Results | Sample Concentration (ng/mL) | % of Cutoff | Number of Observations | Results #Neg/#Pos | | --- | --- | --- | --- | | 0 | -100 | 20 | 20/0 | | 250 | -75 | 20 | 20/0 | | 500 | -50 | 20 | 20/0 | | 750 | -25 | 80 | 80/0 | | 1000 | Cutoff | 80 | 44/36 | | 1250 | 25 | 80 | 0/80 | | 1500 | 50 | 20 | 0/20 | | 1750 | 75 | 20 | 0/20 | | 2000 | 100 | 20 | 0/20 | # PCP Specimen description: human urine spiked with analyte Number of days: 5 Replicates per day: 4 Lots of product used: 1 Number of calibrations performed during the study: 2 {7} Note: the precision studies at the cutoff and $\pm 25\%$ of the cutoff were conducted over ten days, with 4 runs per day and 2 replicates per run, for a total of 80 measurements. The sponsor states that studies were conducted using CLSI Guidelines (EP5-A) for precision as a guide. Results of the studies are presented below. Phencyclidine - Semi-Quantitative Results | Sample Conc. (ng/mL) | Mean ng/mL | Within-run | | Total | | | --- | --- | --- | --- | --- | --- | | | | SD | % CV | SD | % CV | | 0 | 0.00 | 0.00 | N/A | 0.00 | N/A | | 6.25 | 6.65 | 1.57 | 23.54 | 1.58 | 23.81 | | 12.5 | 13.40 | 1.73 | 12.93 | 1.73 | 12.94 | | 19 | 19.54 | 1.72 | 8.81 | 1.91 | 9.77 | | 25 | 27.53 | 2.81 | 10.20 | 2.85 | 10.37 | | 32 | 36.56 | 3.53 | 9.65 | 3.53 | 9.65 | | 37.5 | 38.90 | 1.84 | 4.74 | 1.88 | 4.83 | | 43.75 | 42.20 | 3.46 | 8.21 | 3.48 | 8.25 | | 50 | 50.75 | 4.53 | 8.93 | 4.53 | 8.93 | Phencyclidine- Qualitative Results | Sample Concentration (ng/mL) | % of Cutoff | Number of Observations | Results #Neg/#Pos | | --- | --- | --- | --- | | 0 | -100 | 20 | 20/0 | | 6.25 | -75 | 20 | 20/0 | | 12.5 | -50 | 20 | 20/0 | | 19 | -25 | 80 | 80/0 | | 25 | Cutoff | 80 | 13/67 | | 32 | 25 | 80 | 0/80 | | 37.5 | 50 | 20 | 0/20 | | 43.75 | 75 | 20 | 0/20 | | 50 | 100 | 20 | 0/20 | # CANNABINOIDS Specimen description: human urine spiked with analyte Number of days: 5 Replicates per day: 4 Lots of product used: 1 Number of calibrations performed during the study: 2 {8} Note: the precision studies at the cutoff and $\pm 25\%$ of the cutoff were conducted over ten days, with 4 runs per day and 2 replicates per run, for a total of 80 measurements. The sponsor states that studies were conducted using CLSI Guidelines (EP5-A) for precision as a guide. Results of the studies are presented below. Cannabinoids - Semi-Quantitative Results | Sample Conc. (ng/mL) | Mean ng/mL | Within-run | | Total | | | --- | --- | --- | --- | --- | --- | | | | SD | % CV | SD | % CV | | 0 | 0.00 | 0.00 | N/A | 0.00 | N/A | | 12.5 | 15.30 | 1.00 | 6.54 | 2.67 | 17.48 | | 25 | 32.05 | 2.59 | 8.08 | 2.59 | 8.08 | | 37.5 | 42.50 | 3.44 | 8.08 | 3.46 | 8.14 | | 50 | 55.04 | 2.81 | 5.11 | 3.46 | 6.29 | | 62.5 | 72.14 | 4.64 | 6.43 | 5.22 | 7.23 | | 75 | 87.98 | 5.61 | 6.37 | 6.21 | 7.06 | | 87.5 | 107.70 | 8.04 | 7.47 | 14.89 | 13.82 | | 100 | 126.33 | 9.03 | 7.15 | 11.31 | 8.95 | Cannabinoids- Qualitative Results | Sample Concentration (ng/mL) | % of Cutoff | Number of Observations | Results #Neg/#Pos | | --- | --- | --- | --- | | 0 | -100 | 20 | 20/0 | | 12.5 | -75 | 20 | 20/0 | | 25 | -50 | 20 | 20/0 | | 37.5 | -25 | 80 | 77/3 | | 50 | Cutoff | 80 | 2/78 | | 62.5 | 25 | 80 | 0/80 | | 75 | 50 | 20 | 0/20 | | 87.5 | 75 | 20 | 0/20 | | 100 | 100 | 20 | 0/20 | # b. Linearity/assay reportable range: To evaluate linearity, a series of 7 concentration levels were made by diluting a stock solution (traceable back to NIST standard) of