Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k161214 B. Purpose for Submission: New Device C. Measurand: Amphetamine, Cocaine and Methamphetamine D. Type of Test: Qualitative Lateral Flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established Names: Wondfo Amphetamine Urine Test AMP 500 (Cup, DipCard) Wondfo Cocaine Urine Test COC 150 (Cup, DipCard) Wondfo Methamphetamine Urine Test MET 500 (Cup, DipCard) G. Regulatory Information: | Product Code | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | DIO | Class II | 21 CFR, 862.3250 Cocaine Test System | Toxicology (91) | | DKZ | Class II | 21 CFR, 862.3100 Amphetamine Test System | Toxicology (91) | | DJC | Class II | 21 CFR, 862.3610 Methamphetamine Test System | Toxicology (91) | {1} H. Intended Use: 1. Intended use(s): See Indications for Use below. 2. Indication(s) for use: Wondfo Amphetamine Urine Test AMP 500 Cup is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Amphetamine (calibrator). The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Wondfo Amphetamine Urine Test AMP 500 DipCard is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Amphetamine (calibrator). The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Wondfo Cocaine Urine Test COC 150 Cup is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 ng/mL. This test is calibrated to Benzoylecgonine (calibrator). The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their 2 {2} metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Wondfo Cocaine Urine Test COC 150 DipCard is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 ng/mL. This test is calibrated to Benzoylecgonine (calibrator). The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Wondfo Methamphetamine Urine Test MET 500 Cup is an immunochromatographic assay for the qualitative determination of Methamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Methamphetamine (calibrator). The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Wondfo Amphetamine Urine Test MET 500 DipCard is an immunochromatographic assay for the qualitative determination of Methamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Methamphetamine (calibrator). The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. 3 {3} 3. Special conditions for use statement(s): For in vitro diagnostic use only, for over-the-counter use. 4. Special instrument requirements: Not applicable. The devices are visually read single-use devices. I. Device Description: Wondfo Amphetamine Urine Tests, Wondfo Cocaine Urine Tests and Wondfo Methamphetamine Urine Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-amphetamine, Benzoylecgonine or d-methamphetamine (target analyte) in human urine. It is a single-use visually read in vitro diagnostic device, which comes in the format of DipCard or Cup. The product contains a Test Device (in one of the two formats), a package insert and a urine cup. Each test and format is available separately. Each test device is sealed with a desiccant in an aluminum pouch. J. Substantial Equivalence Information: 1. Predicate device name(s): Advin Multi-Drug Screen Test 2. Predicate 510(k) number(s): k122809 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Candidate Device k161214 Wondfo Amphetamine Urine Test | Predicate device k122809 Advin Multi-Drug Screen Test | | Calibrator | d-Amphetamine | Same | | Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same | | Type of Test | Qualitative | Same | {4} | Similarities | | | | --- | --- | --- | | Item | Candidate Device k161214 Wondfo Amphetamine Urine Test | Predicate device k122809 Advin Multi-Drug Screen Test | | Specimen Type | Human Urine | Same | | Cut-Off Values | 500 ng/mL | Same | | Intended Use | For over-the-counter use. | Same | | Differences | | | | --- | --- | --- | | Item | Candidate Device k161214 Wondfo Amphetamine Urine Test | Predicate device k122809 Advin