Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx
Device Facts
| Record ID | K222667 |
|---|---|
| Device Name | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx |
| Applicant | Vivachek Biotech (Hangzhou) Co., Ltd. |
| Product Code | NFT · Clinical Toxicology |
| Decision Date | Nov 10, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Intended Use
Wisdiag Multi-Drug Urine 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, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: [Table of drugs and cutoffs]. Wisdiag Multi-Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may vield positive results for the prescription drugs Buprenorphine. 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 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. Wisdiag Multi-Drug Urine Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of: [Table of drugs and cutoffs]. Wisdiag Multi-Drug Urine Test Cup Rx offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for prescription use. The tests may vield positive results for the prescription drugs Buprenorphine. 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 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 urine test cup; detects 15 drugs of abuse. Urine sample added to cup; migrates via capillary action. Competitive binding principle: drug in sample competes with immobilized drug-conjugate for monoclonal antibody-coated particles. Absence of colored band at test line indicates positive result (drug concentration above cutoff); presence of band indicates negative result. Control line confirms proper test performance. Used in OTC and clinical settings; visually read by user or healthcare provider. Provides preliminary results; requires confirmatory testing via GC/MS or LC/MS for clinical decision-making.
Clinical Evidence
Bench testing only. Precision/reproducibility studies conducted over 25 days using 3 lots. Analytical specificity/interference studies evaluated cross-reactivity and potential interfering substances (pH 4-9, specific gravity 1.000-1.035). Method comparison study performed with 80 samples compared to LC-MS/MS. Lay user study with 280 participants confirmed usability and performance.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle; antigen-antibody reaction. Form factor: test cup. Connectivity: none. Stability: 2-30°C for 24 months. Materials: test strip, cup, desiccants.
Indications for Use
Indicated for qualitative, simultaneous detection of drugs of abuse in human urine. Intended for OTC and prescription use. Population: individuals requiring drug screening. Contraindications: not intended to distinguish between prescription use and abuse of drugs; results are preliminary and require confirmation by GC/MS or LC/MS.
Regulatory Classification
Identification
An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An amphetamine 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
- Wondfo T-Cup® Multi-Drug Urine Test Cup (K182701)
Related Devices
- K191841 — Accurate Multi Panel Drug Urine Test Cup · Healstone Biotech, Inc. · Aug 7, 2019
- K182530 — BIOEASY Multi-Drug Test Cup · Shenzhen Bioeasy Biotechnology Co., Ltd. · Nov 9, 2018
- K244043 — AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup · Hangzhou AllTest Biotech Co., Ltd. · Feb 27, 2025
- K252259 — AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup · Assure Tech., LLC · Aug 15, 2025
- K250803 — Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup · Anhui Deepblue Medical Technological Co., Ltd. · Apr 15, 2025
Submission Summary (Full Text)
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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. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 10, 2022
Vivachek Biotech (Hangzhou) Co., Ltd % Joe Shia Director LSI International 540 E Diamond Avenue, Suite I Gaithersburg, MD 20877
#### Re: K222667
Trade/Device Name: Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, NGL, PTH, NFV, NFY, PTG, NGG, OBF, QAW, NFW, LCM Dated: September 2, 2022 Received: September 6, 2022
#### 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 mediation-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,
Paula
Digitally signed by
Paula Caposino -S
Caposino -S Date: 2022.11.10
14:59:10 -05'00'
Paula Caposino, Ph.D. Acting Deputy Division 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
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## Indications for Use
510(k) Number (if known) k222667
#### Device Name
Wisdiag Multi-Drug Urine Test Cup
#### Indications for Use (Describe)
Wisdiag Multi-Drug Urine 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, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|----------------------------------------------------------|-------------------------|
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
Wisdiag Multi-Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may vield positive results for the prescription drugs Buprenorphine. 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 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.
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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.
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
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FORM FDA 3881 (6/20)
Page 1 of 1
EF PSC Publishing Services (301) 443-6740
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## Indications for Use
510(k) Number (if known) k222667
#### Device Name
Wisdiag Multi-Drug Urine Test Cup Rx
#### Indications for Use (Describe)
Wisdiag Multi-Drug Urine Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|----------------------------------------------------------|-------------------------|
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
Wisdiag Multi-Drug Urine Test Cup Rx offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for prescription use.