oxycodone, methamphetamine, PCP, and THC with negative human urine. The dilutions were assayed in duplicate over 2 runs. The only deviation from this protocol was that six levels were tested for THC instead of seven. {9} Page 10 of 23 # OXYCODONE | Expected Conc. (ng/ml) | Mean Observed Conc. (ng/ml) | % Recovery | %CV | | --- | --- | --- | --- | | 50 | 58 | 115.0 | 3.3% | | 75 | 76 | 101.7 | 3.3% | | 100 | 103 | 102.5 | 2.9% | | 125 | 126 | 100.6 | 2.7% | | 150 | 157 | 104.8 | 6.1% | | 200 | 211 | 105.6 | 10.8% | | 250 | 239 | 95.6 | 12.0% | A linear regression analysis of linear dilution samples gave the following equation: $\mathrm{Y} = 0.9582\mathrm{X} + 8.4581$ ( $\mathrm{R}^2 = 0.9907$ ). # AMPHETAMINES | Expected Conc. (ng/ml) | Mean Observed Conc. (ng/ml) | % Recovery | %CV | | --- | --- | --- | --- | | 200 | 197 | 98.3 | 4.6% | | 500 | 474 | 94.9 | 4.3% | | 1000 | 934 | 93.4 | 2.0% | | 1500 | 1388 | 92.5 | 5.2% | | 2000 | 1864 | 93.2 | 5.6% | | 4000 | 3916 | 97.9 | 4.6% | | 6000 | 6424 | 107.1 | 10.2% | A linear regression analysis of linear dilution samples gave the following equation: $\mathrm{Y} = 1.0639\mathrm{X} - 139.26$ ( $\mathrm{R}^2 = 0.9962$ ). {10} Page 11 of 23 # PCP | Expected Conc. (ng/ml) | Mean Observed Conc. (ng/ml) | % Recovery | %CV | | --- | --- | --- | --- | | 5 | 4.3 | 85.0 | 11.8% | | 10 | 9.0 | 90.0 | 9.1% | | 15 | 14.0 | 93.3 | 5.8% | | 25 | 22.5 | 90.0 | 2.6% | | 30 | 28.5 | 95.0 | 4.5% | | 60 | 63.5 | 105.8 | 5.2% | | 80 | 88.3 | 110.3 | 1.1% | A linear regression analysis of linear dilution samples gave the following equation: $\mathrm{Y} = 1.123\mathrm{X} - 3.2529$ ( $\mathrm{R}^2 = 0.9971$ ). # CANNABINOIDS | Expected Conc. (ng/ml) | Mean Observed Conc. (ng/ml) | % Recovery | %CV | | --- | --- | --- | --- | | 20 | 18.0 | 90.0% | 11.1% | | 25 | 25.0 | 100.0% | 16.0% | | 37.5 | 41.0 | 109.3% | 8.7% | | 50 | 55.3 | 110.7% | 9.3% | | 62.5 | 66.8 | 106.9% | 12.8% | | 75 | 75.7 | 100.9% | 6.4% | A linear regression analysis of linear dilution samples gave the following equation: $\mathrm{Y} = 1.0632\mathrm{X} - 0.8737$ ( $\mathrm{R}^2 = 0.9882$ ). c. Traceability (controls, calibrators, or method): Calibrators and controls for are traceable to Cerilliant Reference Standards and GC/MS. An intermediate concentration of calibrators (designated as master calibrator) for each analyte was made by diluting Cerilliant References Standard with synthetic urine. This master calibrator was {11} Page 12 of 23 value-assigned by GC/MS. The master calibrators are then gravimetrically diluted using synthetic urine to various concentration levels. The concentration values of diluted calibrators/controls are assigned using GC/MS. These calibrators/controls become internal reference standards. These internal reference standards are aliquoted and stored at below -80°C environments and are used only for testing working calibrators (i.e. calibrators used to produce products). The production protocol for internal reference standards and working calibrators are identical except that the working calibrators are tested against the internal reference standards. Stability: Real time accelerated stability studies have been conducted. Protocols and acceptance criteria were described and found to be acceptable. The stability is listed below: iMDXPrep MMT-I Reagent and Calibration plate stability is 3 months at 2-8°C. iMDXPrep Control stability is 1 month at 2-8°C Calibrators and one level of control are provided in the kit. The