(30 days)
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, Marijuana, Tramadol, Fentanyl, 6-Monoacetylmorphine and Norfentanyl in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 500 ng/mL or 1000 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL or 300 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 500 ng/mL or 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 300 ng/mL or 2000 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 |
| Tramadol (TML) | 100 ng/mL |
| Fentanyl (FYL) | 1 ng/mL |
| 6-Monoacetylmorphine (6-MAM) | 10 ng/mL |
| Norfentanyl (NFYL) | 5 ng/mL |
The single or multi-test cups can consist of up to nineteen (19) of the above listed analytes in any combination but only one cutoff concentration under same drug condition will be included per device with or without on-board adulteration/specimen validity tests (SVT).
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. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
Wisdiag Multi-Drug Urine Home 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, Marijuana, Tramadol, Fentanyl, 6-Monoacetylmorphine and Norfentanyl in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 500 ng/mL or 1000 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL or 300 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 500 ng/mL or 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 300 ng/mL or 2000 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 |
| Tramadol (TML) | 100 ng/mL |
| Fentanyl (FYL) | 1 ng/mL |
| 6-Monoacetylmorphine (6-MAM) | 10 ng/mL |
| Norfentanyl (NFYL) | 5 ng/mL |
Wisdiag Multi-Drug Urine Home Test Cup offers any combinations from 1 to 19 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 over-the-counter use.
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. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
The Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Home Test Cup are rapid, single-use 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 device is in a ready-to-use format and no longer requires assembly before use.
N/A
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.01
September 12, 2025
VivaChek Biotech (Hangzhou) Co., Ltd
℅ Jenny Xia
Director
LSI International Inc
504E Diamond Ave., Suite H
Gaithersburg, Maryland 20877
Re: K252554
Trade/Device Name: Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup
Regulation Number: 21 CFR 862.3100
Regulation Name: Amphetamine test system
Regulatory Class: Class II
Product Code: NFT, PTH, NGL, NFV, NFY, PTG, NGG, NGM, QBF, QAW, NFW
Dated: August 11, 2025
Received: August 13, 2025
Dear Jenny Xia:
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 (the 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 available 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.
Page 2
K252554 – Jenny Xia Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K252554 – Jenny Xia Page 3
assistance/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,
JOSEPH A. KOTAREK -S
Digitally signed by JOSEPH A. KOTAREK -S
Date: 2025.09.12 08:02:59 -04'00'
Joseph Kotarek
Branch Chief for Toxicology
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
Page 4
FORM FDA 3881 (8/23) Page 1 of 2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K252554
Device Name: Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home 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, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Marijuana, Tramadol, Fentanyl, 6-Monoacetylmorphine and Norfentanyl in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 500 ng/mL or 1000 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL or 300 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 500 ng/mL or 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 300 ng/mL or 2000 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 |
| Tramadol (TML) | 100 ng/mL |
| Fentanyl (FYL) | 1 ng/mL |
| 6-Monoacetylmorphine (6-MAM) | 10 ng/mL |
| Norfentanyl (NFYL) | 5 ng/mL |
The single or multi-test cups can consist of up to nineteen (19) of the above listed analytes in any combination but only one cutoff concentration under same drug condition will be included per device with or without on-board adulteration/specimen validity tests (SVT).
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. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
Wisdiag Multi-Drug Urine Home 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, Marijuana, Tramadol, Fentanyl, 6-Monoacetylmorphine and Norfentanyl in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 500 ng/mL or 1000 ng/mL |
Page 5
FORM FDA 3881 (8/23) Page 2 of 2
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL or 300 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 500 ng/mL or 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 300 ng/mL or 2000 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 |
| Tramadol (TML) | 100 ng/mL |
| Fentanyl (FYL) | 1 ng/mL |
| 6-Monoacetylmorphine (6-MAM) | 10 ng/mL |
| Norfentanyl (NFYL) | 5 ng/mL |
Wisdiag Multi-Drug Urine Home Test Cup offers any combinations from 1 to 19 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 over-the-counter use.
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. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
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)
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Page 6
510(k) SUMMARY
-
Date: August 7, 2025
-
Submitter: VivaChek Biotech (Hangzhou) Co., Ltd.
Level 2, Block 2, 146 East Chaofeng Rd.
Hangzhou, China -
Contact Person: Jenny Xia
LSI International Inc.