The tests may vield positive results for the prescription drugs Buprenorphine. 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 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.
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Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
FORM FDA 3881 (6/20)
Page 1 of 1
EF PSC Publishing Services (301) 443-6740
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#### 510(k) SUMMARY
| | 510(k) Number | K222667 |
|---|----------------|-----------------------------------------|
| 1 | Date | November 7, 2022 |
| 2 | Submitter | VivaChek Biotech (Hangzhou) Co., Ltd. |
| | | Level 2, Block 2, 146 East Chaofeng Rd. |
| | | Hangzhou, China |
| 3 | Contact Person | Joe Shia |
| | | LSI International Inc. |
| | | 504 East Diamond Ave., Suite I |
| | | Gaithersburg, MD 20877 |
| | | Telephone: 240-505-7880 |
| | | Fax: 301-916-6213 |
| | | Email: shiajl@yahoo.com |
| | | |
- 4 Device Name Wisdiag Multi-Drug Urine Test Cup Wisdiag Multi-Drug Urine Test Cup Rx
- 5 Classification
| Class II | | |
|----------------------------------------------------------------------------|------------------------------------------|------------|
| Product Code<br>Target Drug | Regulation Section | Cup |
| NFT<br>Amphetamine (AMP) | 862.3100, Amphetamine Test System | Toxicology |
| NGL<br>Buprenorphine (BUP) | 862.3650, Opiate Test System | Toxicology |
| PTH<br>Secobarbital (BAR) | 862.3150, Barbiturate Test System | Toxicology |
| NFV<br>Oxazepam (BZO) | 862.3170,<br>Benzodiazepine Test System | Toxicology |
| NFY<br>Cocaine (COC) | 862.3250, Cocaine Test System | Toxicology |
| PTG<br>2-ethylidene-1,5-<br>dimethyl-3,3-<br>diphenylpyrrolidine<br>(EDDP) | 862.3620, Methadone Test System | Toxicology |
| NGG<br>Methamphetamine<br>(MET) | 862.3610,<br>Methamphetamine Test System | Toxicology |
| NGG<br>Methylenedioxymethamphetamine (MDMA) | 862.3610,<br>Methamphetamine Test System | Toxicology |
| NGL | 862.3650, Opiate Test System | Toxicology |
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| Morphine (MOP/OPI) | | |
|-----------------------|-----------------------------------------------------|------------|
| PTG | 862.3620, Methadone Test System | Toxicology |
| Methadone (MTD) | | |
| NGL | 862.3650, Opiate Test System | Toxicology |
| Oxycodone (OXY) | | |
| LCM | Unclassified | Toxicology |
| Phencyclidine (PCP) | | |
| QBF | 862.3700 Propoxyphene test system. | Toxicology |
| Propoxyphene (PPX) | | |
| QAW | 862.3910 Tricyclic antidepressant drugs test system | Toxicology |
| Nortriptyline (TCA) | | |
| NFW | 862.3870, Cannabinoids Test System | Toxicology |
| Cannabinoids (THC 50) | | |
#### Predicate Device 6. K182701
Wondfo T-Cup® Multi-Drug Urine Test Cup
#### 7. Intended Use
Wisdiag Multi-Drug Urine 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, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|----------------------------------------------------------|-------------------------|
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
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Wisdiag Multi-Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. 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, 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.
Wisdiag Multi-Drug Urine 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, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|----------------------------------------------------------|-------------------------|
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
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Wisdiag Multi-Drug Urine Test Cup Rx offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. 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, 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. Device Description
The Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Test Cup Rx are rapid, singleuse in vitro diagnostic devices. Each test kit contains a test device in one pouch. One pouch contains a test Wisdiag Cup and two desiccants, and a package insert. The Wisdiag Multi-Drug Urine Test Cup is intended for over-the-counter use and the Wisdiag Multi-Drug Urine Test Cup Rx is intended for prescription use.
