WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k122961 B. Purpose for Submission: New Device C. Measurand: Amphetamine, 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 300) Wondfo Methamphetamine Urine Test (MET 500) G. Regulatory Information: | Product code | Classification | Regulation section | Panel | | --- | --- | --- | --- | | DKZ | Class II | 21 CFR §862.3100: Test System, Amphetamine | Toxicology (91) | | LAF | Class II | 21 CFR §862.3610: Test System, Methamphetamine | Toxicology (91) | H. Intended Use: 1. Intended use(s): See Indication(s) for Use 2. Indication(s) for use: Wondfo Amphetamine Urine Test (AMP 300): Wondfo Amphetamine Urine Test (AMP 300) is an immunochromatographic assay for the qualitative determination of d-Amphetamine in human urine at a cutoff concentration 300 ng/mL. The test is available in a Dip Card format and a {1} Cup format. It is only intended for prescription use and is not intended for point-of-care use. 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. **Wondfo Methamphetamine Urine Test (MET 500):** Wondfo Methamphetamine Urine Test (MET 500) is an immunochromatographic assay for the qualitative determination of D(+)-Methamphetamine in human urine at a cutoff concentration 500 ng/mL. The test is available in a Dip Card format and a Cup format. It is only intended for prescription use and is not intended for point-of-care use. 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. 3. **Special conditions for use statement(s):** For prescription use For *in vitro* diagnostic use 4. **Special instrument requirements:** Not applicable, since the devices are visually read single use devices. I. **Device Description:** The AMP 300 and MET 500 Urine tests have two formats: Dip Card format and Cup format. The Dip Card format kit contains a test card and a separate Cup for urine collection. The Cup format kit contains a cup with a built-in test card. Both formats are available as a single test in a pouch with a desiccant. The desiccant is for storage purpose only. The sealed pouch is stable until the expiration date when stored at 4 to 30 °C. J. **Substantial Equivalence Information:** 1. **Predicate device name(s):** ACON® AMP 300 One Step Amphetamine Test Strip, ACON® AMP 300 One Step Amphetamine Test Device ACON® mAMP-500 One Step Methamphetamine Test Strip, ACON® mAMP-500 One Step Methamphetamine Test Device {2} 2. Predicate 510(k) number(s): k041822, k033299 3. Comparison with predicate: Wondfo AMP 300 Urine Test comparison to the predicate device | Item | Candidate Devices: Wondfo Amphetamine Urine Test (AMP 300) | Predicate Devices: ACON AMP 300 One Step Amphetamine Test Strip; ACON AMP 300 One Step Amphetamine Test Device (k041822) | | --- | --- | --- | | Indication(s) for Use | For the qualitative determination of Amphetamine in human urine. | Same | | Calibrator | d-Amphetamine | Same | | Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same | | Type of Test | Immunoassay principles that rely on antigen-antibody interactions to indicate positive or negative result | Same | | Specimen Type | Human Urine | Same | | Cut Off Values | 300 ng/mL | Same | | Configurations | Cup, Dip Card | Test Strip, Test Device | | Intended Use | Prescription Use; Not for Point-of-Care Use | Prescription Use; for Point-of-Care Use | Wondfo MET 500 Urine Test comparison to the predicate device | Item | Candidate Devices: Wondfo Methamphetamine Urine Test (MET 500) | Predicate Devices: ACON mAMP 500 One Step Methamphetamine Test Strip; ACON mAMP 500 One Step Methamphetamine Test Device (k033299) | | --- | --- | --- | | Indication(s) for Use | For the qualitative determination of D(+)-Methamphetamine in human urine. | Same | | Calibrator | D(+)-Methamphetamine | Same | | Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same | | Type of Test | Immunoassay