(97 days)
SAFElife™ T-Cup Multi-Drug Urine Test Cup:
SAFElife™ T-Cup Multi-Drug Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Fentanyl, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Opiates, Methadone, Norfentanyl, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids and Tramadol in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cutoff Level |
|---|---|
| 6-Monoacetylmorphine (6-MAM) | 10 ng/mL |
| 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 |
| Fentanyl (FTY) | 1 ng/mL |
| Methamphetamine (MET/mAMP) | 1000 ng/mL or 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP) | 300 ng/mL |
| Opiates (OPI) | 2000 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Norfentanyl (NFTY) | 5 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 or 20 ng/mL |
| Tramadol (TRA) | 100 ng/mL |
SAFElife™ T-Cup Multi-Drug Urine 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.
The tests may yield positive results for the prescription drugs Buprenorphine, Fentanyl, Nortriptyline, Oxazepam, Secobarbital, Oxycodone and Tramadol 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. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the recommended confirmatory method.
SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx:
SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Fentanyl, Methylenedioxymethamphetamine, Methamphetamine, Morphine, Opiates, Methadone, Norfentanyl, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids and Tramadol in human urine with below cutoff
concentrations and approximate detection time:
| Drug (Identifier) | Calibrator | Cut-off Level |
|---|---|---|
| 6-Monoacetylmorphine (6-MAM) | 6-Monoacetylmorphine | 10 ng/mL |
| Amphetamine (AMP500) | d-Amphetamine | 500 ng/mL |
| Amphetamine (AMP1000) | d-Amphetamine | 1000 ng/mL |
| Secobarbital (BAR) | Secobarbital | 300 ng/mL |
| Buprenorphine (BUP) | Buprenorphine | 10 ng/mL |
| Oxazepam (BZO) | Oxazepam | 300 ng/mL |
| Cocaine (COC150) | Benzoylecgonine | 150 ng/mL |
| Cocaine (COC300) | Benzoylecgonine | 300 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-diphenyl-pyrrolidine | 300 ng/mL |
| Fentanyl (FTY) | Fentanyl | 1 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 3,4-Methylenedioxymethamphetamine | 500 ng/mL |
| Methamphetamine (MET500/mAMP500) | D(+)-Methamphetamine | 500 ng/mL |
| Methamphetamine (MET1000/mAMP1000) | D(+)-Methamphetamine | 1000 ng/mL |
| Morphine (MOP300) | Morphine | 300 ng/mL |
| Opiates (OPI2000) | Morphine | 2000 ng/mL |
| Methadone (MTD) | Methadone | 300 ng/mL |
| Norfentanyl (NFTY) | Norfentanyl | 5 ng/mL |
| Oxycodone (OXY) | Oxycodone | 100 ng/mL |
| Phencyclidine (PCP) | Phencyclidine | 25 ng/mL |
| Propoxyphene (PPX) | d-Propoxyphene | 300 ng/mL |
| Nortriptyline (TCA) | Nortriptyline | 1000 ng/mL |
| Cannabinoids (THC20) | 11-nor-Δ9-THC-9-COOH | 20 ng/mL |
| Cannabinoids (THC50) | 11-nor-Δ9-THC-9-COOH | 50 ng/mL |
| Tramadol (TRA) | Tramadol | 100 ng/mL |
SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx offers any combinations from 1 to 19 drugs of abuse tests with or without on-board adulteration/specimen validity test (SVT) but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use.
The tests may yield positive results for the prescription drugs Buprenorphine, Fentanyl, Nortriptyline, Oxazepam, Secobarbital, Oxycodone and Tramadol 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. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the recommended confirmatory method.
SAFElife™ T-Cup Multi-Drug Urine Test Cup and SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Opiates, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids, 6-Monoacetylmorphine, Fentanyl, Norfentanyl, and Tramadol in human urine. Each SAFElife™ T-Cup Multi-Drug Urine Test Cup or SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx device consists of a test cup and a package insert. Each test cup is sealed with one sachet of desiccant in an aluminum pouch. SAFElife™ T-Cup Multi-Drug Urine Test Cup and SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx have a general identical design. The SAFElife™ T-Cup Multi-Drug Urine Test Cup is for over-the-counter (OTC) use and the SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx is for professional use.
N/A
FDA 510(k) Clearance Letter - SAFElife T-Cup Multi-Drug Urine Test Cup
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.02
November 18, 2025
Guangzhou Wondfo Biotech Co., Ltd.
Kaiyu Xiao
Senior Regulatory Affairs Manager
No.8 Lizhishan Road, Science City, Huangpu District
Guangzhou, 510663
China
Re: K252550
Trade/Device Name: SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx
Regulation Number: 21 CFR 862.3100
Regulation Name: Amphetamine Test System
Regulatory Class: Class II
Product Code: NFT, NGL, PTH, NFV, NFY, PTG, NGG, LCM, QBF, QAW, NFW
Dated: August 13, 2025
Received: October 14, 2025
Dear Kaiyu Xiao:
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.
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.