| Item | Proposed Device | Predicate<br>(K182701) |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Indication(s) for use | For the qualitative determination of Amphetamine,<br>Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-<br>1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine,<br>Methylenedioxymethamphetamine, Morphine, Methadone,<br>Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and<br>Cannabinoids in human urine. | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assay<br>based on antigen-antibody reaction | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Target Drug and<br>Cut Off Values | Target Drug | Cutoff (ng/mL) |
| | Amphetamine (AMP) | 1000 or 500 |
| | Buprenorphine (BUP) | 10 |
| | Secobarbital (BAR) | 300 |
| | Oxazepam (BZO) | 300 |
| | Cocaine (COC) | 300 or 150 |
#### 9. Substantial Equivalence Information
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| 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine (EDDP) | 300 | |
|--------------------------------------------------------------|-------------------------------------------|--------------------------|
| Methamphetamine (MET) | 1000 or 500 | |
| Methylenedioxymethamphetamine (MDMA) | 500 | |
| Morphine (MOP 300/OPI 2000) | 2000 or 300 | |
| Methadone (MTD) | 300 | |
| Oxycodone (OXY) | 100 | |
| Phencyclidine (PCP) | 25 | |
| Propoxyphene (PPX) | 300 | |
| Nortriptyline (TCA) | 1000 | |
| Cannabinoids (THC 50) | 50 | |
| Configurations | Test Cup | Cup |
| Intended Use | Prescription Use and over-the-counter use | For over-the-counter use |
#### 10. Test Principle
Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Test Cup Rx are rapid tests for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1.5-dimethyl-3.3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in urine samples. They are lateral flow chromatographic immunoassay. When urine sample is added to the cup device, urine is absorbed into the test strip and migrates upwards by capillary action. If the concentration of target drug presented in the urine sample is below the cutoff level, the target drug will not saturate the binding sites of its specific monoclonal antibody-coated particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored band will be formed on the test line region. If the concentration of target is beyond the cutoff level, the target drug will saturate the binding sites of its specific monoclonal antibody-particles, thus the antibody-coated particles will not be captured by immobilized drug-conjugate hence no colored band will be formed on the test line region.
A band should be formed on the control line region regardless of target drug or metabolite in the sample to indicate that the tests have been performed properly.
#### 11. 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, cutoff, +25% cut off, +50% cut off, +75% cut off and +100% cut off. Samples with concentration of -100% cutoff were drug-free urines samples. Other samples were prepared by spiking target drug in drug-free urine samples. Each drug concentration was confirmed by LC/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test Cups. The results obtained are summarized in the following tables:
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| Concentration by<br>LC/MS<br>(ng/mL)<br>Lot Number | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| 20.0 | 17.1 | 13.6 | 11.8 | 10.2 | 6.9 | 5.4 | 2.7 | 0 | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
Wisdiag Multi-Drug Urine Test Cup BUP 10
#### Wisdiag Multi-Drug Urine Test Cup PCP 25
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|-----------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL)<br>Lot Number | 52.1 | 43.1 | 37.3 | 29.4 | 25.2 | 17.7 | 12.2 | 6.5 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
# Wisdiag Multi-Drug Urine Test Cup THC 50
| Concentration by<br>LC/MS<br>(ng/mL)<br>Lot Number | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 96.5 | 84.3 | 75.7 | 60.1 | 52.5 | 35.9 | 24.1 | 12.1 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
#### Wisdiag Multi-Drug Urine Test Cup OXY 100
| Concentration by<br>LC/MS<br>(ng/mL)<br>Lot Number | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 200.3 | 177.1 | 158.9 | 131.7 | 108.5 | 78.0 | 51.6 | 27.6 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
{12}------------------------------------------------
# Wisdiag Multi-Drug Urine Test Cup BAR 300
| Concentration by<br>LC/MS<br>(ng/mL)<br>Lot Number | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 588.4 | 525.8 | 457.6 | 383.8 | 301.6 | 228.3 | 157.1 | 80.2 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
Wisdiag Multi-Drug Urine Test Cup BZO 300
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|-----------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | cutoff | cutoff | cutoff | cutoff | cut-off |
| (ng/mL)<br>Lot Number | 596.1 | 536.5 | 470.4 | 370.3 | 290.4 | 219.8 | 157.3 | 78.5 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