Quality Control section of the labeling also recommends the assaying of commercially available controls at ± 25% of the cutoff. In the labeling the sponsor recommends that users follow federal, state and local guidelines for testing external quality control materials. Eight levels of calibrator material are provided with the assay at the following concentrations: | Analyte | Calibrator Compound | Concentration (ng/mL) | | --- | --- | --- | | Oxycodone | Oxycodone | 50 | | | | 75 | | | | 100 | | | | 0 | | | | 125 | | | | 175 | | | | 350 | | | | 1000 | {12} | Analyte | Calibrator Compound | Concentration (ng/mL) | | --- | --- | --- | | Amphetamines | Methamphetamine | 200 | | | | 500 | | | | 750 | | | | 0 | | | | 1000 | | | | 1500 | | | | 6000 | | | | 16000 | | Analyte | Calibrator Compound | Concentration (ng/mL) | | --- | --- | --- | | PCP | PCP | 12.5 | | | | 18 | | | | 25 | | | | 0 | | | | 32 | | | | 50 | | | | 100 | | | | 285 | | Analyte | Calibrator Compound | Concentration (ng/mL) | | --- | --- | --- | | Cannabinoids | (-)-11-nor-9-carboxy-delta9-THC | 25 | | | | 37.5 | | | | 50 | | | | 0 | | | | 75 | | | | 125 | | | | 250 | | | | 800 | # d. Detection limit: Characterization of performance at the low end of the semiquantitative range was defined as the lowest concentration of analyte that can be distinguished from background and is calculated as twice the standard deviation of results obtained for the zero calibrator. The detection limit for the assays is as follows: Oxycodone - 16.8 ng/mL Amphetamine - 73 ng/mL {13} Page 14 of 23 PCP - 1.21 ng/mL Cannabinoids - 9.1 ng/mL e. Analytical specificity: Cross-reactivity was evaluated by spiking various concentrations of similarly structured drug compounds into drug-free urine. By analyzing various concentrations of each compound the sponsor determined the concentration of the drug that produced a response approximately equivalent to the cutoff concentration of the assay. Results of those studies appear in the table(s) below: The following parent compounds and metabolites yielded the following percent cross-reactivity results: Amphetamines | Compound | Quantity equivalent to cutoff (ng/mL) | Approx. % Cross-reactivity | | --- | --- | --- | | d-Amphetamine | 1000 | 100 | | d-Methamphetamine | 1000 | 100 | | MDA | 2800 | 36 | | MDMA | 2500 | 40 | | MDEA | 30000 | 3 | | d,l-BDB | 8000 | 13 | | PMMA | 2500 | 40 | | MBDB | 3000 | 33 | | PMA | 10000 | 10 | | HMMA | 80000 | 1 | Oxycodone | Compound | Quantity equivalent to cutoff (ng/mL) | Approx. % Cross-reactivity | | --- | --- | --- | | Hydrocodone | 175 | 57 | | Hydromorphone | 250 | 40 | | Oxycodone | 100 | 100 | | Oxymorphone | 125 | 80 | {14} Page 15 of 23 Cannabinoids (THC) | Compound | Quantity equivalent to cutoff (ng/mL) | Approx. % Cross-reactivity | | --- | --- | --- | | 11-Hydroxy-Δ⁹-Tetrahydrocannabinol | 80 | 63 | | 11-Nor-Δ⁸-Tetrahydrocannabinol carboxylic acid | 70 | 71 | | 11-Nor-Δ⁹-Tetrahydrocannabinol carboxylic acid | 50 | 100 | | Δ⁸-Tetrahydrocannabinol | 200 | 25 | | Δ⁹-Tetrahydrocannabinol | 200 | 25 | | Cannabinol | 240 | 21 | | cannabidiol | 9000 | 0.5 | | l-9-Carboxyl-11-nor-Δ9-THC-glucuronide | 100 | 100 | Phencyclidine | Compound | Quantity equivalent to cutoff (ng/mL) | Approx. % Cross-reactivity | | --- | --- | --- | | Phencyclidine | 25 | 100 | | 4-hydroxyphencyclidine | 64 | 39 | | Phencyclidine Morpholine | 1250 | 2 | The following compounds were tested with the iMDx Oxycodone assay and gave a negative