504 East Diamond Ave., Suite H
Gaithersburg, MD 20877
Telephone: 301-525-6856
Fax: 301-916-6213
Email: jxia@lsi-consulting.org -
Device Name: Wisdiag Multi-Drug Urine Test Cup
Wisdiag Multi-Drug Urine Home Test Cup -
Classification: Class II
| Product Code | Target Drug | Regulation Section | Panel |
|---|---|---|---|
| NFT | Amphetamine (AMP) | 862.3100, Amphetamine Test System | Toxicology |
| NGL | Buprenorphine (BUP), Morphine (MOP/OPI), Oxycodone (OXY), 6-Monoacetylmorphine(6-MAM), Fentanyl (FYL), Norfentanyl (NFYL), Tramadol (TML) | 862.3650, Opiate Test System | Toxicology |
| PTH | Secobarbital (BAR) | 862.3150, Barbiturate Test System | Toxicology |
| NFV | Oxazepam (BZO) | 862.3170, Benzodiazepine Test System | Toxicology |
| NFY | Cocaine (COC) | 862.3250, Cocaine Test System | Toxicology |
| PTG | 2-ethylidene-1,5-dimethyl-3,3- | 862.3620, Methadone Test System | Toxicology |
Page 7
| diphenylpyrrolidine (EDDP), Methadone (MTD) | | |
| NGG | Methamphetamine (MET), Methylenedioxymethamphetamine (MDMA) | 862.3610, Methamphetamine Test System | Toxicology |
| NGM | Phencyclidine (PCP) | Unclassified | Toxicology |
| QBF | Propoxyphene (PPX) | 862.3700 Propoxyphene test system. | Toxicology |
| QAW | Nortriptyline (TCA) | 862.3910 Tricyclic antidepressant drugs test system | Toxicology |
| NFW | Cannabinoids (THC 50) | 862.3870, Cannabinoids Test System | Toxicology |
-
Predicate Device: K222667
Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Test Cup Rx -
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, Marijuana, Tramadol, Fentanyl, 6-Monoacetylmorphine and Norfentanyl in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 500 ng/mL or 1000 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL or 300 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 500 ng/mL or 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 300 ng/mL or 2000 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
Page 8
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
| Tramadol (TML) | 100 ng/mL |
| Fentanyl (FYL) | 1 ng/mL |
| 6-Monoacetylmorphine (6-MAM) | 10 ng/mL |
| Norfentanyl (NFYL) | 5 ng/mL |
The single or multi-test cups can consist of up to nineteen (19) of the above listed analytes in any combination but only one cutoff concentration under same drug condition will be included per device with or without on-board adulteration/specimen validity tests (SVT).
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. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
Wisdiag Multi-Drug Urine Home 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, Marijuana, Tramadol, Fentanyl, 6-Monoacetylmorphine and Norfentanyl in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 500 ng/mL or 1000 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL or 300 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 500 ng/mL or 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 300 ng/mL or 2000 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
Page 9
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
| Tramadol (TML) | 100 ng/mL |
| Fentanyl (FYL) | 1 ng/mL |
| 6-Monoacetylmorphine (6-MAM) | 10 ng/mL |
| Norfentanyl (NFYL) | 5 ng/mL |
Wisdiag Multi-Drug Urine Home Test Cup offers any combinations from 1 to 19 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 over-the-counter use.
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. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
- Device Description
The Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Home Test Cup are rapid, single-use 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 device is in a ready-to-use format and no longer requires assembly before use.
- Substantial Equivalence Information
| Item | Proposed Device | Predicate (K222667) |
|---|---|---|
| Intended use | Qualitative detection of drugs of abuse in urine. Prescription Use or over-the-counter use. | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assay based on antigen-antibody reaction | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Target Drug and Cut Off Values | Target Drug: Cutoff (ng/mL) - Amphetamine (AMP): 1000 or 500, Buprenorphine (BUP): 10, Secobarbital (BAR): 300 | Same except no 6-Monoacetylmorphine, Fentanyl, Norfentanyl and Tramadol |
Page 10
| Oxazepam (BZO) | 300 |
| Cocaine (COC) | 300 or 150 |
| 2-ethylidene-1,5-dimethyl-3,3-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 |
| Tramadol (TML) | 100 |
| Fentanyl (FYL) | 1 |
| 6-Monoacetylmorphine (6-MAM) | 10 |
| Norfentanyl (NFYL) | 5 |
| Configurations | Test Cup | Cup |
- Test Principle
Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Home Test Cup 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, Marijuana, Tramadol, Fentanyl, 6-Monoacetylmorphine and Norfentanyl 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 the presence of target drug or metabolite in the sample to indicate that the tests have been performed properly.
- Performance Characteristics
1. Analytical Performance
Page 11
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 drugs in drug-free 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 in a randomized order. The results obtained are summarized in the following tables only for Tramadol, Fentanyl, 6-Monoacetylmorphine and Norfentanyl. The rest data were reported in K222667.