principles that rely on antigen-antibody interactions to indicate positive or negative result | Same | | Specimen Type | Human Urine | Same | | Cut Off Values | 500 ng/mL | Same | {3} | Configurations | Cup, Dip Card | Test Strip, Test Device | | --- | --- | --- | | Intended Use | Prescription Use; Not for Point-of-Care Use | Prescription Use; for Point-of-Care Use | K. Standard/Guidance Document Referenced (if applicable): The sponsor has followed two FDA issued guidance: 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: The AMP 300 and MET 500 Urine Tests employ lateral flow immunochromatographic technology, and are based on competitive binding for the qualitative detection of d-Amphetamine and D(+)-Methamphetamine respectively in human urine. Each assay uses a monoclonal antibody-dye conjugate against drug with gold chloride, fixed drug-protein conjugate and anti-mouse IgG polyclonal antibody coated in a nitrocellulose membrane. When the absorbent 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 the sample drug level is zero or below the target cut off, the 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 indicates a negative result. When the sample drug level is at or above the target cutoff, 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: The precision study was conducted by three operators each testing one of the three lots of the devices used in the study. Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, cutoff, +25% cut off, +50% cut off, +75% cut off and +100% cut off. Samples were prepared, concentrations of each sample confirmed by GC/MS, and then each sample was divided in to 300 aliquots. The 300 sample aliquots were divided in to 12 sets of 25 (one set per lot per run for each format). For each concentration, tests were performed two runs per day per lot for 25 days. The results obtained are summarized in the following {4} tables. ## AMP 300 Urine Tests Cup format | Samples Lot No. | -100% cut off | -75% cut off | -50% cut off | -25% Cut off | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | W0770901CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | W0770902CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | W0770903CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | Dip Card Format | Samples Lot No. | -100% cut off | -75% cut off | -50% cut off | -25% cut off | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | W0770901P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | W0770902P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | W0770903P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | ## MET 500 Urine Tests Cup Format | Samples Lot No. | -100% cut off | -75% cut off | -50% cut off | -25% Cut off | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | W1170901CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | W1170902CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | W1170903CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | Dip Card Format | Samples Lot No. | -100% cut off | -75% cut off | -50% cut off | -25% cut off | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | W1170901P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | W1170902P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | W1170903P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): These devices have internal process control. A colored line appearing in the control region confirms sufficient sample volume flowed through the membrane by capillary action. Users are informed that the test is invalid if a line fails to appear in the control regions. Quality control materials are not supplied with these devices. However, as a {5} good laboratory testing practice to confirm the test procedure and to verify proper test performance, the sponsor recommends that the user test these devices using external controls following the appropriate federal, state and local guidelines. Accelerated stability and real time stability tests were performed on three lots of dip cards and cups for AMP 300 and MET 500 urine test devices using samples at -50% cutoff and +50% cutoff, and negative urine. The stability study results support the claimed shelf life of 18 months at 4 to 30 °C. The transport simulation studies supports that the devices are stable for 3 weeks when exposed to extreme temperatures of -20 °C and 40 °C. d. Detection limit: Analytical performance of the device around the cutoff is described in item M1f (Assay cut-off) below. e. Analytical specificity: Cross Reactivity Studies: To evaluate cross reactivity of the AMP 300 and MET 500 Urine Test devices, the target drug, drug metabolites and the structurally related compounds that may cross-react with the target drugs are tested with three lots of the devices using both the Cup and the Dip Card formats. All compounds are added to drug-free urine to a high target concentration of 100,000 ng/mL. Compounds that tested positive at 100,000 ng/mL concentration were serially diluted and retested until the concentration at which the initial negative result is obtained. Two different groups of operators were assigned to test blinded samples (three operators tested the Cup format and three tested the Dip Card format). Each sample testing and reading is performed by a laboratory assistant using a device from one lot. Each result is confirmed by two other laboratory assistants with relevant experience. Percent cross reactivity of a compound is calculated by dividing the cutoff concentration by the minimum concentration required to obtain a positive result and then multiplying by 100. Identical results were obtained with the cup and dip card formats for the AMP 300 and MET 500 Urine tests. Summary of the study results is as follows: Amphetamine 300 Urine Tests (Cup and Dip Card formats) | AMP(Amphetamine) (d-Amphetamine, Cutoff=300 ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | d-Amphetamine | 300 | 100% | | l-Amphetamine | 17500 | 1.7% | | dl-Amphetamine | 850 | 35.3% | | (+/-) 3,4-methylenedioxyamphetamine | 1000 | 30.0% | {6} | (MDA) | | | | --- | --- | --- | | Phentermine | 1000 | 30.0% | | β-Phenylethylamine | 100000 | 0.3% | | Tyramine | 100000 | 0.3% | | p-Hydroxynorephedrine | 100000 | 0.3% | | Phenylpropanolamine | >100,000 | Not detected | | (±)Phenylpropanolamine | >100,000 | Not detected | | p-Hydroxyamphetamine | 100,000 | 0.3% | | d/l-Norephedrine | 100,000 | 0.3% | | d-Methamphetamine | >100,000 | Not detected | | l-Methamphetamine | >100,000 | Not detected | | (+/-)3,4-Methylenedioxyethylamphetamine (MDE) | >100,000 | Not detected | | (+/-)3,4-Methylenedioxymethamphetamine (MDMA) | >100,000 | Not detected | | Benzphetamine | >100,000 | Not detected | | Ephedrine | >100,000 | Not detected | | l-Ephedrine | >100,000 | Not detected | | l-Epinephrine | >100,000 | Not detected | | d/l-Epinephrine | >100,000 | Not detected | Methamphetamine 500 Urine Tests (Cup and Dip Card formats) | MET(Methamphetamine) (D(+)-Methamphetamine, Cutoff=500 ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross- Reactivity | | --- | --- | --- | | D(+)-Methamphetamine | 500 | 100% | | D-Amphetamine | 50000 | 1.0% | | Chloroquine | 10000 | 5.0% | | (+/-)-Ephedrine | 25000 | 2.0% | | (-)-Methamphetamine | 10000 | 5.0% | | (+/-)3,4-methylenedioxymethamphetamine (MDMA) | 1000 | 50.0% | | β-Phenylethylamine | 25000 | 2.0% | | Trimethobenzamide | 5000 | 10.0% | | d/l-Amphetamine | 75,000 | 0.7% | | p-Hydroxymethamphetamine | 15,000 | 3.3% | | Mephentermine | 25,000 | 2.0% | | (1R,2S)-(-)-Ephedrine | 50,000 | 1.0% | | l-Phenylephrine | 100,000 | 0.5% | Interference Studies: Potential interferences of the test devices with $100\mu \mathrm{g / mL}$ of structurally {7} unrelated compounds (endogenous compounds, drugs, drug metabolites) that are commonly found in the urine was evaluated using three lots of the cup and the dip card using urine controls at $-100\%$ and $\pm 25\%$ cutoff concentration of each analyte. Two different groups of operators were assigned to test blinded samples (three operators tested the Cup format and three tested the Dip Card format). Each sample testing and reading is performed by a laboratory assistant using a device from one lot. Each result is confirmed by two other laboratory assistants with relevant experience. Identical results were obtained with the cup and dip card formats for the AMP 300 and MET 500 Urine tests. The following compounds were found not to cross react when tested at $100~\mu \mathrm{g / mL}$ concentration. Amphetamine 300 Urine Tests (Cup and Dip Card formats) | 4-Acetamidophenol | Clonidine | Hydrocodone | Oxalic acid | | --- | --- | --- | --- | | Acetophenetidin | Cocaine hydrochloride | Hydrocortisone | Oxazepam | | N-Acetylprocainamide | Codeine | O-Hydroxyhippuric acid | Oxolinic acid | | Acetylsalicylic acid | Cortisone | 3-Hydroxytyramine | Oxycodone | | Aminopyrine | (-) Cotinine | Ibuprofen | Oxymetazoline | | Amitryptyline | Creatinine | Imipramine | Papaverine | | Amobarbital | Deoxycorticosterone | (-) Isoproterenol | Penicillin-G | | Amoxicillin | Dextromethorphan | Isoxsuprine | Pentazocaine | | Ampicillin | Diazepam | Ketamine | Pentobarbital | | Ascorbic acid | Diclofenac | Ketoprofen | Perphenazine | | Apomorphine | Diflunisal | Labetalol | Phencyclidine | | Aspartame | Digoxin | Levorphanol | Phenelzine | | Atropine | Diphenhydramine | Loperamide | Phendimetrazine | | Benzilic acid | Doxylamine | Maprotiline | Phenobarbital | | Benzoic acid | Ecgonine hydrochloride | Meperidine | Phetoin | | Benzoylecgonine | Ecgonine methylester | Meprobamate | L-Phenylephrine | | Bilirubin | (IR,2S)-(-)-Ephedrine | Methadone | β-Phenylethlamine | | Brompheniramine | L-Ephedrine | Methylphenidate | Phenylpropanolamine | | Caffeine | (-) Y Ephedrine | Morphine-3-Dglucuronide | Prednisolone | | Cannabidiol | Erythromycin | Nalidixic acid | Prednisone | | Cannabinol | β-Estradiol | Naloxone | Procaine | | Chloralhydrate | Estrone-3-sulfate | Naltrexone | Promazine | | Chloramphenicol | Ethyl-p-aminobenzoate | Naproxen | Promethazine | | Chlordiazepoxide | Fenfluramine | Niacinamide | D,L-Propanolol | | Chlorothiazide | Fenoprofen | Nifedipine | Propiomazine | | (±)Chlorpheniramine | Furosemide | Norcodein | D-Propoxyphene | | Chlorpromazine | Gentisic acid | Norethindrone | Quinidine | | Chlorquine | Hemoglobin | D-Norpropoxyphene | Quinine | | Cholesterol | Hydralazine | Noscapine | Ranitidine | | Clomipramine | Hydrochlorothiazide | D,L-Octopamine | Salicylic acid | | Secobarbital | Tetrahydrocortisone | D,L-Thyroxine | Tryptamine | | Serotonin | Tetrahydrozoline | Tolbutamine | D, L-Tyrosine | | Sulfamethazine | Δ9-THC-COOH | Triamterene | Uric acid | {8} Methamphetamine 500 Urine Tests (Cup and Dip Card formats) | A cetamidophen | Diphenhydramine | Methylphenidal | D,L-Propanolol | | --- | --- | --- | --- | | Acetophenetidin | Doxylamine | Methyprylon | D-Propoxyphene | | N-Acetylprocainamide | Ecgonine hydrochloride | Morphine-3-β-Dglucuronide | D-Pseudoephedrine | | Acetylsalicylate | Ecgonine methyl ester | Nalidixic acid | Quinidine | | Aminopyrine | Erythromycin | Nalorphine | Quinine | | Amitryptyline | β-Estradiol | Naloxone | Ranitidine | | Amobarbital | Estrone-3-sulfate | Naltrexone | Salicylic acid | | Amoxicillin | Ethyl-p-aminobenzoate | Naproxen | Secobarbital | | Ampicillin | Fenoprofen | Niacinamide | Serotonin (5-Hydroxytyramine) | | Apomorphine | Furosemide | Nifedipine | Sulfamethazine | | Aspartame | Gentisic acid | Norcodein | Sulindac | | Atropine | Glucuronide | Norethindrone | Temazepam | | Benzilic acid | Glutethimide | Noroxymorphone | Tetracycline | | Benzoic acid | Guaifenesin | D-Norpropoxyphene | Tetrahydrocortisone, 3-Acetate | | Benzoylecgonine | Hippuric acid | Noscapine | Tetrahydrocortisone 3 (β-D glucuronide) | | Butabartital | Hydralazine | Nylidrin | Tetrahydrozoline | | Cannabidiol | Hydrochlorothiazide | D,L-Octopamine | Thebaine | | Chloralhydrate | Hydrocodone | Oxalic acid | Thiamine | | Chloramphenicol | Hydrocortisone | Oxazepam | Thioridazine | | Chlordiazepoxide | O-Hydroxyhippuric acid | Oxolinic acid | Tolbutamine | | Chlorothiazide | 3-Hydroxytyramine | Oxycodone | Triamterene | | Chlorpromazine | Ibuprofen | Oxymetazoline | Trifluoperazine | | Cholesterol | Imipramine | Papaverine | Trimethoprim | | Clomipramine | (-) Isoproterenol | Penicillin-G | Trimipramine | | Clonidine | Isoxsuprine | Pentazocine | D, L-Tryptophan | | Cocaine hydrochloride | Ketamine | Pentobarbital | Tyramine | | Codeine | Ketoprofen | Perphenazine | D, L-Tyrosine | | Cortisone | Labetalol | Phencyclidine | Uric acid | | (-) Cotinine | Levorphanol | Phenelzine | Verapamil | | Creatinine | Loperamide | Phenobarbital | Zomepirac | | Deoxycorticosterone | Loxapine succinate | Prednisolone | Digoxin | | Dextromethorphan | Maprotiline | Phenylpropanolamine | Methaqualone | | Diazepam | Meperidine | Prednisone | Promethazine | | Diclofenac | Meprobamate | Procaine | | | Diflunisal | Methadone | Promazine | | {9} pH: The pH of an aliquoted negative urine pool was adjusted to a pH range of 4.00 to 9.00 in increments of one pH, and was spiked with $\pm 25\%$ cutoff concentration of each analyte. Two different groups of operators were assigned to test blinded samples (three operators tested the Cup format and three tested the Dip Card format). Each sample testing and reading is performed by a laboratory assistant using a device from one lot. Each result is read by two other laboratory assistants with relevant experience. Identical results were obtained with the cup and dip card formats for the AMP 300 and MET 500 Urine tests. The pH range of 4.00 to 9.00 does not affect the accuracy of the cup and dip card formats for the AMP 300 and MET 500 Urine tests. Specific gravity: The specific gravity of an aliquoted negative urine pool was adjusted to 1.000, 1.003, 1.007, 1.008, 1.017, 1.019, 1.020, 1.025, 1.030, 1.031, 1.033 and 1.035, and was spiked with $\pm 25\%$ cutoff concentration of each analyte. Two different groups of operators were assigned to test blinded samples (three operators tested the Cup format and three tested the Dip Card format). Each sample testing and reading is performed by a laboratory assistant using a device from one lot. Each result is read by two other laboratory assistants with relevant experience. Identical results were obtained with the cup and dip card formats for the AMP 300 and MET 500 Urine tests. The specific gravity range of 1.000 to 1,035 does not affect the accuracy of the cup and dip card formats for the AMP 300 and MET 500 Urine tests. f. Assay cut-off: The assay cutoff is established using 25 clinical samples ranging in concentrations from $\sim -50\%$ to $\sim +50\%$ of amphetamine cutoff of $300~\mathrm{ng/mL}$ for AMP 300 urine test, and 25 clinical samples ranging in concentrations from $\sim -50\%$ to $\sim +50\%$ of methamphetamine cutoff of $500~\mathrm{ng/mL}$ for MET 500 urine test. Additionally, 125 drug-free urine samples were spiked with amphetamine and 125 drug-free urine samples were spiked with methamphetamine to prepare samples at concentrations of $-50\%$, $-25\%$, cutoff, $+25\%$ and $+50\%$ respectively of AMP cutoff of $300~\mathrm{ng/mL}$ and MET cutoff of $500~\mathrm{ng/mL}$. The true drug concentrations in each sample were read by GC/MS. Each sample is tested with three lots of the cup format and the dip card format by two separate groups of operators (one for the cup format and one for the dip card format). Three operators in each group who are blind to the samples, performed the test. Each result was confirmed by two other laboratory assistants with relevant experience. The results of the assay cutoff study are as follows: {10} # AMP 300 Urine Tests Cup Format | Concentration ng/mL | Cutoff range | n | W0770901CU2 | | W0770902CU2 | | W0770903CU2 | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | - | + | - | + | - | + | - | + | | 150 | -50% Cutoff | 30 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | | 225 | -25% Cutoff | 30 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | | 300 | Cutoff | 30 | 1 | 29 | 2 | 28 | 3 | 27 | 6 | 84 | | 375 | +25% Cutoff | 30 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | | 450 | +50% Cutoff | 30 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | Dip Card Format | Concentration ng/mL | Cutoff range | n | W0770901P | | W0770902P | | W0770903P | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | - | + | - | + | - | + | - | + | | 150 | -50% Cutoff | 30 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | | 225 | -25% Cutoff | 30 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | | 300 | Cutoff | 30 | 3 | 27 | 2 | 28 | 2 | 28 | 7 | 83 | | 375 | +25% Cutoff | 30 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | | 450 | +50% Cutoff | 30 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | # MET 500 Urine Tests Cup Format | Concentration ng/mL | Cutoff range | n | W1170901CU2 | | W1170902CU2 | | W1170903CU2 | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | - | + | - | + | - | + | - | + | | 250 | -50% Cutoff | 30 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | | 375 | -25% Cutoff | 30 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | | 500 | Cutoff | 30 | 3 | 27 | 3 | 27 | 2 | 28 | 8 | 82 | | 625 | +25% Cutoff | 30 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | | 750 | +50% Cutoff | 30 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | Dip Card Format | Concentration ng/mL | Cutoff range | n | W1170901P | | W1170902P | | W1170903P | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | - | + | - | + | - | + | - | + | | 250 | -50% Cutoff | 30 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | | 375 | -25% Cutoff | 30 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | | 500 | Cutoff | 30 | 2 | 28 | 2 | 28 | 3 | 27 | 7 | 83 | | 625 | +25% Cutoff | 30 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | | 750 | +50% Cutoff | 30 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 2. Comparison studies: a. Method comparison with predicate device: Method comparison studies were performed by comparing the AMP 300 and {11} MET 500 Urine Tests (both the Dip Card and the Cup formats) with the GC/MS reference method. Eighty unaltered samples collected from a drug addiction recovery center were studied using one lot of each format for each analyte. These samples range from drug-free urine (10), $< -50\%$ cutoff, $-50\%$ cutoff $\sim$ cutoff, Cutoff $\sim +50\%$ cutoff and $> +50\%$ cutoff of AMP. Each result was read by three experienced laboratory assistants. A summary of results of the method comparison studies is as follows: # AMP 300 Urine Tests Cup Format | Results read by lab assistants (group 1) | Wondfo Cup Format Device Results | Negative by GC/MS (drug-free) | Low Negative by GC/Ms (less than -50% cutoff) | Near Cutoff Negative by GC/MS (between -50% cutoff and cutoff) | Near Cutoff Positive by GC/MS (between the cutoff and +50% cutoff) | High Positive by GC/MS (greater than +50% cutoff) | | --- | --- | --- | --- | --- | --- | --- | | Viewer A | Positive | 0 | 0 | 2 | 29 | 11 | | | Negative | 10 | 17 | 11 | 0 | 0 | | Viewer B | Positive | 0 | 0 | 1 | 29 | 11 | | | Negative | 10 | 17 | 12 | 0 | 0 | | Viewer C | Positive | 0 | 0 | 1 | 29 | 11 | | | Negative | 10 | 17 | 12 | 0 | 0 | Dip Card Format | Results read by lab assistants (group 2) | Wondfo Dip Card Format Device Results | Negative by GC/MS (drug-free) | Low Negative by GC/Ms (less than -50% cutoff) | Near Cutoff Negative by GC/MS (between -50% cutoff and cutoff) | Near Cutoff Positive by GC/MS (between the cutoff and +50% cutoff) | High Positive by GC/MS (greater than +50% cutoff) | | --- | --- | --- | --- | --- | --- | --- | | Viewer A | Positive | 0 | 0 | 1 | 29 | 11 | | | Negative | 10 | 17 | 12 | 0 | 0 | | Viewer B | Positive | 0 | 0 | 1 | 29 | 11 | | | Negative | 10 | 17 | 12 | 0 | 0 | | Viewer C | Positive | 0 | 0 | 1 | 29 | 11 | | | Negative | 10 | 17 | 12 | 0 | 0 | {12} Discordant Results of AMP 300 Urine Tests | Viewer | Sample Number | GC/MS Result | Viewer Result | | --- | --- | --- | --- | | Cup Format | | | | | Viewer A | AMP3063 | 281 | Positive | | Viewer A | AMP3216 | 259 | Positive | | Viewer B | AMP3218 | 287 | Positive | | Viewer C | AMP3063 | 281 | Positive | | Dip Card Format | | | | | Viewer A | AMP3218 | 287 | Positive | | Viewer B | AMP3216 | 259 | Positive | | Viewer C | AMP3063 | 281 | Positive | # MET 500 Urine Tests Cup Format | Results read by lab assistants (group 1) | Wondfo Cup Format Device Results | Negative by GC/MS (drug-free) | Low Negative by GC/MS (less than -50% cutoff) | Near Cutoff Negative by GC/MS (between -50% cutoff and cutoff) | Near Cutoff Positive by GC/MS (between the cutoff and +50% cutoff) | High Positive by GC/MS (greater than +50% cutoff) | | --- | --- | --- | --- | --- | --- | --- | | Viewer A | Positive | 0 | 0 | 2 | 20 | 20 | | | Negative | 10 | 15 | 13 | 0 | 0 | | Viewer B | Positive | 0 | 0 | 2 | 20 | 20 | | | Negative | 10 | 15 | 13 | 0 | 0 | | Viewer C | Positive | 0 | 0 | 2 | 20 | 20 | | | Negative | 10 | 15 | 13 | 0 | 0 | Dip Card Format | Results read by lab assistants (group 2) | Wondfo Dip Card Format Device Results | Negative by GC/MS (drug-free) | Low Negative by GC/MS (less than -50% cutoff) | Near Cutoff Negative by GC/MS (between -50% cutoff and cutoff) | Near Cutoff Positive by GC/MS (between the cutoff and +50% cutoff) | High Positive by GC/MS (greater than +50% cutoff) | | --- | --- | --- | --- | --- | --- | --- | | Viewer A | Positive | 0 | 0 | 1 | 20 | 20 | | | Negative | 10 | 15 | 14 | 0 | 0 | | Viewer B | Positive | 0 | 0 | 1 | 20 | 20 | | | Negative | 10 | 15 | 14 | 0 | 0 | {13} 14 | Viewer C | Positive | 0 | 0 | 2 | 20 | 20 | | --- | --- | --- | --- | --- | --- | --- | | | Negative | 10 | 15 | 13 | 0 | 0 | Discordant Results of MET 500 Urine Tests | Viewer | Sample Number | GC/MS Result | Viewer Result | | --- | --- | --- | --- | | Cup Format | | | | | Viewer A | MET5061 | 478 | Positive | | Viewer A | MET5216 | 474 | Positive | | Viewer B | MET5063 | 499 | Positive | | Viewer B | MET5215 | 421 | Positive | | Viewer C | MET5061 | 478 | Positive | | Viewer C | MET5063 | 499 | Positive | | Dip Card Format | | | | | Viewer A | MET5063 | 499 | Positive | | Viewer B | MET5061 | 478 | Positive | | Viewer C | MET5061 | 478 | Positive | | Viewer C | MET5063 | 499 | Positive | The results indicate a similar positive, negative, and overall agreement rates for both AMP 300 and MET 500 urine tests using the cup and the dip card formats. The overall average agreement between the Wondfo devices and GC/MS is represented in the following table: | Percent Agreement | AMP 300 Cup format | AMP 300 Dip Card format | MET 500 Cup format | MET 500 Dip Card format | | --- | --- | --- | --- | --- | | Positive | 100% | 100% | 100% | 100% | | Negative | 96.7% | 97.5% | 95% | 96.7% | | Total | 98.4% | 98.8% | 97.5% | 98.4% | b. Matrix comparison: Not applicable; these devices are for use with urine 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. {14} 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. 15