What is the regulatory pathway for BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx?

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

What are the predicate devices for BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx?

AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests (K201630).

Who can help prepare an FDA 510(k) submission like BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx?

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 U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx

Q: Who is the manufacturer of BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx?

Shenzhen Bioeasy Biotechnology Co., Ltd. filed the 510(k) submission for BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx (K230238).

Q: What is the FDA product code for BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx?

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

K230238 · Shenzhen Bioeasy Biotechnology Co., Ltd. · DJG · Mar 31, 2023 · Clinical Toxicology

Device Facts

Record ID	K230238
Device Name	BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx
Applicant	Shenzhen Bioeasy Biotechnology Co., Ltd.
Product Code	DJG · Clinical Toxicology
Decision Date	Mar 31, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.3650
Device Class	Class 2

Intended Use

BIOEASY™ U-Catch MAX Multi-Drug Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1.5-dimethyl-3.3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: [Table of cut-offs]. BIOEASY™ U-Catch MAX Multi-Drug Test Cup offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may vield positive results for the prescription drugs Burenorphine. Oxazenam, Secobarbital, d-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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Device Story

Single-use lateral flow immunochromatographic test cup for qualitative detection of drugs/metabolites in human urine. Device consists of test cup, package insert, and collection cup. Principle: competitive binding; target drugs in urine compete with drug-conjugate for limited antibody binding sites on particles. If drug concentration is below cutoff, antibody-coated particles bind to immobilized drug-conjugate, forming visible colored test line. If drug concentration exceeds cutoff, binding sites are saturated, preventing test line formation. Control line forms regardless of drug presence to verify test performance. Used by lay users (OTC version) or healthcare professionals (Rx version) in point-of-care settings. Results are visual; preliminary only. Positive results require confirmation via GC/MS or LC/MS. Benefits include rapid, on-site screening for drug presence to inform clinical judgment.

Clinical Evidence

Bench testing only. Precision/reproducibility studies performed over 25 days using 3 lots. Cross-reactivity and interference testing conducted with various physiological/pathological substances. Method comparison study performed with 80 clinical samples per drug compared to LC/MS. Lay user study with 140 participants across three sites confirmed performance across various drug concentrations.

Technological Characteristics

Lateral flow immunochromatographic assay. Single-use cup form factor. Materials: test device, desiccant, aluminum pouch, urine collection cup. Principle: competitive binding antigen-antibody immunochemistry. Connectivity: none (standalone). Sterilization: not specified. Software: none.

Indications for Use

Indicated for qualitative, simultaneous detection of drugs of abuse and metabolites in human urine for OTC or prescription use. Target analytes include Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, EDDP, Methamphetamine, MDMA, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline, Marijuana, and 6-Acetylmorphine (Rx only) at specified cutoff levels.

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

AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests (K201630)

Related Devices

K191841 — Accurate Multi Panel Drug Urine Test Cup · Healstone Biotech, Inc. · Aug 7, 2019
K244043 — AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup · Hangzhou AllTest Biotech Co., Ltd. · Feb 27, 2025
K250727 — AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup · Hangzhou AllTest Biotech Co., Ltd. · Apr 4, 2025