Page 2
K252550 - Kaiyu Xiao 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
K252550 - Kaiyu Xiao 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: 2025.11.18 08:22:57 -05'00'
Joseph Kotarek
Branch Chief
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 3
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): K252550
Device Name: SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx
Indications for Use (Describe)
SAFElife™ T-Cup Multi-Drug Urine Test Cup:
SAFElife™ T-Cup Multi-Drug Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Fentanyl, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Opiates, Methadone, Norfentanyl, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids and Tramadol in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cutoff Level |
|---|---|
| 6-Monoacetylmorphine (6-MAM) | 10 ng/mL |
| 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 |
| Fentanyl (FTY) | 1 ng/mL |
| Methamphetamine (MET/mAMP) | 1000 ng/mL or 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP) | 300 ng/mL |
| Opiates (OPI) | 2000 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Norfentanyl (NFTY) | 5 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 or 20 ng/mL |
| Tramadol (TRA) | 100 ng/mL |
SAFElife™ T-Cup Multi-Drug Urine 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.
The tests may yield positive results for the prescription drugs Buprenorphine, Fentanyl, Nortriptyline, Oxazepam, Secobarbital, Oxycodone and Tramadol 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. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the recommended confirmatory method.
SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx:
SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Fentanyl, Methylenedioxymethamphetamine, Methamphetamine, Morphine, Opiates, Methadone, Norfentanyl, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids and Tramadol in human urine with below cutoff
Page 5
FORM FDA 3881 (8/23) Page 2 of 3
concentrations and approximate detection time:
| Drug (Identifier) | Calibrator | Cut-off Level |
|---|---|---|
| 6-Monoacetylmorphine (6-MAM) | 6-Monoacetylmorphine | 10 ng/mL |
| Amphetamine (AMP500) | d-Amphetamine | 500 ng/mL |
| Amphetamine (AMP1000) | d-Amphetamine | 1000 ng/mL |
| Secobarbital (BAR) | Secobarbital | 300 ng/mL |
| Buprenorphine (BUP) | Buprenorphine | 10 ng/mL |
| Oxazepam (BZO) | Oxazepam | 300 ng/mL |
| Cocaine (COC150) | Benzoylecgonine | 150 ng/mL |
| Cocaine (COC300) | Benzoylecgonine | 300 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-diphenyl-pyrrolidine | 300 ng/mL |
| Fentanyl (FTY) | Fentanyl | 1 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 3,4-Methylenedioxymethamphetamine | 500 ng/mL |
| Methamphetamine (MET500/mAMP500) | D(+)-Methamphetamine | 500 ng/mL |
| Methamphetamine (MET1000/mAMP1000) | D(+)-Methamphetamine | 1000 ng/mL |
| Morphine (MOP300) | Morphine | 300 ng/mL |
| Opiates (OPI2000) | Morphine | 2000 ng/mL |
| Methadone (MTD) | Methadone | 300 ng/mL |
| Norfentanyl (NFTY) | Norfentanyl | 5 ng/mL |
| Oxycodone (OXY) | Oxycodone | 100 ng/mL |
| Phencyclidine (PCP) | Phencyclidine | 25 ng/mL |
| Propoxyphene (PPX) | d-Propoxyphene | 300 ng/mL |
| Nortriptyline (TCA) | Nortriptyline | 1000 ng/mL |
| Cannabinoids (THC20) | 11-nor-Δ9-THC-9-COOH | 20 ng/mL |
| Cannabinoids (THC50) | 11-nor-Δ9-THC-9-COOH | 50 ng/mL |
| Tramadol (TRA) | Tramadol | 100 ng/mL |
SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx offers any combinations from 1 to 19 drugs of abuse tests with or without on-board adulteration/specimen validity test (SVT) but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use.
The tests may yield positive results for the prescription drugs Buprenorphine, Fentanyl, Nortriptyline, Oxazepam, Secobarbital, Oxycodone and Tramadol 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. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the recommended confirmatory method.
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.
Page 6
FORM FDA 3881 (8/23) Page 3 of 3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 7
510(k) SUMMARY
1. Date:
November 13, 2025
2. Submitter:
Guangzhou Wondfo Biotech Co., Ltd.
No.8 Lizhishan Road, Science City, Huangpu District
Guangzhou, China
3. Contact Person
Kaiyu Xiao
Senior Regulatory Affairs Manager
Tel: +86-15005196892
E-mail: kaiyu.xiao@wondfo.com.cn
4. Device Name
SAFElife™ T-Cup Multi-Drug Urine Test Cup
SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx
5. Classification
Class II
| Product Code & Target Drug | Regulation Section | Panel |
|---|---|---|
| NFT - Amphetamine (AMP) | 862.3100, Amphetamine Test System | Toxicology (91) |
| NGL - Buprenorphine (BUP), Morphine (MOP), Opiates (OPI), Oxycodone (OXY), Fentanyl (FTY), Norfentanyl (NFTY), Tramadol (TRA), 6-Monoacetylmorphine(6-MAM) | 862.3650, Opiate Test System | Toxicology (91) |
| PTH - Secobarbital (BAR) | 862.3150, Barbiturate Test System | Toxicology (91) |
| NFV - Oxazepam (BZO) | 862.3170, Benzodiazepine Test System | Toxicology (91) |
| NFY - Cocaine (COC) | 862.3250, Cocaine Test System | Toxicology (91) |
| PTG - 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Methadone (MTD) | 862.3620, Methadone Test System | Toxicology (91) |
Page 8
| Product Code & Target Drug | Regulation Section | Panel |
|---|---|---|
| NGG - Methamphetamine (MET), Methylenedioxymethamphetamine (MDMA) | 862.3610, Methamphetamine Test System | Toxicology (91) |
| LCM - Phencyclidine (PCP) | Unclassified | Toxicology (91) |
| QBF - Propoxyphene (PPX) | 862.3700, Propoxyphene test system. | Toxicology (91) |
| QAW - Nortriptyline (TCA) | 862.3910, Tricyclic antidepressant drugs test system | Toxicology (91) |
| NFW - Cannabinoids (THC) | 862.3870, Cannabinoids Test System | Toxicology (91) |
6. Predicate Device
Product name: Wondfo T-Cup® Multi-Drug Urine Test Cup
510(k) Number: K182701
7. Intended Use
SAFElife™ T-Cup Multi-Drug Urine Test Cup
SAFElife™ T-Cup Multi-Drug Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Fentanyl, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Opiates, Methadone, Norfentanyl, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids and Tramadol in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cutoff Level |
|---|---|
| 6-Monoacetylmorphine (6-MAM) | 10 ng/mL |
| 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 |
| Fentanyl (FTY) | 1 ng/mL |
| Methamphetamine (MET/mAMP) | 1000 ng/mL or 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP) | 300 ng/mL |
| Opiates (OPI) | 2000 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Norfentanyl (NFTY) | 5 ng/mL |
Page 9
| Drug (Identifier) | Cutoff Level |
|---|---|
| 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 or 20 ng/mL |
| Tramadol (TRA) | 100 ng/mL |
SAFElife™ T-Cup Multi-Drug Urine 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.
