(24 days)
No.
The device is a lateral flow immunochromatographic assay for qualitative detection of drugs in urine, which does not involve AI models.
No.
This device is an in vitro diagnostic (IVD) test used to detect various drugs in human urine, providing preliminary results and is not designed for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is for in vitro diagnostic use only."
No
The device is described as an "immunochromatographic assay" using a "lateral flow system" in a "cup format." This clearly indicates it is a physical, hardware-based diagnostic device for in vitro use, not a software-only medical device.
Yes.
The "Intended Use / Indications for Use" section explicitly states "It is for in vitro diagnostic use only."
N/A
Intended Use / Indications for Use
AllTest Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine 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 |
| Benzodiazepine (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL or 300 ng/mL |
| Methamphetamine (MET) | 500 ng/mL or 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP/OPI) | 300 ng/mL or 2000 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
| Fentanyl(FYL) | 1 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Tramadol (TRA) | 100 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| 6-monoacetylmorphine (6-MAM) | 10 ng/mL |
AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
AllTest Multi-Drug Rapid Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of:
| Drug (Identifier) | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 500 or 1000 |
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Secobarbital (BAR) | Secobarbital | 300 |
| Benzodiazepine (BZO) | Oxazepam | 300 |
| Cocaine (COC) | Benzoylecgonine | 150 or 300 |
| Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 |
| Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 |
| Morphine (MOP/OPI) | Morphine | 300 or 2000 |
| Methadone (MTD) | Methadone | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Nortriptyline (TCA) | Nortriptyline | 1000 |
| Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 50 |
| Fentanyl (FYL) | Fentanyl | 1 |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 |
| Tramadol (TRA) | Tramadol | 100 |
| Propoxyphene (PPX) | Propoxyphene | 300 |
| 6-monoacetylmorphine (6-MAM) | 6-monoacetylmorphine | 10 |
AllTest Multi-Drug Rapid Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.
The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
Product codes (comma separated list FDA assigned to the subject device)
NFT, PTH, NGL, NFV, NFY, PTG, NGG, QBF, NGM, QAW, NFW
Device Description
AllTest Multi-Drug Urine Test Cup and AllTest Multi-Drug Rapid Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
OTC use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision/Reproducibility:
Precision studies were carried out for samples with concentrations of +100% cutoff, +75% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cut off and -100% cutoff. Other samples were prepared by spiked target drug in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test cups.
The results are summarized in tables for Amphetamine (AMP 1000), Benzoylecgonine (COC 300), Methamphetamine (MET 1000), Morphine (OPI/MOP 2000), 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Tramadol (TRA), Propoxyphene (PPX) and 6-monoacetylmorphine (6-MAM). The precision for the remaining analytes is supported by data in the previously cleared submission K241428.
Stability:
The device is stable at 2-30℃ for 24 months based on real time stability study.
Analytical specificity/Interference:
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 the device. The results obtained are summarized in the tables for Amphetamine (AMP 1000), Benzoylecgonine (COC 300), Methamphetamine (MET 1000), Morphine (OPI/MOP 2000), 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Tramadol (TRA), Propoxyphene (PPX) and 6-monoacetylmorphine (6-MAM). The specificity for the remaining analytes is supported by data in the previously cleared submission K241428.
Interference by pH and specific gravity were also evaluated using pooled urine specimens with concentrations of 0 (drug-free), at 50% below and 50% above each corresponding 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.
Method comparison study:
The method comparison studies for the device were performed in-house with three operators. Operators ran 80 (40 negative and 40 positive) unaltered urine clinical samples for each drug. The samples were blind labeled and compared to LC-MS/MS results. The results are presented in the table for Amphetamine (AMP 1000), Benzoylecgonine (COC 300), Methamphetamine (MET 1000), Morphine (OPI/MOP 2000), 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Tramadol (TRA), Propoxyphene (PPX) and 6-monoacetylmorphine (6-MAM). The method comparison for the remaining analytes is supported by data in the previously cleared submission K241428.
Lay person study:
A lay user study was performed at three intended user sites with 280 lay persons. 117 male and 163 female tested AllTest Multi-Drug Urine Test Cup. They had diverse educational and professional backgrounds and their age range from 20 to > 50. Urine samples were 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/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized in tables for Configuration 1 and Configuration 2.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Performance metrics are described in terms of agreement percentage for the lay person study and positive/negative counts for precision and method comparison studies rather than traditional sensitivity/specificity/PPV/NPV.)