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). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a solid blue square and the full name written in a smaller font next to it. March 31, 2023 Shenzhen Bioeasy Biotechnology Co., Ltd. % Joe Shia Director LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877 ### Re: K230238 Trade/Device Name: BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG, NFT, NFW, NFY, NGG, NGL, NFV, PTG, PTH, NGM, QAW, QBF Dated: January 27, 2023 Received: January 30, 2023 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}------------------------------------------------ eral agencies. You must comply with all the Act's ration and listing (21 CFR Part 807): labeling (21 CFR Part Page 2 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, Digitally signed by Paula V. Paula V. Caposino -S Caposino -S Date: 2023.03.31 Caposino -S 20:52:54 -04'00' Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) k230238 #### Device Name BIOEASYTM U-Catch MAX Multi-Drug Test Cup #### Indications for Use (Describe) BIOEASY™ U-Catch MAX Multi-Drug Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1.5-dimethyl-3.3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |----------------------------------------------------------|---------------| | Amphetamine (AMP) | 500 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Oxazepam (BZO) | 300 ng/mL | | Cocaine (COC) | 150 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Methamphetamine (MET) | 500 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP 300) | 300 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | d-Propoxyphene (PPX) | 300 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Marijuana (THC) | 50 ng/mL | BIOEASY™ U-Catch MAX Multi-Drug Test Cup offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may vield positive results for the prescription drugs Burenorphine. Oxazenam, Secobarbital, d-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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K230238 #### Device Name BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx #### Indications for Use (Describe) BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline Cannabinoids and 6-Acetylmorphine in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |----------------------------------------------------------|---------------| | Amphetamine (AMP) | 500 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Oxazepam (BZO) | 300 ng/mL | | Cocaine (COC) | 150 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Methamphetamine (MET) | 500 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP 300) | 300 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | d-Propoxyphene (PPX) | 300 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Cannabinoids (THC) | 50 ng/mL | | 6-Acetylmorphine | 10 ng/mL | BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use. The tests may yield positive results for the prescription drugs Buprenorphine. Nortriptyline, Oxazepam, Secobarbital, d-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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | <div> ✘ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ▢ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | {5}------------------------------------------------ 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." {6}------------------------------------------------ # 510(k) SUMMARY # K230238 The purpose of this submission is to add analytes Amphetamine 500, Cocaine 150, Methamphetamine 500, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP), and 6-acetylmorphine (6-AM) to previously cleared devices (k182530). These five new analytes were evaluated in this submission. For other analytes, please refer to k182530 for Buprenorphine, Secobarbital, Oxazepam, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline and Cannabinoids. In this submission the performance results are presented for the five new analytes, but the lay user study was conducted using the entire panel except of 6-AM. - March 31, 2023 1. Date: Shenzhen Bioeasy Biotechnology Co., Ltd. 2. Submitter: No.2-1 Liuxian 1st Road, Xin'an Sub-District Shenzhen 518101, China 3. Contact person: Joe Shia LSI International Inc 504E Diamond Ave., Suite