The tests may yield positive results for the prescription drugs Buprenorphine, Fentanyl, Nortriptyline, Oxazepam, Secobarbital, Oxycodone and Tramadol 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. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the recommended confirmatory method.
SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx
SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Fentanyl, Methylenedioxymethamphetamine, Methamphetamine, Morphine, Opiates, Methadone, Norfentanyl, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids and Tramadol in human urine with below cutoff concentrations and approximate detection time:
| Drug (Identifier) | Calibrator | Cut-off Level |
|---|---|---|
| 6-Monoacetylmorphine (6-MAM) | 6-Monoacetylmorphine | 10 ng/mL |
| Amphetamine (AMP500) | d-Amphetamine | 500 ng/mL |
| Amphetamine (AMP1000) | d-Amphetamine | 1000 ng/mL |
| Secobarbital (BAR) | Secobarbital | 300 ng/mL |
| Buprenorphine (BUP) | Buprenorphine | 10 ng/mL |
| Oxazepam (BZO) | Oxazepam | 300 ng/mL |
| Cocaine (COC150) | Benzoylecgonine | 150 ng/mL |
| Cocaine (COC300) | Benzoylecgonine | 300 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-diphenyl-pyrrolidine | 300 ng/mL |
| Fentanyl (FTY) | Fentanyl | 1 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 3,4-Methylenedioxymethamphetamine | 500 ng/mL |
Page 10
| Drug (Identifier) | Calibrator | Cut-off Level |
|---|---|---|
| Methamphetamine (MET500/mAMP500) | D(+)-Methamphetamine | 500 ng/mL |
| Methamphetamine (MET1000/mAMP1000) | D(+)-Methamphetamine | 1000 ng/mL |
| Morphine (MOP300) | Morphine | 300 ng/mL |
| Opiates (OPI2000) | Morphine | 2000 ng/mL |
| Methadone (MTD) | Methadone | 300 ng/mL |
| Norfentanyl (NFTY) | Norfentanyl | 5 ng/mL |
| Oxycodone (OXY) | Oxycodone | 100 ng/mL |
| Phencyclidine (PCP) | Phencyclidine | 25 ng/mL |
| Propoxyphene (PPX) | d-Propoxyphene | 300 ng/mL |
| Nortriptyline (TCA) | Nortriptyline | 1000 ng/mL |
| Cannabinoids (THC20) | 11-nor-Δ9-THC-9-COOH | 20 ng/mL |
| Cannabinoids (THC50) | 11-nor-Δ9-THC-9-COOH | 50 ng/mL |
| Tramadol (TRA) | Tramadol | 100 ng/mL |
SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx offers any combinations from 1 to 19 drugs of abuse tests with or without on-board adulteration/specimen validity test (SVT) but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use.
The tests may yield positive results for the prescription drugs Buprenorphine, Fentanyl, Nortriptyline, Oxazepam, Secobarbital, Oxycodone and Tramadol 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. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the recommended confirmatory method.
8. Device Description
SAFElife™ T-Cup Multi-Drug Urine Test Cup and SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Opiates, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids, 6-Monoacetylmorphine, Fentanyl, Norfentanyl, and Tramadol in human urine. Each SAFElife™ T-Cup Multi-Drug Urine Test Cup or SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx device consists of a test cup and a package insert. Each test cup is sealed with one sachet of desiccant in an aluminum pouch. SAFElife™ T-Cup Multi-Drug Urine Test Cup and SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx have a general identical design. The SAFElife™ T-Cup Multi-Drug Urine Test Cup is for
Page 11
over-the-counter (OTC) use and the SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx is for professional use.
9. Comparison with Predicate
A summary comparison of features of the candidate device with the predicate device is provided in following table.
