Who is the manufacturer of BIOEASY Multi-Drug Test Cup?

Shenzhen Bioeasy Biotechnology Co., Ltd. filed the 510(k) submission for BIOEASY Multi-Drug Test Cup (K193480).

What is the FDA product code for BIOEASY Multi-Drug Test Cup?

NGL. It is classified under 21 CFR 862.3650 as a Class 2 device in the Clinical Toxicology panel.

What is the regulatory pathway for BIOEASY Multi-Drug Test Cup?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like BIOEASY Multi-Drug Test Cup?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BIOEASY Multi-Drug Test Cup

K193480 · Shenzhen Bioeasy Biotechnology Co., Ltd. · NGL · Jan 31, 2020 · Clinical Toxicology

Device Facts

Record ID	K193480
Device Name	BIOEASY Multi-Drug Test Cup
Applicant	Shenzhen Bioeasy Biotechnology Co., Ltd.
Product Code	NGL · Clinical Toxicology
Decision Date	Jan 31, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.3650
Device Class	Class 2

Intended Use

BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of: [Table of cut-offs]. Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical 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.

Device Story

Single-use, lateral flow immunochromatographic assay for qualitative detection of drugs of abuse in human urine; cup format. Operates via competitive binding: target drugs in urine compete with immobilized drug-conjugate for binding sites on monoclonal mouse antibody-coated particles. Absence of colored line at test region indicates drug concentration above cutoff; presence of line indicates concentration below cutoff. Control line confirms proper test performance. Used in point-of-care or home settings by lay users. Provides preliminary results; requires confirmation by GC/MS or LC/MS. Aids in identifying potential drug presence for clinical consideration.

Clinical Evidence

No clinical studies performed. Evidence consists of bench testing (precision, interference, specificity, stability, effect of pH/specific gravity) and a lay-user study. Lay-user study included 300 participants (ages 18 to >50) across three sites, demonstrating high accuracy (90-100%) across various drug concentrations relative to LC/MS-confirmed samples. Method comparison study performed in-house with 80 clinical samples per drug, showing high concordance with LC/MS results.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Single-use cup format. No energy source required. Stable at 4-30°C for 24 months. No specific materials or ASTM standards cited.

Indications for Use

Indicated for qualitative, simultaneous detection of drugs of abuse (Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, MDMA, Phencyclidine, Methadone, Nortriptyline, d-Propoxyphene) in human urine. Intended for OTC use. Not for distinguishing prescription use from abuse.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Predicate Devices