I - Email: shiajl@yahoo.com. 4. Device Name: BIOEASYTM U-Catch MAX Multi-Drug Test Cup BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx Gaithersburg, MD 20877 Telephone: 240-505-7880 | Classification: | Class 2 | | | |---------------------------|----------------|----------------------------------------------------------------|-----------------| | Product Code | Classification | Regulation Section | Panel | | DJG Monoacetylmorphine | II | 21 CFR § 862.3650, Morphine Test System | Toxicology (91) | | DKZ Amphetamine | II | 21 CFR § 862.3100, Amphetamine Test System | Toxicology (91) | | LDJ Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids Test System | Toxicology (91) | | DIO Cocaine | II | 21 CFR § 862.3250, Cocaine and Cocaine Metabolites Test System | Toxicology (91) | | LAF Methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91) | | DJG Morphine | II | 21 CFR § 862.3650, Morphine Test System | Toxicology (91) | | JXM Oxazepam | II | 21 CFR § 862.3170, Benzodiazepine Test System | Toxicology (91) | | DJG Oxycodone | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) | | DIS Secobarbital | II | 21 CFR § 862.3150, Barbiturate Test System | Toxicology (91) | | DJG Buprenorphine | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) | {7}------------------------------------------------ | LAF Methylenedioxy- methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91) | |------------------------------------------------------------------------------|--------------|----------------------------------------------------------------|-----------------| | LCM Phencyclidine | unclassified | Enzyme Immunoassay Phencyclidine | Toxicology (91) | | DJR Methadone | II | 21 CFR § 862.3620, Methadone Test System | Toxicology (91) | | DJR 2-ethylidene-1, 5- dimethyl-3, 3- diphenylpyrrolidine (EDDP) | II | 21 CFR § 862.3620, Methadone Test System | Toxicology (91) | | LFG Nortriptyline | II | 21 CFR, 862.3910 Tricyclic Antidepressant Drugs Test System | Toxicology (91) | | JXN Propoxyphene | II | 21 CFR, 862.3700 Propoxyphene Test System | Toxicology (91) | ### 5. Predicate Devices: K201630 The Assure Tech Panel Dip Tests/AssureTech Quick Cup Tests - 6. Intended Use BIOEASY™ U-Catch MAX Multi-Drug Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2- ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off leve | |----------------------------------------------------------|--------------| | Amphetamine (AMP) | 500 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Oxazepam (BZO) | 300 ng/mL | | Cocaine (COC) | 150 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Methamphetamine (MET) | 500 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP 300) | 300 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | d-Propoxyphene (PPX) | 300 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Marijuana (THC) | 50 ng/mL | BIOEASY™ U-Catch MAX Multi-Drug Test Cup offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, d-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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. {8}------------------------------------------------ BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2- ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline Cannabinoids and 6-Acetylmorphine in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |----------------------------------------------------------|---------------| | Amphetamine (AMP) | 500 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Oxazepam (BZO) | 300 ng/mL | | Cocaine (COC) | 150 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Methamphetamine (MET) | 500 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP 300) | 300 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | d-Propoxyphene (PPX) | 300 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Cannabinoids (THC) | 50 ng/mL | | 6-Acetylmorphine | 10 ng/mL | BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use. The tests may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, d-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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. - 7. Device Description The BIOEASY™ U-Catch MAX Multi-Drug Test Cup and BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx are immunochromatographic assays that use a lateral flow system for the qualitative detection of target drug or drug metabolites in human urine. The products are single-use in vitro diagnostic devices. The BIOEASY™ U-Catch MAX Multi-Drug Test Cup kit contains a Cup 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™ U-Catch MAX Multi-Drug Test Cup and the predicate devices is provided in following tables. # Table 1: Features Comparison of BIOEASY™ U-Catch MAX Multi-Drug Test Cup and the Predicate Devices | Item | Device | Predicate - K201630 | |---------------|-----------------------------------------------|-------------------------| | Indication(s) | For the qualitative determination of drugs of | Same (but the number of | {9}------------------------------------------------ | for Use | abuse in human urine. | drugs detected is different) | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------| | Calibrator and Cut-Off Values | Amphetamine (AMP): 500 ng/ml Oxazepam (BZO):300 ng/ml Cocaine (COC): 150 ng/ml 11-Nor-△9-Tetrahydrocannabinol-9-COOH (THC):50 ng/ml Methamphetamine (MET): 500 ng/ml Morphine (MOR): 300 ng/mL Oxycodone(OXY) : 100 ng/ml Secobarbital (BAR): 300 ng/ml Methadone (MTD): 300 ng/ml Buprenorphine (BUP): 10 ng/ml D,L-Methylenedioxymethamphetamine (MDMA): 500 ng/ml Phencyclidine (PCP): 25 ng/ml Nortriptyline (TCA): 1000 ng/ml 2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine (EDDP): 300 ng/ml d-Propoxyphene (PPX): 300 ng/ml | Same except THC at 20 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 | For prescription use | | Configurations | Cup | Same | Table 2: Features Comparison of BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx and the Predicate Devices | Item | Device | Predicate – K201630 | |----------------------------------|------------------------------------------------------------------------|---------------------| | Indication(s) for Use | For the qualitative determination of drugs of abuse in human urine. | Same | | Calibrator and Cut-Off Values | Amphetamine (AMP): 500 ng/ml | Same except | | | Oxazepam (BZO):300 ng/ml | THC at 20 ng/mL | | | Cocaine(COC): 150 ng/ml | | | | 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH (THC):50 ng/ml | | | | Methamphetamine (MET): 500 ng/ml | | | | Morphine (MOR): 300ng/mL | | | | Oxycodone(OXY) : 100 ng/ml | | | | Secobarbital (BAR): 300 ng/ml Methadone (MTD): 300 ng/ml | | {10}------------------------------------------------ | | Buprenorphine (BUP): 10 ng/ml D,L-Methylenedioxymethamphetamine (MDMA): 500 ng/ml Phencyclidine (PCP): 25 ng/ml Nortriptyline (TCA): 1000 ng/ml 2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine (EDDP): 300 ng/ml d-Propoxyphene (PPX): 300 ng/ml 6-Acetylmorphine (6-AM): 10 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 prescription use | Same | | Configurations | Cup | Cup | # 9. Test Principle The BIOEASY™ U-Catch MAX Multi-Drug Test Cup tests are rapid tests for the qualitative detection of target drug or drug metabolites 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 antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The 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 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, cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative urine 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 tables for Amphetamine 500, Cocaine 150, Methamphetamine 500, 2ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP), and 6-acetylmorphine (6-AM). The data for Buprenorphine, Methylenedioxymethamphetamine, Secobarbital, Oxazepam, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, {11}------------------------------------------------ | AMP500 | | | | | | | | | | |-------------------------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------| | Concentration by LC/MS (ng/mL) | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | Cut-off +25% | Cut-off +50% | Cut-off +75% | Cut-off +100% | | Lot Number | 0 | 127 | 250 | 374 | 480 | 590 | 695 | 825 | 915 | | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | COC150 | | | | | | | | | | | Concentration by LC/ MS (ng/mL) | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | Cut-off +25% | Cut-off +50% | Cut-off +75% | Cut-off +100% | | Lot