Table 1: Features Comparison of SAFElife™ T-Cup Multi-Drug Urine Test Cup and the predicate device
| Item | Candidate Device | Predicate - K182701 |
|---|---|---|
| Device Trade Name | SAFElife™ T-Cup Multi-Drug Urine Test CupSAFElife™ T-Cup Multi-Drug Urine Test Cup Dx | Wondfo T-Cup® Multi-Drug Urine Test Cup |
General Device Similarities
| Item | Candidate Device | Predicate - K182701 |
|---|---|---|
| Indications For Use | Drugs of abuse testing in human urine | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assay based on antigen-antibody reaction | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human urine | Same |
General Device Characteristic Differences
| Analytes and Cutoff | Target Drugs | Cutoff | Same |
|---|---|---|---|
| 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/mAMP) | 1000 ng/mL or 500 ng/mL | ||
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | ||
| Morphine (MOP) | 300 ng/mL | ||
| Opiates (OPI) | 2000 ng/mL | ||
| Methadone (MTD) | 300 ng/mL |
Page 12
| Item | Candidate Device | Predicate - K182701 |
|---|---|---|
| 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 | |
| 6-Monoacetylmorphine (6-MAM) | 10 ng/mL | Not included in K182701 |
| Fentanyl (FTY) | 1 ng/mL | |
| Norfentanyl (NFTY) | 5 ng/mL | |
| Cannabinoids (THC) | 20 ng/mL | |
| Tramadol (TRA) | 100 ng/mL |
10. Test Principle
SAFElife T-Cup Multi-Drug Urine Test Cup is a 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.
11. Performance Characteristics
1. Analytical Performance
Performance data of AMP500/1000, BAR300, BUP10, BZO300, COC150/300, EDDP300, MDMA500, MET500/MET1000, MOP300, MTD300, OPI2000, OXY100, PCP25, PPX300, TCA1000 and THC50 were presented in the 510(k)-cleared submission K182701. In this submission, 6-Monoacetylmorphine (6-MAM10), Fentanyl (FTY1), Norfentanyl (NFTY5), Cannabinoids (THC20), and Tramadol (TRA100) study data are summarized and presented below.
a. Precision/Reproducibility
Precision studies were carried out for samples with concentrations of -100% cutoff, -75% cut off, -50% cutoff, -25% cutoff, cutoff, +25% cutoff, +50% cutoff, +75% cutoff and +100% cutoff. Samples with concentration of -100% cutoff were drug-free urine samples. Other samples were prepared by spiking target drug in drug-free urine samples. Each drug concentration was confirmed by LC/MS or GC/MS. For each concentration, tests were
Page 13
performed two runs per day for 25 days using three lots of test cups. The results of a representative lot are summarized in the following tables:
| Drug | Lot Number | -100% Cutoff | -75% Cutoff | -50% Cutoff | -25% Cutoff | Cutoff | +25% Cutoff | +50% Cutoff | +75% Cutoff | +100% Cutoff |
|---|---|---|---|---|---|---|---|---|---|---|
| 6-MAM 10 | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 1-/49+ | 0-/50+ | 0-/50+ | 0-/50+ |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 25-/25+ | 1-/49+ | 0-/50+ | 0-/50+ | 0-/50+ | |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 26-/24+ | 2-/48+ | 0-/50+ | 0-/50+ | 0-/50+ | |
| FTY1 | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 23-/27+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 24-/26+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 25-/25+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | |
| NFTY5 | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 24-/26+ | 2-/48+ | 0-/50+ | 0-/50+ | 0-/50+ |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 26-/24+ | 1-/49+ | 0-/50+ | 0-/50+ | 0-/50+ | |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 24-/26+ | 1-/49+ | 0-/50+ | 0-/50+ | 0-/50+ | |
| THC20 | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 1-/49+ | 0-/50+ | 0-/50+ | 0-/50+ |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 25-/25+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 23-/27+ | 2-/48+ | 0-/50+ | 0-/50+ | 0-/50+ | |
| TRA100 | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ |
b. Linearity/assay reportable range
Not applicable. This device is intended for qualitative use only.
c. Stability
The devices are stable at 2-30℃ for 24 months based on the real-time stability study data.
d. Analytical specificity
Analytical specificity for this device was determined through adding the potential interfering substances to drug-free urine samples. The relative cross-reactivity represents the minimum concentration necessary to yield a result similar to the cutoff level of the respective assay. Percent cross-reactivity, provided in the below table, was calculated as the concentration of analyte tested that yielded a positive result, divided by the cutoff concentration, 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.