Wisdiag Multi-Drug Urine Test Cup EDDP 300
| Concentration by<br>LC/MS<br>(ng/mL) | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 646.2 | 545.3 | 455.1 | 371.0 | 290.7 | 229.5 | 148.8 | 77.0 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 28-/22+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
#### Wisdiag Multi-Drug Urine Test Cup MTD 300
| Concentration by<br>LC/MS<br>(ng/mL)<br>Lot Number | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 620.5 | 547.0 | 469.9 | 380.9 | 328.6 | 240.2 | 143.9 | 71.4 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
{13}------------------------------------------------
# Wisdiag Multi-Drug Urine Test Cup MOP 300
| Concentration by<br>LC/MS<br>(ng/mL)<br>Lot Number | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|----------------------------------------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| | 622.4 | 530.2 | 468.8 | 381.8 | 322.8 | 220.8 | 159.0 | 75.4 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
Wisdiag Multi-Drug Urine Test Cup PPX 300
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|-----------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL)<br>Lot Number | 622.3 | 562.7 | 451.3 | 383.3 | 297.7 | 218.3 | 152.5 | 75.8 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 28-/22+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
Wisdiag Multi-Drug Urine Test Cup COC 150
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|-----------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL)<br>Lot Number | 298.2 | 246.1 | 237.0 | 193.6 | 157.7 | 106.5 | 76.2 | 36.0 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 28-/22+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
# Wisdiag Multi-Drug Urine Test Cup MDMA 500
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|-----------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL)<br>Lot Number | 1048.5 | 861.5 | 740.8 | 614.9 | 522.8 | 342.0 | 250.6 | 128.4 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
{14}------------------------------------------------
# Wisdiag Multi-Drug Urine Test Cup TCA 1000
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL) | 2175.2 | 1841.2 | 1597.5 | 1261.6 | 1081.5 | 708.2 | 493.1 | 251.5 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
Wisdiag Multi-Drug Urine Test Cup AMP 500
| | Concentration<br>by LC/MS<br>(ng/mL) | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|------------|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| Lot Number | | 1011.8 | 846.4 | 772.7 | 646.8 | 544.3 | 357.6 | 225.0 | 120.9 | 0 |
| Lot I | | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
# Wisdiag Multi-Drug Urine Test Cup MET 500
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL) | 1072.7 | 873.9 | 731.7 | 633.1 | 477.8 | 386.1 | 249.2 | 122.5 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
# Wisdiag Multi-Drug Urine Test Cup OPI 2000
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|-----------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL)<br>Lot Number | 4208.2 | 3672.9 | 3119.0 | 2590.5 | 2050.0 | 1460.4 | 1007.5 | 493.0 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
{15}------------------------------------------------
# Wisdiag Multi-Drug Urine Test Cup COC 300
| Concentration by<br>LC/MS<br>(ng/mL)<br>Lot Number | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 610.6 | 558.5 | 461.6 | 373.4 | 329.9 | 235.6 | 156.7 | 74.5 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
# Wisdiag Multi-Drug Urine Test Cup AMP 1000
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS<br>(ng/mL) | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| Lot Number | 1933.3 | 1805.2 | 1562.7 | 1262.0 | 1051.1 | 812.0 | 540.9 | 271.9 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
# Wisdiag Multi-Drug Urine Test Cup MET 1000
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|--------------------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS<br>(ng/mL)<br>Lot Number | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| 1954.6 | 1824.2 | 1593.1 | 1304.9 | 1003.4 | 736.7 | 464.8 | 251.1 | 0 | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
The following cutoff values are verified:
| Target Drug | Cut-off level |
|----------------------------------------------------------|-------------------------|
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
{16}------------------------------------------------
| Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL |
|--------------------------------------|-------------------------|
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Cannabinoids (THC 50) | 50 ng/mL |
#### b. Linearity
Not applicable
#### c. Stability
The devices are stable at 2-30℃ for 24 months based on accelerated stability studies at 55℃.
#### d. Interference
Potential interfering substances were added to drug-free urine samples with target drugs of -25% cutoff and +25% cutoff level.