Multi-Drug Screen Test | | Indication(s) for Use | For the qualitative determination of d-amphetamine in human urine. | For the qualitative determination of multiple drugs in human urine. | | Configurations | Cup and Dip Card | Cup, Dip Card, Cassette | | Similarities | | | | --- | --- | --- | | Item | Candidate Device k161214 Wondfo Cocaine Urine Test | Predicate device k122809 Advin Multi-Drug Screen Test | | Calibrator | Benzoylecgonine | Same | | Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same | | Type of Test | Qualitative | Same | | Specimen Type | Human Urine | Same | | Cut-Off Values | 150 ng/mL | Same | | Intended Use | For over-the-counter use. | Same | {5} | Differences | | | | --- | --- | --- | | Item | Candidate Device k161214 Wondfo Cocaine Urine Test | Predicate device k122809 Advin Multi-Drug Screen Test | | Indication(s) for Use | For the qualitative determination of Benzoylecgonine in human urine. | For the qualitative determination of multiple drugs in human urine. | | Configurations | Cup and Dip Card | Cup, Dip Card, Cassette | | Similarities | | | | --- | --- | --- | | Item | Candidate Device k161214 Wondfo Methamphetamine Urine Test | Predicate device k122809 Advin Multi-Drug Screen Test | | Calibrator | d-methamphetamine | Same | | Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same | | Type of Test | Qualitative | Same | | Specimen Type | Human Urine | Same | | Cut-Off Values | 500 ng/mL | Same | | Intended Use | For over-the-counter use. | Same | | Differences | | | | --- | --- | --- | | Item | Candidate Device k161214 Wondfo Methamphetamine Urine Test | Predicate device k122809 Advin Multi-Drug Screen Test | | Indication(s) for Use | For the qualitative determination of d-methamphetamine in human urine. | For the qualitative determination of multiple drugs in human urine. | | Configurations | Cup and Dip Card | Cup, Dip Card, Cassette | {6} 7 K. Standard/Guidance Document Referenced (if applicable): In Vitro Diagnostic Devices; Guidance for the Preparation of 510(k) Submission, HHS Publication FDA 97-4224. Premarket Submission and labeling Recommendations for Drugs of Abuse Screening Tests, Draft Guidance, December 2, 2003. L. Test Principle: Wondfo Amphetamine Urine Tests, Wondfo Cocaine Urine Tests and Wondfo Methamphetamine Urine Tests use a lateral flow, one step system for the qualitative detection of d-Amphetamine, Benzoylecgonine or d-Methamphetamine in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes. When the absorb end is immersed into the urine specimen, the urine is absorbed into the device by capillary action, mixes with the antibody-dye conjugate, and flows across the pre-coated membrane. When sample drug levels are zero or below the target Cut-Off (the detection sensitivity of the test), antibody-dye conjugate binds to the drug-protein conjugate immobilized in the Test Region (T) of the device. This produces a colored Test line that, regardless of its intensity, indicates a negative result. When sample drug levels are at or above the target Cut-Off, the free drug in the sample binds to the antibody-dye conjugate preventing the antibody-dye conjugate from binding to the drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a potentially positive result. To serve as a procedure control, a colored line will appear at the Control Region (C), if the test has been performed properly because of the antibody-dye conjugate binding to anti-mouse IgG immobilized in the Control Region(C) of the device. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision studies were carried out for Wondfo Amphetamine Urine Tests and Wondfo Cocaine Urine Tests using samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blindly labeled and randomized. For each concentration, tests were performed by six operators in two runs per day for 25 days per device. The results obtained are summarized in the following tables: {7} 8 # Amphetamine (AMP) Dip Card Format | Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | # Amphetamine (AMP) Cup Format | Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | # Cocaine (COC) Dip Card Format | Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | # Cocaine (COC) Cup Format | Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | The Wondfo Methamphetamine Urine Test MET 500 (Cup, DipCard) precision performance data are found in k122961. ## b. Linearity/assay reportable range: Not applicable. ## c. Traceability, Stability, Expected values (controls, calibrators, or methods): Device stability for Wondfo Amphetamine Urine Tests and Wondfo Cocaine Urine Tests has been evaluated through accelerated and real-time studies. A transport simulation study was performed to test extreme shipping temperatures. Protocols and acceptance criteria were reviewed and found to be acceptable. The manufacturer claims that the devices are stable at $4 - 30^{\circ}\mathrm{C}$ {8} (39-86°F) for 24 months. The Wondfo Methamphetamine Urine Test MET 500 (Cup, DipCard) stability performance data are found in k122961. The manufacturer claims that the devices are stable at 4-30 °C (39-86°F) for 18 months. This device has internal process controls. A colored line appearing in the control region confirms that sufficient sample volume and that the correct technique has been used. Users are instructed that the test is invalid if a colored line failed to appear in the control region. External control materials are not supplied with these devices; however the labeling provides information on how to obtain quality control materials. d. Detection limit: Not applicable. e. Analytical specificity: To test specificity of Wondfo Amphetamine Urine Tests and Wondfo Cocaine Urine Tests, drug metabolites and other components that are likely to interfere in urine samples were tested by three operators using three lots of each device. The lowest concentration that caused a positive result for each compound device are listed below. There were no differences observed for the cup and dipcard test formats. Amphetamine | Compound | Concentration (ng/mL) | % Cross-reactivity | | --- | --- | --- | | d- Amphetamine | 500 | 100% | | l - Amphetamine | 25000 | 2% | | d,l - Amphetamine | 1500 | 33% | | Phentermine | 1500 | 33% | | Hydroxyamphetamine | 8000 | 6% | | Methylenedioxyamphetamine (MDA) | 2500 | 20% | | d-Methamphetamine | Negative at 100000 | <1% | | 1-Methamphetamine | Negative at 100000 | <1% | | ephedrine | Negative at 100000 | <1% | | Methylenedioxyethylamphetamine (MDEA) | Negative at 100000 | <1% | | 3,4-methylenedioxy-methamphetamine (MDMA) | Negative at 100000 | <1% | {9} 10 Cocaine | Compound | Concentration (ng/mL) | % Cross-reactivity | | --- | --- | --- | | Benzoylecogonine | 150 | 100% | | Cocaine HCl | 375 | 40% | | Cocaethylene | 6250 | 2.4% | | Ecgonine | 16000 | 0.9% | | Norcocaine | Positive at 50000 | 0.3% | Methamphetamine | Compound | Concentration (ng/mL) | % Cross-reactivity | | --- | --- | --- | | (+/-) 3,4-Methylenedioxy-n-ethylamphetamine(MDEA) | 500 | 100% | | (+/-) 3,4-Methylenedioxyamphetamine (MDA) | 500 | 100% | | d/l-Methamphetamine | 500 | 100% | | l-Methamphetamine | 10,000 | 5% | | l-Amphetamine | 37,500 | 1.3% | Additional cross reactivity performance data for Wondfo Methamphetamine Urine Test MET 500 (Cup, DipCard) are found in k122961. For Wondfo Amphetamine Urine Tests and Wondfo Cocaine Urine Tests potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested by three operators using three lots of each device. Compounds that showed no interference at a concentration of 100μg/mL are summarized in the following tables. There were no differences observed for the cup and dipcard test formats. Amphetamine | 4-Acetamidophenol | L-Ephedrine | Oxycodone | | --- | --- | --- | | Acetophenetidin | (-) Y Ephedrine | Oxymetazoline | | N-Acetylprocainamide | Erythromycin | Papaverine | | Acetylsalicylic acid | β-Estradiol | Penicillin-G | | Aminopyrine | Estrone-3-sulfate | Pentazocaine | | Amitryptyline | Ethyl aminobenzoate | Pentobarbital | | Amobarbital | Fenfluramine | Perphenazine | | Amoxicillin | Fenoprofen | Phencyclidine | | Ampicillin | Furosemide | Phenelzine | {10} | Ascorbic acid | Gentisic acid | Phenobarbital | | --- | --- | --- | | Aspartame | Hemoglobin | Phetoin | | Atropine | Hydralazine | L-Phenylephrine | | Benzilic acid | Hydrochlorothiazide | Phenylpropanolamine | | Benzoic acid | Hydrocodone | Prednisolone | | Benzoylecgonine | Hydrocortisone | Prednisone | | Bilirubin | O-Hydroxyhippuric acid | Procaine | | Brompheniramine | 3-Hydroxytyramine | Promazine | | Caffeine | Ibuprofen | Promethazine | | Cannabidiol | Imipramine | D,L-Propanolol | | Cannabinol | (-) Isoproterenol | D-Propoxyphene | | Chloralhydrate | Isoxsuprine | Quinidine | | Chloramphenicol | Ketamine | Quinine | | Chlordiazepoxide | Ketoprofen | Ranitidine | | Chlorothiazide | Labetalol | Salicylic acid | | (±) Chlorpheniramine | Levorphanol | Secobarbital | | Chlorpromazine | Loperamide | Sulfamethazine | | Chloroquine | Maprotiline | Sulindac | | Cholesterol | Meperidine | Temazepam | | Clomipramine | Meprobamate | Tetracycline | | Clonidine | Methadone | Tetrahydrocortisone | | Cocaine hydrochloride | Methylphenidate | Tetrahydrozoline | | Codeine | Morphine-3-D-glucuronide | Δ9-THC-COOH | | Cortisone | Nalidixic acid | Thebaine | | (-) Cotinine | Naloxone | Thiamine | | Creatinine | Naltrexone | Thioridazine | | Deoxycorticosterone | Naproxen | D,L-Thyroxine | | Dextromethorphan | Niacinamide | Tolbutamide | | Diazepam | Nifedipine | Triamterene | | Diclofenac | Norcodein | Trifluoperazine | | Diflunisal | Norethindrone | Trimethoprim | | Digoxin | D-Norpropoxyphene | Trimipramine | | Diphenhydramine | Noscapine | Tryptamine | | Doxylamine | D,L-Octopamine | D, L-Tyrosine | | Ecgonine hydrochloride | Oxalic acid | Uric acid | | Ecgonine methylester | Oxazepam | Verapamil | | (IR,2S)-(-)-Ephedrine | Oxolinic acid | Zomepirac | 11 {11} Cocaine | Acetaminophen | Estrone-3-sulfate | Oxymetazoline | | --- | --- | --- | | Acetophenetidin | Ethyl-p-aminobenzoate | Papaverine | | N-Acetylprocainamide | Fenoprofen | Penicillin-G | | Acetylsalicylic acid | Furosemide | Pentobarbital | | Aminopyrine | Gentisic acid | Perphenazine | | Amitryptyline | Hemoglobin | Phencyclidine | | Amobarbital | Hydralazine | Phenelzine | | Amoxicillin | Hydrochlorothiazide | Phenobarbital | | Ampicillin | Hydrocodone | Phentermine | | L-Ascorbic acid | Hydrocortisone | L-Phenylephrine | | DL-Amphetamine Sulfate | O-Hydroxyhippuric acid | β-Phenylethylamine | | Apomorphine | p-Hydroxymethamphetamine | Phenylpropanolamine | | Aspartame | 3-Hydroxytyramine | Prednisolone | | Atropine | Ibuprofen | Prednisone | | Benzilic acid | Imipramine | Procaine | | Benzoic acid | Iproniazid | Promazine | | Benzphetamine | (±) - Isoproterenol | Promethazine | | (±) -Brompheniramine | Isoxsuprine | DL-Propranolol | | Caffeine | Ketamine | D-Propoxyphene | | Cannabidiol | Ketoprofen | D-Pseudoephedrine | | Cannabinol | Labetalol | Quinidine | | Chloralhydrate | Levorphanol | Quinine | | Chloramphenicol | Loperamide | Ranitidine | | Chlordiazepoxide | Maprotiline | Salicylic acid | | Chlorothiazide | Meperidine | Secobarbital | | (±) -Chlorpheniramine | Meprobamate | Serotonin | | Chlorpromazine | Methadone | Sulfamethazine | | Chloroquine | Methoxyphenamine | Sulindac | | Cholesterol | (±) -3,4-Methylene dioxyamphetamine | Temazepam | | Clomipramine | Methylene-dioxymethamphetamine | Tetracycline | | Clonidine | Morphine-3-β-D glucuronide | Tetrahydrocortisone 3-(β-D glucuronide) | | Codeine | Morphine Sulfate | Tetrahydrozoline | | Cortisone | Nalidixic acid | Thebaine | | (-) Cotinine | Naloxone | Thiamine | | Creatinine | Naltrexone | Thioridazine | 12 {12} | Deoxycorticosterone | Naproxen | DL-Tyrosine | | --- | --- | --- | | Dextromethorphan | Niacinamide | Tolbutamide | | Diazepam | Nifedipine | Triamterene | | Diclofenac | Norcodein | Trifluoperazine | | Diflunisal | Norethindrone | Trimethoprim | | Digoxin | D-Norpropoxyphene | Trimipramine | | Diphenhydramine | Noscapine | Tryptamine | | Doxylamine | DL-Octopamine | DL-Tryptophan | | Ecgonine methylester | Oxalic acid | Tyramine | | (-) - Ψ-Ephedrine | Oxazepam | Uric acid | | Erythromycin | Oxolinic acid | Verapamil | | β-Estradiol | Oxycodone | Zomepirac | The Wondfo Methamphetamine Urine Test MET 500 (Cup, DipCard) interference performance data are found in k122961. Effect of Urine Specific Gravity and Urine pH: To investigate the effect of urine specific gravity and urine pH, urine samples for Wondfo Amphetamine Urine Tests and Wondfo Cocaine Urine Tests, with 1.000 to 1.035 specific gravity (1.000, 1.003, 1.008, 1.014, 1.018, 1.020, 1.022, 1.025, 1.028, 1.030, 1.032, and 1.035) and urine samples with pH 4 to 9 (4.0, 5.0, 6.0, 7.0, 8.0, and 9.0) were spiked with target drugs at $25\%$ below and $25\%$ above Cut-Off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above $+25\%$ Cut-Off and all negative for samples at and below $-25\%$ Cut-Off. There were no differences observed for the cup and dipcard test formats and the sponsor claims that pH and specific gravity do not affect urine testing results around each analyte cut-off. The Wondfo Methamphetamine Urine Test MET 500 (Cup, DipCard) Urine Specific Gravity and Urine pH performance data are found in k122961. f. Assay cut-off: Cutoff studies were performed for Wondfo Amphetamine Urine Tests and Wondfo Cocaine Urine Tests using a combination of clinical and spiked samples for each drug (n=150 per drug). The testing protocol was identical for each drug. 25 clinical samples were collected for each drug. Concentrations of amphetamine and cocaine in the samples were determined by GC/MS. An additional 125 drug free negative samples were obtained for each drug and spiked with either amphetamine or cocaine at -50% cutoff, -25% cutoff, cutoff, +25% cutoff, and +50% cutoff. 30 samples were tested at each concentration for each drug in replicates of 30 using three lots and 3 operators (n=270). {13} Results are summarized below: Amphetamine | | Concentration of sample ng/mL | Number of determinations | Dip Card Results #Neg/#Pos | Cup Results #Neg/#Pos | | --- | --- | --- | --- | --- | | Lot 1 | -50% cutoff | 90 | 90/0 | 90/0 | | | -25% cutoff | 90 | 90/0 | 90/0 | | | Cutoff | 90 | 11/79 | 12/78 | | | +25%cutoff | 90 | 0/90 | 0/90 | | | +50% cutoff | 90 | 0/90 | 0/90 | | Lot 2 | -50% cutoff | 90 | 90/0 | 90/0 | | | -25% cutoff | 90 | 90/0 | 90/0 | | | Cutoff | 90 | 12/78 | 11/79 | | | +25%cutoff | 90 | 0/90 | 0/90 | | | +50% cutoff | 90 | 0/90 | 0/90 | | Lot 3 | -50% cutoff | 90 | 90/0 | 90/0 | | | -25% cutoff | 90 | 90/0 | 90/0 | | | Cutoff | 90 | 11/79 | 12/78 | | | +25%cutoff | 90 | 0/90 | 0/90 | | | +50% cutoff | 90 | 0/90 | 0/90 | Cocaine | | Concentration of sample ng/mL | Number of determinations | Dip Card Results #Neg/#Pos | Cup Results #Neg/#Pos | | --- | --- | --- | --- | --- | | Lot 1 | -50% cutoff | 90 | 90/0 | 90/0 | | | -25% cutoff | 90 | 90/0 | 90/0 | | | Cutoff | 90 | 12/78 | 12/78 | | | +25%cutoff | 90 | 0/90 | 0/90 | | | +50% cutoff | 90 | 0/90 | 0/90 | | Lot 2 | -50% cutoff | 90 | 90/0 | 90/0 | | | -25% cutoff | 90 | 90/0 | 90/0 | | | Cutoff | 90 | 12/78 | 12/78 | | | +25%cutoff | 90 | 0/90 | 0/90 | | | +50% cutoff | 90 | 0/90 | 0/90 | | Lot 3 | -50% cutoff | 90 | 90/0 | 90/0 | | | -25% cutoff | 90 | 90/0 | 90/0 | | | Cutoff | 90 | 12/78 | 12/78 | | | +25%cutoff | 90 | 0/90 | 0/90 | | | +50% cutoff | 90 | 0/90 | 0/90 | The Wondfo Methamphetamine Urine Test MET 500 (Cup, DipCard) cut off performance data are found in k122961. {14} 2. Comparison studies: a. Method comparison with predicate device: The method comparison studies for Wondfo Amphetamine Urine Tests and Wondfo Cocaine Urine Tests were performed in-house with three different laboratory assistants for each format of the device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to GC/MS results. The results are presented in the tables below: Amphetamine (AMP) Dip Card | Dip Card format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) | | --- | --- | --- | --- | --- | --- | --- | | Viewer A | Positive | 0 | 0 | 2 | 30 | 10 | | | Negative | 10 | 17 | 11 | 0 | 0 | | Viewer B | Positive | 0 | 0 | 2 | 30 | 10 | | | Negative | 10 | 17 | 11 | 0 | 0 | | Viewer C | Positive | 0 | 0 | 1 | 29 | 10 | | | Negative | 10 | 17 | 12 | 0 | 0 | Discordant Results of AMP Dip Card | Viewer | Sample Number | GC/MS Result | Dipcard Format Viewer Results | | --- | --- | --- | --- | | Viewer A | AMP5062 | 480 | Positive | | Viewer A | AMP5065 | 481 | Positive | | Viewer B | AMP5062 | 480 | Positive | | Viewer C | AMP5062 | 480 | Positive | | Viewer B | AMP5218 | 365 | Positive | {15} 16 Amphetamine (AMP) Cup | Cup format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) | | --- | --- | --- | --- | --- | --- | --- | | Viewer A | Positive | 0 | 0 | 2 | 30 | 10 | | | Negative | 10 | 17 | 11 | 0 | 0 | | Viewer B | Positive | 0 | 0 | 1 | 30 | 10 | | | Negative | 10 | 17 | 12 | 0 | 0 | | Viewer C | Positive | 0 | 0 | 2 | 30 | 10 | | | Negative | 10 | 17 | 11 | 0 | 0 | Discordant Results of AMP Cup | Viewer | Sample Number | GC/MS Result | Cup Format Viewer Results | | --- | --- | --- | --- | | Viewer A | AMP5062 | 480 | Positive | | Viewer A | AMP5065 | 481 | Positive | | Viewer B | AMP5062 | 480 | Positive | | Viewer C | AMP5062 | 480 | Positive | | Viewer C | AMP5065 | 481 | Positive | Cocaine (COC) Dip Card | Dip Card format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) | | --- | --- | --- | --- | --- | --- | --- | | Viewer A | Positive | 0 | 0 | 2 | 30 | 10 | | | Negative | 10 | 18 | 10 | 0 | 0 | | Viewer B | Positive | 0 | 0 | 2 | 30 | 10 | | | Negative | 10 | 18 | 10 | 0 | 0 | | Viewer C | Positive | 0 | 0 | 1 | 29 | 11 | | | Negative | 10 | 18 | 11 | 0 | 0 | {16} Discordant Results of COC DipCard | Viewer | Sample Number | GC/MS Result (ng/mL) | DipCard Format Viewer Results | | --- | --- | --- | --- | | Viewer A | COC1215 | 145 | Positive | | Viewer A | COC1217 | 146 | Positive | | Viewer B | COC1215 | 145 | Positive | | Viewer B | COC1217 | 146 | Positive | | Viewer C | COC1217 | 146 | Positive | Cocaine (COC) Cup | Cup format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) | | --- | --- | --- | --- | --- | --- | --- | | Viewer A | Positive | 0 | 0 | 2 | 30 | 10 | | | Negative | 10 | 18 | 10 | 0 | 0 | | Viewer B | Positive | 0 | 0 | 1 | 30 | 10 | | | Negative | 10 | 18 | 11 | 0 | 0 | | Viewer C | Positive | 0 | 0 | 2 | 30 | 10 | | | Negative | 10 | 18 | 10 | 0 | 0 | Discordant Results of COC Cup | Viewer | Sample Number | GC/MS Result (ng/mL) | Cup Format Viewer Results | | --- | --- | --- | --- | | Viewer A | COC1215 | 145 | Positive | | Viewer B | COC1215 | 145 | Positive | | Viewer C | COC1215 | 145 | Positive | | Viewer C | COC1217 | 146 | Positive | | Viewer A | COC1217 | 146 | Negative | The Wondfo Methamphetamine Urine Test MET 500 (Cup, DipCard) method comparison performance data are found in k122961. {17} b. Matrix comparison: Not applicable. This device is 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): Consumer / lay person study: A lay user study was performed by a total of 840 lay users at three intended user sites: two hospitals and one drug addiction recovery center in P.R. China. The Wondfo Amphetamine Urine Test devices were tested by 280 lay persons, the Wondfo Cocaine Urine Test devices were tested by 280 lay persons and the Wondfo Methamphetamine Urine Test devices were tested by 280 lay persons. The participants had diverse educational and professional backgrounds and ranged in age from 21 to 63 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device (cup or dipcard). Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions could be easily followed. The lay user study was performed using English only labeling. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7. The results are summarized below: 18 {18} Comparison between GC/MS and Amphetamine Cup | % of Cutoff | Number of samples | d-Amphetamine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) | | --- | --- | --- | --- | --- | --- | | | | | No. of Positive | No. of Negative | | | -100% Cutoff | 20 | 0 | 0 | 20 | 100 | | -75% Cutoff | 20 | 126.3 | 0 | 20 | 100 | | -50% Cutoff | 20 | 248.6 | 0 | 20 | 100 | | -25% Cutoff | 20 | 377.1 | 1 | 19 | 95.0 | | +25% Cutoff | 20 | 625.8 | 18 | 2 | 90.0 | | +50% Cutoff | 20 | 753.2 | 20 | 0 | 100 | | +75% Cutoff | 20 | 874.3 | 20 | 0 | 100 | Comparison between GC/MS and Amphetamine Dip Card | % of Cutoff | Number of samples | d-Amphetamine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) | | --- | --- | --- | --- | --- | --- | | | | | No. of Positive | No. of Negative | | | -100% Cutoff | 20 | 0 | 0 | 20 | 100 | | -75% Cutoff | 20 | 126.3 | 0 | 20 | 100 | | -50% Cutoff | 20 | 248.6 | 0 | 20 | 100 | | -25% Cutoff | 20 | 377.1 | 2 | 18 | 90.0 | | +25% Cutoff | 20 | 625.8 | 18 | 2 | 90.0 | | +50% Cutoff | 20 | 753.2 | 20 | 0 | 100 | | +75% Cutoff | 20 | 874.3 | 20 | 0 | 100 | Comparison between GC/MS and Cocaine Cup | % of Cutoff | Number of samples | Benzoylecgonine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) | | --- | --- | --- | --- | --- | --- | | | | | No. of Positive | No. of Negative | | | -100% Cutoff | 20 | 0 | 0 | 20 | 100 | | -75% Cutoff | 20 | 38.1 | 0 | 20 | 100 | | -50% Cutoff | 20 | 75.6 | 0 | 20 | 100 | | -25% Cutoff | 20 | 113.4 | 2 | 18 | 90.0 | | +25% Cutoff | 20 | 186.7 | 18 | 2 | 90.0 | | +50% Cutoff | 20 | 226.3 | 20 | 0 | 100 | | +75% Cutoff | 20 | 259.8 | 20 | 0 | 100 | {19} Comparison between GC/MS and Cocaine Dip Card | % of Cutoff | Number of samples | Benzoylecgonine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) | | --- | --- | --- | --- | --- | --- | | | | | No. of Positive | No. of Negative | | | -100% Cutoff | 20 | 0 | 0 | 20 | 100 | | -75% Cutoff | 20 | 38.1 | 0 | 20 | 100 | | -50% Cutoff | 20 | 75.6 | 0 | 20 | 100 | | -25% Cutoff | 20 | 113.4 | 2 | 18 | 90.0 | | +25% Cutoff | 20 | 186.7 | 18 | 2 | 90.0 | | +50% Cutoff | 20 | 226.3 | 20 | 0 | 100 | | +75% Cutoff | 20 | 259.8 | 20 | 0 | 100 | Comparison between GC/MS and Methamphetamine Cup | % of Cutoff | Number of samples | Methamphetamine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) | | --- | --- | --- | --- | --- | --- | | | | | No. of Positive | No. of Negative | | | -100% Cutoff | 20 | 0 | 0 | 20 | 100 | | -75% Cutoff | 20 | 124.8 | 0 | 20 | 100 | | -50% Cutoff | 20 | 251.3 | 0 | 20 | 100 | | -25% Cutoff | 20 | 377.6 | 2 | 18 | 90.0 | | +25% Cutoff | 20 | 625.9 | 18 | 2 | 90.0 | | +50% Cutoff | 20 | 748.3 | 20 | 0 | 100 | | +75% Cutoff | 20 | 878.1 | 20 | 0 | 100 | Comparison between GC/MS and Methamphetamine Dip Card | % of Cutoff | Number of samples | Methamphetamine Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) | | --- | --- | --- | --- | --- | --- | | | | | No. of Positive | No. of Negative | | | -100% Cutoff | 20 | 0 | 0 | 20 | 100 | | -75% Cutoff | 20 | 124.8 | 0 | 20 | 100 | | -50% Cutoff | 20 | 251.3 | 0 | 20 | 100 | | -25% Cutoff | 20 | 377.6 | 2 | 18 | 90.0 | | +25% Cutoff | 20 | 625.9 | 18 | 2 | 90.0 | | +50% Cutoff | 20 | 748.3 | 20 | 0 | 100 | | +75% Cutoff | 20 | 878.1 | 20 | 0 | 100 | {20} 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 Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 21