| Drug/Cutoff | Compound | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
|---|---|---|---|
| 6-MAM10 | Heroin | 60 | 16.7% |
| Morphine | 75000 | 0.01% | |
| Normorphine | 150000 | Not detected | |
| Nalorphine HCl | 150000 | Not detected | |
| Hydrocodone | 150000 | Not detected |
Page 14
| Drug/Cutoff | Compound | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
|---|---|---|---|
| Hydromorphone | 150000 | Not detected | |
| Chlordiazepoxide | 150000 | Not detected | |
| Clobazam | 150000 | Not detected | |
| D-Amphetamine | 150000 | Not detected | |
| (±)-Amphetamine | 150000 | Not detected | |
| Levorphanol tartrate | 150000 | Not detected | |
| Codeine | 150000 | Not detected | |
| Ethylmorphine | 150000 | Not detected | |
| Morphine3-β-D-glucuronide | 150000 | Not detected | |
| Norcodeine | 150000 | Not detected | |
| Oxycodone | 150000 | Not detected | |
| Oxymorphone | 150000 | Not detected | |
| Procaine hydrochloride | 150000 | Not detected | |
| Thebaine | 150000 | Not detected | |
| 6-Acetylcodeine | 150000 | Not detected | |
| Buprenorphine | 150000 | Not detected | |
| Dihydrocodeine | 150000 | Not detected | |
| Dextromethorphan | 150000 | Not detected | |
| Imipramine hydrochloride | 150000 | Not detected | |
| Meperidine | 150000 | Not detected | |
| (±)-Methadone | 150000 | Not detected | |
| Mitragynine(kratom) | 150000 | Not detected | |
| Morphine-6-β-D-glucuonide | 150000 | Not detected | |
| Naloxone hydrochloride | 150000 | Not detected | |
| Naltrexone hydrochloride | 150000 | Not detected | |
| Naproxen | 150000 | Not detected | |
| Norbuprenorphine | 150000 | Not detected | |
| Norbuprenorphine glucuronide | 150000 | Not detected | |
| Noroxycodone HCL | 150000 | Not detected | |
| Noroxymorphone HCL | 150000 | Not detected | |
| (+)-Norpropoxyphene maleate | 150000 | Not detected | |
| Oxymorphone-3β-D-glucuronide | 150000 | Not detected | |
| Tapentadol HCl | 150000 | Not detected | |
| Tramadol | 150000 | Not detected | |
| FTY1 | Acetyl fentanyl | 16 | 6.25% |
| Acrylfentanyl | 1 | 100.00% | |
| ω-1-Hydroxyfentanyl | 20,000 | 0.005% | |
| Isobutyryl fentanyl | 1 | 100.00% | |
| Ocfentanil | 2.3 | 43.48% |
Page 15
| Drug/Cutoff | Compound | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
|---|---|---|---|
| Butyryl fentanyl | 2 | 50.00% | |
| Furanyl fentanyl | 1 | 100.00% | |
| Valeryl fentanyl | 2.5 | 40.00% | |
| (±) β-hydroxythiofentanyl | 2.5 | 40.00% | |
| 4-Fluoro-isobutyrylfentanyl | 3 | 33.33% | |
| Para-fluorobutyryl fentanyl | 4 | 25.00% | |
| Para-fluoro fentanyl | 2.5 | 40.00% | |
| (+)-3-cis-methyl fentanyl | 50 | 2.00% | |
| Carfentanil | 2 | 50.00% | |
| Sufentanil | 15 | 6.67% | |
| Alfentanil | 7500 | 0.01% | |
| Despropionyl fentanyl (4-ANPP) | 2,000 | 0.05% | |
| Remifentanil | 150000 | Not detected | |
| Norfentanyl | 150000 | Not detected | |
| Acetyl norfentanyl | 150000 | Not detected | |
| Norcarfentanil | 150000 | Not detected | |
| Trazodone | 25000 | 0.004% | |
| NFTY5 | Fentanyl | 10 | 50% |
| Acetyl fentanyl | 150 | 3.3% | |
| Acetyl Norfentanyl | 200 | 2.5% | |
| （±)-β-Hydroxythiofentanyl HCl | 2500 | 0.2% | |
| Acryl Fentanyl | 2500 | 0.2% | |
| Butyryl Fentanyl | 5000 | 0.1% | |
| Furanyl Fentanyl | 10000 | 0.05% | |
| Para-fluoro butyrl Fentanyl (P-FBF) | 80000 | 0.006% | |
| Para-fluoro Fentanyl | 40000 | 0.013% | |
| 9-HydroxyRisperidone | 10000 | 0.05% | |
| Alfentanil | 20000 | 0.025% | |
| Isobutyryl Fentanyl | 5000 | 0.1% | |
| Remifentanil | 15000 | 0.03% | |
| Valeryl Fentanyl | 20000 | 0.025% | |
| Thienyl Fentanyl | 50 | 10% | |
| (+)-3-cis-methyl fentanyl | 50 | 10% | |
| 4-Fluoro-isobutyryl Fentanyl | 30000 | Not detected | |
| Despropionyl fentanyl (4-ANPP) | 30000 | Not detected | |
| MT-45 diHCL | 150000 | Not detected | |
| Ocfentanil | 150000 | Not detected | |
| Risperidone | 150000 | Not detected |
Page 16
| Drug/Cutoff | Compound | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
|---|---|---|---|
| Sufentanil | 150000 | Not detected | |
| Carfentanil | 150000 | Not detected | |
| Labetalol Hydrochloride | 150000 | Not detected | |
| Trazodone | 150000 | Not detected | |
| U-47700 | 150000 | Not detected | |
| ω-1-Hydroxyfentanyl | 30000 | Not detected | |
| 6-Acetyl morphine | 150000 | Not detected | |
| (±)-Amphetamine | 150000 | Not detected | |
| Buprenorphine | 150000 | Not detected | |
| Buprenorphine-3ß-D-glucuronide | 150000 | Not detected | |
| Codeine | 150000 | Not detected | |
| Dextromethorphan | 150000 | Not detected | |
| Dihydrocodeine | 150000 | Not detected | |
| EDDP | 150000 | Not detected | |
| EMDP | 150000 | Not detected | |
| Fluoxetine | 150000 | Not detected | |
| Heroin | 150000 | Not detected | |
| Hydrocodone | 150000 | Not detected | |
| Hydromorphone | 150000 | Not detected | |
| Ketamine | 150000 | Not detected | |
| Levorphanol tartrate | 150000 | Not detected | |
| Meperidine | 150000 | Not detected | |
| (±)-Methadone | 150000 | Not detected | |
| Morphine | 150000 | Not detected | |
| Morphine-3-β-D-glucuronide | 150000 | Not detected | |
| Naloxone hydrochloride | 150000 | Not detected | |
| Naltrexone hydrochloride | 150000 | Not detected | |
| Norbuprenorphine | 150000 | Not detected | |
