ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE

{0} # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE ONLY TEMPLATE A. 510(k) Number: K040445 B. Analyte: Propoxyphene C. Type of Test: Qualitative immunoassay D. Applicant: Acon Laboratories, Inc. E. Proprietary and Established Names: ACON® One Step Propoxyphene Test Device and Test Strip F. Regulatory Information: 1. Regulation section: 21 CFR § 862.3700 2. Classification: Class II 3. Product Code: JXN 4. Panel: Toxicology (91) G. Intended Use: 1. Intended use(s): Refer to Indications for use. 2. Indication(s) for use: The ACON® One Step Propoxyphene Test Device and Test Strip are enzyme immunoassays for the qualitative determination of propoxyphene in human urine. The assay has a cutoff concentration of 300 ng/mL. The device is for in vitro diagnostic use. The device is for prescription use. 3. Special condition for use statement(s): The ACON® One Step Propoxyphene Test Device and Test Strip provide only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas {1} Page 2 of 16 chromatography/Mass spectrometry is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The assay is intended for use in point-of-care settings. 4. Special instrument Requirements: Not applicable. The device is a visually read single-use device. H. Device Description: This submission includes both a single-use dipstick (referred to as a test strip) and a cassette (referred to as a test device). With the dipstick, operators dip the test strip into the urine and the reaction is initiated by movement of the sample through the test strip. With the cassette, operators add several drops of the sample to the sample well. The test reaction is initiated by movement of the sample through the test strip. I. Substantial Equivalence Information: 1. Predicate device name(s): Instant-View® Propoxyphene (PPX) Urine Test Cassette 2. Predicate K number(s): K022915 3. Comparison with predicate: Both devices are for the qualitative determination of the same analyte in the same matrix, and utilize the same cutoff concentration. Both are visually-read single use devices. | Similarities | | | | --- | --- | --- | | Item | Devices (Dipstick and Cassette) | Predicate | | Methodology | Same | Lateral flow immunochromatographic | | Type of assay | Same | Qualitative | | Matrix | Same | Urine | | Cutoff | Same | 300 ng/mL | | Intended user | Same | Professional use | | Endpoint | Same | Colored lines | | Differences | | | | Item | Device (Dipstick and Cassette) | Predicate | | Read time | 5 minutes | 4 – 7 minutes | {2} Page 3 of 16 ## J. Standard/Guidance Document Referenced (if applicable): The sponsor referenced the following guidance document(s) in their submission: Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests - Draft Guidance for Industry and FDA Staff, published December 2003 The sponsor indicated deviation from this guidance in regards to interference testing. ## K. Test Principle: The test employs lateral flow immunochromatographic technology. Drug in the sample and drug-labeled conjugate (containing a chromagen) compete for antibody binding sites in the test area of the test strip. Binding of drug in the sample causes the absence of a line at the test area, i.e., a positive result. When drug is not present in the sample, the drug-labeled conjugate binds at the test line, resulting in formation of a line, i.e., a negative result. The absence or presence of the line is determined visually by the operator. The test antibody consists of monoclonal mouse antibody against propoxyphene. The internal process control consists of goat anti-rabbit IgG antibody as the stationary phase and rabbit IgG-colloidal gold conjugate as the mobile phase. ## L. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Specimen description: drug free urine spiked with propoxyphene Number of days: three Replicates per day: ten Lots of product used: three Number of operators: three Operator: laboratorian Testing Facility: manufacturer's laboratory Results of the study are presented below: {3} Page 4 of 16 Propoxyphene Precision Study Results, Lot 1, Day 1 – Test Strip | Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos | | --- | --- | --- | | 0 | 30 | 30/0 | | 150 | 30 | 30/0 | | 225 | 30 | 24/6 | | 375 | 30 | 7/23 | | 450 | 30 | 0/30 | | 600 | 30 | 0/30 | Propoxyphene Precision Study Results, Lot 2, Day 2 – Test Strip | Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos | | --- | --- | --- | | 0 | 30 | 30/0 | | 150 | 30 | 30/0 | | 225 | 30 | 25/5 | | 375 | 30 | 8/22 | | 450 | 30 | 0/30 | | 600 | 30 | 0/30 | Propoxyphene Precision Study Results, Lot 3, Day 3 – Test Strip | Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos | | --- | --- | --- | | 0 | 30 | 30/0 | | 150 | 30 | 30/0 | | 225 | 30 | 26/4 | | 375 | 30 | 7/23 | | 450 | 30 | 0/30 | | 600 | 30 | 0/30 | Propoxyphene Precision Study Results, Lot 1, Day 1 – Test Device | Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos | | --- | --- | --- | | 0 | 30 | 30/0 | | 150 | 30 | 30/0 | | 225 | 30 | 26/4 | | 375 | 30 | 8/22 | | 450 | 30 | 0/30 | | 600 | 30 | 0/30 | {4} Page 5 of 16 Propoxyphene Precision Study Results, Lot 2, Day 2 – Test Device | Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos | | --- | --- | --- | | 0 | 30 | 30/0 | | 150 | 30 | 30/0 | | 225 | 30 | 26/4 | | 375 | 30 | 7/23 | | 450 | 30 | 0/30 | | 600 | 30 | 0/30 | Propoxyphene Precision Study Results, Lot 3, Day 3 – Test Device | Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos | | --- | --- | --- | | 0 | 30 | 30/0 | | 150 | 30 | 30/0 | | 225 | 30 | 27/3 | | 375 | 30 | 7/23 | | 450 | 30 | 0/30 | | 600 | 30 | 0/30 | b. Linearity/assay reportable range: Not applicable. The assay is intended for qualitative use. c. Traceability (controls, calibrators, or method): Control materials are required but are not specifically identified in the labeling. The sponsor’s Package Insert directs the user to follow local, state, and federal guidelines for testing QC materials and to process the controls in the same manner as unknown samples The device has an internal process control which confirms sufficient specimen volume, adequate membrane wicking, and correct procedural technique. d. Detection limit: Sensitivity of this assay is characterized by validating performance around the claimed cutoff concentration of the assay, including a determination of the lowest concentration of drug that is capable of producing a positive result. {5} Page 6 of 16 Drug-free urine specimens were spiked with propoxyphene to concentrations of 0, 150, 225, 300, 375, 450, and 600 ng/mL. The spiked samples were then tested with both the test strip and test device, with the following results: Test Strip | Concentration of sample, ng/mL | % 0f cutoff | Number of determinations | Results # Neg/ #Pos | | --- | --- | --- | --- | | 0 | 0 | 30 | 30/0 | | 150 | -50% | 30 | 30/0 | | 225 | -25% | 30 | 24/6 | | 300 | Cutoff | 30 | 17/13 | | 375 | +25% | 30 | 7/23 | | 450 | +50% | 30 | 0/30 | | 600 | +100% | 30 | 0/30 | Test Device | Concentration of sample, ng/mL | % 0f cutoff | Number of determinations | Results # Neg/ #Pos | | --- | --- | --- | --- | | 0 | 0 | 30 | 30/0 | | 150 | -50% | 30 | 30/0 | | 225 | -25% | 30 | 26/4 | | 300 | Cutoff | 30 | 19/11 | | 375 | +25% | 30 | 8/22 | | 450 | +50% | 30 | 0/30 | | 600 | +100% | 30 | 0/30 | e. Analytical specificity: Cross-reactivity was established by spiking various concentrations of similarly structured drug compounds into drug-free urine. By analyzing various concentration of each compound the sponsor determined the concentration of the drug that produced a response approximately equivalent to the cutoff concentration of the assay. Results of those studies appear in the table below: Propoxyphene | Drug Compound | Response equivalent to cutoff in ng/mL | | --- | --- | | D-norpropoxyphene | 300 | {6} Page 