Compounds that show no interference at a concentration of 100µg/mL are summarized in the following table.
| Acetaminophen | Acetophenetidin | Acetylsalicylic Acid |
|-----------------------------|-------------------------------|----------------------|
| Acyclovir | Amiodarone Hydrochloride | Apomorphine |
| Afrin | Albumin (100mg/dL) | Amlodipine Mesylate |
| Aminophylline | Amoxicillin | Aripiprazole |
| Aminopyrine | Ampicillin | Aspartame |
| Benzilic Acid | Atropine | Atomoxetine |
| Benzoic Acid | Carbamazepine | Atorvastatin Calcium |
| Bilirubin | Cefradine | Chloramphenicol |
| Bupropion | Cephalexin | Chlorothiazide |
| Captopril | Chloral Hydrate | Chloroquine |
| Ciprofloxacin Hydrochloride | Clonidine | Cholesterol |
| Citalopram | Clopidogrel Hydrogen Sulphate | (-) Cotinine |
| Clarithromycin | Clozapine | chlorpheniramine |
| Deoxy- corticosterone | D,L-Tyrosine | D,L-Octopamine |
| Dextromethorphan | Digoxin | D,L-Propranolol |
| Diclofenac | Diphenhydramine | D-Norpropoxy- phene |
| Diflunisal | Dirithromycin | Domperidone |
{17}------------------------------------------------
| D-Pseudo- ephedrine | Ecgonine Methyl Ester | Doxylamine |
|--------------------------|----------------------------|-----------------------------------------|
| Duloxetine | Effexor | Epinephrine Hydrochloride |
| Dicyclomine | Enalapril Maleate | Erythromycin |
| β-Estradiol | Fentanyl Citrate | Esomeprazole Magnesium |
| Ethanol (1%) | Fluoxetine Hydrochloride | Furosemide |
| Fenofibrate | Fluvoxamine | Gabapentin |
| Fenoprofen | Glucose | Gentisic Acid |
| Glibenclamide | Haloperidol | 3-Hydroxy- tyramine |
| Gliclazide | Hemoglobin | Isosorbide Dinitrate |
| Glipizide | Ketamine | Isoxsuprine |
| Ibuprofen | Kratom powder | Lamotrigine |
| Ketoconazole | Labetalol | Levofloxacin Hydrochloride |
| Ketoprofen | Liverite | Levonorgestrel |
| Lidocaine Hydrochloride | Loperamide | Levothyroxine Sodium |
| Lisinopril | Loratadine | Minocycline |
| Lithium Carbonate | Naproxen | Nalidixic Acid |
| Metoprolol Tartrate | Mifepristone | Niacinamide |
| Magnesium | Mirtazapine | Nifedipine |
| Meperidine | Montelukast Sodium | Nikethamide |
| Meprobamate | Phenelzine | Sulfamethazine |
| Mosapride Citrate | Pioglitazone Hydrochloride | Sulindac |
| Maprotiline | Piracetam | Tetrahydrocortisone 3 -acetate |
| Nimodipine | Pravastatin Sodium | Tetrahydrocortisone 3-(β-D-glucuronide) |
| Norethindrone | Prednisone | Tetrahydrozoline |
| N-Acetylprocain-amide | Propylthiouracil | Tetracycline |
| O-Hydroxyhippu-ric Acid | Promethazine | Thiamine |
| Olanzapine | Quetiapine Fumarate | Thioridazine |
| Omeprazole | Quinine | Topiramate |
| Oxalic Acid | Ranitidine | Tramadol Hydrochloride |
| Oxolinic Acid | Rifampicin | Trazodone Hydrochloride |
| Oxymetazoline | Risperidone | Triamterene |
| Ondansetran | Salicylic Acid | Trifluoperazine |
| Paliperidone | Serotonin | Trimethoprim |
| Pantoprazole | Sertraline Hydrochloride | Uric Acid |
| Papaverine | Sildenafil Citrate | Valproate |
| Paroxetine Hydrochloride | Simvastatin | Verapamil |
| Penfluridol | Sodium Valproate | Vitamin B2 |
| PenicillinV Potassium | Spironolactone | Vitamin C |
{18}------------------------------------------------
- Specificity e.
To test the specificity, drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine. These urine samples were tested using three lots of each device.