Predicate Device(s)
AllTest Multi-Drug Rapid Test Cup (K244043)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
U.S. Food & Drug Administration FDA 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 4, 2025
Hangzhou Alltest Biotech Co.,Ltd
℅ Jenny Xia
Director
LSI International Inc
504E Diamond Ave., Suite H
Gaithersburg, Maryland 20877
Re: K250727
Trade/Device Name: AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine 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, QBF, NGM, QAW, NFW
Dated: March 9, 2025
Received: March 11, 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.
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
K250727 - 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
K250727 - 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: 2025.04.04 07:32:33 -04'00'
Joseph Kotarek, Ph.D.
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 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): K250727
Device Name: AllTest Multi-Drug Urine Test Cup; AllTest Multi-Drug Rapid Urine Test Cup
Indications for Use (Describe)
AllTest Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine 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 |
| Benzodiazepine (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL or 300 ng/mL |
| Methamphetamine (MET) | 500 ng/mL or 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP/OPI) | 300 ng/mL or 2000 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
| Fentanyl(FYL) | 1 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Tramadol (TRA) | 100 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| 6-monoacetylmorphine (6-MAM) | 10 ng/mL |
AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
AllTest Multi-Drug Rapid Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of:
| Drug (Identifier) | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 500 or 1000 |
Page 5
FORM FDA 3881 (8/23) Page 2 of 2
| Drug (Identifier) | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Secobarbital (BAR) | Secobarbital | 300 |
| Benzodiazepine (BZO) | Oxazepam | 300 |
| Cocaine (COC) | Benzoylecgonine | 150 or 300 |
| Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 |
| Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 |
| Morphine (MOP/OPI) | Morphine | 300 or 2000 |
| Methadone (MTD) | Methadone | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Nortriptyline (TCA) | Nortriptyline | 1000 |
| Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 50 |
| Fentanyl (FYL) | Fentanyl | 1 |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 |
| Tramadol (TRA) | Tramadol | 100 |
| Propoxyphene (PPX) | Propoxyphene | 300 |
| 6-monoacetylmorphine (6-MAM) | 6-monoacetylmorphine | 10 |
AllTest Multi-Drug Rapid Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.
The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☒ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Page 6
510(k) SUMMARY
-
Date: March 26, 2025
-
Submitter: Hangzhou AllTest Biotech Co., Ltd.
Plant Bldg. 3, 4, 5, No. 550 Yinhai Street, Baiyang
Street, Hangzhou ETDZ, Jianggan District -
Contact person: Jenny Xia
LSI International Inc.
504 East Diamond Ave., Suite H
Gaithersburg, MD 20877
Telephone: 301-525-6856
Email: jxia@lsi-consulting.org -
Device Name: AllTest Multi-Drug Urine Test Cup
AllTest Multi-Drug Rapid Urine Test Cup -
Classification: Class II
| Product Code | Target Drug | Regulation Section | Panel |
|---|---|---|---|
| NFT | Amphetamine (AMP) | 862.3100, Amphetamine Test System | Toxicology |
| PTH | Secobarbital (BAR) | 862.3150, Barbiturate Test System | Toxicology |
| NGL | Buprenorphine (BUP), Fentanyl (FYL), Morphine (MOP/OPI), Oxycodone (OXY), 6-Monoacetylmorphine(6-MAM), Tramadol (TML) | 862.3650, Opiate Test System | Toxicology |
| NFV | Oxazepam (BZO) | 862.3170, Benzodiazepine Test System | Toxicology |
| NFY | Cocaine (COC) | 862.3250, Cocaine and cocaine metabolite test system | Toxicology |
| PTG | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Methadone (MTD) | 862.3620, Methadone Test System | Toxicology |
| NGG | Methylenedioxymethamphetamine (MDMA), Methamphetamine (MET) | 862.3610, Methamphetamine Test System | Toxicology |
| QBF | Propoxyphene(PPX) | 862.3700 Propoxyphene test system. | Toxicology |
| NGM | Phencyclidine (PCP) | Unclassified | Toxicology |
Page 7
| Product Code | Target Drug | Regulation Section | Panel |
|---|---|---|---|
| QAW | Nortriptyline (TCA) | 862.3910 Tricyclic antidepressant drugs test system | Toxicology |
| NFW | Cannabinoids (THC) | 862.3870, Cannabinoids Test System | Toxicology |
-
Predicate Devices:
AllTest Multi-Drug Rapid Test Cup (K244043) -
Intended Use
AllTest Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off |
|---|---|
| Amphetamine (AMP) | 500 ng/mL or 1000 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Benzodiazepine (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL or 300 ng/mL |
| Methamphetamine (MET) | 500 ng/mL or 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP/OPI) | 300 ng/mL or 2000 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
| Fentanyl (FYL) | 1 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Tramadol (TRA) | 100 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| 6-monoacetylmorphine (6-MAM) | 10 ng/mL |
AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may yield positive results for the prescription drugs 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.