Number | 0 | 38.2 | 77.8 | 113 | 154 | 191 | 230 | 262 | 302 | | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 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+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | MET500 | | | | | | | | | | | Concentration by LC/MS (ng/mL) | -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 Number | 0 | 129 | 240 | 368 | 476 | 605 | 705 | 860 | 1010 | | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | EDDP | | | | | | | | | | | Concentration by LC/MS (ng/mL) Lot | -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 | | Number | 0 | 72.0 | 146 | 216 | 293 | 360 | 426 | 507 | 582 | | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | 6-AM Concentration by LC/MS (ng/mL) | -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 | | LC/MS (ng/mL) | -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 Number | 0 | 2.46 | 4.88 | 7.42 | 9.98 | 12.3 | 14.6 | 16.8 | 20.1 | | 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+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | # The following cut-off values are verified | A BAY AVAAV AAR VAA VATERIA PAY TAAAAA VI | | |---------------------------------------------------|---------------| | Vrug (Identifier) | Cut-off level | | | | {12}------------------------------------------------ | Amphetamine (AMP) | 500 ng/mL | |------------------------------------------------------------|-----------| | Cocaine (COC) | 150 ng/mL | | Methamphetamine (MET) | 500 ng/mL | | 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | 6-acetylmorphine (6-AM) | 10 ng/mL | b. Linearity Not applicable. c. Stability and Traceability The devices are stable at 4-30 ℃ for 24 months based on real time stability studies. All drug calibrators of the device are traceable to available commercial reference materials. ### 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 lots of each device. Compounds that showed no interference at a concentration of 100ug/mL are summarized in the following tables | Acetaminophen | Creatinine | Ketamine | Prednisone | |----------------------|------------------------|------------------|--------------------------------------------| | Acetophenetidin | Deoxycorticosterone | Ketoprofen | (±)-Propranolol | | N-Acetylprocainamide | Dextromethorphan | Labetalol | Pseudoephedrine | | Acetylsalicylic acid | Diclofenac | Loperamide | Quinine | | Albumin (100mg/dL) | Diflunisal | Meperidine | Ranitidine | | Aminopyrine | Digoxin | Meprobamate | Salicylic acid | | Amoxicillin | Diphenhydramine | Methoxyphenamine | Serotonin (5- Hydroxytyramine) | | Ampicillin | 1% Ethanol | Nalidixic acid | Sulfamethazine | | Apomorphine | Ecgonine methyl ester | Naloxone | Sulindac | | Ascorbic acid | ß-Estradiol | Naltrexone | Tetrahydrocortisone 3-(ß- Dglucuronide) | | Aspartame | Erythromycin | Naproxen | Tetrahydrocortisone 3-acetate | | Atropine | Fenoprofen | Niacinamide | Tetrahydrozoline | | Benzilic acid | Furosemide | Nifedipine | Thiamine | | Benzoic acid | Gentisic acid | Norethindrone | Thioridazine | | Bilirubin | Hemoglobin | Noscapine | Triamterene | | Chloral hydrate | Hydralazine | (±)-Octopamine | Trifluoperazine | | Chloramphenicol | Hydrochlorothiazide | Oxalic acid | Trimethoprim | | Chlorothiazide | Hydrocortisone | Oxolinic acid | DL-Tryptophan | | Chlorpromazine | O-Hydroxyhippuric acid | Oxymetazoline | Tyramine | | Cholesterol | 3-Hydroxytyramine | Papaverine | DL-Tyrosine | | Clonidine | Ibuprofen | Penicillin G | Uric acid | | Cortisone | Isoproterenol | Perphenazine | Verapamil | | (-)-Cotinine | Isoxsuprine | Phenelzine | Zomepirac | ### e. Specificity To test specificity, 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 lots of each device. The lowest concentration that caused a positive result for each compound are listed below for Amphetamine 500, Cocaine 150, {13}------------------------------------------------ Methamphetamine 500, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP), and 6-acetylmorphine (6-AM). The data for Buprenorphine, Methylenedioxymethamphetamine, Secobarbital, Oxazepam, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline and Cannabinoids were reported in k182530. | AMP500 | Result | %Cross-Reactivity | |----------------------------------------------|---------------------|-------------------| | (Cut-off=500 ng/mL) | Positive at (ng/ml) | | | D - Amphetamine | 500 | 100% | | L - Amphetamine | 10000 | 5% | | DL - Amphetamine | 1500 | 33% | | Phentermine | 15000 | 3.3% | | Hydroxyamphetamine | 4000 | 12.5% | | Methylenedioxyamphetamine (MDA) | 10000 | 5% | | d-Methamphetamine | > 100000 | <0.5% | | 1-Methamphetamine | > 100000 | <0.5% | | Ephedrine | > 100000 | <0.5% | | Methylenedioxyethylamphetamine (MDE) | > 100000 | <0.5% | | 3,4-methylenedioxy-methamphetamine (MDMA) | > 100000 | <0.5% | | COC150 (Cut-off=150 ng/mL) | Result Positive at (ng/ml) | %Cross-Reactivity | |-------------------------------|-------------------------------|-------------------| | Benzoylecgonine | 150 | 100% | | Cocaine HCl | 375 | 40% | | Cocaethylene | 6250 | 2.4% | | Ecgonine | 16000 | 0.9% | | Norcocaine | 50000 | 0.3% | | MET500 | Result | %Cross-Reactivity | |------------------------------------------------------|---------------------|-------------------| | (Cut-off=500 ng/mL) | Positive at (ng/ml) | | | D(+)-Methamphetamine | 500 | 100% | | (+/-)3,4-Methylenedioxy-n-ethylamphetamine (MDEA) | 5000 | 10% | | D/L-Methamphetamine | 500 | 100% | | p-Hydroxymethamphetamine | 5000 | 10% | | D-Amphetamine | > 100000 | <0.5% | | L-Amphetamine | >100000 | <0.5% | | Chloroquine | 25000 | 2% | | (+/-)-Ephedrine | 2000 | 25% | | L-Methamphetamine | 5000 | 10% | | (+/-)3,4-Methylenedioxyamphetamine (MDA) | > 100000 | <0.5% | | β-Phenylethylamine | 3750 | 13.3% | | Trimethobenzamide | 10000 | 5% | | (+/-)3,4- methylenedioxymethamphetamine(MDMA) | 5000 | 10% | | EDDP (Cut-off=300 ng/mL) | Result Positive at (ng/ml) | % Cross-Reactivity | |-----------------------------|-------------------------------|--------------------| |-----------------------------|-------------------------------|--------------------| {14}------------------------------------------------ | EDDP | 300 | 100% | |----------------|---------|-------| | Methadone | 300000 | 0.1% | | Doxylamine | >100000 | <0.3% | | LAAM HCl | >100000 | <0.3% | | Alpha Methadol | >100000 | <0.3% | | EMDP | >100000 | <0.3% | | Disopyramide | >100000 | <0.3% | | 6-AM (Cut-off=10 ng/mL) | Result Positive at (ng/ml) | % Cross-Reactivity | |------------------------------|-------------------------------|--------------------| | 6-acetylmorphine | 10 | 100% | | Acetylcodeine | >10000 | <0.1% | | Buprenorphine | >10000 | <0.1% | | Codeine | >10000 | <0.1% | | Diacetylmorphine | 1000 | 0.01% | | Dihydrocodeine | >10000 | <0.1% | | Ethylmorphine | >10000 | <0.1% | | Hydrocodone | >10000 | <0.1% | | Hydromorphone | 5000 | 0.002% | | Morphine | 10000 | 0.001% | | Morphine-3-glucuronide | >10000 | <0.1% | | Nalorphine | 5000 | 0.002% | | Thebaine | >20000 | <0.05% | | Dextromethorphan | >100,000 | <0.01% | | Heroin | 100000 | 0.0001% | | Imipramine | >100,000 | <0.01% | | LAAM (Levacetylmethadol) | >100,000 | <0.01% | | Levorphanol | >100,000 | <0.01% | | Meperidine | >100,000 | <0.01% | | Methadone | >100,000 | <0.01% | | Mitragynine (kratom) | >20,000 | <0.05% | | Morphine 6-D-glucuronide | >100,000 | <0.01% | | Naloxone | >100,000 | <0.01% | | Naltrexone | >100,000 | <0.01% | | Naproxen | >100,000 | <0.01% | | Norbuprenorphine | >10,000 | <0.1% | | Norbuprenorphine glucuronide | >100,000 | <0.01% | | Norcodeine | >100,000 | <0.01% | | Norhydrocodone | >100,000 | <0.01% | | Normorphine | >100,000 | <0.01% | | Noroxycodone | >100,000 | <0.01% | | Noroxymorphone | >100,000 | <0.01% | | Norpropoxyphene | >100,000 | <0.01% | | Oxycodone | >100,000 | <0.01% | | Oxymorphone | >100,000 | <0.01% | | Oxymorphone-3β-D-glucuronide | >100,000 | <0.01% | | Tapentadol HCl | >100,000 | <0.01% | {15}------------------------------------------------ | Tramadol | >100,000 | <0.01% | |----------|----------|--------| |----------|----------|--------| 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. - 2. Comparison Studies Method comparison studies for the BIOEASY™ U-Catch MAX Multi-Drug Test Cup were performed in-house with three laboratory assistants. 