Percent cross-reactivity, provided in the below table, was calculated as the cutoff concentration divided by the concentration of analyte tested that yielded a positive result, multiplied by 100; compounds that did not yield a positive result at the highest concentration tested have relative cross reactivity results represented by a dash in the table below:
| BUP 10 (Buprenorphine,<br>Cutoff=10 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|--------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Buprenorphine -3-D-Glucuronide | 15 | 66.67% |
| Norbuprenorphine | 20 | 50% |
| Norbuprenorphine-3-D-Glucuronide | 200 | 5% |
| Morphine | >100000 | - |
| Oxymorphone | >100000 | - |
| Hydromorphone | >100000 | - |
| PCP (Phencyclidine)<br>(Phencyclidine,<br>Cutoff=25 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| 4-Hydroxyphencyclidine | 12500 | 0.2% |
| THC 50<br>(11-nor-Δ9-THC-9-COOH,<br>Cutoff=50 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| (-)-11-nor-9-carboxy-Δ9-THC | 50 | 100% |
| 11-nor-Δ8-THC-9-COOH | 50 | 100% |
| 11-nor-Δ9-THC-carboxy glucuronide | 100 | 50% |
| Cannabidiol | 100,000 | -- |
| Cannabinol | 100,000 | -- |
| Δ8- Tetrahydrocannabinol | 15,000 | 0.5% |
| Δ9- Tetrahydrocannabinol | 15,000 | 0.5% |
| 11-hydroxy-Δ9-Tetrahydrocannabinol | 5,000 | 1% |
| OXY 100<br>(Oxycodone, Cutoff=100 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Dihydrocodeine | 20,000 | 0.5% |
| Hydrocodone | 80 | 125% |
| Oxymorphone | 1,000 | 10% |
{19}------------------------------------------------
| Codeine | 100,000 | -- |
|----------------|---------|--------|
| Hydromorphone | 36,000 | 0.278% |
| Morphine | 100,000 | -- |
| Acetylmorphine | 100,000 | -- |
| Buprenorphine | 100,000 | -- |
| Ethylmorphine | 100,000 | -- |
| Thebaine | 100,000 | -- |
| COC 150<br>(Benzoylecgonine, Cutoff=150 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Cocaine | 375 | 40% |
| Cocaethylene | 6,250 | 2.4% |
| Ecgonine | 16,000 | <1% |
| Ecgonine methyl ester | 100,000 | -- |
| Norcocaine | 100,000 | -- |
| BAR 300<br>(Secobarbital, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|--------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Amobarbital | 300 | 100% |
| Alphenol | 600 | 50% |
| Aprobarbital | 200 | 150% |
| Butabarbital | 100 | 300% |
| Butethal | 200 | 150% |
| Butalbital | 2,000 | 15% |
| Cyclopentobarbital | 400 | 75% |
| Pentobarbital | 200 | 150% |
| Phenobarbital | 200 | 150% |
| BZO 300<br>(Oxazepam, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|----------------------------------------|--------------------------------------------------------------------------|------------------------|
| Alprazolam | 190 | 63.3% |
| a-Hydroxyalprazolam | 300 | 100% |
| Bromazepam | 500 | 60% |
| Chlordiazepoxide | 1,500 | 20% |
| Clobazam | 110 | 272.7% |
| Clonazepam | 100,000 | -- |
| Clorazepate dipotassium | 300 | 100% |
| Delorazepam | 100,000 | -- |
| Desalkylflurazepam | 200 | 150% |
{20}------------------------------------------------
| Diazepam | 190 | 157.9% |
|---------------------|---------|--------|
| Estazolam | 5,000 | 6% |
| Flunitrazepam | 400 | 75% |
| Midazolam | 2,200 | 13.6% |
| Nitrazepam | 200 | 150% |
| Norchlordiazepoxide | 800 | 37.5% |
| Nordiazepam | 150 | 200% |
| Temazepam | 100 | 300% |
| Triazolam | 6,000 | 5% |
| Demoxepam | 2,000 | 15% |
| Flurazepam | 100,000 | -- |
| D,L-Lorazepam | 75,000 | 4% |
| EDDP 300<br>(2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine, Cutoff = 300 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Methadone | >100000 | - |
