GENPRIME DRUGS OF ABUSE READER SYSTEM

{0} 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K130082 B. Purpose for Submission: New Device C. Measurand: Amphetamine, Barbiturates, Cocaine, Marijuana, Methadone, Methamphetamine, Morphine, Oxycodone, Phencyclidine D. Type of Test: Qualitative immunochromatographic tests for drugs of abuse in urine E. Applicant: GenPrime Inc. F. Proprietary and Established Names: The GenPrime Drugs of Abuse (DOA) Reader System G. Regulatory Information: 1. Regulation section: 21 CFR §862.3100, Amphetamine Test System 21 CFR §862.3150, Barbiturate Test System 21 CFR §862.3250, Cocaine and cocaine metabolite Test System 21 CFR §862.3870, Cannabinoid Test System 21 CFR §862.3620, Methadone Test System 21 CFR §862.3610, Methamphetamine Test System 21 CFR §862.3640, Morphine test system 21 CFR §862.3650, Opiate Test System Phencyclidine, Unclassified 21 CFR §862.2400, Densitometer/Scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use 2. Classification: Class II – for all except Phencyclidine and the Densitometer/Scanner Phencyclidine – Unclassified Densitometer/Scanner – Class I 3. Product code: DKZ, DIS, DIO, LDJ, DJR, DJC, DJG, LCM, DNK, JQT {1} 4. Panel: Clinical Toxicology (91) and Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indications for Use below. 2. Indication(s) for use: The GenPrime Drugs of Abuse (DOA) Reader System consists of the GenPrime DOA Reader, GenPrime DOA Windows®-compatible Software and compatible qualitative immunochromatographic, OS Cup and Split Key Cup (SK Cup) test devices. The GenPrime DOA Reader System is for in vitro diagnostic use and is intended for prescription use in laboratories, point-of-care, and workplaces by trained users. The test is not intended for over-the-counter use. The GenPrime DOA Reader System test devices cannot be read visually. The GenPrime DOA Reader and compatible DOA test devices qualitatively detect drug classes in human urine at the cutoff concentrations shown below: OS Cup | AMP | Amphetamine (d-Amphetamine) | 500 ng/mL | | --- | --- | --- | | BAR | Barbiturates (Secobarbital) | 300 ng/mL | | COC | Cocaine (Benzoylecgonine) | 150 ng/mL | | MET | Methamphetamine (d-Methamphetamine) | 500 ng/mL | | THC | Marijuana (Delta-9-THC-COOH) | 50 ng/mL | SK Cup | AMP | Amphetamine (d-Amphetamine) | 500 ng/mL | | --- | --- | --- | | MET | Methamphetamine (d-Methamphetamine) | 500 ng/mL | | MTD | Methadone | 300 ng/mL | | MOP 300 | Morphine | 300 ng/mL | | MOP 2000 | Morphine | 2000 ng/mL | | OXY | Oxycodone | 100 ng/mL | | PCP | Phencyclidine | 25 ng/mL | | THC | Marijuana (Delta-9-THC-COOH) | 50 ng/mL | Configurations of the OS Cup and SK cup may consist of any combination of the above listed drug analytes associated with the respective cup. The GenPrime DOA reader system provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GC/MS), high performance liquid chromatography (HPLC) or liquid chromatography / tandem mass spectrometry (LC/MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. {2} 3. Special conditions for use statement(s): For in vitro diagnostic prescription use in laboratories, point-of-care, and workplace sites 4. Special instrument requirements: The GenPrime DOA Reader I. Device Description: The GenPrime Drugs of Abuse (DOA) Reader System consists of a small, portable high resolution flatbed scanner, customized GenPrime DOA Reader Software, and lateral flow tests that are intended for use in the system. The scanner has a custom scanner lid with an opening for the test device, and a scanner stand, which places the scanner bed at the appropriate angle for running and reading the test devices. The system is intended for use with two test devices, the OS Cup and the Split Key Cup, both of which are rapid, single use, disposable immunochromatographic tests for the qualitative detection of drugs of abuse in human urine. During analysis, an image of a compatible test device is captured and the software algorithm determines from the image whether the presence or absence of colored test lines is associated with a positive or negative result for each analyte on a test format. The software also confirms the validity of the results by verifying the presence of control lines. J. Substantial Equivalence Information: 1. Predicate device name(s): PROFILE®-V MEDTOXScan® Drugs of