| Norcodeine | 150000 | Not detected | |
| Norketamine | 150000 | Not detected | |
| Normeperidine | 150000 | Not detected | |
| Normorphine | 150000 | Not detected | |
| Noroxycodone | 150000 | Not detected | |
| Oxycodone | 150000 | Not detected | |
| Oxymorphone | 150000 | Not detected | |
| Pentazocine (Talwin) | 150000 | Not detected | |
| Pipamperone | 150000 | Not detected | |
| Tapentadol hydrochloride | 150000 | Not detected | |
| Thioridazine | 150000 | Not detected |
Page 17
| Drug/Cutoff | Compound | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
|---|---|---|---|
| Tilidine | 150000 | Not detected | |
| Tramadol | 150000 | Not detected | |
| O-Desmethyl -cris-Tramadol | 150000 | Not detected | |
| N-Desmethyl -cris-Tramadol | 150000 | Not detected | |
| Norcarfentanil | 150000 | Not detected | |
| THC 20 | (−)-11-nor-9-carboxy-Delta8-THC | 20 | 100% |
| (-)-11-Nor-Δ9-THC- 9-carboxylic acid glucuronide | 30 | 66.7% | |
| (±)-11-Hydroxy-Δ9-THC | 20 | 100% | |
| (-)-11-nor-9-carboxy-Δ 9-THC | 20 | 100% | |
| (-)-Δ9-THC | 6000 | 0.3% | |
| (-)-Δ8-THC | 4000 | 0.5% | |
| Cannabinol | 8000 | 0.25% | |
| Cannabidiol | 150000 | Not detected | |
| TRA100 | n-Desmethyl -cris-Tramadol | 400 | 25% |
| o-Desmethyl -cris-Tramadol | 1000 | 10% | |
| o-Desmethyl Venlafaxine | 15000 | Not detected | |
| Venlafaxine HCl | 150000 | Not detected |
e. Interference
Potential interference from compounds chemically dissimilar to the target drugs (6-Monoacetylmorphine (6-MAM10), Fentanyl (FTY1), Norfentanyl (NFTY5), Cannabinoids (THC20), and Tramadol (TRA100)) and from endogenous agents was performed by spiking the substances into pooled urine containing target drugs at near-cutoff concentrations (at +50% and -50% of cutoff). Unless otherwise indicated, substances were tested for potential interference at concentrations of 100 μg/mL.
The following substances demonstrated no positive. The following substances demonstrated no positive or negative interference on the assays encompassed in this submission.
| Acetaminophen | Effexor | Nimodipine |
| Acetophenetidin | Enalapril Maleate | Nitroglycerin |
| Acetylsalicylic Acid | Erythromycin | Norethindrone |
| Acyclovir | Esomeprazole Magnesium | N-Acetylprocainamide |
| Afrin | β-Estradiol | O-Hydroxyhippuric Acid |
| Albumin (100mg/dL) | 1% ethanol | Olanzapine |
| Aminophylline | Fenofibrate | Omeprazole |
| Aminopyrine | Fenoprofen | Oxalic Acid |
| Amiodarone Hydrochloride | Fentanyl Citrate | Oxolinic Acid |
| Amlodipine Mesylate | Fluoxetine Hydrochloride | Oxymetazoline |
| Amoxicillin | Fluvoxamine | Ondansetran |
Page 18
| Ampicillin | Furosemide | Paliperidone |
| Apomorphine | Gabapentin | Pantoprazole |
| Aripiprazole | Gentisic Acid | Papaverine |
| Aspartame | Glibenclamide | Paroxetine Hydrochloride |
| Atomoxetine | Gliclazide | Penfluridol |
| Atorvastatin Calcium | Glipizide | PenicillinV Potassium |
| Atropine | Glucose | Penicillin-G |
| Benzilic Acid | Haloperidol | Phenelzine |
| Benzoic Acid | Hemoglobin | Pioglitazone Hydrochloride |
| Bilirubin | Hydrochlorothiazide | Piracetam |
| Bupropion | Hydrocortisone | Pravastatin Sodium |
| Captopril | 3-Hydroxytyramine | Prednisone |
| Carbamazepine | Isosorbide Dinitrate | Propylthiouracil |
| Cefradine | Isoxsuprine | Quetiapine Fumarate |
| Cephalexin | Ibuprofen | Quinine |
| Chloral Hydrate | Ketoconazole | Ranitidine |
| Chloramphenicol | Ketoprofen | Rifampicin |
| Chlorothiazide | Ketamine | Risperidone |
| Cholesterol | Kratom powder | Salicylic Acid |
| Ciprofloxacin Hydrochloride | Labetalol | Serotonin |
| Citalopram | Lamotrigine | Sertraline Hydrochloride |
| Clarithromycin | Levofloxacin Hydrochloride | Sildenafil Citrate |
| Clonidine | Levonorgestrel | Simvastatin |
| Clopidogrel Hydrogen Sulphate | Levothyroxine Sodium | Sodium Valproate |
| Clozapine | Lidocaine Hydrochloride | Spironolactone |
| Conjugated Estrogens | Lisinopril | Sulfamethazine |
| Cortisone | Lithium Carbonate | Sulindac |
| Creatinine | Liverite | Tetracycline |
| (-) Cotinine | Loperamide | Tetrahydrocortisone 3 -acetate |
| chlorpheniramine | Loratadine | Tetrahydrocortisone 3-(β-D glucuronide) |
| D,L-Octopamine | Magnesium | Tetrahydrozoline |
| D,L-Propranolol | Meperidine | Thiamine |
| D,L-Tyrosine | Meprobamate | Thioridazine |
| Deoxycorticosterone | Metoprolol Tartrate | Topiramate |
| Dextromethorphan | Mifepristone | Tramadol Hydrochloride |
| Diclofenac | Mirtazapine | Trazodone Hydrochloride |
| Diflunisal | Montelukast Sodium | Triamterene |
| Digoxin | Mosapride Citrate | Trifluoperazine |
| Diphenhydramine | Minocycline | Trimethoprim |
Page 19
| Dirithromycin | Nalidixic Acid | Uric Acid |
| Domperidone | Naproxen | Valproate |
| D-Pseudoephedrine | Niacinamide | Verapamil |
| Duloxetine | Nifedipine | Vitamin B2 |
| Dicyclomine | Nikethamide | Vitamin C |
| Chloroquine | Ecgonine Methyl Ester | Promethazine |
f. Urine Density&pH
Interference by pH and specific gravity were also evaluated using pooled urine specimens containing target drugs at near-cutoff concentrations (at +50% and -50% of cutoff). The results demonstrated that pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 do not affect the results of the assays.