TRA100
| Concentration by LC/MS (ng/mL) | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
|---|---|---|---|---|---|---|---|---|---|
| 202.64 | 176.98 | 151.08 | 124.45 | 102.50 | 75.68 | 51.80 | 25.90 | 0 | |
| Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
FYL1
| Concentration by LC/MS (ng/mL) | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
|---|---|---|---|---|---|---|---|---|---|
| 1.82 | 1.76 | 1.52 | 1.26 | 0.96 | 0.76 | 0.50 | 0.25 | 0 | |
| Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 23-/27+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
6-MAM10
| Concentration by LC/MS (ng/mL) | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
|---|---|---|---|---|---|---|---|---|---|
| 20.55 | 17.66 | 15.48 | 12.85 | 10.20 | 7.59 | 5.04 | 2.53 | 0 |
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| Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 25-/25+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 23-/27+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
NFYL5
| Concentration by LC/MS (ng/mL) | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
|---|---|---|---|---|---|---|---|---|---|
| 10.27 | 8.63 | 7.72 | 6.31 | 5.28 | 3.72 | 2.54 | 1.22 | 0 | |
| Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 27-/23+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 26-/24+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
The following cutoff values are verified:
| Target Drug | Cut-off level |
|---|---|
| Tramadol (TRA) | 100 ng/mL |
| Fentanyl (FYL) | 1 ng/mL |
| 6-monoacetylmorphine (6-MAM) | 10 ng/mL |
| Norfentanyl (NFYL) | 5 ng/mL |
b. Linearity
Not applicable
c. Stability
The devices are stable at 2-30℃ for 30 months based on accelerated stability studies at 55°C.
d. Interference
Potential interfering substances were added to drug-free urine sample and samples with target drugs of -50% cutoff and +50% cutoff level.
Compounds that show no interference at a concentration of 100µg/mL are summarized in the following table.
| (-) Cotinine | Domperidone | Norethindrone |
| 3-Hydroxytyramine | Dopamine HCl | Norpropoxyphene(except PPX test) |
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| 7-Aminoclonazepam(except BZO test) | Doxepine(except TCA test) | Norpseudoephedrine |
| 7-Aminoflunitrazepam(except BZO test) | Doxylamine | Nortriptyline(except TCA test) |
| 7-Aminonitrazepam(except BZO test) | D-Pseudoephedrine | Noscapine |
| Acetaminophen | Duloxetine(except TCA test) | Octopamine |
| Acetone (1000 mg/dL) | Ecgonine methyl ester | O-Hydroxyhippuric acid |
| Acetophenetidin | Effexor | Olanzapine |
| Acetylsalicylic acid | EMDP | Omeprazole |
| Acyclovir | Enalapril Maleate | Oxalic acid (100mg/dL) |
| Afrin | Ephedrine hydrochloride | Oxazepam (except BZO test) |
| Albumin(100mg/dL) | Erythromycin | Oxazepam Glucuronide(except BZO test) |
| Albuterol | Esomeprazole Magnesium | Oxolinic acid |
| Albuterol sulfate(Proair HFA) | Estradiol | Oxymetazoline |
| Alpha Methadol | Estrone | Ondansetran |
| Aminophylline | Ethanol(1%) | Paliperidone |
| Aminopyrine | Fenfluramine(except MET test) | Pantoprazole |
| Amiodarone Hydrochloride | Fenofibrate | Papaverine |
| Amitriptyline(except TCA test) | Fenoprofen | Paroxetine Hydrochloride |
| Amlodipine besylate | Fentanyl Citrate(except FYL and NFYL test) | Penfluridol |
| Amlodipine Mesylate | Fluoxetine Hydrochloride | Penicillin-G |
| Amobarbital(except BAR test) | Fluphenazine | PenicillinV Potassium |
| Amoxicillin | Fluvoxamine | Perphenazine |
| Ampicillin | Fotemustine | Phenacetin |
| Apomorphine | Furosemide | Phencyclidine(except PCP test) |
| Aripiprazole | Gabapentin | Phenelzine |
| Ascorbic acid | Galactose | Phenylethylamine(except MET test) |
| Aspartame | Gatifloxacin | Phenobarbital(except BAR test) |
| Aspirin | Gemfibrozil | Phentermine(except AMP test) |
| Atomoxetine | Gentisic acid | Phenylpropanolamine |
| Atorvastatin Calcium | Glibenclamide | Pioglitazone Hydrochloride |
| Atropine | Gliclazide | Piracetam |
| Azithromycin | Glipizide | Pravastatin Sodium |
| Baclofen | Glucose(3000 mg/dL) | Prednisone |
| Benzilic acid | Guaiacolglyceryl ether | Pregablin |
| Benzocaine | Haloperidol | Procaine |
| Benzoic acid | Hemoglobin | Promazine(except TCA test) |
Page 14
| Benzoylecogonine(except COC test) | Hexobarbital | Promethazine |
| Benzphetamine | Hydralazine | Propoxyphene(except PPX test) |
| Benzylpiperiazine | Hydrochlorothiazide | Propranolol |
| Bilirubin | Hydrocortisone | Propylthiouracil |
| Boric Acid (1%) | Hydroxybutyric Acid | Pseudoephedrine |
| Bromo-2,5,Dimethoxyphenethylamine | Ibuprofen | Pyridoxine |
| Bupropion | Imipramine(except TCA test) | Pyrilamine |
| Caffeine | Isoproterenol | Pyrogallol |
| Cannabidiol | Isosorbide Dinitrate | Quetiapine |
| Captopril | Isoxsuprine | Quetiapine Fumarate |
| Carbamazepine | Ketamine | Quinidine |
| Carfentanil(except FYLand NFYL test) | Ketoconazole | Quinine |
| Carisoprodol | Ketoprofen | Quinolinic Acid |
| Cefradine | Kratom powder | Ranitidine |
| Cephalexin | LAAM HCl | Riboflavin |
| Cetirizine | Labetalol | Rifampicin |
| Chloral hydrate | Lamotrigine | Risperidone(except NFYL test) |
| Chloramphenicol | L-Ephedrine | Salicylic acid |
| Chlordiazepoxide(except BZO test) | L-Epinephrine | Secobarbital(except BAR test) |
| Chloroquine | Levofloxacin Hydrochloride | Serotonin |
| Chlorothiazide | Levonorgestrel | Serotonin (5- Hydroxytyramine) |
| Chlorpheniramine(except TCA test) | Levothyroxine Sodium | Sertraline |
| Chlorpromazine | Lidocaine Hydrochloride | Sertraline Hydrochloride |
| Cholesterol | Lisinopril | Sildenafil Citrate |
| Ciprofloxacin Hydrochloride | Lithium Carbonate | Simvastatin |
| Citalopram | Liverite | Sodium Azide |
| Clarithromycin | Loperamide | Sodium Valproate |
| Clofibrate | Loratidine | Spironolactone |
| Clomipramine(except TCA test) | Lorazepam Glucuronide(except BZO test) | Sulfamethazine |
| Clonidine | L-phenylephrine | Sulindac |
| Clopidogrel Hydrogen Sulphate | LSD | Telmisartan |
| Clozapine | L-thyroxine | Tetracycline |
| Conjugated Estrogens | Magnesium | Tetrahydrocortisone 3-(β-D-glucuronide) |
| Cortisone | Maprotiline | Tetrahydrocortisone, 3-acetate |
| Creatine Hydrate | Meperidine | Tetrahydrozoline |
Page 15
| Creatinine | Meprobamate | THC (except THC test) |
| Cyclobenzaprine(except TCA test) | Metformin | Theophylline |
| Cyproheptadine | Methapyrilene | Thiamine |
| D,L-Epinephrine | Methaqualone | Thioridazine |
| D,L-Isoproterenol | Methoxyphenamine (except MET test) | Topiramate |
| D,L-Lorazepam (except BZO test) | Methylphenidate | Tramadol Hydrochloride |
| D,L-Octopamine | Metoprolol Tartrate | Trazodone Hydrochloride |
| D,L-Propranolol | Metronidazole | Triamterene |
| D,L-Tryptophan | Mifepristone | Trifluoperazine |
| D,L-Tyrosine | Mirtazapine | Trifluoromethylphenyl-piperazine |
| Delorazepam | Montelukast Sodium | Trimethobenzamide |
| Demoxepam(except BZO test) | Mosapride Citrate | Trimethoprim |
| Deoxycorticosterone | Minocycline | Tryptamine |
| Desloratadine | N-Acetylprocainamide | Tyramine (except AMP test) |
| Desipramine(except TCA, PPX test) | Nacl (4000 mg/dL) | Urea (2000 mg/dL) |
| Dextromethorphan | Nalidixic acid | Uric acid |
| Diclofenac | Naloxone hydrochloride(except OXY test) | Valproic acid (250 μg/mL) |
| Diclofenac sodium | Naltrexone hydrochloride(except OXY test) | Venlafaxine HCl |
| Dicyclomine | Naproxen | Verapamil |
| Diflunisal | N-desmethyl Tapentadol | Vitamin B2 |
| Digoxin | Niacinamide | Vitamin C |
| Dimethyl-aminoantipyrine | Nicotine | Zaleplon |
| Diphenhydramine | Nicotinic Acid | Zolpidem |
| Diphenhydramine HCl | Nifedipine | Zomepirac |
| Diphenylhydantoin | Nikethamide | β-Estradiol |
| Dirithromycin | Nimodipine | γ-Cyclodextrin |
| Disopyramide | Nitroglycerin | γ-Globulin (500mg/dL) |
e. Specificity
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 was calculated as the cutoff concentration divided by the concentration of analyte tested that yielded a positive result, multiplied by 100. The results obtained are summarized in the following tables only for Tramadol, Fentanyl, 6-Monoacetylmorphine and Norfentanyl. The rest data were reported in K222667.
Page 16
Tramadol (Cutoff=100ng/mL)
| Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | |
|---|---|---|
| Tramadol | 100 | 100% |
| n-Desmethyl Tramadol | 200 | 50% |
| o-Desmethyl Tramadol | 1,000 | 10% |
| o-Desmethyl Venlafaxine | >100,000 | -- |
| Venlafaxine HCl | >100,000 | -- |
| Rac N, O-didesmethyltramadol | 15,000 | 0.67% |
| O-desmethyl tramadol beta-D- | 90 | 111.11% |
| Ketamine | >100,000 | -- |
| Dehydronorketamine | 10,000 | 1% |
| Norketamine | 20,000 | 0.50% |
| Phencyclidine (PCP) | >100,000 | -- |
6-monoacetylmorphine (Cutoff=10ng/mL)
| Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | |
|---|---|---|
| 6-Monoacetylmorphine (6-MAM) | 10 | 100% |
| Heroin | 40 | 25% |
| Morphine | >100,000 | -- |
| Normorphine | >100,000 | -- |
| Nalorphine hydrochloride | >100,000 | -- |
| Hydrocodone | >100,000 | -- |
| Hydromorphone | >100,000 | -- |
| Chlordiazepoxide | >100,000 | -- |
| Clobazam | >100,000 | -- |
| D-Amphetamine | >100,000 | -- |
| (±)-Amphetamine | >100,000 | -- |
| Levorphanol tartrate | >100,000 | -- |
| Codeine | >100,000 | -- |
| Ethylmorphine | >100,000 | -- |
| Morphine3-β-D-glucuronide | >100,000 | -- |
| Norcodeine | >100,000 | -- |
| Oxycodone | >100,000 | -- |
| Oxymorphone | >100,000 | -- |
| Procaine hydrochloride | >100,000 | -- |
| Thebaine | >100,000 | -- |
| 6-Acetylcodeine | >100,000 | -- |
| Buprenorphine | >100,000 | -- |
| Dihydrocodeine | >100,000 | -- |
| Dextromethorphan | >100,000 | -- |
Page 17
| Imipramine hydrochloride | >100,000 | -- |
| Meperidine | >100,000 | -- |
| (±)-Methadone | >100,000 | -- |
| Mitragynine(kratom) | >100,000 | -- |
| Morphine-6-β-D-glucuronide | >100,000 | -- |
| Naloxone | >100,000 | -- |
| Naltrexone hydrochloride | >100,000 | -- |
| Naproxen | >100,000 | -- |
| Norbuprenorphine | >100,000 | -- |
| Norbuprenorphine-3-D-Glucuronide | >100,000 | -- |
| Noroxycodone hydrochloride | >100,000 | -- |
| Noroxymorphone hydrochloride | >100,000 | -- |
| Norpropoxyphene | >100,000 | -- |
| Oxymorphone-3β-D-glucuronide | >100,000 | -- |
| Tapentadol hydrochloride | >100,000 | -- |
| Tramadol hydrochloride | >100,000 | -- |
| Acetylcodeine | >100,000 | -- |
| Levacetylmethadol (LAAM) | >100,000 | -- |
| Noroxycodone HCL | >100,000 | -- |
Fentanyl (Cutoff=1ng/mL)
| Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | |
|---|---|---|
| (±) β-hydroxythiofentanyl | 10 | 10% |
| (±)-3-cis-methyl fentanyl | 4 | 25% |
| 4-Fluoro-isobutyrylfentanyl | 3 | 33.33% |
| Acetyl fentanyl | 1 | 100% |
| Acryl fentanyl | 2 | 50% |
| Butyryl fentanyl | 2 | 50% |
| Fentanyl | 1 | 100% |
| Furanyl fentanyl | 2 | 50% |
| Isobutyryl fentanyl | 2 | 50% |
| Ocfentanil | 1 | 100% |
| Para-fluoro fentanyl | 2 | 50% |
| Para-fluorobutyryl fentanyl | 4 | 25% |
| Valeryl fentanyl | 5 | 20% |
| ω-1-Hydroxyfentanyl | 20,000 | -- |
| Acetyl norfentanyl | >100,000 | -- |
| Alfentanil | >100,000 | -- |
| Norcarfentanil | >100,000 | -- |
| Norfentanyl | >100,000 | -- |
| Remifentanil | 1,500 | 0.07% |
Page 18
| Risperidone | >100,000 | -- |
| Sufentanil | 50 | 2% |
| Carfentanil | 5 | 20% |