Abuse Test System 2. Predicate 510(k) number(s): K080635 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Device | Predicate (K080635) | | Intended Use | Determines qualitative positive or negative result from drugs of abuse immunoassay screens using an instrument reader | Same | {3} | Differences | | | | --- | --- | --- | | Item | Device | Predicate (K080635) | | Test Device Format | Cup | Cassette | | Test Time and Timing Method | Operator manually times test development for 5 minutes and then operates the instrument. | Instrument internally times test strip development for 10 minutes and then scans the test cassette. | | Detection Method | Measures density of visible lines against background on single-use test device. | Measures reflectance of visible lines on single use test cassette. | | Cutoff values | BAR cutoff is 300ng MTD cutoff is 300ng | BAR cutoff is 200ng MTD cutoff is 200ng | # K. Standard/Guidance Document Referenced (if applicable): - ISO 14971:2007 Second Addition: Medical devices-Application of risk management to medical devices - IEC 62304 First edition 2006-05, Medical device software - Software life cycle processes - AAMI/ANSI/IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests - UL 60950-1, $1^{\text{st}}$ Edition, 2006-07-07 Information Technology Equipment - Safety - Part 1: General Requirements - CLSI EP12-A2, User Protocol for Evaluation of Qualitative Test Performance {4} L. Test Principle: The GenPrime Drugs of Abuse (DOA) Reader System measures density of visible lines against background for two single-use immunochromatographic drug test formats: the OS Cup and the Split Key Cup. At the conclusion of the test (5 minutes for both the OS Cup and the Split Key Cup), the image of the device is captured by the scanner and the software algorithm determines from the image whether the presence or absence of colored test lines is associated with a positive or negative result for each analyte on a test format. The software also confirms the validity of the results by verifying the presence of control lines. The results are recorded and archived in a database along with an image of the test, patient and operator information and the time of image capture. The OS Cup consists of a test card with drug strips integrated into a one-step urine cup. Each drug strip consists of: (1) a purple colored pad containing mouse monoclonal anti-drug antibodies conjugated with colloidal gold and rabbit IgG antibodies conjugated with colloidal gold, and (2) a nitrocellulose membrane strip containing 1-3 Test lines and a Control line. The Test line is coated with drug-protein conjugate and the Control line is coated with goat anti-rabbit IgG antibodies. The Split Key Cup consists of a test card with drug strips integrated into a urine cup with a partition that requires a key activation step to disperse urine into the cup for testing to begin. Each drug strip consists of: (1) a purple colored pad containing mouse monoclonal anti-drug antibodies conjugated with colloidal gold and rabbit IgG antibodies conjugated with colloidal gold, and (2) a nitrocellulose membrane strip containing 1-3 Test lines and a Control line. The Test line is coated with drug-protein conjugate and the Control line is coated with goat anti-rabbit IgG antibodies. For each cup, a line must form at the Control line position to indicate that sufficient sample was applied and that the reagents are migrating properly. If a Control line does not form, the test is invalid. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The precision studies were performed at three sites representative of laboratory, workplace, and POC settings with a minimum of two operators per site. The operators performed the tests following the instructions for use, which are included with the GenPrime DOA Reader and with each test device intended for use with the GenPrime DOA Reader System. Precision studies were performed with the target analytes at 0%, 25%, 50%, 75%, 125%, 150%, 175%, and 200% of the cutoff during a 20 working day period using solutions containing drug concentrations confirmed by GC/MS. The identity of the samples was masked from the operator. Performance of the GenPrime DOA Reader was evaluated for each drug analyte by testing each drug at the stated concentration using a minimum of 10 tests per operator. {5} Results are shown below: | OS Cup, AMP (500 ng/mL) | | | | | | | --- | --- | --- | --- | --- | --- | | % of Cutoff | ng/mL | N | # NEG | # POS | Precision | | NEG | 0 | 65 | 65 | 0 | 100% | | 25% | 100 | 57 | 57 | 0 | 100% | | 50% | 250 | 57 | 48 | 9 | 84.2% | | 75% | 375 | 57 | 19 | 38 | 33.3% | | 125% | 625 | 58 | 2 | 56 | 96.6% | | 150% | 750 | 58 | 0 | 58 | 100% | | 175% | 875 | 57 | 1 | 56 | 98.2% | | 200% | 1000 | 57 | 0 | 57 | 100% | | OS Cup, BAR (300 ng/mL) | | | | | | | --- | --- | --- | --- | --- | --- | | % of Cutoff | ng/mL | N | # NEG | # POS | Precision | | NEG | 0 | 65 | 65 | 0 | 100% | | 25% | 75 | 57 | 57 | 0 | 100% | | 50% | 150 | 57 | 53 | 4 | 93.0% | | 75% | 225 | 57 | 22 | 35 | 38.6% | | 125% | 375 | 58 | 3 | 55 | 94.8% | | 150% | 450 | 58 | 0 | 58 | 100% | | 175% | 525 | 57 | 0 | 57 | 100% | | 200% | 600 | 57 | 2 | 55 | 96.5% | | OS Cup, COC (150 ng/mL) | | | | | | | --- | --- | --- | --- | --- | --- | | % of Cutoff | ng/mL | N | # NEG | # POS | Precision | | NEG | 0 | 65 | 65 | 0 | 100% | | 25% | 37.5 | 57 | 57 | 0 | 100% | | 50% | 75 | 57 | 43 | 14 | 75.4% | | 75% | 112.5 | 57 | 14 | 43 | 24.6% | | 125% | 187.5 | 58 | 1 | 57 | 98.3% | | 150% | 225 | 58 | 0 | 58 | 100% | | 175% | 262.5 | 57 | 0 | 57 | 100% | | 200% | 300 | 57 | 0 | 57 | 100% | | OS Cup, MET (500 ng/mL) | | | | | | | --- | --- | --- | --- | --- | --- | | % of Cutoff | ng/mL | N | # NEG | # POS | Precision | | NEG | 0 | 65 | 65 | 0 | 100% | | 25% | 100 | 57 | 57 | 0 | 100% | | 50% | 250 | 57 | 53 | 4 | 93.0% | | 75% | 375 | 57 | 18 | 39 | 31.6% | | 125% | 625 | 58 | 0 | 58 | 100% | | 150% | 750 | 58 | 0 | 58 | 100% | | 175% | 875 | 57 | 0 | 57 | 100% | | 200% | 1000 | 57 | 0 | 57 | 100% | | OS Cup, THC (50 ng/mL) | | | | | | | --- | --- | --- | --- | --- | --- | | % of Cutoff | ng/mL | N | # NEG | # POS | Precision | | NEG | 0 | 65 | 65 | 0 | 100% | | 25% | 12.5 | 57 | 57 | 0 | 100% | | 50% | 25 | 57 | 51 | 6 | 89.5% | | SK Cup, AMP (500 ng/mL) | | | | | | --- | --- | --- | --- | --- | | ng/mL | N | # NEG | # POS | Precision | | 0 | 86 | 86 | 0 | 100% | | 100 | 88 | 88 | 0 | 100% | | 250 | 84 | 78 | 6 | 92.9% | | 375 | 85 | 47 | 38 | 55.3% | | 625 | 84 | 3 | 81 | 96.4% | | 750 | 85 | 8 | 77 | 90.6% | | 875 | 87 | 2 | 85 | 97.7% | | 1000 | 89 | 0 | 89 | 100% | | SK Cup, MET (500 ng/mL) | | | | | | --- | --- | --- | --- | --- | | ng/mL | N | # NEG | # POS | Precision | | 0 | 86 | 86 | 0 | 100% | | 100 | 88 | 88 | 0 | 100% | | 250 | 84 | 81 | 3 | 96.4% | | 375 | 85 | 57 | 28 | 67.1% | | 625 | 84 | 4 | 80 | 95.2% | | 750 | 85 | 3 | 82 | 96.5% | | 875 | 87 | 0 | 87 | 100% | | 1000 | 89 | 2 | 87 | 97.8% | | SK Cup, MTD (300 ng/mL) | | | | | | --- | --- | --- | --- | --- | | ng/mL | N | # NEG | # POS | Precision | | 0 | 86 | 86 | 0 | 100% | | 75 | 88 | 88 | 0 | 100% | | 150 | 84 | 83 | 1 | 98.8% | | 225 | 85 | 72 | 13 | 84.7% | | 375 | 84 | 10 | 74 | 88.1% | | 450 | 85 | 3 | 82 | 96.5% | | 525 | 87 | 0 | 87 | 100% | | 600 | 89 | 0 | 89 | 100% | | SK Cup, MOP (300 ng/mL) | | | | | | --- | --- | --- | --- | --- | | ng/mL | N | # NEG | # POS | Precision | | 0 | 86 | 86 | 0 | 100% | | 75 | 45 | 45 | 0 | 100% | | 150 | 45 | 43 | 2 | 95.6% | | 225 | 46 | 29 | 17 | 63.0% | | 375 | 45 | 4 | 41 | 91.1% | | 450 | 45 | 1 | 44 | 97.8% | | 525 | 45 | 0 | 45 | 100% | | 600 | 46 | 0 | 46 | 100% | | SK Cup, MOP (2000 ng/mL) | | | | | | --- | --- | --- | --- | --- | | ng/mL | N | # NEG | # POS | Precision | | 0 | 86 | 86 | 0 | 100% | | 500 | 88 | 88 | 0 | 100% | | 1000 | 84 | 83 | 1 | 98.8% | {6} | 75% | 37 | 57 | 46 | 11 | 80.7% | | --- | --- | --- | --- | --- | --- | | 125% | 62 | 58 | 7 | 51 | 87.9% | | 150% | 75 | 58 | 5 | 53 | 91.4% | | 175% | 87.5 | 57 | 4 | 53 | 93.0% | | 200% | 100 | 57 | 0 | 57 | 100% | | 1500 | 85 | 63 | 22 | 74.1% | | --- | --- | --- | --- | --- | | 2500 | 84 | 11 | 73 | 86.9% | | 3000 | 85 | 2 | 83 | 97.6% | | 3500 | 87 | 0 | 87 | 100% | | 4000 | 89 | 0 | 89 | 100% | | SK Cup, OXY (100 ng/mL) | | | | | | --- | --- | --- | --- | --- | | ng/mL | N | # NEG | # POS | Precision | | 0 | 86 | 86 | 0 | 100% | | 25 | 88 | 88 | 0 | 100% | | 50 | 84 | 81 | 3 | 96.4% | | 75 | 85 | 57 | 28 | 67.1% | | 125 | 84 | 15 | 69 | 82.1% | | 150 | 85 | 12 | 73 | 85.9% | | 175 | 87 | 5 | 82 | 94.3% | | 200 | 89 | 1 | 88 | 98.9% | | SK Cup, PCP (25 ng/mL) | | | | | | ng/mL | N | # NEG | # POS | Precision | | 0 | 86 | 86 | 0 | 100% | | 6.25 | 88 | 88 | 0 | 100% | | 12.5 | 84 | 81 | 3 | 96.4% | | 18.75 | 85 | 50 | 35 | 58.8% | | 31.25 | 84 | 6 | 78 | 92.9% | | 37.5 | 85 | 4 | 81 | 95.3% | | 43.75 | 87 | 0 | 87 | 100% | | 50 | 89 | 0 | 89 | 100% | | SK Cup, THC (50 ng/mL) | | | | | | ng/mL | N | # NEG | # POS | Precision | | 0 | 86 | 86 | 0 | 100% | | 12.5 | 88 | 88 | 0 | 100% | | 25 | 84 | 82 | 2 | 97.6% | | 37 | 85 | 63 | 22 | 74.1% | | 62 | 84 | 14 | 70 | 83.3% | | 75 | 85 | 8 | 77 | 90.61% | | 87.5 | 87 | 5 | 82 | 94.3% | | 100 | 89 | 0 | 89 | 100% | The sponsor conducted several studies to determine the root cause of the poor performance demonstrated by some of the drug analytes in the precision study shown above. The root cause was identified to be a preservative contained in the original samples tested. To verify that the root cause was correctly identified, a supplemental study was conducted at two point of care sites using new samples that did not contain the interfering substance. Results from this testing compared to the results from the original precision study are shown in the tables below. {7} | OS Cup | | | | | --- | --- | --- | --- | | Test (Cutoff) | Solution (% of Cutoff) | Percent Agreement | | | | | Original Precision Data (N≥57) | Additional Testing N=30 | | AMP (500) | 50% | 84.2% | 100% | | AMP (500) | 150% | 100% | 100% | | BAR (300) | 50% | 93.0% | 100% | | BAR (300) | 150% | 100% | 100% | | COC (150) | 50% | 75.4% | 100% | | COC (150) | 150% | 100% | 100% | | MET (500) | 50% | 93.0% | 100% | | MET (500) | 150% | 100% | 100% | | THC (50) | 50% | 89.5% | 100% | | THC (50) | 150% | 91.4% | 100% | | SK Cup | | | | | Test (Cutoff) | Solution (% of Cutoff) | Percent Agreement | | | | | Original Precision Data (N≥57) | Additional Testing N=30 | | AMP(500) | 50% | 92.9% | 100% | | AMP(500) | 150% | 90.6% | 100% | | MET(500) | 50% | 96.4% | 100% | | MET(500) | 150% | 96.5% | 100% | | MTD (300) | 50% | 98.8% | 100% | | MTD (300) | 150% | 96.5% | 100% | | MOP (2000) | 50% | 98.8% | 100% | | MOP (2000) | 150% | 97.6% | 100% | | OXY (100) | 50% | 96.4% | 100% | | OXY (100) | 150% | 85.9% | 100% | | PCP(25) | 50% | 96.4% | 100% | | PCP(25) | 150% | 95.3% | 100% | | THC(50) | 50% | 97.6% | 100% | | THC(50) | 150% | 90.6% | 100% | b. Linearity/assay reportable range: Not applicable. This is a qualitative test. c. Traceability, Stability, Expected values (controls, calibrators, or methods): The sponsor specifies in the labeling the quality control products that must be used with the device systems. The quality control products were previously cleared under k121122. The sponsor states in the labeling: "Users should follow the appropriate federal, state, and local guidelines concerning the running of external quality controls." Stability Accelerated and real time shelf-life studies were conducted. Protocols and acceptance criteria were reviewed and found to be acceptable. The manufacturer claims the following expiration {8} date for shelf-life stability: 12 months for both devices (OS Cup and SK Cup). Shelf-life studies are ongoing. # d. Detection limit: Analytical performance of the device around the cutoff is described in the precision section M.1.a above. # e. Analytical specificity: Analytical specificity studies were performed to determine whether drugs and drug metabolites within the same class of drugs or with similar molecular structures cross-react in the test systems. Reference standards for the various metabolites and compounds were prepared at $100\mu \mathrm{g / mL}$ in pooled negative human urine samples. Compounds that tested positive were serially diluted until a negative result was observed. Results shown are expressed as the minimum concentration producing a positive result in the indicated assay. A list of these compounds and their level of cross reactivity is shown below for each cup. OS Cup Related Compounds and Cross-Reactants | Related Compound or Cross-Reactant | Result | % Cross Reactive | | --- | --- | --- | | Amphetamines (AMP)(d-Amphetamine) 500 ng/mL | | | | 3,4-Methylenedioxyamphetamine (MDA) | Positive at 500 ng/mL | 100% | | Amphetamine (d,l) | Positive at 1000 ng/mL | 50% | | Phentermine | Positive at 2250 ng/mL | 22% | | b-Phenylethylamine (phenethylamine) | Positive at 50000 ng/mL | 1% | | 3,4-methylenedioxy-N-ethylamphetamine- | Negative