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 are presented in the tables below for Amphetamine 500, Cocaine 150, Methamphetamine 500, 2-ethylidene-1, 5-dimethyl-3, 3diphenylpyrrolidine (EDDP), and 6-acetylmorphine (6-AM). The data for Buprenorphine, Methylenedioxymethamphetamine, Secobarbital, Oxazepam, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline and Cannabinoids were reported in k182530. AMP500 U-Catch Low Near Cutoff Near Cutoff MAX Multi-Negative by Positive by Negative Negative by High Positive Drug Test TC/MS LC/MS LC/MS by LC/MS Cup (less than (Between (Between the (greater than -50%) -50% and cutoff and +50%) cutoff) +50%) 0 0 3 17 20 Viewer Positive A Negative 7 16 14 3 0 Positive 0 0 2 18 20 Viewer 7 2 B Negative । ୧ ા ર 0 0 3 18 20 Viewer Positive 0 C Negative 7 16 14 2 0 ### Discordant Results | Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results | |----------|---------------|--------------|----------------------------| | Viewer A | AMPLC063 | 473 | Positive | | Viewer C | AMPLC063 | 473 | Positive | | Viewer B | AMPLC040 | 477 | Positive | | Viewer A | AMPLC039 | 490 | Positive | | Viewer B | AMPLC039 | 490 | Positive | | Viewer C | AMPLC039 | 490 | Positive | | Viewer A | AMPLC004 | 494 | Positive | | Viewer C | AMPLC004 | 494 | Positive | | Viewer A | AMPLC018 | 520 | Negative | | Viewer B | AMPLC018 | 520 | Negative | | Viewer A | AMPLC064 | 525 | Negative | | Viewer B | AMPLC064 | 525 | Negative | | Viewer C | AMPLC064 | 525 | Negative | {16}------------------------------------------------ | Viewer A | AMPLC009 | 540 | Negative | |----------|----------|-----|----------| | Viewer C | AMPLC014 | 570 | Negative | | COC150 | | | | | | | |-------------------------------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------| | U-Catch MAX Multi- Drug Test Cup | | 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 A | Positive | 0 | 0 | 2 | 19 | 19 | | | Negative | 7 | 16 | 15 | 2 | 0 | | Viewer B | Positive | 0 | 0 | 2 | 18 | 19 | | | Negative | 7 | 16 | 15 | 3 | 0 | | Viewer C | Positive | 0 | 0 | 2 | 19 | 19 | | | Negative | 7 | 16 | 15 | 2 | 0 | # Discordant Results | Discordant Results | | | | |--------------------|---------------|--------------|-------------------------| | Viewer | Sample Number | LC/MS Result | Easy Cup Viewer Results | | Viewer B | COCLC046 | 139 | Positive | | Viewer A | COCLC019 | 142 | Positive | | Viewer C | COCLC019 | 142 | Positive | | Viewer B | COCLC026 | 142 | Positive | | Viewer A | COCLC060 | 145 | Positive | | Viewer C | COCLC060 | 145 | Positive | | Viewer A | COCLC049 | 154 | Negative | | Viewer B | COCLC049 | 154 | Negative | | Viewer C | COCLC049 | 154 | Negative | | Viewer A | COCLC024 | 157 | Negative | | Viewer B | COCLC062 | 157 | Negative | | Viewer C | COCLC062 | 157 | Negative | | Viewer B | COCLC029 | 159 | Negative | # MET500 | U-Catch MAX Multi- Drug Test Cup | | 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 A | Positive | 0 | 0 | 2 | 17 | 20 | | | Negative | 7 | 16 | 15 | 3 | 0 | | Viewer B | Positive | 0 | 0 | 3 | 18 | 20 | | | Negative | 7 | 16 | 14 | 2 | 0 | | Viewer C | Positive | 0 | 0 | 2 | 17 | 20 | | | Negative | 7 | 16 | 15 | 3 | 0 | # Discordant Results {17}------------------------------------------------ | Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results | |----------|---------------|--------------|-------------------------| | Viewer B | METL055 | 427 | Positive | | Viewer B | METL005 | 447 | Positive | | Viewer C | METL005 | 447 | Positive | | Viewer A | METL020 | 465 | Positive | | Viewer B | METL020 | 465 | Positive | | Viewer A | METL063 | 486 | Positive | | Viewer C | METL063 | 486 | Positive | | Viewer B | METL053 | 525 | Negative | | Viewer C | METL053 | 525 | Negative | | Viewer A | METL060 | 530 | Negative | | Viewer C | METL060 | 530 | Negative | | Viewer A | METL036 | 540 | Negative | | Viewer B | METL036 | 540 | Negative | | Viewer A | METL059 | 555 | Negative | | Viewer C | METL059 | 555 | Negative | # EDDP | U-Catch MAX Multi- Drug Test Cup | | 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 A | Positive | 0 | 0 | 2 | 18 | 20 | | | Negative | 6 | 18 | 14 | 2 | 0 | | Viewer B | Positive | 0 | 0 | 2 | 18 | 20 | | | Negative | 6 | 18 | 14 | 2 | 0 | | Viewer C | Positive | 0 | 0 | 3 | 18 | 20 | | | Negative | 6 | 18 | 13 | 2 | 0 | # Discordant Results | Viewer | Sample Number | LC/MS Result | Easy Cup Viewer Results | |----------|---------------|--------------|-------------------------| | Viewer A | EDDPLC042 | 244 | Positive | | Viewer C | EDDPLC042 | 244 | Positive | | Viewer B | EDDPLC004 | 291 | Positive | | Viewer C | EDDPLC004 | 291 | Positive | | Viewer A | EDDPLC051 | 294 | Positive | | Viewer B | EDDPLC051 | 294 | Positive | | Viewer C | EDDPLC051 | 294 | Positive | | Viewer A | EDDPLC074 | 303 | Negative | | Viewer B | EDDPLC074 | 303 | Negative | | Viewer C | EDDPLC074 | 303 | Negative | | Viewer B | EDDPLC052 | 327 | Negative | | Viewer A | EDDPLC018 | 330 | Negative | {18}------------------------------------------------ | Viewer C | EDDPLC018 | 330 | Negative | |----------|-----------|-----|----------| |----------|-----------|-----|----------| | 6-AM | | | | | | | |-------------------------------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------| | U-Catch MAX Multi- Drug Test Cup | | 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 A | Positive | 0 | 0 | 2 | 16 | 22 | | | Negative | 6 | 17 | 15 | 2 | 0 | | Viewer B | Positive | 0 | 0 | 2 | 16 | 22 | | | Negative | 6 | 17 | 15 | 2 | 0 | | Viewer C | Positive | 0 | 0 | 2 | 15 | 22 | | | Negative | 6 | 17 | 15 | 3 | 0 | ### Discordant Results | Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results | |----------|---------------|--------------|-------------------------| | Viewer B | 6-AMLC016 | 9.23 | Positive | | Viewer A | 6-AMLC074 | 9.68 | Positive | | Viewer C | 6-AMLC074 | 9.68 | Positive | | Viewer B | 6-AMLC026 | 9.93 | Positive | | Viewer A | 6-AMLC037 | 9.95 | Positive | | Viewer C | 6-AMLC037 | 9.95 | Positive | | Viewer A | 6-AMLC009 | 10.3 | Negative | | Viewer C | 6-AMLC009 | 10.3 | Negative | | Viewer B | 6-AMLC027 | 11.1 | Negative | | Viewer C | 6-AMLC027 | 11.1 | Negative | | Viewer A | 6-AMLC038 | 11.4 | Negative | | Viewer B | 6-AMLC038 | 11.4 | Negative | | Viewer C | 6-AMLC035 | 11.8 | Negative | # Lay-user study A lay user study was performed at three intended user sites with 140 lay persons. The lay users had diverse educational and professional backgrounds and ranged in age from 20 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. Results are shown below. | Drugs | % of Cut-off | Number of samples | Concentration by LC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) | |-------|---------------|-------------------|--------------------------------|--------------------|--------------------|---------------------------------------| | AMP | -100% Cut-off | 20 | 0 | No. of Positive 0 | No. of Negative 20 | 100 | | | -75% Cut-off | 20 | 130 | No. of Positive 0 | No. of Negative 20 | 100 | | | -50% Cut-off | 20 | 251 | 0 | 20 | 100 | | | -25% Cut-off | 20 | 383 | 0 | 20 | 100 | | | +25% Cut-off | 20 | 635 | 19 | 1 | 95 | | | +50% Cut-off | 20 | 755 | 20 | 0 | 100 | | | +75% Cut-off | 20 | 885 | 20 | 0 | 100 | | BAR | -100% Cut-off | 20 | 0 | 0 | 20 | 100 | | | -75% Cut-off | 20 | 75.9 | 0 | 20 | 100 | | | -50% Cut-off | 20 | 150 | 0 | 20 | 100 | | | -25% Cut-off | 20 | 220 | 0 | 20 | 100 | | | +25% Cut-off | 20 | 360 | 19 | 1 | 95 | | | +50% Cut-off | 20 | 429 | 20 | 0 | 100 | | | +75% Cut-off | 20 | 501 | 20 | 0 | 100 | | COC | -100% Cut-off | 20 | 0 | 0 | 20 | 100 | | | -75% Cut-off | 20 | 37.6 | 0 | 20 | 100 | | | -50% Cut-off | 20 | 74.8 | 0 | 20 | 100 | | | -25% Cut-off | 20 | 110 | 1 | 19 | 95 | | | +25% Cut-off | 20 | 183 | 19 | 1 | 95 | | | +50% Cut-off | 20 | 224 | 20 | 0 | 100 | | | +75% Cut-off | 20 | 248 | 20 | 0 | 100 | | BZO | -100% Cut-off | 20 | 0 | 0 | 20 | 100 | | | -75% Cut-off | 20 | 70.8 | 0 | 20 | 100 | | | -50% Cut-off | 20 | 148 | 0 | 20 | 100 | | | -25% Cut-off | 20 | 224 | 1 | 19 | 95 | | | +25% Cut-off | 20 | 390 | 19 | 1 | 95 | | | +50% Cut-off | 20 | 452 | 20 | 0 | 100 | | | +75% Cut-off | 20 | 504 | 20 | 0 | 100 | | MET | -100% Cut-off | 20 | 0 | 0 | 20 | 100 | | | -75% Cut-off | 20 | 124 | 0 | 20 | 100 | | | -50% Cut-off | 20 | 242 | 0 | 20 | 100 | | | -25% Cut-off | 20 | 367 | 0 | 20 | 100 | | | +25% Cut-off | 20 | 610 | 19 | 1 | 95 | | | +50% Cut-off | 20 | 705 | 20 | 0 | 100 | | | +75% Cut-off | 20 | 825 | 20 | 0 | 100 | | MTD | -100% Cut-off | 20…

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BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx