AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY ## I Background Information: A 510(k) Number K234006 B Applicant AllSource Screening Solutions C Proprietary and Established Names AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | NGL | Class II | 21 CFR 862.3650 - Opiate Test System | TX - Clinical Toxicology | ## II Submission/Device Overview: A Purpose for Submission: New device B Measurand: Fentanyl C Type of Test: Qualitative lateral flow immunochromatographic assay ## III Intended Use/Indications for Use: A Intended Use(s): See Indications for Use below. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} K234006 - Page 2 of 9 ## B Indication(s) for Use: AllSource Drug Detector FenTest is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at the cutoff concentrations of 1 ng/mL. 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 or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only. The AllSource Drug Detector Fentanyl Test is a rapid, one-step immunoassay for the qualitative detection of fentanyl in human urine at the cutoff concentrations of 1 ng/mL. This device provides only preliminary drug test results. To obtain a quantitative result or a confirmation of a presumptive positive result, a more specific alternative method must be used. GC/MS or LC/MS is the preferred confirmatory method. Professional judgment should be applied to drug test results, particularly when preliminary positive results are indicated. It is for in vitro diagnostic use only. ## C Special Conditions for Use Statement(s): OTC – Over The Counter ## D Special Instrument Requirements: None ## IV Device/System Characteristics: ### A Device Description: AllSource Drug Detector Fentanyl Test is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllSource Drug Detector Fentanyl Test device consists of a Test Dip Card and a package insert. Each Test Dip Card is sealed with sachets of desiccant in an aluminum pouch. ### B Principle of Operation: AllSource Drug Detector Fentanyl Test is a competitive and immunochromatography assay, and uses monoclonal antibody as the indicator marker to qualitatively detect fentanyl in human urine. The test cassette contains fentanyl test strip. The nitrocellulose membrane test area (T) of the test strip is correspondingly coated with fentanyl-bovine serum albumin conjugate, and the quality control area (C) is coated with goat anti-rabbit IgG polyclonal antibody. When the concentration {2} of fentanyl in the sample is higher than or equal to the cut-off of the product, it will compete with the corresponding conjugate coated on the test area (T) to bind to the monoclonal antibody, the test line is inhibited and the result is positive; while when the sample does not contain fentanyl or its concentration is lower than the cut-off of the product, the corresponding conjugate on the test line reacts with sufficient monoclonal antibodies; the test line will be visible and the result is negative. If there is no control line, it is an invalid result. V Substantial Equivalence Information: A Predicate Device Name(s): AllTest Fentanyl Urine Test Cassette B Predicate 510(k) Number(s): K233417 C Comparison with Predicate(s): | Device & Predicate Device(s): | K234006 | K233417 | | --- | --- | --- | | Device Trade Name | AllSource Drug Detector Fentanyl Test | AllTest Fentanyl Urine Test Cassette | | General Device Characteristic Similarities | | | | Intended Use/Indications For Use | For the qualitative determination of fentanyl in human urine. | Same | | Specimen | Human urine | Same | | Methodology | Competitive binding, lateral flow immunochromatographi c assay based on antigen-antibody reaction | Same | | Cut-off | 1 ng/ml | Same | | General Device Characteristic Differences | | | | Configuration | Dip Card | Cassette | VI Standards/Guidance Documents Referenced: CLSI Guideline EP5-A3: Evaluation of Precision Performance of Quantitative Measurement Methods. K234006 - Page 3 of 9 {3} K234006 - Page 4 of 9 # VII Performance Characteristics (if/when applicable): ## A Analytical Performance: ### 1. Precision/Reproducibility: Precision studies were carried out in three sites for samples with concentrations of +100% cutoff, +75% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cut off and -100% cutoff. These samples were prepared by spiked target drug in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. All sample aliquots were blindly labeled by the person who prepared the samples but didn't take part in the sample testing. For each concentration, tests were performed two tests per day for 10 days per device lot in a randomized order by three operators. | Lot Number | -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 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Lot 1 | 60-/0+ | 60-/0+ | 60-/0+ | 46-/14+ | 28+/32- | 60+/0- | 60+/0- | 60+/0- | 60+/0- | | Lot 2 | 60-/0+ | 60-/0+ | 60-/0+ | 44-/16+ | 28+/32- | 60+/0- | 60+/0- | 60+/0- | 60+/0- | | Lot 3 | 60-/0+ | 60-/0+ | 60-/0+ | 45-/15+ | 30+/30- | 60+/0- | 60+/0- | 60+/0- | 60+/0- | ### 2. Linearity: Not Applicable. ### 3. Analytical Specificity/Interference: #### Cross-Reactivity: To test cross-reactivity, drug metabolites and other structurally related compounds that are likely to cross-react in urine samples were spiked into negative urine and were tested using three device lots. The lowest concentration that caused a positive result for each compound is listed below (if no cross reactivity was observed the highest concentration tested is shown): | Cross Reactant | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | | --- | --- | --- | | Norfentanyl | 50 | 2% | | Acetyl fentanyl | 1 | 100% | | Acrylfentanyl | 10 | 10% | | Isobutyryl fentanyl | 2.5 | 40% | | Ocfentanil | 10 | 10% | | Butyryl fentanyl | 2.5 | 40% | | Furanyl fentanyl | 7.5 | 13.3% | | Valeryl fentanyl | 10 | 10% | | (±) β-hydroxythiofentanyl | 5 | 20% | | Para-fluorobutyrylfentanyl (p-FBF) | 10 | 10% | {4} K234006 - Page 5 of 9 | Para-fluoro fentanyl | 1 | 100% | | --- | --- | --- | | (±)-3-cis-methylfentanyl | 10 | 10% | | Carfentanil | 10000 | 0.01% | | Sufentanil | 10000 | 0.01% | | Norcarfentanil | 100000 | <0.001% | | Acetyl norfentanyl | 10 | 10% | | Remifentanil | 10000 | 0.01% | | Alfentanil | 10000 | 0.01% | | ω-1-Hydroxyfentanyl | 20000 | 0.005% | | 4-Fluoro-isobutyrylfentanyl | 50 | 2% | | Despropionyl fentanyl (4-ANPP) | 2500 | 0.04% | The following opioids compounds were tested at a concentration of 100µg/mL. Negative results were obtained for all these compounds. | 6-Acetyl morphine | Naltrexone | | --- | --- | | Amphetamine | Norbuprenorphine | | Buprenorphine | Norcodeine | | Buprenorphineglucuronide | Norketamine | | Codeine | Normeperidine | | Dextromethorphan | Normorphine | | Dihydrocodeine | Noroxycodone | | EDDP | Oxycodone | | EMDP | Oxymorphone | | Fluoxetine | Pentazocine (Talwin) | | Heroin | Pipamperone | | Hydrocodone | Risperidone | | Hydromorphone | Tapentadol | | Ketamine | Thioridazine | | Levorphanol | Tilidine | | Meperidine | Tramadol | | Methadone | Tramadol-O-Desmethyl | | Morphine | Tramadol-N-Desmethyl | | Morphine-3-glucuronide | Trazodone | | Naloxone | | ## Interfering substances: To evaluate potential interference, non-structurally related compounds were added to drug-free urine and target drug fentanyl urine with concentrations at 50% below and 50% above the cutoff. Compounds that show no interference at a concentration of 100µg/mL are summarized in the following table. | Acetaminophen | Doxepin | Nortriptyline | | --- | --- | --- | | Acetone (1000mg/dL) | Ecgonine methyl ester | Noscapine | | Acetophenetidin | Ephedrine | O-Hydroxyhippuric acid | | Acetylsalicylic acid | Erythromycin | Octopamine | {5} K234006 - Page 6 of 9 | Albumin (100mg/dL) | Ethanol (1%) | Oxalic acid (100 mg/dL) | | --- | --- | --- | | Albuterol | Fenoprofen | Oxazepam | | Aminopyrine | Fluphenazine | Oxolinic acid | | Amitriptyline | Furosemide | Oxymetazoline | | Amobarbital | Galactose (10mg/dL) | Papaverine | | Amoxicillin | Gamma Globulin (500mg/dL) | Penicillin G | | Ampicillin | Gentisic acid | Perphenazine | | Apomorphine | Glucose (3000mg/dL) | Phencyclidine | | Ascorbic acid | Hemoglobin | Phenelzine | | Aspartame | Hydralazine | Phenobarbital | | Atropine | Hydrochlorothiazide | Prednisone | | Benzilic acid | Hydrocortisone | Propoxyphene (50μg/ml) | | Benzoic acid | Hydroxytyramine | Propranolol | | Benzoylecgonine | Ibuprofen | Pseudoephedrine | | Bilirubin | Imipramine | Quinine | | Boric Acid (1%) | Isoproterenol | Ranitidine | | Bupropion | Isoxsuprine | Riboflavin (10mg/dL) | | Caffeine | Ketamine | Salicylic acid | | Carbamazepine | Ketoprofen | Secobarbital | | Chloral hydrate | Labetalol | Serotonin (5-Hydroxytyramine) | | Chloramphenicol | Lidocaine | Sulfamethazine | | Chlorothiazide | Loperamide | Sulindac | | Chlorpromazine | Maprotiline | Tetrahydrocortisone 3-(β-Dglucuronide) | | Cholesterol | Meperidine | Tetrahydrocortisone 3-acetate | | Clomipramine | Meprobamate | Tetrahydrozoline | | Clonidine | Methapyrilene | Thiamine | | Cortisone | Methaqualone | Thioridazine | | Cotinine | Methoxyphenamine | Triamterene | | Creatinine | Metronidazole (300ug/ml) | Trifluoperazine | | Cyclobenzaprine | N-Acetylprocainamide | Trimethoprim | | Deoxycorticosterone | NaCl (4000mg/dL) | Tyramine | | Desipramine | Nalidixic acid | Urea (2000mg/dL) | | Dextromethorphan | Naloxone | Uric acid | | Diclofenac | Naltrexone | Valproic acid (250μg/ml) | | Diflunisal | Naproxen | Venlafaxine | | Digoxin | Niacinamide | Verapamil | | Diphenhydramine | Nicotine | Zomepirac | | DL-Tryptophan | Nifedipine | β-Estradiol | | DL-Tyrosine | Norethindrone | | {6} K234006 - Page 7 of 9 # Effect of Urinary Specific Gravity and pH: To investigate the effect of urine specific gravity and urine pH, urine samples, with specific gravity ranging from 1.000 to 1.035 or urine samples with pH ranging from 4 to 9 were spiked with the target drugs to concentrations at 50% below and 50% above Cutoff levels. These samples were tested using three lots of device. The results demonstrated that pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 do not affect the results of the assays. 4. Assay Reportable Range: Not Applicable 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods): The device is traceable to commercially available materials. 6. Detection Limit: Not applicable. 7. Assay Cut-Off: Refer to Section VII.A.1 # B Comparison Studies: 1. Method Comparison with Predicate Device: Method comparison studies for the AllSource Drug Detector Fentanyl Test were performed at three point-of-care test sites. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below. | | | Negative | Low Negative by LC/MS (Less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (Greater than +50%) | | --- | --- | --- | --- | --- | --- | --- | | Site 1 | Positive | 0 | 0 | 4 | 22 | 17 | | | Negative | 10 | 17 | 9 | 1 | 0 | | Site 2 | Positive | 0 | 0 | 6 | 21 | 17 | | | Negative | 10 | 17 | 7 | 2 | 0 | | Site 3 | Positive | 0 | 0 | 6 | 21 | 17 | | | Negative | 10 | 17 | 7 | 2 | 0 | Discordant Results: | Site | Sample Number | LC/MS Result (ng/mL) | AllSource Result | | --- | --- | --- | --- | | Site 1 | CP167 | 0.835 | Positive | | Site 1 | CP322 | 0.937 | Positive | {7} | Site 1 | CP298 | 0.941 | Positive | | --- | --- | --- | --- | | Site 1 | CP127 | 0.967 | Positive | | Site 1 | CP365 | 1.059 | Negative | | Site 2 | CP352 | 0.792 | Positive | | Site 2 | CP167 | 0.835 | Positive | | Site 2 | CP322 | 0.937 | Positive | | Site 2 | CP318 | 0.957 | Positive | | Site 2 | CP127 | 0.967 | Positive | | Site 2 | CP191 | 0.98 | Positive | | Site 2 | CP365 | 1.059 | Negative | | Site 2 | CP279 | 1.036 | Negative | | Site 3 | CP308 | 0.818 | Positive | | Site 3 | CP294 | 0.838 | Positive | | Site 3 | CP298 | 0.941 | Positive | | Site 3 | CP318 | 0.957 | Positive | | Site 3 | CP127 | 0.967 | Positive | | Site 3 | CP191 | 0.98 | Positive | | Site 3 | CP253 | 1.099 | Negative | | Site 3 | CP365 | 1.059 | Negative | 2. Lay user study: A lay user study was performed at three intended user sites with 140 lay persons. They had diverse educational and professional backgrounds and ranged in age from 18 to $&gt;50$ years. Urine samples were prepared at the following concentrations: $-100\%$ , $+/-75\%$ , $+/-50\%$ , $+/-25\%$ of the cut-off by spiking fentanyl into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers, blind-labeled and randomized. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below: | % Cutoff | Number of samples | Fentanyl Concentration (ng/mL) | Results | | Correct results (%) | | --- | --- | --- | --- | --- | --- | | | | | Number of Positive | Number of Negative | | | -100% Cutoff | 20 | 0 | 0 | 20 | 100 | | -75% Cutoff | 20 | 0.31 | 0 | 20 | 100 | | -50% Cutoff | 20 | 0.48 | 0 | 20 | 100 | | -25% Cutoff | 20 | 0.77 | 5 | 15 | 75 | | +25% Cutoff | 20 | 1.22 | 20 | 0 | 100 | | +50% Cutoff | 20 | 1.42 | 20 | 0 | 100 | | +75% Cutoff | 20 | 1.78 | 20 | 0 | 100 | 3. Matrix Comparison: Not applicable. C Clinical Studies: Not applicable. K234006 - Page 8 of 9 {8} 1. Clinical Sensitivity: Not applicable. 2. Clinical Specificity: Not applicable. 3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable): Not applicable. D Clinical Cut-Off: Not applicable. E Expected Values/Reference Range: Not applicable. VIII Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. IX Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. K234006 - Page 9 of 9