at 100000 ng/mL | N/A | | Amphetamine (l) | Negative at 100000 ng/mL | N/A | | (1R,2S)-(-)-Ephedrine | Negative at 100000 ng/mL | N/A | | 3,4-Methylenedioxymethamphetamine | Negative at 100000 ng/mL | N/A | | Fenfluramine | Negative at 100000 ng/mL | N/A | | Methamphetamine (d) | Negative at 100000 ng/mL | N/A | | Methamphetamine (l) | Negative at 100000 ng/mL | N/A | | Tryptamine | Negative at 100000 ng/mL | N/A | | Tyramine | Negative at 100000 ng/mL | N/A | | Barbiturate (BAR) (Secobarbital) (300 ng/mL) | | | | Butabarbital | Positive at 75 ng/mL | 400% | | Butethal | Positive at 250 ng/mL | 120% | | Pentobarbital | Positive at 250 ng/mL | 120% | | Phenobarbital | Positive at 250 ng/mL | 120% | | Aprobarbital | Positive at 400 ng/mL | 75% | | Barbital | Positive at 500 ng/mL | 60% | | Alphenal | Positive at 600 ng/mL | 50% | | Amobarbital | Positive at 850 ng/mL | 35% | | Cyclopentobarbital | Positive at 1500 ng/mL | 20% | | Allobarbital | Positive at 3500 ng/mL | 9% | | Butalbital | Positive at 11000 ng/mL | 3% | | Mephobarbital | Positive at 100000 ng/mL | 0% | | Barbituric Acid | Negative at 100000 ng/mL | N/A | | Glutethimide | Negative at 100000 ng/mL | N/A | | Hexobarbital | Negative at 100000 ng/mL | N/A | | Phenytoin (diphenylhydantoin) | Negative at 100000 ng/mL | N/A | | Thiopental | Negative at 100000 ng/mL | N/A | {9} | Cocaine (COC) (Benzoylecgonine) 150 ng/mL | | | | --- | --- | --- | | Cocaethylene | Positive at 4000 ng/mL | 4% | | Cocaine | Positive at 10000 ng/mL | 2% | | Ecgonine | Positive at 10000 ng/mL | 2% | | Ecgonine Methyl Ester | Negative at 100000 ng/mL | N/A | | Methamphetamines (MET) (d-Methamphetamine) 500 ng/mL | | | | 3,4-Methylenedioxymethamphetamine | Positive at 1250 ng/mL | 40% | | Methamphetamine (l) | Positive at 6000 ng/mL | 8% | | 3,4-methylenedioxy-N-ethylamphetamine- | Positive at 25000 ng/mL | 2% | | b-Phenylethylamine (phenethylamine) | Positive at 25000 ng/mL | 2% | | p-Hydroxymethamphetamine | Positive at 25000 ng/mL | 2% | | Amphetamine (d) | Positive at 50000 ng/mL | 1% | | Chloroquine | Positive at 50000 ng/mL | 1% | | Mephentermine | Positive at 50000 ng/mL | 1% | | 3,4-Methylenedioxyamphetamine (MDA) | Negative at 100000 ng/mL | N/A | | Amphetamine (d,l) | Negative at 100000 ng/mL | N/A | | Amphetamine (l) | Negative at 100000 ng/mL | N/A | | Ephedrine | Negative at 100000 ng/mL | N/A | | Fenfluramine | Negative at 100000 ng/mL | N/A | | Phenmetrazine | Negative at 100000 ng/mL | N/A | | Phentermine | Negative at 100000 ng/mL | N/A | | Phenylephrine (l) | Negative at 100000 ng/mL | N/A | | Procaine | Negative at 100000 ng/mL | N/A | | Tyramine | Negative at 100000 ng/mL | N/A | | Marijuana (THC) (11-nor-D9-THC-9 COOH) 50 ng/mL | | | | 11-nor-D8-THC-9 COOH | Positive at 50 ng/mL | 100% | | 11-Hydroxy- Δ9-THC | Positive at 5000 ng/mL | 1% | | Cannabinol | Positive at 20000 ng/mL | 0% | | Δ9-THC | Negative at 100000 ng/mL | N/A | | Cannabidiol | Negative at 100000 ng/mL | N/A | | Δ8-THC | Negative at 100000 ng/mL | N/A | Split Key Cup Related Compounds and Cross-Reactants | Related Compound or Cross-Reactant | Result | % Cross Reactive | | --- | --- | --- | | Amphetamines (AMP) (d-Amphetamine) 500 ng/mL | | | | Amphetamine (d,l) | Positive at 1000 ng/mL | 50% | | 3,4-Methylenedioxyamphetamine (MDA) | Positive at 4000 ng/mL | 13% | | b-Phenylethylamine (phenethylamine) | Positive at 25000 ng/mL | 2% | | 3,4-methylenedioxy-N-ethylamphetamine- (1R,2S)-(-)-Ephedrine | Negative at 100000 | 1% | | 3,4-Methylenedioxymethamphetamine | Negative at 100000 | N/A | | Amphetamine (l) | Negative at 100000 | N/A | | Fenfluramine | Negative at 100000 | N/A | | Methamphetamine (d) | Negative at 100000 | N/A | | Methamphetamine (l) | Negative at 100000 | N/A | | Phentermine | Negative at 100000 | N/A | | Tryptamine | Negative at 100000 | N/A | | Tyramine | Negative at 100000 | N/A | | Methamphetamines (MET) (d-Methamphetamine) 500 ng/mL | | | | 3,4-Methylenedioxymethamphetamine | Positive at 1000 ng/mL | 50% | | Methamphetamine (l) | Positive at 5000 ng/mL | 10% | | p-Hydroxymethamphetamine | Positive at 15000 ng/mL | 3% | | b-Phenylethylamine (phenethylamine) | Positive at 50000 ng/mL | 1% | {10} | Chloroquine | Positive at 50000 ng/mL | 1% | | --- | --- | --- | | Mephentermine | Positive at 50000 ng/mL | 1% | | 