K182530

Related Devices

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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 31, 2020 Shenzhen Bioeasy Biotechnology Co., Ltd. % Joe Shia Director LSI 504E Diamond Ave., Suite I Gaithersburg, MD 20877 Re: k193480 Trade/Device Name: BIOEASY Multi-Drug Test Cup Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: NGL, NGI, NFW, NFY, NGG, NFT, NFV, PTH, NGM, PTG, QAW, QBF Dated: December 11, 2019 Received: December 16, 2019 Dear Joe Shia: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Marianela Perez-Torres, M.T., Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K193480 Device Name BIOEASY Multi-Drug Test Cup #### Indications for Use (Describe) BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of: | Drug(Identifier) | Cut-off level | |--------------------------------|-------------------------| | Amphetamine | 1000 ng/mL | | Oxazepam | 300 ng/mL | | Cocaine | 300 ng/mL | | Marijuana | 50 ng/mL | | Methamphetamine | 1000 ng/mL | | Morphine | 300 ng/mL or 2000 ng/mL | | Oxycodone | 100 ng/mL | | Secobarbital | 300 ng/mL | | Buprenorphine | 10 ng/mL | | Methylenedioxy-methamphetamine | 500 ng/mL | | Phencyclidine | 25 ng/mL | | Methadone | 300 ng/mL | | Nortriptyline | 1000 ng/mL | | d-Propoxyphene | 300 ng/mL | Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical 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. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # K193480 510(k) SUMMARY - January 27, 2020 1. Date: Shenzhen Bioeasy Biotechnology Co., Ltd. 2. Submitter: No.2-1, Liuxian 1st Road Baoan District Shenzhen, China 518101 - Joe Shia 3. Contact person: LSI International Inc. 504 East Diamond Ave. Gaithersburg, MD 20877 Telephone: 240-505-7880 Email: shiajl@yahoo.com - 4. Device Name: BIOEASY Multi-Drug Test Cup | Classification: | Class 2 | | | |-------------------------------------------|----------------|-------------------------------------------------------------------|-----------------| | Product Code | Classification | Regulation Section | Panel | | NFT Amphetamine | II | 21 CFR § 862.3100, Amphetamine Test System | Toxicology (91) | | NFW Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids Test System | Toxicology (91) | | NFY Cocaine | II | 21 CFR § 862.3250, Cocaine and Cocaine Metabolites Test System | Toxicology (91) | | NGG Methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91) | | NGI Morphine | II | 21 CFR § 862.3640, Morphine Test System | Toxicology (91) | | NFV Oxazepam | II | 21 CFR § 862.3170, Benzodiazepine Test System | Toxicology (91) | | NGL Oxycodone | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) | | PTH Secobarbital | II | 21 CFR § 862.3150, Barbiturate Test System | Toxicology (91) | | NGL Buprenorphine | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) | | NGG Methylenedioxy- methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91) | | NGM Phencyclidine | unclassified | Enzyme Immunoassay Phencyclidine | Toxicology (91) | | PTG Methadone | II | 21 CFR § 862.3620, Methadone Test System | Toxicology (91) | | QAW Nortriptyline | II | 21 CFR, 862.3910 Tricyclic Antidepressant Drugs Test System | Toxicology (91) | | QBF Propoxyphene | II | 21 CFR, 862.3700 Propoxyphene Test System | Toxicology (91) | - 5. Predicate Devices: K182530 {5}------------------------------------------------ The Shenzhen Bioeasy Biotechnology's BIOEASY Multi-Drug Test Cup - 6. Indications for Use BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |--------------------------------|-------------------------| | Amphetamine | 1000 ng/mL | | Oxazepam | 300 ng/mL | | Cocaine | 300 ng/mL | | Marijuana | 50 ng/mL | | Methamphetamine | 1000 ng/mL | | Morphine | 300 ng/mL or 2000 ng/mL | | Oxycodone | 100 ng/mL | | Secobarbital | 300 ng/mL | | Buprenorphine | 10 ng/mL | | Methylenedioxy-methamphetamine | 500 ng/mL | | Phencyclidine | 25 ng/mL | | Methadone | 300 ng/mL | | Nortriptyline | 1000 ng/mL | | d-Propoxyphene | 300 ng/mL | | | | Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. 