Page 8
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.
AllTest Multi-Drug Rapid Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of:
| Drug (Identifier) | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 500 or 1000 |
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Secobarbital (BAR) | Secobarbital | 300 |
| Benzodiazepine (BZO) | Oxazepam | 300 |
| Cocaine (COC) | Benzoylecgonine | 150 or 300 |
| Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 |
| Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 |
| Morphine (MOP/OPI) | Morphine | 300 or 2000 |
| Methadone (MTD) | Methadone | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Nortriptyline (TCA) | Nortriptyline | 1000 |
| Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 50 |
| Fentanyl (FYL) | Fentanyl | 1 |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 |
| Tramadol (TRA) | Tramadol | 100 |
| Propoxyphene (PPX) | Propoxyphene | 300 |
| 6-monoacetylmorphine (6-MAM) | 6-monoacetylmorphine | 10 |
AllTest Multi-Drug Rapid Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.
The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
- Device Description
AllTest Multi-Drug Urine Test Cup and AllTest Multi-Drug Rapid Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
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The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format.
- Substantial Equivalence Information
Similarities
| Item | Device | Predicate (K244043) |
|---|---|---|
| Intended use | Qualitative detection of drugs of abuse in urine. For 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 Drugs Cutoff (ng/mL) Same | |
| Amphetamine(AMP) 1000 or 500 | ||
| Secobarbital (BAR) 300 | ||
| Buprenorphine (BUP) 10 | ||
| Oxazepam (BZO) 300 | ||
| Cocaine (COC) 150 or 300 | ||
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 | ||
| Methylenedioxymethamphetamine (MDMA) 500 | ||
| Methamphetamine (MET) 1000 or 500 | ||
| Morphine (MOP300/OPI2000) 2000 or 300 | ||
| Methadone (MTD) 300 | ||
| Oxycodone (OXY) 100 | ||
| Phencyclidine (PCP) 25 | ||
| Propoxyphene(PPX) 300 | ||
| Nortriptyline (TCA) 1000 | ||
| Cannabinoids (THC) 50 | ||
| 6-Monoacetylmorphine(6-MAM) 10 | ||
| Fentanyl (FYL) 1 | ||
| Tramadol (TRA) 100 | Same | |
| Configurations | Test cup | Cup |
| Test Strips | MET, AMP, MOP/OPI, and TCA strips differ | MET, AMP, MOP/OPI, and TCA strips |
- Standard/Guidance Document Reference (if applicable)
None referenced.
- Test Principle
AllTest Multi-Drug Rapid Urine Test Cup or AllTest Multi-Drug Urine Test Cup is a competitive
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immunoassay that is used to screen for the presence of various drugs and drug metabolites in urine. It is chromatographic absorbent device in which, drugs within a urine sample, competitively combined to a limited number of drug monoclonal antibody (mouse) conjugate binding sites.
When the test is activated, the urine is absorbed into each test strip by capillary action, mixes with the respective drug monoclonal antibody conjugate, and flows across a pre-coated membrane. When drug within the urine sample is below the detection level of the test, respective drug monoclonal antibody conjugate binds to the respective drug-protein conjugate immobilized in the Test Region (T) of the test strip. This produces a colored Test line in the Test Region (T) of the strip, which, regardless of its intensity, indicates a negative test result.
When sample drug levels are at or above the detection level of the test, the free drug in the sample binds to the respective drug monoclonal antibody conjugate, preventing the respective drug monoclonal antibody conjugate from binding to the respective drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result.
To serve as a procedure control, a colored line will appear at the Control Region (C) of each strip, if the test has been performed properly.
- Performance Characteristics
A. Analytical performance
a. Precision/Reproducibility:
Precision studies were carried out for samples with concentrations of +100% cutoff, +75% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cut off and -100% cutoff. Other samples were prepared by spiked target drug in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test cups. The results obtained are summarized in the following table for Amphetamine (AMP 1000), Benzoylecgonine (COC 300), Methamphetamine (MET 1000), Morphine (OPI/MOP 2000), 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Tramadol (TRA), Propoxyphene (PPX) and 6-monoacetylmorphine (6-MAM). The precision for the remaining analytes is supported by data in the previously cleared submission K241428.