| Despropionyl fentanyl (4-ANPP) | 300 | 0.33% |
| Isotonitaze | >100,000 | -- |
| AH-7921 HCL | >100,000 | -- |
Norfentanyl (Cutoff=5ng/mL)
| Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity | |
|---|---|---|
| (±)-β-Hydroxythiofentanyl | 100 | 5% |
| 4-Fluoro-isobutyryl Fentanyl | 1,000 | 0.50% |
| 9-HydroxyRisperidone | 10,000 | 0.05% |
| Acetyl Fentanyl | 200 | 2.50% |
| Acetyl Norfentanyl | 200 | 2.50% |
| Acryl Fentanyl | 200 | 2.50% |
| Alfentanil | >10,000 | -- |
| Butyryl Fentanyl | 200 | 2.50% |
| (±)-3-cis-methyl fentanyl | 1,000 | 0.50% |
| Fentanyl | 80 | 6.25% |
| Furanyl Fentanyl | 1,000 | 0.50% |
| Isobutyryl Fentanyl | 1,000 | 0.50% |
| Labetalol Hydrochloride | >100,000 | -- |
| MT-45 | 8,000 | -- |
| Norfentanyl | 5 | 100% |
| Ocfentanil | 2,000 | 0.25% |
| Para-fluorobutyryl fentanyl | 1,000 | 0.50% |
| Para-fluoro fentanyl | 300 | 1.67% |
| Risperidone | 37,500 | -- |
| Thienyl Fentnayl | 100 | 5% |
| Valeryl Fentanyl | 1,000 | 0.50% |
| ω- 1-Hydroxyfentanyl | >50,000 | -- |
| trans-d, l-3-methylfentanyl | 200 | 2.50% |
| Carfentanil | >10,000 | -- |
| Despropionyl fentanyl (4-ANPP) | >20,000 | -- |
| Norcarfentanil | >10,000 | -- |
| Remifentanil | >10,000 | -- |
| Sufentanil | 3,000 | 0.17% |
| Trazodone | >10,000 | -- |
| U-47700 | >100,000 | -- |
| Cis-d, I 3-Methylfentanyl | 70 | 7.14% |
Page 19
Negative fentanyl and norfentanyl results were obtained for all opioids compounds tested at 100 μg/mL. There is no cross-reactivity with fentanyl and norfentanyl for these compounds at the concentrations tested.
| 6-Acetyl morphine | Methadone | Tapentadol |
| Amphetamine | Morphine | Tilidine |
| Buprenorphine | Morphine-3-glucuronide | Tramadol |
| Buprenorphineglucuronide | Norbuprenorphine | Tramadol-O-Desmethyl |
| Codeine | Norcodeine | Tramadol-N-Desmethyl |
| Dihydrocodeine | Norketamine | Dextromethorphan |
| EDDP | Normeperidine | Ketamine |
| EMDP | Normorphine | Meperidine |
| Fluoxetine | Noroxycodone | Naloxone |
| Heroin | Oxycodone | Naltrexone |
| Hydrocodone | Oxymorphone | Thioridazine |
| Hydromorphone | Pentazocine (Talwin) | |
| Levorphanol | Pipamperone | |
f. Effect of Urine Specific Gravity and Urine pH
To investigate the effect of urine specific gravity, urine samples with specific gravity from 1.000 to 1.035 were spiked with target drugs at +50% cutoff and -50% cutoff levels. Three Operators tested each sample using test devices from three different lots. The results were all positive for samples at +50% cutoff and all negative for samples at -50% cutoff, indicating that urine specific gravity between 1.000 and 1.035 has no effect on the accuracy and precision of the test device.
To investigate the effect of urine pH, urine samples with pH value from 4 to 9 were spiked with target drugs at +50% cutoff and -50% cutoff levels. Three Operators tested each sample using test devices from three different lots. The results were all positive for samples at +50% cutoff and all negative for samples at -50% cutoff, indicating that urine pH value between 4.0 and 9.0 has no effect on the accuracy and precision of the test device.