3,4-Methylenedioxyamphetamine (MDA) | Negative at 100000 | N/A | | 3,4-methylenedioxy-N-ethylamphetamine- | Negative at 100000 | N/A | | Amphetamine (d,l) | Negative at 100000 | N/A | | Amphetamine (d) | Negative at 100000 | N/A | | Amphetamine (l) | Negative at 100000 | N/A | | Ephedrine | Negative at 100000 | N/A | | Fenfluramine | Negative at 100000 | N/A | | Phenmetrazine | Negative at 100000 | N/A | | Phentermine | Negative at 100000 | N/A | | Phenylephrine (l) | Negative at 100000 | N/A | | Procaine | Negative at 100000 | N/A | | Tyramine | Negative at 100000 | N/A | | Morphine 300 ng/mL | | | | Morphine 6-β-D-Glucuronide | Positive at 250 ng/mL | 120% | | 6-Monoacetylmorphine (6-MAM) | Positive at 300 ng/mL | 100% | | Codeine | Positive at 300 ng/mL | 100% | | Diacetylmorphine | Positive at 500 ng/mL | 60% | | Dihydrocodeine | Positive at 2500 ng/mL | 12% | | Morphine 3-β-D-Glucuronide | Positive at 3000 ng/mL | 10% | | Ethylmorphine | Positive at 5000 ng/mL | 6% | | Hydromorphone | Positive at 10000 ng/mL | 3% | | Thebaine | Positive at 20000 ng/mL | 2% | | Hydrocodone | Positive at 25000 ng/mL | 1% | | Nalorphine | Positive at 50000 ng/mL | 1% | | Apomorphine | Negative at 100000 | N/A | | Levorphanol (tartrate dihydrate) | Negative at 100000 | 0% | | Naloxone | Negative at 100000 | N/A | | Naltrexone | Negative at 100000 | N/A | | Norcodeine | Negative at 100000 | N/A | | Norhydrocodone | Negative at 100000 | N/A | | Normorphine | Negative at 100000 | N/A | | Noroxymorphone | Negative at 100000 | N/A | | Oxycodone | Negative at 100000 | N/A | | Oxymorphone | Negative at 100000 | N/A | | Procaine | Negative at 100000 | N/A | | Methadone (MTD) (Methadone) 300 ng/mL | | | | Buprenorphine (MTD Replacement) | Negative at 100000 | N/A | | EDDP (Primary Metabolite) | Negative at 100000 | N/A | | EMDP (Secondary Metabolite) | Negative at 100000 | N/A | | Morphine 2000 ng/mL | | | | Morphine 6-β-D-Glucuronide | Positive at 2500 ng/mL | 80% | | Nalorphine | Positive at 2500 ng/mL | 80% | | Codeine | Positive at 3000 ng/mL | 67% | | Hydromorphone | Positive at 4000 ng/mL | 50% | | 6-Monoacetylmorphine (6-MAM) | Positive at 5000 ng/mL | 40% | | Dihydrocodeine | Positive at 5000 ng/mL | 40% | | Ethylmorphine | Positive at 5000 ng/mL | 40% | | Morphine 3-β-D-Glucuronide | Positive at 5000 ng/mL | 40% | | Normorphine | Positive at 10000 ng/mL | 20% | | Hydrocodone | Positive at 12500 ng/mL | 16% | | Diacetylmorphine | Positive at 15000 ng/mL | 13% | | Norcodeine | Positive at 15625 ng/mL | 13% | | Oxymorphone | Positive at 25000 ng/mL | 8% | | Thebaine | Positive at 25000 ng/mL | 8% | {11} | Apomorphine | Negative at 100000 | N/A | | --- | --- | --- | | Levorphanol (tartrate dihydrate) | Negative at 100000 | N/A | | Naloxone | Negative at 100000 | N/A | | Naltrexone | Negative at 100000 | N/A | | Norhydrocodone | Negative at 100000 | N/A | | Noroxymorphone | Negative at 100000 | N/A | | Oxycodone | Negative at 100000 | N/A | | Procaine | Negative at 100000 | N/A | | Oxycodone (OXY) (Oxycodone) 100 ng/mL | | | | Oxymorphone | Positive at 400 ng/mL | 25% | | Noroxymorphone | Positive at 2500 ng/mL | 4% | | Hydrocodone | Positive at 12500 ng/mL | 1% | | Naloxone | Positive at 37500 ng/mL | 0% | | Hydromorphone | Positive at 50000 ng/mL | 0% | | Levorphanol | Positive at 50000 ng/mL | 0% | | Naltrexone | Positive at 50000 ng/mL | 0% | | Norhydrocodone | Positive at 50000 ng/mL | 0% | | 6-Monoacetylmorphine | Negative at 100000 | N/A | | Apomorphine | Negative at 100000 | N/A | | Codeine | Negative at 100000 | N/A | | Diacetylmorphine | Negative at 100000 | N/A | | Dihydrocodeine | Negative at 100000 | N/A | | Ethylmorphine | Negative at 100000 | N/A | | Morphine | Negative at 100000 | N/A | | Morphine 3-β-D-Glucuronide | Negative at 100000 | N/A | | Morphine 6-β-D-Glucuronide | Negative at 100000 | N/A | | Nalorphine | Negative at 100000 | N/A | | Norcodeine | Negative at 100000 | N/A | | Normorphine | Negative at 100000 | N/A | | Thebaine | Negative at 100000 | N/A | | Phencyclidine (PCP) (Phencyclidine) 25 ng/mL | | | | 4-Hydroxyphencyclidine | Positive at 1500 ng/mL | 2% | | Marijuana (THC) (11-Nor-9-carboxy-Δ9-THC) 50 ng/mL | | | | 11-Hydroxy- Δ9-THC | Positive at 5000 ng/mL | 1% | | 11-nor-D8-THC-9 COOH | Positive at 5000 ng/mL | 1% | | Cannabinol | Positive at 20000 ng/mL | 0% | | Cannabidiol | Negative at 100000 | N/A | | Δ8-THC | Negative at 100000 | N/A | | Δ9-THC | Negative at 100000 | N/A | ## pH and Specific Gravity The GenPrime DOA Reader System was assayed with pH values of 3.0, 4.0, 7.0 and 9.0. Each sample was assayed in triplicate. The pH samples were fortified with drug concentrations at 50% (negative) and 150% (positive) of cutoff. All pH samples gave negative results in the 50% of cutoff level for each drug, and all gave positive results at the 150% of cutoff level for each drug. The GenPrime DOA Reader System was assayed in triplicate with samples with specific gravity values of 1.003, 1.015 and 1.030. The specific gravity samples were fortified with drug concentrations as described above for pH. All specific gravity samples gave negative results in the 50% of cutoff level for each drug, and all gave positive results at the 150% of cutoff level for each drug. ## Common Drugs Drug free urine samples were spiked with drug concentrations that were at 50% (negative) and 150% (positive) of cutoff. Concentrations of 100,000 ng/mL of the {12} common drugs were then added to the preparation and assayed by the GenPrime DOA Reader System. None of the common drugs listed in the following table affected the expected results for the OS Cup or the Split Key Cup. ## Common Drugs Evaluated with the OS Cup with the GenPrime DOA Reader System | Acetylsalicylic Acid | Chlorpheniramine | Morphine | | --- | --- | --- | | Acetaminophen | Cocaine - COC | Phenobarbital – BAR | | Brompheniramine maleate | Dextromethorphan | Phenytoin (Diphenylhydantoin) – | | Caffeine | Doxylamine | d-Pseudoephedrine | | Carbamazepine | Ibuprofen | Salicylic Acid | ## Common Drugs Evaluated with the Split Key Cup with the GenPrime DOA Reader System | Acetylsalicylic Acid | Chlorpheniramine | Morphine | | --- | --- | --- | | Acetaminophen | Cocaine - COC | Phenobarbital – BAR | | Brompheniramine maleate | Dextromethorphan | Phenytoin (Diphenylhydantoin) – | | Caffeine | Doxylamine | d-Pseudoephedrine | | Carbamazepine | Ibuprofen | Salicylic Acid | ## f. Assay cut-off: Characterization of how the device performs around the claimed cutoff concentration appears in the precision section M.1.a. above. ## 2. Comparison studies: ### a. Method comparison with predicate device: The accuracy of the GenPrime DOA Reader System was evaluated at three sites representative of laboratory, workplace, and POC settings with blind coded clinical urine samples that contained varying concentrations of drugs as determined by GC/MS or LC/MS/MS. Results summaries are provided below for the OS Cup and for the Split Key Cup, for all sites combined. Summary of method comparison data for the OS Cup (all sites combined) | DRUG (cutoff) | GenPrime Test System OS Cup | No Drug | Negative (Less than -50% cutoff) | Near Cutoff Negative (between -50% and cutoff) | Near Cutoff Positive (Between cutoff and +50%) | Positive (greater than +50%) | GenPrime OS Cup Agreement with Reference | | --- | --- | --- | --- | --- | --- | --- | --- | | AMP (500) | Positive | 0 | 0 | 3 | 5 | 36 | 100% | | | Negative | 40 | 1 | 4 | 0 | 0 | 93.8% | | BAR (300) | Positive | 0 | 0 | 3 | 4 | 36 | 100% | | | Negative | 40 | 11 | 1 | 0 | 0 | 94.5% | | COC (150) | Positive | 0 | 0 | 3 | 4 | 38 | 100% | | | Negative | 40 | 0 | 1 | 0 | 0 | 93.2% | | MET (500) | Positive | 0 | 0 | 2 | 4 | 36 | 100% | | | Negative | 40 | 8 | 2 | 0 | 0 | 96.2% | {13} Discordant Results for the OS Cup | THC (50) | Positive | 0 | 0 | 0 | 4 | 36 | 100% | | --- | --- | --- | --- | --- | --- | --- | --- | | | Negative | 40 | 0 | 4 | 0 | 0 | 100% | | Cutoff Value (ng/mL) | Drug | GenPrime DOA Reader System | GC/MS or LC/MS/MS Value | | --- | --- | --- | --- | | 500 | AMP | Presumptive Positive | Amphetamine at 306 ng/mL | | | AMP | Presumptive Positive | Amphetamine at 437 ng/mL | | | AMP | Presumptive Positive | Amphetamine at 370 ng/mL | | 300 | BAR | Presumptive Positive | Phenobarbital at 210 ng/mL (=252 ng/mL BAR equiv) | | | BAR | Presumptive Positive | Butalbital at 6000 ng/mL (=240 ng/mL BAR equiv) | | | BAR | Presumptive Positive | Butalbital at 4644 ng/mL (=186 ng/mL BAR equiv) | | 150 | COC | Presumptive Positive | Benzoylecgonine at 130 ng/mL | | | COC | Presumptive Positive | Benzoylecgonine at 110 ng/mL | | | COC | Presumptive Positive | Benzoylecgonine