MOP 2000
| Concentration (ng/mL) | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot Number | 4211.662 | 3462.759 | 3030.531 | 2431.941 | 2132.487 | 1511.933 | 1015.242 | 515.108 | 0.000 |
| Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
EDDP
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| Concentration (ng/mL) | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot Number | 587.020 | 517.618 | 487.965 | 355.764 | 294.641 | 223.848 | 157.757 | 81.993 | 0.000 |
| Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 21-/29+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
COC 300
| Concentration (ng/mL) | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot Number | 609.678 | 515.747 | 451.622 | 376.434 | 299.386 | 232.496 | 149.316 | 81.012 | 0.000 |
| Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 21-/29+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
TRA
| Concentration (ng/mL) | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot Number | 204.718 | 169.671 | 149.969 | 129.661 | 97.564 | 74.650 | 47.592 | 26.174 | 0.000 |
| Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 21-/29+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
PPX
| Concentration (ng/mL) | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot Number | 558.684 | 559.396 | 472.685 | 352.338 | 311.349 | 206.969 | 158.805 | 69.773 | 0.000 |
| Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 21-/29+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 21-/29+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
AMP 1000
| Concentration (ng/mL) | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot Number | 2025.713 | 1760.840 | 1497.784 | 1226.200 | 1063.069 | 739.120 | 487.230 | 250.343 | 0.000 |
| Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
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MET 1000
| Concentration (ng/mL) | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot Number | 1976.054 | 1710.253 | 1592.753 | 1244.352 | 1072.277 | 702.076 | 486.231 | 242.057 | 0.000 |
| Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 21-/29+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 20-/30+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
6-MAM
| Concentration (ng/mL) | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot Number | 21.827 | 16.871 | 15.734 | 12.237 | 10.188 | 7.566 | 4.659 | 2.503 | 0.000 |
| Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
b. Linearity/assay reportable range:
Not applicable. This device is intended for qualitative use only.
c. Stability:
The device is stable at 2-30℃ for 24 months based on real time stability study.
d. Analytical specificity/Interference:
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 the device. The results obtained are summarized in the following table for Amphetamine (AMP 1000), Benzoylecgonine (COC 300), Methamphetamine (MET 1000), Morphine (OPI/MOP 2000), 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Tramadol (TRA), Propoxyphene (PPX) and 6-monoacetylmorphine (6-MAM). The specificity for the remaining analytes is supported by data in the previously cleared submission K241428.
Percent cross-reactivity, provided in the below table, was calculated as the cutoff concentration divided by the concentration of analyte tested that yielded a positive result, multiplied by 100.
| Drug/Cutoff | Compound | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
|---|---|---|---|
| MOP 2000 | Morphine | 2000 | 100% |
| Codeine | 5000 | 40% | |
| Codeine-6-β-D-glucuronide | >100000 | 100000 |
Result of AllTest Multi-Drug Urine Test Cup: Configuration 1
| Drug | Cutoff (ng/mL) | Results | Concentration |
|---|---|---|---|
| -100% cutoff | |||
| AMP | 1000 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| BAR | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% |
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| Drug | Cutoff (ng/mL) | Results | Concentration |
|---|---|---|---|
| -100% cutoff | |||
| BZO | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| BUP | 10 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| COC | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| MDMA | 500 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| MET | 1000 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| MOP | 2000 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| MTD | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| OXY | 100 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| PCP | 25 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| TCA | 1000 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| THC | 50 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| FYL | 1 | Negative | 20 |
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| Drug | Cutoff (ng/mL) | Results | Concentration |
|---|---|---|---|
| -100% cutoff | |||
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| 6-MAM | 10 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| TRA | 100 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| PPX | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| EDDP | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% |
Result of AllTest Multi-Drug Urine Test Cup: Configuration 2
| Drug | Cutoff (ng/mL) | Results | Concentration |
|---|---|---|---|
| -100% cutoff | |||
| AMP | 500 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| BAR | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| BZO | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| BUP | 10 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| COC | 150 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| MDMA | 500 | Negative | 20 |
Page 23
| Drug | Cutoff (ng/mL) | Results | Concentration |
|---|---|---|---|
| -100% cutoff | |||
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| MET | 500 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| MOP | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| MTD | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| OXY | 100 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| PCP | 25 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| TCA | 1000 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| THC | 50 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| FYL | 1 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| 6-MAM | 10 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| TRA | 100 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| PPX | 300 | Negative | 20 |
| Positive | 0 |
Page 24
| Drug | Cutoff (ng/mL) | Results | Concentration |
|---|---|---|---|
| -100% cutoff | |||
| Total | 20 | ||
| Agreement (%) | 100% | ||
| EDDP | 300 | Negative | 20 |
| Positive | 0 | ||
| Total | 20 | ||
| Agreement (%) | 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 AllTest Multi-Drug Rapid Urine Test Cup and AllTest Multi-Drug Urine Test Cup are substantially equivalent to the predicate device.