2. Comparison Studies
The method comparison studies for Wisdiag Multi-Drug Urine Test Cup were performed in-house with three operators. Operators ran 80 (40 negative and 40 positive) unaltered urine samples. The samples were blind labeled and compared to LC/MS results. The results are presented in the table below only for Tramadol, Fentanyl, 6-Monoacetylmorphine and Norfentanyl. The rest data were reported in K222667.
TRA 100
| Wisdiag Cup | Drug-Free | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and the Cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
|---|
Page 20
| Operator A | Positive: 0, Negative: 10 | Positive: 0, Negative: 15 | Positive: 1, Negative: 14 | Positive: 19, Negative: 0 | Positive: 21, Negative: 0 |
| Operator B | Positive: 0, Negative: 10 | Positive: 0, Negative: 15 | Positive: 1, Negative: 14 | Positive: 19, Negative: 0 | Positive: 21, Negative: 0 |
| Operator C | Positive: 0, Negative: 10 | Positive: 0, Negative: 15 | Positive: 1, Negative: 14 | Positive: 19, Negative: 0 | Positive: 21, Negative: 0 |
Discordant Results for TRA 100:
| Operator | Sample Number | LC/MS Result (ng/mL) | Hightop Result |
|---|---|---|---|
| Operator A, C | VCTC054 | 97.45 | + |
| Operator B | VCTC079 | 96.18 | + |
FYL 1
| Wisdiag Cup | Drug-Free | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and the Cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
|---|---|---|---|---|---|
| Operator A | Positive: 0, Negative: 10 | Positive: 0, Negative: 18 | Positive: 2, Negative: 10 | Positive: 19, Negative: 1 | Positive: 20, Negative: 0 |
| Operator B | Positive: 0, Negative: 10 | Positive: 0, Negative: 18 | Positive: 2, Negative: 10 | Positive: 29, Negative: 1 | Positive: 20, Negative: 0 |
| Operator C | Positive: 0, Negative: 10 | Positive: 0, Negative: 18 | Positive: 1, Negative: 11 | Positive: 18, Negative: 2 | Positive: 20, Negative: 0 |
Discordant Results for FYL 1:
| Operator | Sample Number | LC/MS Result (ng/mL) | Hightop Result |
|---|---|---|---|
| Operator A, B | VCFC048 | 0.946 | + |
| Operator A, B | VCFC059 | 0.985 | + |
| Operator C | VCFC010 | 0.934 | + |
| Operator A | VCFC057 | 1.063 | - |
| Operator B | VCFC036 | 1.104 | - |
| Operator C | VCFC035 | 1.104 | - |
| Operator C | VCFC066 | 1.084 | - |
6-MAM 10
Page 21
| Wisdiag Cup | Drug-Free | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and the Cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
|---|---|---|---|---|---|
| Operator A | Positive: 0, Negative: 10 | Positive: 0, Negative: 16 | Positive: 0, Negative: 14 | Positive: 19, Negative: 1 | Positive: 20, Negative: 0 |
| Operator B | Positive: 0, Negative: 10 | Positive: 0, Negative: 16 | Positive: 0, Negative: 14 | Positive: 19, Negative: 1 | Positive: 20, Negative: 0 |
| Operator C | Positive: 0, Negative: 10 | Positive: 0, Negative: 16 | Positive: 0, Negative: 14 | Positive: 19, Negative: 1 | Positive: 20, Negative: 0 |
Discordant Results for 6-MAM 10:
| Operator | Sample Number | LC/MS Result (ng/mL) | Hightop Result |
|---|---|---|---|
| Operator A | VCMC132 | 10.08 | - |
| Operator B, C | VCMC090 | 10.37 | - |
NFYL 5
| Wisdiag Cup | Drug-Free | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and the Cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
|---|---|---|---|---|---|
| Operator A | Positive: 0, Negative: 10 | Positive: 0, Negative: 17 | Positive: 1, Negative: 12 | Positive: 19, Negative: 1 | Positive: 20, Negative: 0 |
| Operator B | Positive: 0, Negative: 10 | Positive: 0, Negative: 17 | Positive: 0, Negative: 13 | Positive: 18, Negative: 2 | Positive: 20, Negative: 0 |
| Operator C | Positive: 0, Negative: 10 | Positive: 0, Negative: 17 | Positive: 1, Negative: 12 | Positive: 19, Negative: 1 | Positive: 20, Negative: 0 |
Discordant Results for NFYL 5:
| Operator | Sample Number | LC/MS Result (ng/mL) | Hightop Result |
|---|---|---|---|
| Operator A, C | VCNC013 | 4.49 | + |
| Operator A, B | VCNC099 | 5.79 | - |
| Operator B, C | VCNC036 | 5.03 | - |
Lay-user study:
A lay user study was performed using urine samples prepared at the following concentrations; -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS or LC/MS. Each
Page 22
sample was aliquoted into individual containers and blind-labeled. A total of 280 participants with diverse educational and professional backgrounds aged 20 years and older were recruited from three sites. Sixty-eight males and 72 females tested Wisdiag Multi-Drug Urine Test Cup Configuration 1 (including AMP 500, MET 500, MOP 300, COC 150); 62 male and 78 females tested Wisdiag Multi-Drug Urine Test Cup Configuration 2 (including AMP 1000, MET 1000, MOP 2000 (OPI), COC 300). Each participant was provided one package insert, one blind labeled test solution, and one test device. The results are summarized below:
Lay-User Study Results for Wisdiag Multi-Drug Urine Test Cup Configuration 1 (including AMP 500, MET 500, MOP 300, COC 150):
| Drug | Cutoff (ng/mL) | Results | Concentration |||||||||
|------|----------------|---------|---------------|
| | | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff |
| AMP | 500 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 95 | 95 | 100 | 100 |
| BUP | 10 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 95 | 95 | 100 | 100 |
| BAR | 300 | Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 90 | 100 | 100 | 100 |
| BZO | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 95 | 95 | 100 | 100 |
| COC | 150 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 100 | 95 | 100 | 100 |
| EDDP | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 95 | 95 | 100 | 100 |
| MDMA | 500 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 95 | 90 | 100 | 100 |
| MET | 500 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
Page 23
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 95 | 95 | 100 | 100 |
| MOP | 300 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 95 | 100 | 100 | 100 |
| MTD | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 95 | 95 | 100 | 100 |
| OXY | 100 | Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 100 | 100 | 100 | 100 |
| PCP | 25 | Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 100 | 100 | 100 | 100 |
| PPX | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 95 | 95 | 100 | 100 |
| TCA | 1000 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 90 | 95 | 100 | 100 |
| THC | 50 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 90 | 95 | 100 | 100 |
| TRA | 100 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 95 | 90 | 100 | 100 |
| FYL | 1 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 95 | 95 | 100 | 100 |
| 6-MAM | 10 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
Page 24
| | | Agreement (%) | 100 | 100 | 100 | 90 | 90 | 100 | 100 |
| NFYL | 5 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 90 | 95 | 100 | 100 |
Lay-User Study Results for Wisdiag Multi-Drug Urine Test Cup Configuration 2 (AMP 1000, MET 1000, MOP 2000 (OPI), COC 300):
| Drug | Cutoff (ng/mL) | Results | Concentration |||||||||
|------|----------------|---------|---------------|
| | | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff |
| AMP | 1000 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 95 | 95 | 100 | 100 |
| BUP | 10 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 100 | 95 | 100 | 100 |
| BAR | 300 | Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 100 | 100 | 100 | 100 |
| BZO | 300 | Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 90 | 100 | 100 | 100 |
| COC | 300 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 100 | 95 | 100 | 100 |
| EDDP | 300 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 90 | 95 | 100 | 100 |
| MDMA | 500 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 95 | 100 | 100 | 100 |
| MET | 1000 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
Page 25
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 95 | 100 | 100 | 100 |
| OPI | 2000 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 95 | 95 | 100 | 100 |
| MTD | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 95 | 95 | 100 | 100 |
| OXY | 100 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 95 | 90 | 100 | 100 |
| PCP | 25 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 90 | 95 | 100 | 100 |
| PPX | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 95 | 95 | 100 | 100 |
| TCA | 1000 | Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 90 | 100 | 100 | 100 |
| THC | 50 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 90 | 95 | 100 | 100 |
| TRA | 100 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 90 | 95 | 100 | 100 |
| FYL | 1 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 95 | 90 | 100 | 100 |
| 6-MAM | 10 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 95 | 95 | 100 | 100 |
Page 26
| NFYL | 5 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100 | 100 | 100 | 90 | 90 | 100 | 100 |
Participants were given surveys on the ease of understanding the instruction for use. All participants indicated that the device instruction is easy to understand and follow. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.
Clinical Studies:
Not applicable.
- Conclusion
Based on the test principle and performance characteristics of the device including precision, cut-off, interference, specificity, method comparison and lay-user studies of the devices, it's concluded that Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Home Test Cup are substantially equivalent to the predicate devices.
§ 862.3100 Amphetamine test system.
(a)
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.(b)
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).