response when tested at the concentration listed below: | Compound | μg/mL | | --- | --- | | Acetaminophen | 100 | | Acetylsalicylic acid | 250 | | Amobarbital | 100 | | Benzoylecgonine | 100 | | Bromopheniramine | 200 | {15} | Compound | μg/mL | | --- | --- | | Bupropion | 250 | | Caffeine | 300 | | Chlorpheniramine | 250 | | Chlorpromazine | 150 | | Codeine | 0.5 | | d,l-Phenylpropanolamine | 25 | | d-Ephedrine | 200 | | l-Ephedrine | 60 | | Dextromethorphan | 300 | | Dihydrocodeine | 0.5 | | D-Methamphetamine | 300 | | Ecgonine | 500 | | Hydromorphine | 500 | | Levorphanol | 1.5 | | Morphine 3-gluco. | 1.2 | | Morphine 6-gluco. | 0.3 | | Meperidine | 150 | | Methadone | 150 | | Morphine | 1 | | Naloxone | 0.625 | | Nicotine | 300 | | Norcodeine | 40 | | Norpropoxphene | 100 | | Phencyclidine | 100 | | Promethiazine | 100 | | Propanol | 100 | | Secobarbital | 100 | | Trazodone | 250 | | Tyramine | 50 | | Valproic | 300 | Structurally unrelated compounds were tested with the iMDx Amphetamines assay and gave a negative response when tested at the concentration listed below: | Compound | μg/mL | | --- | --- | | Acetaminophen | 3000 | | Acetylsalicylic Acid | 3000 | | Amorbarbital | 3000 | | l-Amphetamine | 24 | | Benzoylecgonine | 3000 | | Benzphetamine | 2000 | | Bromopheniramine | 3000 | | Bupropion | 2000 | {16} | Compound | μg/mL | | --- | --- | | Buspirone | 3000 | | Caffeine | 3000 | | Chlorpheniramine | 3000 | | Chorpromazine | 3000 | | Codeine | 3000 | | Dextromethorphan | 3000 | | d-Ephedrine | 3000 | | D,l-Ephedrine | 700 | | l-Ephedrine | 400 | | Fenfluramine | 7 | | 3-Hydroxy-Tyramine | 1700 | | Isoxsuprine | 3000 | | l-Methamphetamine | 10 | | Meperidine | 3000 | | Mephentermine | 50 | | Methadone | 3000 | | Methapyrilene | 3000 | | Methaqualone | 3000 | | Morphine | 3000 | | Oxazepam | 3000 | | Phencyclidine | 1000 | | Phendimetrazine | 300 | | Phenethylamine | 40 | | Phenmetrazine | 75 | | Phenobarbital | 3000 | | Phenothiazine | 100 | | Phentermine | 40 | | Phenylephrine | 500 | | d-Phenylpropanolamine | 2500 | | D,l-Phenylpropanolamine | 500 | | l-Phenylpropanolamine | 240 | | Procainamide | 800 | | Promethazine | 3000 | | Propoxyphene | 3000 | | Propranolol | 3000 | | d-Pseudoephedrine | 250 | | l-Pseudoephedrine | 2500 | | Ranitidine | 800 | | Scopolamine | 3000 | | Secobarbital | 3000 | | Sertraline | 1000 | | Thioridazine | 3000 | | Trazodone | 2900 | {17} | Compound | μg/mL | | --- | --- | | Trifluoperazine | 3000 | | Triflupromazine | 3000 | | Triprolidine | 3000 | | Tyramine | 600 | | Valproic Acid | 3000 | Structurally unrelated compounds were tested with the iMDx PCP assay and gave a negative response when tested at the concentration listed below: | Compound | μg/mL | | --- | --- | | Acetaminophen | 1000 | | Acetylsalicylic Acid | 1000 | | Amobarbital | 1000 | | Amphetamine | 1000 | | Benzoylecgonine | 3000 | | Bromopheniramine | 100 | | Bupropion | 100 | | Caffeine | 100 | | Chlorpheniramine | 50 | | Chlorpromazine | 100 | | Codeine | 100 | | Dextromethorphan | 1000 | | Diphenhydramine | 1000 | | Ephedrine | 1000 | | Ketamine | 100 | | Meperidine | 100 | | Methadone | 1000 | | Methamphetamine | 1000 | | Methaqualone | 100 | | Morphine | 500 | | Naloxone | 1000 | | Naltrexone | 25 | | Nicotine | 1000 | | Norpropoxyphene | 100 | | Nortriptyline | 100 | | Oxazepam | 1000 | | Phenobarbital | 1000 | | Phenylpropanolamine | 1000 | | Primidone | 1000 | | Promethazine | 100 | | Propranolol | 100 | | Propoxyphene | 1000 | | Pseudoephedrine | 1000 | | Phenobarbital | 1000 | | Phenobarbital | 100 | | Phenobarbital | 100 | | Phenobarbital | 100 | | Phenobarbital | 100 | | Phenobarbital | 100 | | Phenobarbital | 100 | | Phenobarbital | 100 | | Phenobarbital | 100 | | Phenobarbital | 100 | | Phenobarbital | 100 | {18} | Compound | μg/mL | | --- | --- | | Ranitidine | 1000 | | Secobarbital | 1000 | | Thioridazine | 1000 | | Triprolidine | 150 | | Tyramine | 1000 | | Valproic Acid | 10000 | Structurally unrelated compounds were tested with the iMDx THC assay and gave a negative response when tested at the concentration listed below: | Compound | μg/mL | | --- | --- | | Acetaminophen | 1000 | | Acetylsalicylic Acid | 1000 | | Amitriptyline | 1000 | | Amobarbital | 1000 | | Amphetamine | 1000 | | Benzoylecgonine | 1000 | | Bupropion | 1000 | | Caffeine | 1000 | | Chlorpheniramine | 1000 | | Chlorpromazine | 1000 | | Cocaine | 1000 | | Codeine | 1000 | | Dextromethorphan | 1000 | | Ecgonine | 1000 | | Ephedrine | 1000 | | Imipramine | 1000 | | Lidocaine | 1000 | | Meperidine | 1000 | | Methadone | 1000 | | Methamphetamine | 1000 | | Methaqualone | 1000 | | Morphine | 1000 | | Nortriptyline | 1000 | | Oxazepam | 1000 | | Phencyclidine | 1000 | | Phenobarbital | 1000 | | Promethazine | 1000 | | Propoxyphene | 1000 | | Ranitidine | 1000 | | Secobarbital | 1000 | {19} The effect of sample pH on assay performance was assessed through analyte recovery at their respective cutoff levels with three runs using the iMDx analyzer and associated reagents. During each run, three urine samples containing analytes at cutoff concentration with different pH (pH 4.0, pH 7.3, and pH 9.0) are assayed in duplicate. The average recovery of the concentration at pH 4.0 and pH 9.0 were compared to pH 7.3, the control condition. The results are summarized in the table below. | Analyte | pH 4.0 | pH 9.0 | | --- | --- | --- | | Oxycodone | 92.75% | 94.10% | | Amphetamines | 97.06% | 102.49% | | PCP | 96.90% | 93.02% | | Cannabinoids | 91.70% | 111.50% | The evaluation of urine sample specific gravity (SG) on assay performance was conducted with two runs for all analytes at their respective cutoff levels. During each run, six urine samples with different specific gravities (SG 1.003, SG 1.005, SG 1.015, SG 1.020, SG 1.025 and SG 1.030) containing cutoff levels of analyte are assayed in duplicate. The average recovery of the concentration is compared to SG 1.020, the control condition. The results are summarized in the table below. | Analyte | SG 1.003 | SG 1.005 | SG 1.015 | SG 1.025 | SG 1.03 | | --- | --- | --- | --- | --- | --- | | Oxycodone | 104.90% | 102.20% | 106.40% | 100.50% | 100.00% | | Amphetamines | 100.60% | 99.60% | 104.00% | 102.70% | 103.40% | | PCP | 99.70% | 100.70% | 99.90% | 98.90% | 100.00% | | THC | 89.40% | 97.70% | 90.30% | 94.90% | 91.70% | The effect of ascorbic acid, bilirubin and hemoglobin was assessed through analyte recovery at the cutoff levels. Samples were spiked with high levels of the potential interferents and the recovery was compared to a control sample. Recoveries ranged from a low of $90\%$ to a high of $110\%$ . # f. Assay cut-off: The identified cutoff concentration of the amphetamines, phencyclidine, and cannabinoids assay are recommended for use by the Substance Abuse and Mental Health Services Administration (SAMHSA). SAMHSA has not made cutoff recommendations for oxycodone assays. Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section, above. {20} Page 21 of 23 2. Comparison studies: a. Method comparison with predicate device: The candidate device was compared to a reference method, GC/MS. Both negative and positive samples were evaluated by the candidate device and by GC/MS as follows: | Analyte | Positives | Negatives | Total | | --- | --- | --- | --- | | Oxycodone | 53 | 50 | 103 | | Amphetamines | 65 | 50 | 115 | | PCP | 58 | 50 | 108 | | THC | 51 | 80 | 131 | Unaltered clinical urine samples were evaluated. The study included an adequate number of samples that contained drugs near to the cutoff concentration of the assay. Approximately 10% of the study samples are evenly distributed between plus and minus 50% of the claimed cutoff concentration. Number of study sites: three Description of the site(s): POC setting Operator description: POC staff Number of instruments used: Not specified Candidate Device Results vs. stratified GC/MS Values OXYCODONE | Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) | | --- | --- | --- | --- | --- | | Positive | 1* | 0 | 3 | 49 | | Negative | 40 | 9 | 1 | 0 | GC/MS values used to categorize samples in this table are based on the concentration of oxycodone found in the sample. *sample was found to contain 508 ng/mL of hydrocodone % Agreement among positives is 98% % Agreement among negatives is 98% {21} Page 22 of 23 # Candidate Device Results vs. stratified GC/MS Values AMPHETAMINES | Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) | | --- | --- | --- | --- | --- | | Positive | 0 | 12 | 16 | 49 | | Negative | 32 | 6 | 0 | 0 | GC/MS values used to categorize samples in this table are determined by adding together the concentration of amphetamine and methamphetamine. % Agreement among positives is 100% % Agreement among negatives is 76% Candidate Device Results vs. stratified GC/MS Values PCP | Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | 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) | | --- | --- | --- | --- | --- | | Positive | 0 | 1 | 8 | 48 | | Negative | 36 | 13 | 2 | 0 | GC/MS values used to categorize samples in this table are based on the concentration of PCP found in the sample. % Agreement among positives is 97% % Agreement among negatives is 98% Candidate Device Results vs. stratified GC/MS Values THC | Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff | Near Cutoff Positive (Between the cutoff and 50% above the cutoff | High Positive (greater than 50% above the cutoff concentration) | | --- | --- | --- | --- | --- | | | | concentration) | | | {22} Page 23 of 23 | | | concentration) | concentration) | | | --- | --- | --- | --- | --- | | Positive | 1* | 11 | 13 | 38 | | Negative | 45 | 23 | 0 | 0 | GC/MS values used to categorize samples in this table are based on the concentration of THC found in the sample. *sample was found to contain 20 ng/mL of THC % Agreement among positives is 100% % Agreement among negatives is 85% b. Matrix comparison: Not applicable. The assay is intended for only one sample matrix. 3. Clinical studies: a. Clinical sensitivity: Not applicable. Clinical studies are not typically submitted for this device type. b. Clinical specificity: Not applicable. Clinical studies are not typically submitted for this device type. c. Other clinical supportive data (when a and b are not applicable): 4. Clinical cut-off: Not applicable. 5. Expected values/Reference range: Not applicable. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.