| EMDP | >100000 | - |
| Doxylamine | >100000 | - |
| Disopyramide | >100000 | - |
| LAAM (Levo-alpha-acetylmethadol) HCl | >100000 | - |
| Alpha Methadol | >100000 | - |
| MTD 300<br>(Methadone, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|-----------------------------------------|--------------------------------------------------------------------------|------------------------|
| Doxylamine | >100000 | - |
| EDDP | >100000 | - |
| EMDP | >100000 | - |
| LAAM | >100000 | - |
| Alpha Methadol | >100000 | - |
| MOP 300<br>(Morphine, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|----------------------------------------|--------------------------------------------------------------------------|------------------------|
| Normorphine | 300 | 100% |
| Codeine | 300 | 100% |
| s-Monoacetylmorphine | 300 | 100% |
| Ethyl Morphine | 200 | 150% |
| Heroin | 300 | 100% |
| Hydrocodone | 700 | 42.8% |
| Hydromorphone | 200 | 150% |
{21}------------------------------------------------
| Morphinie-3-β-d-glucuronide | 1,000 | 30% |
|------------------------------|---------|------|
| Oxycodone | 100,000 | -- |
| Oxymorphone | 100,000 | -- |
| Thebaine | 20,000 | 1.5% |
| Levorphanol | 10,000 | 3% |
| 6-Monoacetylmorphine (6-MAM) | 300 | 100% |
| Norcodeine | 6,250 | 4.8% |
| Procaine | 100,000 | -- |
| PPX 300<br>(d-Propoxyphene, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|----------------------------------------------|--------------------------------------------------------------------------|------------------------|
| d-Norpropoxyphene | 300 | 100% |
| MDMA 500<br>(3,4-Methylenedioxymethamphetamine HCl,<br>Cutoff=500ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| 3,4-Methylenedioxyamphetamine HCl (MDA) | 4,000 | 12.5% |
| 3,4-Methylenedioxyethylamphetamine (MDE) | 400 | 125% |
| d-methamphetamine | >100000 | - |
| d-amphetamine | >100000 | - |
| l-methamphetamine | >100000 | - |
| l-amphetamine | >100000 | - |
| AMP (Amphetamine) (Amphetamine,<br>Cutoff=500ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|-----------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| l-Amphetamine | >100000 | - |
| dl- Amphetamine | 1,500 | 33.3% |
| (+/-) 3,4-Methylenedioxyamphetamine (MDA) | 500 | 100% |
| Phentermine | 6,000 | 8.3% |
| Hydroxyamphetamine | >100000 | - |
| d-Methamphetamine | >100000 | - |
| l-Methamphetamine | >100000 | - |
| (+/-) 3,4-Methylenedioxyethylamphetamine (MDE) | >100000 | - |
| (+/-)3,4-Methylenedioxymethamphetamine (MDMA) | >100000 | - |
| β-Phenylethylamine | >100000 | - |
| Tyramine | >100000 | - |
| p-Hydroxynorephedrine | >100000 | - |
| Phenylpropanolamine | >100000 | - |
{22}------------------------------------------------
| (±)Phenylpropanolamine | >100000 | - |
|------------------------|---------|---|
| p-Hydroxyamphetamine | >100000 | - |
| d/l-Norephedrine | >100000 | - |
| Benzphetamine | >100000 | - |
| l-Ephedrine | >100000 | - |
| l-Epinephrine | >100000 | - |
| d/l-Epinephrine | >100000 | - |
| Ephedrine | >100000 | - |
| MET 500<br>(D(+)-Methamphetamine, Cutoff=500ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|-----------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| (+/-)3,4-Methylenedioxy-n-<br>ethylamphetamine(MDE) | 12,500 | 4% |
| D/L-Methamphetamine | 500 | 100% |
| p-Hydroxymethamphetamine | 15,000 | 3.3% |
| D-Amphetamine | >100000 | - |
| L-Amphetamine | >100000 | - |
| Chloroquine | 50,000 | 1% |
| (+/-)-Ephedrine | 100,000 | - |
| (-)-Methamphetamine | 65,000 | 0.8% |
| (+/-)3,4-Methyl…