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. - 7. Device Description The BIOEASY Multi-Drug Test Cup tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch - 8. Substantial Equivalence Information A summary comparison of features of the BIOEASY Multi-Drug Test Cup tests and the predicate devices is provided in following table. {6}------------------------------------------------ # Table 1: Features Comparison of BIOEASY Multi-Drug Test Cup tests and the Predicate Devices | Item | Device | Predicate - K182530 | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------| | Indication(s) for Use | For the qualitative determination of drugs of abuse in human urine. | Same | | Calibrator and Cut-Off Values | Amphetamine (AMP): 1,000 ng/ml Oxazepam (BZO):300 ng/ml Cocaine(COC): 300 ng/ml Marijuana (THC):50 ng/ml Methamphetamine (MET): 1,000 ng/ml Morphine (MOP): 300ng/ml or 2000ng/mL Oxycodone(OXY) : 100 ng/ml Secobarbital (BAR): 300 ng/ml Buprenorphine (BUP): 10 ng/ml Methylenedioxy- methamphetamine(MDMA): 500 ng/ml Phencyclidine (PCP): 25 ng/ml Methadone (MTD): 300 ng/ml Nortriptyline (TCA): 1000 ng/ml Propoxyphene (PPX): 300 ng/ml | Same except for morphine 2000 ng/mL | | 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 | | Intended Use | For over-the-counter | Same | | Configurations | Cup | Same | # 9. Test Principle The BIOEASY Multi-Drug Test Cup tests are rapid tests for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibodycoated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been {7}------------------------------------------------ performed properly. ### 10. Performance Characteristics - 1. Analytical Performance - a. Precision Precision studies were carried out for 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 LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following table for Morphine 2000 ng/mL. The data for Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene were reported in k182530. | Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | +25% cut off | +50% cut off | +75% cut off | +100% cut off | | |------------|---------------|--------------|--------------|-------------|--------------|--------------|--------------|---------------|--------| | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | ## Morphine 2000 ng/mL ### c. Stability The devices are stable at 4-30 ℃ for 24 months based on the real time stability studies at both 4 ℃ and 30 ℃. - d. Interference 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 using three batches of the device. Compounds that showed no interference at a concentration of 100ug/mL (albumin was tested at 100 mg/dL, ethanol at 1%) are summarized in the following tables. | Acetaminophen | ß-Estradiol | Oxalic acid | |----------------------|------------------------|--------------------------------| | Acetophenetidin | Erythromycin | Oxolinic acid | | N-Acetylprocainamide | Ethanol | Oxymetazoline | | Acetylsalicylic acid | Fenoprofen | Papaverine | | Albumin (100 mg/dL) | Furosemide | Penicillin G | | Aminopyrine | Gentisic acid | Perphenazine | | Amoxicillin | Hemoglobin | Phenelzine | | Ampicillin | Hydralazine | Prednisone | | Apomorphine | Hydrochlorothiazide | (±)-Propranolol | | Ascorbic acid | Hydrocortisone | Pseudoephedrine | | Aspartame | O-Hydroxyhippuric acid | Quinine | | Atropine | 3-Hydroxytyramine | Ranitidine | | Benzilic acid | Ibuprofen | Salicylic acid | | Benzoic acid | Isoproterenol | Serotonin (5- Hydroxytyramine) | | Bilirubin | Isoxsuprine | Sulfamethazine | | Chloral hydrate | Ketamine | Sulindac | {8}------------------------------------------------ | Chloramphenicol | Ketoprofen | Tetrahydrocortisone 3-(β-Dglucuronide) | |-----------------------|------------------|----------------------------------------| | Chlorothiazide | Labetalol | Tetrahydrocortisone 3-acetate | | Chlorpromazine | Loperamide | Tetrahydrozoline | | Cholesterol | Meperidine | Thiamine | | Clonidine | Meprobamate | Thioridazine | | Cortisone | Methoxyphenamine | Triamterene | | (-)-Cotinine | Nalidixic acid | Trifluoperazine | | Creatinine | Naloxone | Trimethoprim | | Deoxycorticosterone | Naltrexone | DL-Tryptophan | | Dextromethorphan | Naproxen | Tyramine | | Diclofenac | Niacinamide | DL-Tyrosine | | Diflunisal | Nifedipine | Uric acid | | Digoxin | Norethindrone | Verapamil | | Diphenhydramine | Noscapine | Zomepirac | | Ecgonine methyl ester | (±)-Octopamine | | ### e. Specificity To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound are listed below for Morphine 2000 ng/mL cut-off. The data for Amphetamine, Oxazepam, Cocaine, Marijuana. Methamphetamine. Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene were reported in k182530 | Morphine, Cut-off=2000 ng/mL | Result | %Cross-Reactivity | |------------------------------|--------------------------|-------------------| | Morphine | Positive at 2000 ng/mL | 100% | | Codeine | Positive at 200 ng/mL | 1000% | | Ethylmorphine | Positive at 2500 ng/mL | 80% | | Hydrocodone | Negative at 100000 ng/mL | <2% | | Hydromorphone | Positive at 4000 ng/mL | 50% | | Levorphanol | Negative at 100000 ng/mL | <2% | | 6-Acetylmorphine | Positive at 3000 ng/mL | 67% | | Morphine-3- β -D-glucuronide | Positive at 6000 ng/mL | 33% | | Normorphine | Negative at 100000 ng/mL | <2% | | Oxycodone | Negative at 100000 ng/mL | <2% | | Oxymorphone | Negative at 100000 ng/mL | <2% | | Procaine | Negative at 100000 ng/mL | <2% | | Thebaine | Negative at 100000 ng/mL | <2% | | Heroin | Positive at 3500 ng/mL | 57% | f. Effect of Urine Specific Gravity and Urine pH To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 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 different devices. {9}------------------------------------------------ # 2. Comparison Studies Method comparison studies for the BIOEASY Multi-Drug Test Cup tests were performed inhouse with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results. The results obtained are summarized in the following table for Morphine 2000 ng/mL. The data for Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene were reported in k182530. # Morphine 2000 ng/mL | | | 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 the cutoff and +50%) | High Positive by LC/MS (greater than +50%) | |--------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------| | Viewer | Positive | 0 | 0 | 2 | 20 | 18 | | A | Negative | 7 | 15 | 16 | 2 | 0 | | Viewer | Positive | 0 | 0 | 2 | 21 | 18 | | B | Negative | 7 | 15 | 16 | 1 | 0 | | Viewer | Positive | 0 | 0 | 2 | 21 | 18 | | C | Negative | 7 | 15 | 16 | 1 | 0 | ## Discordant Results | Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results | |----------|---------------|--------------|-------------------------------| | Viewer A | OPIC341 | 1920 | Positive | | Viewer A | OPIC335 | 1870 | Positive | | Viewer B | OPIC450 | 1860 | Positive | | Viewer B | OPIC335 | 1870 | Positive | | Viewer C | OPIC341 | 1920 | Positive | | Viewer C | OPIC450 | 1860 | Positive | | Viewer A | OPIC475 | 2150 | Negative | | Viewer A | OPIC408 | 2100 | Negative | | Viewer B | OPIC408 | 2100 | Negative | | Viewer C | OPIC475 | 2150 | Negative | # Lay-user study A lay user study was performed at three intended user sites with 300 lay persons for the device. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to > 50 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 LC/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. Each device was tested. Summary results are shown below. ### The results summary for AMP: | % of Cutoff | Number of | Drug Concentration | Lay person Results | The percentage of | |-------------|-----------|--------------------|--------------------|-------------------| |-------------|-----------|--------------------|--------------------|-------------------| {10}------------------------------------------------ | | samples | by LC/MS/MS (ng/mL) | No. of Positive | No. of Negative | correct results (%) | |--------------|---------|------------------------|--------------------|--------------------|---------------------| | -100% Cutoff | 20 | 0 | 0 | 20 | 100 | | -75% Cutoff | 20 | 261 | 0 | 20 | 100 | | -50% Cutoff | 160 | 507 | 0 | 160 | 100 | | -25% Cutoff | 20 | 771 | 1 | 19 | 95 | | +25% Cutoff | 20 | 1290 | 20 | 0 | 100 | | +50% Cutoff | 40 | 1560 | 40 | 0 | 100 | | +75% Cutoff | 20 | 1870 | 20 | 0 | 100 | The results summary for BAR: | % of Cutoff | Number of samples | Drug Concentration by LC/MS/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 | 75.9 | 0 | 20 | 100 | | -50% Cutoff | 160 | 150 | 0 | 160 | 100 | | -25% Cutoff | 20 | 220 | 1 | 19 | 95 | | +25% Cutoff | 20 | 360 | 19 | 1 | 95 | | +50% Cutoff | 40 | 429 | 40 | 0 | 100 | | +75% Cutoff | 20 | 501 | 20 | 0 | 100 | The results summary for COC: | % of Cutoff | Number of samples | Drug Concentration by LC/MS/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 | 81.5 | 0 | 20 | 100 | | -50% Cutoff | 160 | 151 | 0 | 160 | 100 | | -25% Cutoff | 20 | 225 | 1 | 19 | 95 | | +25% Cutoff | 20 | 395 | 19 | 1 | 95 | | +50% Cutoff | 40 | 455 | 40 | 0 | 100 | | +75% Cutoff | 20 | 520 | 20 | 0 | 100 | The results summary for BUP: | % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS(ng/mL) | Lay person Results | | The percentage of correct results (%) | |--------------|-------------------|---------------------------------------|--------------------|-----|---------------------------------------| | -100% Cutoff | 20 | 0 | 0 | 20 | 100 | | -75% Cutoff | 20 | 2.57 | 0 | 20 | 