2. Method comparison Studies
Comparison Study Performance data of AMP500/1000, BAR300, BUP10, BZO300, COC150/300, EDDP300, MDMA500, MET500/MET1000, MOP300, MTD300, OPI2000, OXY100, PCP25, PPX300, TCA1000 and THC50 were presented in the cleared 510(k) K182701 submission.
In this submission, the method comparison study for 6-Monoacetylmorphine (6-MAM10), Fentanyl (FTY1), Cannabinoids (THC20), Tramadol (TRA100) and Norfentanyl (NFTY5), was performed b three operators with 80 unaltered urine samples. These samples were blind labeled and compared to LC/MS or GC/MS results. The results are shown in the table below.
| Drug | Operator | Results | Drug-free by LC/MS | Low Neg by LC/MS (less than -50%) | Near Cutoff Neg by LC/MS (Between -50% and the Cutoff) | Near Cutoff Pos by LC/MS (Between the cutoff and +50%) | High Pos by LC/MS (greater than +50%) |
|---|---|---|---|---|---|---|---|
| 6-MAM 10 | A | Positive | 0 | 0 | 3 | 21 | 18 |
| Negative | 13 | 14 | 10 | 1 | 0 | ||
| B | Positive | 0 | 0 | 2 | 21 | 18 | |
| Negative | 13 | 14 | 11 | 1 | 0 | ||
| C | Positive | 0 | 0 | 1 | 21 | 18 | |
| Negative | 13 | 14 | 12 | 1 | 0 | ||
| FTY 1 | A | Positive | 0 | 0 | 2 | 21 | 18 |
| Negative | 12 | 16 | 10 | 1 | 0 | ||
| B | Positive | 0 | 0 | 1 | 20 | 18 | |
| Negative | 12 | 16 | 11 | 2 | 0 | ||
| C | Positive | 0 | 0 | 2 | 21 | 18 | |
| Negative | 12 | 16 | 10 | 1 | 0 | ||
| NFTY 5 | A | Positive | 0 | 0 | 3 | 23 | 16 |
| Negative | 10 | 16 | 11 | 1 | 0 |
Page 20
| Drug | Operator | Results | Drug-free by LC/MS | Low Neg by LC/MS (less than -50%) | Near Cutoff Neg by LC/MS (Between -50% and the Cutoff) | Near Cutoff Pos by LC/MS (Between the cutoff and +50%) | High Pos by LC/MS (greater than +50%) |
|---|---|---|---|---|---|---|---|
| B | Positive | 0 | 0 | 2 | 22 | 16 | |
| Negative | 10 | 16 | 12 | 2 | 0 | ||
| C | Positive | 0 | 0 | 2 | 22 | 16 | |
| Negative | 10 | 16 | 12 | 2 | 0 | ||
| THC 20 | A | Positive | 0 | 0 | 2 | 28 | 10 |
| Negative | 9 | 15 | 14 | 2 | 0 | ||
| B | Positive | 0 | 0 | 2 | 29 | 10 | |
| Negative | 9 | 15 | 14 | 1 | 0 | ||
| C | Positive | 0 | 0 | 2 | 28 | 10 | |
| Negative | 9 | 15 | 14 | 2 | 0 | ||
| TRA 100 | A | Positive | 0 | 0 | 2 | 27 | 12 |
| Negative | 10 | 18 | 10 | 1 | 0 | ||
| B | Positive | 0 | 0 | 1 | 27 | 12 | |
| Negative | 10 | 18 | 11 | 1 | 0 | ||
| C | Positive | 0 | 0 | 1 | 27 | 12 | |
| Negative | 10 | 18 | 11 | 1 | 0 |
Discordant Results are summarized below:
| Drug | Operator | Sample Number | LC/MS Results (ng/mL) | Discordant Device Results |
|---|---|---|---|---|
| 6-MAM 10 | Operator A | SU25050045 | 7.867 | Positive |
| Operator A | SU25050057 | 8.193 | Positive | |
| Operator A | SU25050075 | 9.192 | Positive | |
| Operator A | SU25050029 | 10.863 | Negative | |
| Operator B | SU25050057 | 8.193 | Positive | |
| Operator B | SU25050075 | 9.192 | Positive | |
| Operator B | SU25050074 | 10.359 | Negative | |
| Operator C | SU25050075 | 9.192 | Positive | |
| Operator C | SU25050074 | 10.359 | Negative | |
| FTY 1 | Operator A | SU25050271 | 0.848 | Positive |
| Operator A | SU25050284 | 0.965 | Positive | |
| Operator A | SU25050249 | 1.136 | Negative | |
| Operator B | SU25050284 | 0.965 | Positive | |
| Operator B | SU25050249 | 1.136 | Negative | |
| Operator B | SU25050270 | 1.184 | Negative | |
| Operator C | SU25050271 | 0.848 | Positive | |
| Operator C | SU25050284 | 0.965 | Positive | |
| Operator C | SU25050270 | 1.184 | Negative | |
| NFTY 5 | Operator A | SU25060042 | 4.315 | Positive |
| Operator A | SU25060030 | 4.765 | Positive | |
| Operator A | SU25060011 | 4.879 | Positive | |
| Operator A | SU25060065 | 5.341 | Negative | |
| Operator B | SU25060030 | 4.765 | Positive |
Page 21
| Drug | Operator | Sample Number | LC/MS Results (ng/mL) | Discordant Device Results |
|---|---|---|---|---|
| Operator B | SU25060011 | 4.879 | Positive | |
| Operator B | SU25060075 | 5.526 | Negative | |
| Operator B | SU25060073 | 5.699 | Negative | |
| Operator C | SU25060042 | 4.315 | Positive | |
| Operator C | SU25060011 | 4.879 | Positive | |
| Operator C | SU25060065 | 5.341 | Negative | |