7 of 16 The following compounds were evaluated for potential positive and/or negative interference with the assay. To evaluate for interference the sponsor prepared three urine pools with propoxyphene concentrations of 0, 150, and 450 ng/mL. To aliquots of these pools the sponsor added the potential interferent at a concentration of 100 µg/mL. There were no deviations from the expected results: | Compounds Tested at 100 µg/mL Conc. | ACON PPX One Step Propoxyphene Test Strip | | | ACON PPX One Step Propoxyphene Test Device | | | | --- | --- | --- | --- | --- | --- | --- | | | 0 ng/mL PPX | 150 ng/mL PPX | 450 ng/mL PPX | 0 ng/mL PPX | 150 ng/mL PPX | 450 ng/mL PPX | | 4-Acetaminophenol | Negative | Negative | Positive | Negative | Negative | Positive | | Acetone | Negative | Negative | Positive | Negative | Negative | Positive | | Acetophenetidin | Negative | Negative | Positive | Negative | Negative | Positive | | N-Acetylprocainamide | Negative | Negative | Positive | Negative | Negative | Positive | | Acetylsalicylic acid | Negative | Negative | Positive | Negative | Negative | Positive | | Albumin | Negative | Negative | Positive | Negative | Negative | Positive | | Amitryptyline | Negative | Negative | Positive | Negative | Negative | Positive | | Amobarbital | Negative | Negative | Positive | Negative | Negative | Positive | | Amoxapine | Negative | Negative | Positive | Negative | Negative | Positive | | Amoxicillin | Negative | Negative | Positive | Negative | Negative | Positive | | Ampicillin | Negative | Negative | Positive | Negative | Negative | Positive | | Ascorbic acid | Negative | Negative | Positive | Negative | Negative | Positive | | DL-Amphetamine | Negative | Negative | Positive | Negative | Negative | Positive | | Apomorphine | Negative | Negative | Positive | Negative | Negative | Positive | | Aspartame | Negative | Negative | Positive | Negative | Negative | Positive | | Atropine | Negative | Negative | Positive | Negative | Negative | Positive | | Benzilic acid | Negative | Negative | Positive | Negative | Negative | Positive | | Benzoic acid | Negative | Negative | Positive | Negative | Negative | Positive | | Benzoylecgonine | Negative | Negative | Positive | Negative | Negative | Positive | | Benzphetamine | Negative | Negative | Positive | Negative | Negative | Positive | | Bilirubin | Negative | Negative | Positive | Negative | Negative | Positive | | (±)- Brompheniramine | Negative | Negative | Positive | Negative | Negative | Positive | | Buspirone | Negative | Negative | Positive | Negative | Negative | Positive | | Caffeine | Negative | Negative | Positive | Negative | Negative | Positive | | Cannabidiol | Negative | Negative | Positive | Negative | Negative | Positive | | Cannabinol | Negative | Negative | Positive | Negative | Negative | Positive | | Chloralhydrate | Negative | Negative | Positive | Negative | Negative | Positive | | Chloramphenicol | Negative | Negative | Positive | Negative | Negative | Positive | | Chlordiazepoxide | Negative | Negative | Positive | Negative | Negative | Positive | | Chloroquine | Negative | Negative | Positive | Negative | Negative | Positive | | Chlorothiazide | Negative | Negative | Positive | Negative | Negative | Positive | {7} Page 8 of 16 | Compounds Tested at 100 µg/mL Conc. | ACON PPX One Step Propoxyphene Test Strip | | | ACON PPX One Step Propoxyphene Test Device | | | | --- | --- | --- | --- | --- | --- | --- | | | 0 ng/mL PPX | 150 ng/mL PPX | 450 ng/mL PPX | 0 ng/mL PPX | 150 ng/mL PPX | 450 ng/mL PPX | | (±) - Chlorpheniramine | Negative | Negative | Positive | Negative | Negative | Positive | | Chlorpromazine | Negative | Negative | Positive | Negative | Negative | Positive | | Chlorprothixene | Negative | Negative | Positive | Negative | Negative | Positive | | Cholesterol | Negative | Negative | Positive | Negative | Negative | Positive | | Clomipramine | Negative | Negative | Positive | Negative | Negative | Positive | | Clonidine | Negative | Negative | Positive | Negative | Negative | Positive | | Cocaine HCl | Negative | Negative | Positive | Negative | Negative | Positive | | Cortisone | Negative | Negative | Positive | Negative | Negative | Positive | | (-) Cotinine | Negative | Negative | Positive | Negative | Negative | Positive | | Creatinine | Negative | Negative | Positive | Negative | Negative | Positive | | Cyclobenzaprine | Negative | Negative | Positive | Negative | Negative | Positive | | Deoxycorticosterone | Negative | Negative | Positive | Negative | Negative | Positive | | (-) Deoxyephedrine | Negative | Negative | Positive | Negative | Negative | Positive | | R(-) Deprenyl HCl | Negative | Negative | Positive | Negative | Negative | Positive | | Dextromethorphan | Negative | Negative | Positive | Negative | Negative | Positive | | Diclofenac | Negative | Negative | Positive | Negative | Negative | Positive | | Diflunisal | Negative | Negative | Positive | Negative | Negative | Positive | | Digoxin | Negative | Negative | Positive | Negative | Negative | Positive | | 4-Dimethylaminoantipyrine | Negative | Negative | Positive | Negative | Negative | Positive | | Diphenhydramine | Negative | Negative | Positive | Negative | Negative | Positive | | Dicylamine | Negative | Negative | Positive | Negative | Negative | Positive | | 5,5 - Diphenylhydantoin | Negative | Negative | Positive | Negative | Negative | Positive | | Doxylamine | Negative | Negative | Positive | Negative | Negative | Positive | | Ecgonine HCl | Negative | Negative | Positive | Negative | Negative | Positive | | Ecgonine Methylester | Negative | Negative | Positive | Negative | Negative | Positive | | EDDP | Negative | Negative | Positive | Negative | Negative | Positive | | EMDP | Negative | Negative | Positive | Negative | Negative | Positive | | Ephedrine | Negative | Negative | Positive | Negative | Negative | Positive | | (-) -Ψ-Ephedrine | Negative | Negative | Positive | Negative | Negative | Positive | | [1R,2S] (-) Ephedrine | Negative | Negative | Positive | Negative | Negative | Positive | | (+/-) Epinephrine | Negative | Negative | Positive | Negative | Negative | Positive | | Erythromycin | Negative | Negative | Positive | Negative | Negative | Positive | | β-Estradiol | Negative | Negative | Positive | Negative | Negative | Positive | | Estrone-3-sulfate | Negative | Negative | Positive | Negative | Negative | Positive | | Ethanol | Negative | Negative | Positive | Negative | Negative | Positive | | Ethyl-p-aminobenzoate | Negative | Negative | Positive | Negative | Negative | Positive | | Fenfluramine | Negative | Negative | Positive | Negative | Negative | Positive | | Fenoprofen | Negative | Negative | Positive | Negative | Negative | Positive | | Furosemide | Negative | Negative | Positive | Negative | Negative | Positive | {8} Page 9 of 16 | Compounds Tested at 100 µg/mL Conc. | ACON PPX One Step Propoxyphene Test Strip | | | ACON PPX One Step Propoxyphene Test Device | | | | --- | --- | --- | --- | --- | --- | --- | | | 0 ng/mL PPX | 150 ng/mL PPX | 450 ng/mL PPX | 0 ng/mL PPX | 150 ng/mL PPX | 450 ng/mL PPX | | Gentisic acid | Negative | Negative | Positive | Negative | Negative | Positive | | D-Glucose | Negative | Negative | Positive | Negative | Negative | Positive | | Guaiacol Glyceryl Ether | Negative | Negative | Positive | Negative | Negative | Positive | | Hemoglobin | Negative | Negative | Positive | Negative | Negative | Positive | | Hydralazine | Negative | Negative | Positive | Negative | Negative | Positive | | Hydrochlorothiazide | Negative | Negative | Positive | Negative | Negative | Positive | | Hydrocodone | Negative | Negative | Positive | Negative | Negative | Positive | | Hydrocortisone | Negative | Negative | Positive | Negative | Negative | Positive | | O-Hydroxyhippuric acid | Negative | Negative | Positive | Negative | Negative | Positive | | p -Hydroxyamphetamine | Negative | Negative | Positive | Negative | Negative | Positive | | p-Hydroxymethamphetamine | Negative | Negative | Positive | Negative | Negative | Positive | | p-Hydroxynorephedrine | Negative | Negative | Positive | Negative | Negative | Positive | | 3-Hydroxytyramine | Negative | Negative | Positive | Negative | Negative | Positive | | Hydroxyzine | Negative | Negative | Positive | Negative | Negative | Positive | | Ibuprofen | Negative | Negative | Positive | Negative | Negative | Positive | | Imipramine | Negative | Negative | Positive | Negative | Negative | Positive | | Iproniazid | Negative | Negative | Positive | Negative | Negative | Positive | | (-) Isoproterenol | Negative | Negative | Positive | Negative | Negative | Positive | | Isoxsuprine | Negative | Negative | Positive | Negative | Negative | Positive | | Ketoprofen | Negative | Negative | Positive | Negative | Negative | Positive | | Labetalol | Negative | Negative | Positive | Negative | Negative | Positive | | Lidocaine | Negative | Negative | Positive | Negative | Negative | Positive | | Lithium Carbonate | Negative | Negative | Positive | Negative | Negative | Positive | | Loperamide | Negative | Negative | Positive | Negative | Negative | Positive | | Maprotiline | Negative | Negative | Positive | Negative | Negative | Positive | | Meperidine | Negative | Negative | Positive | Negative | Negative | Positive | | Mephentamine | Negative | Negative | Positive | Negative | Negative | Positive | | Meprobamate | Negative | Negative | Positive | Negative | Negative | Positive | | Methamphetamine | Negative | Negative | Positive | Negative | Negative | Positive | | L-Methamphetamine | Negative | Negative | Positive | Negative | Negative | Positive | | Methaqualone | Negative | Negative | Positive | Negative | Negative | Positive | | Methadol | Negative | Negative | Positive | Negative | Negative | Positive | | Methoxyphenamine | Negative | Negative | Positive | Negative | Negative | Positive | | Methylphenidate | Negative | Negative | Positive | Negative | Negative | Positive | | (+/-)3,4-Methylenedioxyamphetamine | Negative | Negative | Positive | Negative | Negative | Positive | | Methyprylon | Negative | Negative | Positive | Negative | Negative | Positive | | Nalidixic acid | Negative | Negative | Positive | Negative | Negative | Positive | | Nalorphine | Negative | Negative | Positive | Negative | Negative | Positive | {9} | Compounds Tested at 100 μg/mL Conc. | ACON PPX One Step Propoxyphene Test Strip | | | ACON PPX One Step Propoxyphene Test Device | | | | --- | --- | --- | --- | --- | --- | --- | | | 0 ng/mL PPX | 150 ng/mL PPX | 450 ng/mL PPX | 0 ng/mL PPX | 150 ng/mL PPX | 450 ng/mL PPX | | Naloxone | Negative | Negative | Positive | Negative | Negative | Positive | | Naltrexone | Negative | Negative | Positive | Negative | Negative | Positive | | α-Naphthaleneacetic acid | Negative | Negative | Positive | Negative | Negative | Positive | | Naproxen | Negative | Negative | Positive | Negative | Negative | Positive | | Niacinamide | Negative | Negative | Positive | Negative | Negative | Positive | | Nifedipine | Negative | Negative | Positive | Negative | Negative | Positive | | NorMOR | Negative | Negative | Positive | Negative | Negative | Positive | | Nimesulide | Negative | Negative | Positive | Negative | Negative | Positive | | Norethindrone | Negative | Negative | Positive | Negative | Negative | Positive | | Noscapine | Negative | Negative | Positive | Negative | Negative | Positive | | D,L-Octopamine | Negative | Negative | Positive | Negative | Negative | Positive | | Orphenadrine | Negative | Negative | Positive | Negative | Negative | Positive | | Oxalic acid | Negative | Negative | Positive | Negative | Negative | Positive | | Oxazepam | Negative | Negative | Positive | Negative | Negative | Positive | | Oxolinic acid | Negative | Negative | Positive | Negative | Negative | Positive | | Oxycodone | Negative | Negative | Positive | Negative | Negative | Positive | | Oxymetazoline | Negative | Negative | Positive | Negative | Negative | Positive | | OxyMOR | Negative | Negative | Positive | Negative | Negative | Positive | | Penicillin-G | Negative | Negative | Positive | Negative | Negative | Positive | | Pentazocine | Negative | Negative | Positive | Negative | Negative | Positive | | Pentobarbital | Negative | Negative | Positive | Negative | Negative | Positive | | Perphenazine | Negative | Negative | Positive | Negative | Negative | Positive | | Phencyclidine | Negative | Negative | Positive | Negative | Negative | Positive | | Phenelzine | Negative | Negative | Positive | Negative | Negative | Positive | | Pheniramine | Negative | Negative | Positive | Negative | Negative | Positive | | Phenobarbital | Negative | Negative | Positive | Negative | Negative | Positive | | Phenothiazine | Negative | Negative | Positive | Negative | Negative | Positive | | Phentermine | Negative | Negative | Positive | Negative | Negative | Positive | | L-Phenylephrine | Negative | Negative | Positive | Negative | Negative | Positive | | β-Phenylethylamine | Negative | Negative | Positive | Negative | Negative | Positive | | Phenylpropanolamine | Negative | Negative | Positive | Negative | Negative | Positive | | Prednisolone | Negative | Negative | Positive | Negative | Negative | Positive | | Prednisone | Negative | Negative | Positive | Negative | Negative | Positive | | Procaine | Negative | Negative | Positive | Negative | Negative | Positive | | Promazine | Negative | Negative | Positive | Negative | Negative | Positive | | Promethazine | Negative | Negative | Positive | Negative | Negative | Positive | | DL-Propranolol | Negative | Negative | Positive | Negative | Negative | Positive | | D-Pseudoephedrine | Negative | Negative | Positive | Negative | Negative | Positive | | Quinacrine | Negative | Negative | Positive | Negative | Negative | Positive | {10} | Compounds Tested at 100 μg/mL Conc. | ACON PPX One Step Propoxyphene Test Strip | | | ACON PPX One Step Propoxyphene Test Device | | | | --- | --- | --- | --- | --- | --- | --- | | | 0 ng/mL PPX | 150 ng/mL PPX | 450 ng/mL PPX | 0 ng/mL PPX | 150 ng/mL PPX | 450 ng/mL PPX | | Quinidine | Negative | Negative | Positive | Negative | Negative | Positive | | Quinine | Negative | Negative | Positive | Negative | Negative | Positive | | Ranitidine | Negative | Negative | Positive | Negative | Negative | Positive | | Riboflavin | Negative | Negative | Positive | Negative | Negative | Positive | | Salicylic acid | Negative | Negative | Positive | Negative | Negative | Positive | | Secobarbital | Negative | Negative | Positive | Negative | Negative | Positive | | Serotonin (5-Hydroxytyramine) | Negative | Negative | Positive | Negative | Negative | Positive | | Sodium Chloride | Negative | Negative | Positive | Negative | Negative | Positive | | Sulfamethazine | Negative | Negative | Positive | Negative | Negative | Positive | | Sulindac | Negative | Negative | Positive | Negative | Negative | Positive | | Sustiva | Negative | Negative | Positive | Negative | Negative | Positive | | Tetracycline | Negative | Negative | Positive | Negative | Negative | Positive | | Tetrahydrocortexolone | Negative | Negative | Positive | Negative | Negative | Positive | | Tetrahydrocortisone, 3-acetate | Negative | Negative | Positive | Negative | Negative | Positive | | Tetrahydrocortisone 3-(β-D-glucuronide) | Negative | Negative | Positive | Negative | Negative | Positive | | Tetrahydrozoline | Negative | Negative | Positive | Negative | Negative | Positive | | Theophylline | Negative | Negative | Positive | Negative | Negative | Positive | | Thiamine | Negative | Negative | Positive | Negative | Negative | Positive | | Thioridazine | Negative | Negative | Positive | Negative | Negative | Positive | | L-Thyroxine | Negative | Negative | Positive | Negative | Negative | Positive | | Tolbutamide | Negative | Negative | Positive | Negative | Negative | Positive | | Trans-2-phenylcyclopropylamine | Negative | Negative | Positive | Negative | Negative | Positive | | Trazodone | Negative | Negative | Positive | Negative | Negative | Positive | | Trimethobenzamide | Negative | Negative | Positive | Negative | Negative | Positive | | Triamterene | Negative | Negative | Positive | Negative | Negative | Positive | | Trifluoperazine | Negative | Negative | Positive | Negative | Negative | Positive | | Trimethoprim | Negative | Negative | Positive | Negative | Negative | Positive | | Trimipramine | Negative | Negative | Positive | Negative | Negative | Positive | | Tryptamine | Negative | Negative | Positive | Negative | Negative | Positive | | DL-Tryptophan | Negative | Negative | Positive | Negative | Negative | Positive | | Tyramine | Negative | Negative | Positive | Negative | Negative | Positive | | DL-Tyrosine | Negative | Negative | Positive | Negative | Negative | Positive | | Uric acid | Negative | Negative | Positive | Negative | Negative | Positive | | Verapamil | Negative | Negative | Positive | Negative | Negative | Positive | | Zomepirac | Negative | Negative | Positive | Negative | Negative | Positive | There is the possibility that other substances and/or factors not listed above may interfere with the test and cause false results, e.g., technical or procedural errors. {11} To test for potential positive/and or negative interference from varying pH conditions, the sponsor prepared four sample pools with propoxyphene concentrations of 0, 150, 450, and $600\mathrm{ng / mL}$ . Aliquots of these samples were then adjusted to a $\mathsf{pH}$ of 5 to 9 with HCl or NaOH. Results are reported below: Effect of Urinary pH - Test Strip | pH | 0 ng/mL Propoxyphene | 150 ng/mL Propoxyphene | 450 ng/mL Propoxyphene | 600 ng/mL Propoxyphene | | --- | --- | --- | --- | --- | | 5 | - | - | + | + | | 5 | - | - | + | + | | 6 | - | - | + | + | | 6 | - | - | + | + | | 7 | - | - | + | + | | 7 | - | - | + | + | | 8 | - | - | + | + | | 8 | - | - | + | + | | 9 | - | - | + | + | | 9 | - | - | + | + | Effect of Urinary pH - Test Device | pH | 0 ng/mL Propoxyphene | 150 ng/mL Propoxyphene | 450 ng/mL Propoxyphene | 600 ng/mL Propoxyphene | | --- | --- | --- | --- | --- | | 5 | - | - | + | + | | 5 | - | - | + | + | | 6 | - | - | + | + | | 6 | - | - | + | + | | 7 | - | - | + | + | | 7 | - | - | + | + | | 8 | - | - | + | + | | 8 | - | - | + | + | | 9 | - | - | + | + | | 9 | - | - | + | + | To test for potential positive/and or negative interference from varying specific gravity, the sponsor selected fifteen drug-free samples with a specific gravity from 1.007 to 1.029. Each sample was then split into three aliquots and spiked to propoxyphene concentrations of 0, 150, and $450\mathrm{ng / mL}$ . Results are shown below: {12} Page 13 of 16 ## Effects of Urinary Specific Gravity - Test Strip | SG | n | 0 ng/mL | 150 ng/mL | 450 ng/mL | | --- | --- | --- | --- | --- | | 1.007 | 2 | - | - | + | | 1.012 | 2 | - | - | + | | 1.013 | 2 | - | - | + | | 1.014 | 2 | - | - | + | | 1.014 | 2 | - | - | + | | 1.017 | 2 | - | - | + | | 1.019 | 2 | - | - | + | | 1.021 | 2 | - | - | + | | 1.022 | 2 | - | - | + | | 1.024 | 2 | - | - | + | | 1.025 | 2 | - | - | + | | 1.026 | 2 | - | - | + | | 1.027 | 2 | - | - | + | | 1.028 | 2 | - | - | + | | 1.029 | 2 | - | - | + | ## Effects of Urinary Specific Gravity - Test Device | SG | n | 0 ng/mL | 150 ng/mL | 450 ng/mL | | --- | --- | --- | --- | --- | | 1.007 | 2 | - | - | + | | 1.012 | 2 | - | - | + | | 1.013 | 2 | - | - | + | | 1.014 | 2 | - | - | + | | 1.014 | 2 | - | - | + | | 1.017 | 2 | - | - | + | | 1.019 | 2 | - | - | + | | 1.021 | 2 | - | - | + | | 1.022 | 2 | - | - | + | | 1.024 | 2 | - | - | + | | 1.025 | 2 | - | - | + | | 1.026 | 2 | - | - | + | | 1.027 | 2 | - | - | + | | 1.028 | 2 | - | - | + | | 1.029 | 2 | - | - | + | The sponsor did not evaluate the effects of albumin on the assay. {13} Page 14 of 16 f. Assay cut-off: The Substance Abuse and Mental Health Services Administration (SAMHSA) has not recommended a cutoff concentration for propoxyphene. Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section, above. 2. Comparison studies: a. Method comparison with predicate device: A total of 352 samples (177 negative and 175 positive) were evaluated by the candidate device and by GC/MS and/or the predicate device. Sample description: Unaltered clinical urine samples were evaluated. Fifty-one additional diluted samples were also included in the study. The samples were prepared by diluting clinical samples with high drug concentrations with drug-free urine. This was done in order to obtain samples near the cutoff concentration of the assay, because the sponsor was not able to obtain unaltered samples near the cutoff. Sample selection: A portion of the negative samples were chosen for the study based on whether they screened positive or negative by the predicate device. Another portion of the negative samples having drug concentrations that were below the cutoff concentration of the assay were analyzed by GC-MS. All of the positive samples with concentrations above the cutoff were evaluated by GC-MS. The study included an adequate number of samples that contained drugs near to the cutoff concentration of the assay. Approximately 10% of the study samples are evenly distributed between plus and minus 50% of the claimed cutoff concentration. Number of study sites: one Type of study site(s): Manufacturer's facility Operator description: Manufacturer's laboratory staff {14} Page 15 of 16 # Candidate Device Results vs. Predicate Device Results – Test Strip | | Positive by Predicate Device | Negative by Predicate Device | | --- | --- | --- | | Positive by Candidate Device | 157 | 0 | | Negative by Candidate Device | 0 | 157 | % Agreement among positives is 100% % Agreement among negatives is 100% # Candidate Device Results vs. Predicate Device Results – Test Device | | Positive by Predicate Device | Negative by Predicate Device | | --- | --- | --- | | Positive by Candidate Device | 157 | 0 | | Negative by Candidate Device | 0 | 157 | % Agreement among positives is 100% % Agreement among negatives is 100% # Candidate Device Results vs. stratified GC/MS Values – Test Strip | Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) | | --- | --- | --- | --- | --- | | Positive | 0 | 2 | 7 | 158 | | Negative | 157 | 18 | 10 | 0 | GC/MS values used to categorize samples in this table are based on the sum of the concentrations of propoxyphene and norpropoxyphene found in the sample. % Agreement among positives is 94% % Agreement among negatives is 99% {15} Page 16 of 16 Candidate Device Results vs. stratified GC/MS Values – Test Device | Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) | | --- | --- | --- | --- | --- | | Positive | 0 | 2 | 7 | 158 | | Negative | 157 | 18 | 10 | 0 | GC/MS values used to categorize samples in this table are based on the sum of the concentrations of propoxyphene and norpropoxyphene found in the sample. % Agreement among positives is 94% % Agreement among negatives is 99% b. Matrix comparison: Not applicable. The assay is intended for only one sample matrix. 3. Clinical studies: a. Clinical sensitivity: Not applicable. Clinical studies are not typically submitted for this device type. b. Clinical specificity: Not applicable. Clinical studies are not typically submitted for this device type. c. Other clinical supportive data (when a and b are not applicable): 4. Clinical cut-off: Not applicable. 5. Expected values/Reference range: Propoxyphene or its metabolites should not be present in the urine of persons who have not ingested propoxyphene. M. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.