100 | | -50% Cutoff | 160 | 5.14 | 0 | 160 | 100 | | -25% Cutoff | 20 | 6.76 | 1 | 19 | 95 | | +25% Cutoff | 20 | 12.8 | 18 | 2 | 90 | | +50% Cutoff | 40 | 15.1 | 40 | 0 | 100 | | +75% Cutoff | 20 | 17.2 | 20 | 0 | 100 | The results summary for MET: {11}------------------------------------------------ | % of Cutoff | Number of samples | Drug Concentration by LC/MS/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 | 268 | 0 | 20 | 100 | | -50% Cutoff | 160 | 526 | 0 | 160 | 100 | | -25% Cutoff | 20 | 769 | 1 | 19 | 95 | | +25% Cutoff | 20 | 1270 | 19 | 1 | 95 | | +50% Cutoff | 40 | 1560 | 40 | 0 | 100 | | +75% Cutoff | 20 | 1780 | 20 | 0 | 100 | The results summary for MTD: | % of Cutoff | Number of samples | Drug Concentration by LC/MS/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 | 76.8 | 0 | 20 | 100 | | -50% Cutoff | 160 | 147 | 0 | 160 | 100 | | -25% Cutoff | 20 | 226 | 1 | 19 | 95 | | +25% Cutoff | 20 | 375 | 19 | 1 | 95 | | +50% Cutoff | 40 | 441 | 40 | 0 | 100 | | +75% Cutoff | 20 | 504 | 20 | 0 | 100 | The results summary for Morphine: | % of Cutoff | Number of samples | Drug Concentration by LC/MS/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 | 535 | 0 | 20 | 100 | | -50% Cutoff | 160 | 1010 | 0 | 160 | 100 | | -25% Cutoff | 20 | 1580 | 0 | 20 | 100 | | +25% Cutoff | 20 | 2600 | 19 | 1 | 95 | | +50% Cutoff | 40 | 3050 | 40 | 0 | 100 | | +75% Cutoff | 20 | 3240 | 20 | 0 | 100 | The results summary for OXY: | % of Cutoff | Number of samples | Drug Concentration by LC/MS/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 | 24.5 | 0 | 20 | 100 | | -50% Cutoff | 160 | 49.3 | 0 | 160 | 100 | | -25% Cutoff | 20 | 71.1 | 1 | 19 | 95 | | +25% Cutoff | 20 | 118 | 19 | 1 | 95 | | +50% Cutoff | 40 | 147 | 40 | 0 | 100 | | +75% Cutoff | 20 | 169 | 20 | 0 | 100 | The results summary for PCP: {12}------------------------------------------------ | % of Cutoff | Number of samples | Drug Concentration by LC/MS/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 | 6.27 | 0 | 20 | 100 | | -50% Cutoff | 160 | 12.5 | 0 | 160 | 100 | | -25% Cutoff | 20 | 17.9 | 1 | 19 | 95 | | +25% Cutoff | 20 | 30.8 | 20 | 0 | 100 | | +50% Cutoff | 40 | 36.4 | 40 | 0 | 100 | | +75% Cutoff | 20 | 42.8 | 20 | 0 | 100 | The results summary for THC: | % of Cutoff | Number of samples | Drug Concentration by LC/MS/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 | 13 | 0 | 20 | 100 | | -50% Cutoff | 160 | 25.3 | 0 | 160 | 100 | | -25% Cutoff | 20 | 41 | 2 | 18 | 90 | | +25% Cutoff | 20 | 65 | 19 | 1 | 95 | | +50% Cutoff | 40 | 79 | 40 | 0 | 100 | | +75% Cutoff | 20 | 93 | 20 | 0 | 100 | The results summary for BZO: | % of Cutoff | Number of samples | Drug Concentration by LC/MS/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 | 70.8 | 0 | 20 | 100 | | -50% Cutoff | 160 | 148 | 0 | 160 | 100 | | -25% Cutoff | 20 | 224 | 1 | 19 | 95 | | +25% Cutoff | 20 | 390 | 19 | 1 | 95 | | +50% Cutoff | 40 | 452 | 40 | 0 | 100 | | +75% Cutoff | 20 | 504 | 20 | 0 | 100 | The results summary for MDMA: | % of Cutoff | Number of samples | Drug Concentration by LC/MS/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 | 137 | 0 | 20 | 100 | | -50% Cutoff | 160 | 250 | 0 | 160 | 100 | | -25% Cutoff | 20 | 351 | 1 | 19 | 95 | | +25% Cutoff | 20 | 600 | 19 | 1 | 95 | | +50% Cutoff | 40 | 745 | 40 | 0 | 100 | | +75% Cutoff | 20 | 925 | 20 | 0 | 100 | The results summary for TCA: {13}------------------------------------------------ | % of Cutoff | Number of samples | Drug Concentration by LC/MS/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 | 273 | 0 | 20 | 100 | | -50% Cutoff | 160 | 509 | 0 | 160 | 100 | | -25% Cutoff | 20 | 809 | 1 | 19 | 95 | | +25% Cutoff | 20 | 1190 | 19 | 1 | 95 | | +50% Cutoff | 40 | 1510 | 40 | 0 | 100 | | +75% Cutoff | 20 | 1680 | 20 | 0 | 100 | ### The results summary for PPX: | % of Cutoff | Number of samples | Drug Concentration by LC/MS/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 | 77.4 | 0 | 20 | 100 | | -50% Cutoff | 160 | 150 | 0 | 160 | 100 | | -25% Cutoff | 20 | 227 | 1 | 19 | 95 | | +25% Cutoff | 20 | 351 | 19 | 1 | 95 | | +50% Cutoff | 40 | 420 | 40 | 0 | 100 | | +75% Cutoff | 20 | 492 | 20 | 0 | 100 | Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7. ### 3. Clinical Studies Not applicable. ### 11. Conclusion Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison, and lay-user studies of the device, it's concluded that the BIOEASY Multi-Drug Test Cup tests are substantially equivalent to the predicate.