| Operator C | SU25060073 | 5.699 | Negative | |
| THC 20 | Operator A | SU25050194 | 18.614 | Positive |
| Operator A | SU25050181 | 19.363 | Positive | |
| Operator A | SU25050167 | 20.499 | Negative | |
| Operator A | SU25050220 | 20.645 | Negative | |
| Operator B | SU25050194 | 18.614 | Positive | |
| Operator B | SU25050181 | 19.363 | Positive | |
| Operator B | SU25050167 | 20.499 | Negative | |
| Operator C | SU25050185 | 18.422 | Positive | |
| Operator C | SU25050181 | 19.363 | Positive | |
| Operator C | SU25050220 | 20.645 | Negative | |
| Operator C | SU25050230 | 21.541 | Negative | |
| TRA 100 | Operator A | SU25050130 | 98.136 | Positive |
| Operator A | SU25050098 | 98.772 | Positive | |
| Operator A | SU25050120 | 102.471 | Negative | |
| Operator B | SU25050130 | 98.136 | Positive | |
| Operator B | SU25050144 | 108.094 | Negative | |
| Operator C | SU25050098 | 98.772 | Positive | |
| Operator C | SU25050120 | 102.471 | Negative |
3. Lay-user study
A lay user study was presented in the cleared 510(k) K182701 submission involving a total of 280 participants from 3 sites. 89 males and 51 females tested T-Cup® Multi-Drug Urine Test Cup Configuration 1 (including AMP 500, BAR 300, BUP 10, BZO 300, COC 150, EDDP 300, MDMA 500, MET 500, MOP 300, MTD 300, OXY 100, PCP 25, PPX 300, TCA 1000, THC 50); 84 male and 56 females tested T-Cup® Multi-Drug Urine Test Cup Configuration 2 (Group 2, including AMP 1000, BAR 300, BUP 10, COC 300, EDDP 300, MDMA 500, MET 1000, OPI 2000, MTDD 300, OXY 100, PCP 25, PPX 300, TCA 1000, THC 50).
In this submission, a lay user study was performed involving a total of 140 participants from 3 sites. 76 males and 64 females tested one configuration of SAFElife™ T-Cup Multi-Drug Urine Test Cup (including 6-MAM10, THC20, TRA100, NFTY5, FTY1, and AMP1000, BAR300, BUP10, BZO300, COC300, mAMP1000, MDMA500, MTD300, OPI2000, OXY100). Each participant was provided one package insert, one blind labeled test solution, and one test device. Test solutions were randomly assigned to participants, one for each.
Page 22
Following testing, users completed a study questionnaire to assess usability and user comprehension, and the results from this questionnaire were found to be acceptable. Participants aged 18 and over, with diverse educational backgrounds, were recruited. Results from the lay user testing are provided in the below table:
| Drug/ Cutoff | Result | Concentration | ||||||
|---|---|---|---|---|---|---|---|---|
| -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff | ||
| 6-MAM10 | 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% | |
| AMP1000 | 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% | |
| BAR300 | 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% | |
| BUP10 | 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% | |
| BZO300 | 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% | |
| COC300 | 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% | |
| FTY1 | 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% | |
| mAMP 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% | |
| MDMA500 | 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% |
Page 23
| Drug/ Cutoff | Result | Concentration | ||||||
|---|---|---|---|---|---|---|---|---|
| -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff | ||
| MTD300 | 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% | |
| NFTY5 | 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% | |
| OPI2000 | 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% | |
| OXY100 | 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% | |
| THC20 | 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% | |
| TRA100 | 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 users completed given surveys on the ease of understanding the package insert. 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.
4. Clinical Study
Not applicable.
12. Conclusion
Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison and Lay-user studies of the devices, it's concluded a substantial equivalence decision.
§ 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).