at 126 ng/mL | | 500 | MET | Presumptive Positive | Methamphetamine at 264 ng/mL | | | MET | Presumptive Positive | Methamphetamine at 277 ng/mL | {14} Summary of method comparison data for the Split Key Cup (all sites combined) | DRUG (cutoff) | GenPrime Test System Split Key Cup | No Drug | Negative (Less than -50% cutoff) | Near Cutoff Negative (between -50% and cutoff) | Near Cutoff Positive (Between cutoff and +50%) | Positive (greater than +50%) | GenPrime Split Key Cup Agreement with Reference | | --- | --- | --- | --- | --- | --- | --- | --- | | AMP (500) | Positive | 0 | 0 | 4 | 4 | 36 | 100% | | | Negative | 40 | 1 | 4 | 0 | 0 | 91.8% | | MET (500) | Positive | 0 | 0 | 1 | 4 | 36 | 100% | | | Negative | 40 | 0 | 3 | 0 | 0 | 97.7% | | MTD (300) | Positive | 0 | 0 | 0 | 4 | 36 | 100% | | | Negative | 40 | 0 | 4 | 0 | 0 | 100% | | MOP (300) | Positive | 0 | 0 | 1 | 3 | 36 | 97.5% | | | Negative | 40 | 0 | 3 | 1 | 0 | 97.7% | | MOP (2000) | Positive | 0 | 1 | 2 | 4 | 36 | 100% | | | Negative | 40 | 0 | 3 | 0 | 0 | 93.5% | | OXY (100) | Positive | 0 | 0 | 2 | 4 | 36 | 100% | | | Negative | 40 | 0 | 2 | 0 | 0 | 95.45% | | PCP (25) | Positive | 0 | 0 | 0 | 3 | 39 | 97.7% | | | Negative | 40 | 17 | 4 | 1 | 0 | 100% | | THC (50) | Positive | 0 | 2 | 0 | 3 | 38 | 100% | | | Negative | 40 | 31 | 8 | 0 | 0 | 97.5% | {15} Discordant Results for the Split Key Cup | Cutoff Value (ng/mL) | Drug | GenPrime DOA Reader | GC/MS or LC/MS/MS Value | | --- | --- | --- | --- | | 500 | AMP | Presumptive Positive | Amphetamine at 250 ng/mL | | | AMP | Presumptive Positive | Amphetamine at 437 ng/mL | | | AMP | Presumptive Positive | Amphetamine at 365 ng/mL | | | AMP | Presumptive Positive | Amphetamine at 370 ng/mL | | 500 | MET | Presumptive Positive | Amphetamine at 307 ng/mL | | 300 | MOP | Negative | Codeine at 333 ng/mL (=333 ng/mL MOP equiv) | | | MOP | Presumptive Positive | Codeine at 283 ng/mL (=283 ng/mL MOP equiv) | | 2000 | MOP | Presumptive Positive | Morphine at 377 ng/mL, Codeine at 2097 ng/mL (=1782 MOP equiv) | | | MOP | Presumptive Positive | Morphine at 962 ng/mL, Codeine at 1437 ng/mL (=1925 MOP equiv) | | | MOP | Presumptive Positive | Morphine at 843 ng/mL, Codeine at 328 ng/mL (=893 MOP equiv) | | 100 | OXY | Presumptive Positive | Oxycodone at 65 ng/mL | | | OXY | Presumptive Positive | Oxycodone at 50 ng/mL | | 25 | PCP | Negative | Phencyclidine at 35 ng/mL | | 50 | THC | Presumptive Positive | 11-nor-9-carboxy-D9-THC at 22 ng/mL | | | THC | Presumptive Positive | 11-nor-9-carboxy-D9-THC at 24 ng/mL | 16 {16} A second study was submitted by the sponsor to support discrepant resolution of the discordant results obtained in the original method comparison studies for OPI and THC analytes for the SK Cup at the less than -50% cutoff level. Clinical specimens with OPI and THC concentrations at 0%-50% of the cutoff were tested in-house using the SK Cup with the GenPrime DOA Reader System and compared to GC/MS values. The results are below. Additional of method comparison data for the Split Key Cup | DRUG (cutoff) | GenPrime Test System Split Key Cup | Near Cutoff Negative (between -50% and cutoff) | GenPrime Split Key Cup Agreement with Reference | | --- | --- | --- | --- | | MOP (2000 ng/mL) | Positive | 0 | 100% | | | Negative | 112 | 100% | | THC (50 ng/mL) | Positive | 0 | 100% | | | Negative | 120 | 100% | b. Matrix comparison: Not applicable. The assay is intended for use with urine samples only. 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 {17} 18 N. Instrument Name: GenPrime Drugs of Abuse Reader O. System Descriptions: 1. Modes of Operation: 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ☐ X or No ☐ 3. Specimen Identification: There is no sample identification function with this device. Samples are applied directly to the OS Cup or the Split Key Cup. 4. Specimen Sampling and Handling: This device is intended to be used with urine samples. The labeling provides instructions for storage of samples. 5. Calibration: Factory Calibrated 6. Quality Control: The sponsor specifies in the labeling the quality control products that must be used with the device systems. The quality control products were previously cleared under k121122. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above: None Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.